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Judgment
V. Dhanapalan, J.—Heard Mr. G. Masilamani, learned Senior Counsel appearing for Mr. C. Mohan, Learned Counsel for the Petitioner
and Mr. S. Haja Mohideen Gisthi, learned Senior Central Government Standing Counsel appearing for the Respondents.
Challenging the Notification dated 10.02.2011 issued by the 1st Respondent in GSR No. 82 (E) published in Gazette of India Extraordinary
Part--II Section 3--Sub-section (i), seeking to quash the same in so far as it relates to Item No. 3 viz., Phenylpropanolamine with a direction to the
Respondents to review the prohibition after giving an opportunity to him, the Petitioner has come up with the present writ petition.
Facts, in a nutshell run thus:
3(i). Chemical, Industrial & Pharmaceutical Laboratories of India, popularly known as CIPLA, the Petitioner herein, was formed in the year 1935.
It is among the largest pharmaceutical Companies in India with a gross annual turnover of more than Rs. 5,000 crores per annum. In the year
1952, a research division was set up by the Petitioner with the view to attain self-sufficiency in technological development and since then, the
Petitioner has been progressing steadily in pharmaceutical, medicinal and drug development fields. At present, the Petitioner has 31 world-class
manufacturing facilities spread across the country with dedicated plants for oncology products, hormones, inhalers, carbapenems and
cephlosporins among others. The various manufacturing facilities of the Petitioner have been approved by several regulatory authorities, (both
national and international) including:
(i) Food and Drug Administration (FDA), USA;
(ii) Medicines and Healthcare Products Regulatory Agency (MHRA), UK;
(iii)Therapeutic Goods Administration (TGA), Australia;
(iv) Medicines Control Council (MCC), South Africa;
(v) National Institute of Pharmacy (NIP), Hungary;
(vi) Pharmaceutical Inspection Convention (PIC),Germany;
(vii) World Health Organisation (WHO);
(viii) Department of Health, Canada;
(ix) State Institute for the Control of Drugs, Solvak Republic and
(x) ANVISA, Brazil.
3 (ii). According to the Petitioner, their Active Pharmaceutical Ingredients (API) manufacturing plants are amongst the most sophisticated plants in
the world, capable of complex multi-storage synthesis producing over 120 API''s from high potency actives in grams to those made in several
tonnes. The Petitioner produces one of the widest range of products and dosage forms in the world today including metered-dose inhalers, pre-
filled syringes, trans-dermal spray patches, lyophilized injections, nasal sprays, medical devices and thermolabile foams. The Petitioner was the first
company in the world to offer the Triple drug AIDS cocktail for less than $1 a day to patients in several countries. In fact, one out of every three
patients in Africa suffering from HIV AIDS, who are under treatment, are using the drugs/medicines manufactured by the Petitioner.
3(iii). The Petitioner would submit that Phenylpropanolamine (for short ''PPA'') is a synthetic sympathomimetic amine, which is commonly used in
cough and cold preparations and is also used as a nasal decongestant and respirator. The Petitioner has been selling products with PPA for the last
20 years and the products containing PPA have been duly approved by the relevant authorities under the Drugs and Cosmetics Act, 1940
(hereinafter referred to as the ''Act'') without any objection or complaint of after/side adverse effects. PPA is openly sold in USA, UK, Japan and
in neighbouring Asian countries and the ban on the sales of products containing PPA with immediate effect is completely illegal, unlawful and
contrary to law. The proposal for the ban of the said drug ought not to have been kept as closely guarded secret, but it should have been
transparent and all the stake-holders ought to have been consulted and considered, as the drug is openly available in most countries of the world
on prescription or over the counter. It is noteworthy that PPA has been in the world market since more than 50 years and in the Indian market
since 20 years.
3(iv). The impugned notification of the Government claims that the Government is satisfied that there are risks in the use of PPA and that safer
alternatives are available. Whether the alleged alternatives are available and if so whether they are efficacious or risky is an issue which requires
consultation and debate. Further, it is not disclosed, what risk was involved and what was the reliable and proven evidence or report which
deserve acceptance unquestionably. Such a consultation having not been done, the so called satisfaction of the Government is completely
misplaced and unsupported by proven or recorded evidence. For any pharmaceutical company to make available alternate drugs, minimum time
gap of six months is required considering the time consumed in preparation of new formulations, packaging preparations, approvals by the
authorities under the Act, etc. and also the time consumed in development, analysis, stability studies, etc. Thus, the immediate ban is drastic
especially when hundreds of crores of worth formulations are lying distributed in more than about four lakh retail drug shops in the country and it is
practically very difficult to withdraw the products besides the huge loss that will be caused to manufacturers. It would also result in denial of access
to medicines to patients across the country and to consumers who have been using PPA products regularly.
3(v). In the pharmaceutical industry, it is a well known fact that there is a complete cycle which is established from the procurement of raw material
till the sale to the patients. The manufacturing and sale involves preparation of various formulations, manufacturing processes under stringent
conditions, preparation of packaging like strips, bottles, cartons, blister packs, etc. The products are thereafter distributed through super-stockists,
stockists, pharmacists, chemists, hospitals, healthcare centres across the country. Any immediate ban which is resulting in overnight withdrawal of
products from all these parties across the supply chain is not only drastic, but also results in huge losses for all the enterprises involved, as also a
complete and immediate denial of this medicine to the patients. Moreover, immediate withdrawal of drugs which are manufactured under stringent
manufacturing conditions and quality standards of companies like the Petitioner, would also result in patients exposed to medicines which are non-
standard, spurious, adulterated or mis-branded. Patients may also be forced to take recourse to various other remedies which may not be equally
efficacious and also harmful for the health of the public.
3(vi). The ban on PPA without any reported side effects in India is completely un-thought of inasmuch as the drug PPA which is in use for the last
20 years does not have any reported side effects. The Petitioner, being a well known pharmaceutical company, if any report of side effects had
been known to it, would have immediately notified the Government of the same. The fact that several established manufacturers of pharmaceutical
preparations sell formulations with PPA as an ingredient without any reported side effects establishes that there was no requirement to ban PPA in
India. The ban is per se illegal, unlawful and is liable to quashed immediately.
3(vii). The impugned notification dated 10.02.2011 came into the public domain only after 14.02.2011 and the Respondents prohibited the
manufacture, sale and distribution of six drugs including PPA and its formulations for human use, which is violative of the Petitioner''s Fundamental
Rights.
3(viii). Referring to the Act and Rules, the Petitioner would submit that a very elaborate and stringent procedure has been prescribed for the
purposes of ensuring that the powers conferred on the Central Government under the Act inter-alia u/s 26A is not misused and is not exercised in
an arbitrary and irrational manner. The said Act provides for the constitution of a Drugs Technical Advisory Board u/s 5. Further, u/s 7 of the Act,
the Central Government is also to be advised by a Drugs Consultative Committee on any matter tending to secure uniformity throughout India in
the administration of the Act. The constitution of these expert bodies have been provided to enable the Government to receive informed advice so
that the satisfaction of the Government warranting the exercise of drastic powers under the Act is based on relevant considerations and on the
basis of materials generated from and deliberated upon by the experts in the relevant field. 3(ix). Without prejudice to what has been stated
hereinabove, the Petitioner would submit that the consultation with the duly constituted Technical Board is a sine-qua-non before the exercise of
power u/s 26A. In the absence of such consideration/consultation, the action of the Respondent/Union of India would be wholly vitiated, especially
when the Union of India has no technical skill and competence within specialized field of science, without jurisdiction and would deserve to be
struck down and quashed on this ground alone. It is important to note that in a batch of writ petitions filed by the Drug Action Forum and others
the Supreme Court had noted and recorded the Respondent/Union of India''s statement that the Drugs Technical Advisory Board (for short
''DTAB'') shall meet at least once in six months and the Expert committee shall meet atleast once in two months. In that context, the Supreme
Court disposed of a batch of writ petitions with the direction that ""If the Petitioners or any other body or undertaking has/have any suggestion to
make with regard to any of the drug formulations, they will be at liberty to send the suggestions or the representation to the DTAB which shall
consider the same as expeditiously as possible and if possible in the next meeting.
3(ix). In the present case, the Petitioner believes and has learnt that before the issuance of the impugned notification, there has been no mandatory
consultation whatsoever with the DTAB or the Expert Committee under the Act and on that ground alone, the impugned notification deserves to
be quashed. The Respondent Union of India has also not invited suggestions or representations from the stake-holders for consideration of the
Board or the Committees. According to the Petitioner, there is no Board in existence since February 2010. u/s 5 of the Act, the tenure of the
Board constituted thereunder is only for a period of 3 years. The Board, u/s 5 of the Act, was last constituted, vide notification dated 02.02.2007
and the tenure of the aforesaid Board would have expired on 02.02.2010 in accordance with Section 5 of the Act. It is the case of the Petitioner
that the impugned notification is not only ultra-vires the Act, but is clearly and completely vitiated on account of non-application of mind.
3(x). The Petitioner has referred to Sub-rule (b) of Rule 74 of the Drugs and Cosmetics Rules, 1945, which clearly provides that ""the licencee shall
comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently
made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come into force, four
months after publication in the Official Gazette."" and also, for the violation of the provisions of Section 26A of the Act is punishable u/s 28B of the
Act with imprisonment and fine. Considering such scheme of the Act, it is improbable that the Legislature ever intended that a ban can be imposed
with immediate effect especially when the decision making process has not been notified to all the stake-holders. Furthermore, the stocks on hand
of the manufacturers can by itself expose the parties to criminal actions. It is a statutory obligation of the Central Government specifically
incorporated in the Act itself that while taking a decision in imposing any prohibition/restriction under the Act, the entitlements/obligations
respectively which have come into existence thereby also creating vested rights, should always be suitably provided for in any subsequent policy.
3(xi). The sudden ban of the use of the drug in the formulation, shall result in exposing the Petitioner to criminal prosecution u/s 18(vi) read with
Section 28-B of the Act, for no fault of their own. Further, the ban order cannot be implemented or enforced overnight. The products containing
the prohibited drug has gone into the hands of more than 4 lakh retail outlets located across the length and width of this vast country, over whom
the Petitioner has no direct control. Hence, the enforcement of the ban order is beyond the control and capability of the Petitioner.
Respondents have filed counter affidavit stating as follows:
4(i). The notification GSR 82(E) dated 10.02.2011 was issued by the Central Government prohibiting certain drugs in public interest on the
recommendations of the Expert Committees constituted for that purpose. The notification u/s 26-A is issued by the Central Government on
satisfaction that it is necessary and expedient to prohibit the manufacture, sale and distribution of certain drugs in public interest. The drugs for
which harmful effects are reported in the published literature or in the media or if therapeutic justification is considered inadequate in the context of
current medical evidence, are examined by Expert Committees on a continuous basis. The use of the drug is assessed on the basis of available
technical information benefit ratio-risk ratio, local needs and availability of safer alternatives etc. The action to prohibit the drug is taken by the
Government on the basis of the recommendations of the Expert Committee set up to examine issues relating to safety and effectiveness of the drug.
The drugs which were earlier examined by the Expert Committee could be further reviewed depending upon the fresh scientific facts coming into
knowledge, requiring fresh examination.
4(ii). The Central Government has prohibited the drug Phenylpropanoalmine (PPA) in public interest on the recommendations of the Expert
Committee, as its continued use is associated with harmful effects. The safety of the drug formulations presently permitted to be marketed in the
country are examined by the Expert Committee in the context of the present scientific knowledge about the use of the drug and the risk associated
with use. In case, it is found that the risks now considered to be associated with the use of the drug, outweighs the benefit accrued from the drug
and safer alternatives are available, it is considered in public interest to prohibit the use of the drug u/s 26A. The Central Government has acted in
public interest and in powers vested to it under the Act to prohibit the drugs which have been considered as likely to involve risk to human beings
and whereas, safer alternatives to the drug are available. u/s 26A, there is no provision for issuance of any prior notice before banning of a drug. It
gives power to the Central Government to ban a drug upon its satisfaction that the drug is likely to cause risk and harm to the public. The
contention of the Petitioner that the drug which is in use for many years cannot be banned, is untenable in view of the reasons mentioned herein.
4(iii). PPA is a stimulant, decongestant and anorectic agent. It is one of the ingredients in various drug formulations used in the treatment of
common cold, body pain and fever and is a non-prescription drug in the country. Various fixed dose combinations containing PPA were being
marketed in the country and available to the consumers with or without any prescription depending on other drugs in the combination.
4(iv). It is a fact that PPA was withdrawn in USA in November 2000 due to its association with cardiac congestive failure/haemorrhagic stroke at
higher doses. Based on the reports of increased haemorrhagic strokes associated with the use of PPA, other countries including Canada,
Singapore, Malaysia, Brazil, Cuba, Oman, etc., have also decided for withdrawal of PPA containing products from the market in the year 2000-
01.
4(v). Bayers Pharmaceutical Pvt. Ltd. has informed that they have re-formulated its PPA containing products with the decongestant phenylephrine.
GlaxoSmithKline Pharmaceuticals Ltd., has also informed that GSK''s Pharmaceutical and consumer business currently does not market any
product containing phenylpropanolamine globally. A copy of the information in that regard is annexed as Annexure R2 and therefore, it is not
correct to say that PPA is in continuous use in several countries. Its use is being restricted in many countries and is being replaced by safer
alternatives by the manufacturers.
4(vi). In India, DTAB, in its meeting held on June 21, 2002 had examined the issues related to continued marketing of products containing PPA in
India and then recommended that PPA could be used with the maximum dose restricted to 50mg/day for children and 100mg/day for adults as had
been recommended by Medicine Safety Committee of UK for Great Britain. The matter was again examined by the Expert Committee on 8th
November, 2010. The Expert Committee opined that PPA being a non-prescription drug, is available in various combinations as decongestant for
cough and cold. The drug could therefore be taken by the consumer at his will in the doses which may be harmful. The drug is not a drug of choice
to be used as decongestant in cough and cold preparations because of its association with hypertensive episodes. There are relatively safer
alternatives available such as Pseudoephedrine and Phenylepherine. Alternative as nasal drops and spray for use as nasal decongestants are also
available.
4(vii). The matter was again examined by the Expert Committee on 8th November 2010. The Expert Committee opined that PPA being a non-
prescription drug, is available in various combinations as decongestant for cough & cold. The drug could therefore be taken by the consumer at his
will in the doses which may be harmful. The drug is not a drug of choice to be used as decongestant in cough & cold preparations because of its
association with hypertensive episodes. There are relatively safer alternatives available such as Pseudoephedrine & Phenylepherine. Alternative as
nasal drops and spray for use as nasal decongestants are also available. In view of the above, the Expert Committee, after deliberation,
recommended that all PPA formulations should be discontinued for use in the country.
4(viii). Once the Central Government arrives at a conclusion and is satisfied that the drugs are harmful to the public, it cannot be allowed to be
manufactured, sold and distributed as it would mean compromising with the health and safety of the general public. Banning of the drug with
immediate effect or not also depends upon the recommendations of the Expert Committees. In cases where the Committee had reasons to believe
that a time limit may be provided for withdrawing the drugs from the market, a suitable time period is provided through the notification. In cases,
where no such consideration has been made, the drugs are prohibited with immediate effect in public interest.
4(ix). Once a Gazette Notification is published, it comes under the public domain. The Petitioner is trying to mislead this Court by stating that the
Notification came into existence only after 14.02.2011. According to the Respondents, on 11.02.2011 itself, the Minister of Health and Family
Welfare, Shri Ghulam Nabi Azad, in reply to a question in the Lok Sabha, gave the information about the drugs prohibited by the Government of
India on 10.02.2011 in the Parliament. The news about the banning of the said drugs was reported in the major Dailies on 12.02.2011. It is further
denied that the notification is violative of the Constitution. The banning of a drug has been dealt with u/s 26A of the Act, wherein there is no
provision of issuance of any prior notice before banning of a drug. The Section gives power to the Central Government to ban a drug upon its
satisfaction that the drug is likely to cause risk and harm to the public.
4(x). As the impugned notification has been issued in public interest keeping in mind the health and safety of the general public, the Respondents
pray for dismissal of the writ petition.
5(a). Learned Senior Counsel appearing for the Petitioner has raised the following contentions:
(i) Whether there is urgency to prohibit the drugs containing PPA, as it has been in the world market for more than 50 years and in the Indian
market for 20 years?
(ii) Whether DTAB is validly constituted u/s 26A of the Act to discharge its obligations under the Act?
(iii) Whether the Expert Committee, in its meeting dated 08.11.2010 had recommended the immediate ban on the drug PPA? and
(iv) Whether the ban on the usage of drugs containing PPA is in the interest of larger public?
5(b). In support of his case, learned Senior Counsel for the Petitioner, has relied on the following decisions:
(i). Supreme Court: Smt. Indira Nehru Gandhi Vs. Shri Raj Narain and Another, :
A sovereign in any system of civilized jurisprudence is not like an oriental despot who can do anything he likes.
On Sunday morning, November 10, 1607, there was a remarkable interview in Whitehall between Sir Edward Coke, Chief Justice of the
Common Pleas and James I. We have only Coke''s account of the interview and not the King''s, but there is no reason to doubt its essential
authenticity. The question between them was whether the King in his own person might take what causes he pleased from the determination of the
judges and determine them himself. This is what Coke says happened: ""Then the King said that he though the law was founded upon reason and
that he and Ors. had reason as well as the Judges: to which it was answered by me. that true it was that God had endowed His Majesty with
excellent science and great endowments of nature, but His Majesty was not learned in the laws of his realm of England, and causes which concern
the life, or inheritance, or goods, or fortunes of his subjects, are not to be decided by natural reason but by the artificial reason and judgment of
law, which law is an act which requires long study and experience before that a man can attain to the cognisance of it; and that the law was the
golden metwand and measure to try the causes of the subjects; and which protected His Majesty in safety and peace: with which the King was
greatly offended and said, that then he should be under the law which was treason to affirm, as he said: to which I said that Bracton saith quod Rex
non debet esse sub-homine sed sub Deo etlege."" It would be hard to find a single paragraph in which more of the essence of English constitutional
law and history could be found. The King ought not to be under a man, non debet esse sub homine but under God and the law sed sub Deo et
lege....
(ii) Supreme Court: 1994 Supp (1) SCC 160 in the case of Systopic Laboratories (Pvt.) Ltd. v. Dr. Prem Gupta and Ors.:
Reference, at this stage, may be made to the relevant provisions of the Act. As stated in the preamble, the Act has been enacted to regulate the
import, manufacture, distribution and sale of drugs and medicines. Section 5 of the Act provides for the constitution of the Drugs Technical
Advisory Board (hereinafter referred to as ''the Board'') by the Central Government to advise the Central Government and the State Governments
on technical matters arising out of the administration of the Act and to carry out the other functions assigned to it by the Act. Section 7 empowers
the Central Government to constitute an advisory committee to be called as Drugs Consultative Committee (in short DCC) to advise the Central
Government and the State Governments and the Board on any matter tending to secure uniformity throughout India in the administration of the Act.
Section 26-A, which was introduced in the Act by Drugs Amendment Act, 1982 (Act No. 68 of 1982), provides as under:
26-A. Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or
cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be
claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary
or expedient so to do, then, the Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug
or cosmetic.
In 1979, the DCC had set up an Experts Committee as a Sub-Committee of the DCC for screening the formulations of drugs prevalent in the
Indian market from the point of view of therapeutic rationale in order to weed out irrational/harmful combination of drugs. The Sub-Committee
examined a number of fixed dose combinations of drugs which did not appear to have adequate rationale or appeared to be harmful and made the
following recommendation in respect of fixed dose combinations of steroids:
Fixed dose combinations of steroids with any other category of drugs should not be allowed as they are considered harmful for the following
reasons:
(a) The adrenal suppressing accompanying steroid therapy leads to symptoms and signs of adrenal insufficiency, if the steroid is abruptly
withdrawn.
(b) It is difficult to titrate the dose of a steroid when it is present in fixed dose combinations with other drugs.
The recommendations of the DCC were considered by the Board at its meeting held on December 31, 1981 and the Board made the following
recommendation:
Steroid combinations.--Fixed combinations of steroids with other drugs for internal use should not be allowed.
However, the Board felt that so far as combination of steroids with other drugs for the treatment of asthma are concerned there was a need for
examining the matter in further detail and getting wider medical opinion in the matter. The Board, therefore, felt that such combination may continue
for the present.
After the incorporation of Section 26-A in the Act, notification dated July 23, 1983 was issued by the Government of India in the light of the
recommendations made by the Board and the manufacture and sale of 22 drugs were prohibited u/s 26-A of the Act. Out of these 22 drugs, Items
2 to 17, including Item 14, were fixed dose combinations of certain drugs. Item 14 in the said notification was:
Fixed dose combination of Steroids for internal use except combination of Steroids with other drugs for the treatment of asthma.
The Sub-Committee expressed the following view:
In this context, it may be pertinent to mention that the expert body and the DCC had also earlier held the same views now expressed by the expert
group. As advised by the DTAB, examination of the above mentioned categories have been done and their recommendations with reasons are
now placed before the DTAB for taking a final decision in the matter.
The matter was thereafter considered by the Board at its meeting held on April 22, 1988 and the following view was expressed:
The Board agreed that the fixed dose combination of chloramphenicol and streptomycin should not be allowed to be marketed.
After exchange of views amongst the members it was agreed that the fixed dose combinations of corticosteroids with other drugs for use in asthma
should be banned because asthma therapy is a long term therapy and corticosteroids even in low dosage when administered for longer periods are
reported to cause more harm than good to the patients. The Board approved that the Entry No. 14 appearing in the notification GSR No. 578(E)
dated July 23, 1983 may be suitably amended.
Having considered the submissions made by the Learned Counsel for the Petitioners and the learned Additional Solicitor General in this regard,
we must express our inability to make an assessment about the relative merits of the various studies and reports which have been placed before us.
Such an evaluation is required to be done by the Central Government while exercising its powers u/s 26-A of the Act on the basis of expert advice
and the Act makes provision for obtaining such advice through the Board and the DCC.
If the present case is considered in the light of the aforesaid tests, it cannot be said that the impugned notification prohibiting the manufacture
and sale of the drug in question suffers from the vice of unreasonableness. In taking this step the Central Government appears to have moved in a
cautious manner. In the earlier notification dated July 23, 1983, whereby manufacture and sale of a number of drugs, including fixed dose
combinations of certain drugs was prohibited, an exception was made in respect of fixed dose combinations of corticosteroids with other drugs for
the treatment of asthma. At that time also the DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs were
considered harmful for the reasons that (i)the adrenal suppression accompanying steroid therapy leads to symptoms and signs of adrenal
insufficiency, if the steroid is abruptly withdrawn; and (ii) it is difficult to titrate the dose of a steroid when it is present in fixed dose combinations
with other drugs. The DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs are not justifiable as
indiscriminate use of corticosteroids can produce serious side effects and in certain clinical conditions where administration of steroids is
considered necessary, the drug can be prescribed separately. The Board, however, felt that so far as combination of steroids with other drugs for
treatment of asthma are concerned, there was need for examining the matter in further detail and getting wider opinion on the matter and therefore,
the Board recommended that such combination may continue for the present. Keeping in view the said recommendation of the Board the Central
Government excluded combination of steroids with other drugs for the treatment of asthma from the ban imposed by notification dated July 23,
1983. The matter was thereafter examined in detail by the Sub-Committee of the DCC as well as the Experts Committee in 1987-88 and the
representatives of the manufacturers were given adequate opportunity of producing material in support of continued marketing of the said drugs
and they were also personally heard. After taking into consideration all the relevant data that were made available, the Sub-Committee of Experts
for weeding out harmful/irrational formulations expressed the same view as was held by DCC earlier and they opined that fixed dose combinations
of corticosteroids with any other drug should not be allowed because in the recommended upper dosage limit the daily dose of corticosteroid often
exceeds safe pharmacological limit for adrenocortical suppression and that the combinations do not permit titration of the steroid doses which is
often required in practice or the administration of the minimum daily dose once a day so as to avoid adrenocortical suppression. The experts also
pointed out that there is hardly any authentic reference to support that fixed dose combination of corticosteroids with bronchodilators or
antihistamines are recommended in the treatment of asthma. Agreeing with the said view the Board recommended that the fixed dose combinations
of corticosteroids with other drugs for use in asthma should be banned because asthma therapy is a long term therapy and corticosteroids in
dosage when administered for longer periods are reported to cause more harm than good to the patients. While examining the reasonableness of
the prohibition against manufacture and sale of the said drugs the harmful potentialities of the drugs have to be considered in the context of the
conditions as prevalent in the country where, on account of illiteracy, people are not aware of the ill effects of the drugs available in the market and
are often misled and misguided by quacks and inexperienced doctors. The less drastic course of permitting manufacture and sale of the drugs with
a warning about its use, suggested by the Learned Counsel for the Petitioner, would, in our opinion, not be adequate to protect the general public
from the harmful consequences. It is, therefore, not possible to hold that the prohibition which has been imposed by the impugned notification on
the manufacture and sale of the drug in question imposes an unreasonable restriction so as to be violative of the right guaranteed under Article
19(1)(g) of the Constitution.
The learned Additional Solicitor General has pointed out that in view of the observations made by this Court in its order dated January 6, 1992
in SLP(C). No. 1588 of 1989, the matter is being considered by the Technical Advisory Board in the light of the fresh material that has been
placed before the Board. Having regard to the aforesaid observations in the order dated January 6, 1992, the Petitioners as well as other
manufacturers who have filed writ petitions in the High Court and whose writ petitions are pending in the High Court can also approach the Board
and produce any fresh material in support of their claim for revocation of the ban on manufacture and sale of fixed dose combination of
corticosteroids with any drug for internal use for treatment of asthma. The Board, while considering the matter would take into account the said
material which is placed before it. The Petitioners and other manufacturers desirous of availing this opportunity of reconsideration of the matter may
submit the material in pursuance of this order before the Board within a period of one month.
(iii) Delhi High Court: CDJ 2000 DHC 1111 in the case of E. Merck India Limited v. Union of India:
6.... Record shows that Supreme Court in the aforementioned Writ Petition had passed order dated 17.11.1994 directing the Drug Technical
Advisory Board (hereinafter referred to as the DTAB, for short) to obtain fresh report on reassessment of the quality and nature of the drugs
specified in the petition and for other drugs which may be specified on behalf of the Forum from the DTAB constituted u/s 5 of the Act, to enable
the Court to deal appropriately with the questions raised in the petition. The DTAB was permitted to constitute a technical sub-Committee for the
purpose of expediting its work and it was specifically directed that in this Sub-Committee Dr. Nitya Nand, Dr. N.H. Antia and Dr. Naresh
Banerjee be included as Members. It was further directed that the DTAB should submit its report within three months and monthly interim reports
be also filed in the meantime. Technical Subcommittee was constituted which held sittings from time to time.
Respondents produced the records during the course of hearing. The record shows that the DTAB in its 47th meeting held on 27.10.1998
discussed the report of the Core Group and agreed with its recommendations that such FDCs should be phased out from the market because of
their improper use and lacking rationality.......
It was accordingly submitted that Section 26-A of the Act confers uncontrolled and unguided power on the Government and therefore it was
unsustainable being violative of Article 14 and 19 of the Constitution of India and the judgment of the Supreme Court in the case of B.B. Rajvanshi
v. State of U.P. 1998 (2) SCC 415 was cited in support of the argument.
10.3. It was also submitted that even if it was assumed that the Act provides for procedure for evaluation of the drugs, the records produced do
not disclose that such procedure was followed ie. no material relating to the findings of the Core Group were placed before DTAB for
consideration; no material showing that findings arrived at by the Core Group was considered by DTAB or by the Central Government for its
decision and no material was placed showing that the Central Government considered the report of the DTAB or Drug Consultative Committee
while arriving at its satisfaction. A decision without following any principle or rule is unpredictable and antithesis of a decision in accordance with
rule and law. It was the contention of the Petitioners that nothing is placed by the Government to show any material in support of banning the drug.
On the contrary, there was sufficient material to show that the drug has therapeutic value....
In so far as the challenge to vires of Section 26-A of the Act is concerned, we are not impressed. There is hardly any basis for the contention
that Section 26-A of the Act is unconstitutional or violative of Articles 14 and 19 of the Constitution of India. The Act was passed in the year 1940
with the purpose to regulate the import, manufacture, distribution and sale of drugs and cosmetics. By the Amendment Act 68 of 1982, apart from
other provisions, Section 26-A was incorporated by way of amendment to this Act. The purpose behind introduction of such a provision is
obvious. Central Government is empowered, by the Parliament, to prohibit the manufacture, sale or distribution of a drug or cosmetic. Before
imposition of such ban following ingredients as contained in Section 26-A of the Act are to be fulfilled: (i) Satisfaction of the Central Government;
(ii) Satisfaction has to relate to: (a) likely to involve risk to humans and animals or (b) it does not have a therapeutic value as claimed or purported
to be claimed for it; or (c) it contains ingredients and in such quantity for which there is no therapeutic justification; (iii) it is necessary or expedient
in public interest to do so.
The intention of the legislature is that the drugs which are hazardous or without therapeutic value or without any therapeutic justification should
not be allowed to be manufactured, sold or distributed. The provision made has laudable objective and it is clearly a reasonable restriction on the
freedom of carrying business by any person. In fact in Cynamide India case (supra) challenge to vires of Section 26-A of the Act was repelled by
Supreme Court. Further, the ingredients mentioned above clearly spell out that the power given to the Central Government is neither uncontrolled
nor unguided. A particular drug would be banned only if the Government is satisfied about the hazarduous nature of the drug or its nil therapeutic
value or no therapeutic justification. Above all, the Government is also to be satisfied that public interest warrants such prohibition. All these factors
constitute definite guide-lines to the Central Government before it acts to issue the Notification u/s 26-A of the Act prohibiting manufacture, sale or
distribution of a drug or cosmetic and therefore removes the elements of arbitrariness. For such a provision to sustain, it is not necessary that
statutory appeal has to be provided. Even in the absence of statutory appeal, the aggrieved person has the constitutional remedy of challenging the
Notification by filing Writ Petition under Article 226 to the High Court or under Article 32 to the Supreme Court. The Scheme of the Act further
provides for constitution of Drugs Technical Advisory Board, Central Drugs Laboratory and Drugs Consultative Committee for the purpose of
carrying out the functions assigned to it by the Act. Before the government records its satisfaction to prohibit the manufacture, sale, distribution etc.
of a particular drug, opinion of the DTAB and/or Drugs Consultative Committee is obtained. Whenever decision of the Central Government taken
u/s 26-A of the Act is challenged, while exercising the power of judicial review of such a decision, the Court can go into the questions as to issue
and that it was not an arbitrary exercise of power. Thus, we hold that provision of Section 26-A are not ultra-vires the Constitution of India. In so
far as other argument of the Petitioners are concerned, the type of glance or legal consideration they require would depend on the question as to
whether the power exercised u/s 26-A of the Act is legislative in nature or it is an administrative function being discharged by the Central
Government. We may say that there appears to be force in the submission of the Respondents that the power is legislative in nature keeping in
view the principles laid down by the Supreme Court in Cynamide India Limited (supra). However, it is not necessary to examine this question in
detail in the instant Petition inasmuch as even if it is treated to be administrative in its flavour, on the facts of this case we have no hesitation to come
to the conclusion that the exercise of power u/s 26-A of the Act by issuing the impugned Notification dated 14.10.1999 is valid and the impugned
Notification does not suffer from any infirmity.
In so far as argument of non-grant of fair and purposeful hearing is concerned, we do not agree with the Petitioners that they did not have
opportunity to present their point of view. One cannot lose sight of the fact that the exercise undertaken by the Respondents was pursuant to the
direction issued from time to time by the Supreme Court in the Writ Petition filed by the Forum. It has already been noted above that as far back
as on 17.11.1994, Supreme Court had passed the Order directing DTAB to go into the question relating to the drugs mentioned in the Petition
filed by the Forum and submit its report in relation to these drugs. For this purpose, DTAB was permitted to constitute a technical Sub-Committee
and the Supreme Court directed the members of this Sub-Committee would include Dr. Nitya and Dr. N.H. Antia and Dr. Naresh Banerjee.
Petitioners are also impleaded as party in the said Writ Petition pending in the Supreme Court and have been participating in the hearings.
Petitioners, as per their own admission, submitted the material and data in their possession in support of continuation of FDC of banned Drug
which was duly considered by the Sub-Committee. Not only this, by order dated 12.02.1997, while constituting the Core Group, Supreme Court
specifically gave an opportunity to the Petitioners and other affected parties to supply any material which they considered relevant to Additional
Solicitor General of India for being transmitted to the Convener of the Core Group for its consideration before the formation of its opinion. It is
also an admitted position that the Petitioners in fact submitted the material in support of its case which was duly considered by the Core Group.
Thus, not only, the view point of Petitioners were considered, the Respondents in fact acted in the manner directed by the Supreme Court from
time to time. This according to us, would be sufficient compliance of the principles of natural justice....
There is also no merit in the contention that the impugned Notification was passed without any material on record. As already pointed out
above, voluminous material was placed before the Sub-Committee in the first instance. The Core Group also considered this material including the
material furnished by the Petitioners; After considering this material the Core Group opined that the drug in question should be banned....
22.... In any case the Core Group had discussed the entire matter before accepting such opinion and did not blindly follow the opinion of these
doctors. Same exercise was done by DTAB and thereafter by the Central Government....
After all this Court is not sitting in appeal against the decision of the Respondents. Judicial review of such a decision is available on limited grounds.
While on the one hand, Court is not sitting on appeal over the decision making authority, it has to preserve democratic values of rule of law. From
this angle, Court is to ensure that the authority who has taken the decision acts within the bounds of law and its power....
(iv) Bombay High Court: AIR 1988 Bombay 134 in the case of Unichem Laboratories Ltd., Bombay and Anr. v. Union of India:
Petitioners are a pharmaceutical company engaged in the manufacture of a variety of drugs and pharmaceutical products. One of the products
manufactured by them is a drug known as ""Trinergic"". The product is brought out in two forms, viz. Capsules and injections. Trinergic is a
combination of Anabolic Steroid known as Methandienone and Vitamins B1, B6 and B12. Geigy of Basle, Switzerland took a decision to
withdraw their Anabolic Steroid, a preparation of Methandienone being marketed under the brand name ''Dianabol'' from the world market. Their
Indian subsidary informed the Director General of Health Services of this decision and the reason indicated by them to the Drugs Controller was
thus:
Clinical evaluation has indicated that the balance between clinical benefit on the one hand and side-effects such as virilisation on the other, now
appears to be less favourable, except possibly in osteoporosis and in the management of certain forms of anaemia. Moreover, the drug is being
abused by athletics to improve their physical appearance.
5.... In order to justify an action taken under this provision, the Government has to establish its satisfaction to firstly, that the use of any drug or
cosmetic is likely to involve any risk to human being or animals or that the said drug does not have the therapeutic value claimed or purported to be
claimed for it and, secondly, that in the public interest, it is necessary or expedient to ban or prohibit the manufacture, sale or distribution of such
drug. The return tendered by the Union of India records the necessary refutations of the claims made in the petition about Trinergic being outside
the pale of Section 26-A....
Per contra, learned Senior Central Government Standing Counsel appearing for the Respondents submitted that the action to prohibit the drug is
taken by the Government u/s 26A of the Act on the basis of the recommendations of the Expert Committee set up to examine the issues relating to
safety and effectiveness of the drug. It is his further submission that once the Central Government arrives at a conclusion and is satisfied that the
drugs are harmful to the public, it cannot be allowed to be manufactured, sold and distributed as it would mean compromising with the health and
safety of the general public. He has also placed reliance on the decision of the Supreme Court reported in 1994 Supp (1) SCC 160 in the case of
Systopic Laboratories (Pvt.) Ltd. v. Dr. Prem Gupta and Ors. wherein, in paragraphs 26 and 29, it is held as under.
If the present case is considered in the light of the aforesaid tests, it cannot be said that the impugned notification prohibiting the manufacture
and sale of the drug in question suffers from the vice of unreasonableness. In taking this step the Central Government appears to have moved in a
cautious manner. In the earlier notification dated July 23, 1983, whereby manufacture and sale of a number of drugs, including fixed dose
combinations of certain drugs was prohibited, an exception was made in respect of fixed dose combinations of corticosteroids with other drugs for
the treatment of asthma. At that time also the DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs were
considered harmful for the reasons that (i)the adrenal suppression accompanying steroid therapy leads to symptoms and signs of adrenal
insufficiency, if the steroid is abruptly withdrawn; and (ii) it is difficult to titrate the dose of a steroid when it is present in fixed dose combinations
with other drugs. The DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs are not justifiable as
indiscriminate use of corticosteroids can produce serious side effects and in certain clinical conditions where administration of steroids is
considered necessary, the drug can be prescribed separately. The Board, however, felt that so far as combination of steroids with other drugs for
treatment of asthma are concerned, there was need for examining the matter in further detail and getting wider opinion on the matter and therefore,
the Board recommended that such combination may continue for the present. Keeping in view the said recommendation of the Board the Central
Government excluded combination of steroids with other drugs for the treatment of asthma from the ban imposed by notification dated July 23,
1983. The matter was thereafter examined in detail by the Sub-Committee of the DCC as well as the Experts Committee in 1987-88 and the
representatives of the manufacturers were given adequate opportunity of producing material in support of continued marketing of the said drugs
and they were also personally heard. After taking into consideration all the relevant data that were made available, the Sub-Committee of Experts
for weeding out harmful/irrational formulations expressed the same view as was held by DCC earlier and they opined that fixed dose combinations
of corticosteroids with any other drug should not be allowed because in the recommended upper dosage limit the daily dose of corticosteroid often
exceeds safe pharmacological limit for adrenocortical suppression and that the combinations do not permit titration of the steroid doses which is
often required in practice or the administration of the minimum daily dose once a day so as to avoid adrenocortical suppression. The experts also
pointed out that there is hardly any authentic reference to support that fixed dose combination of corticosteroids with bronchodilators or
antihistamines are recommended in the treatment of asthma. Agreeing with the said view the Board recommended that the fixed dose combinations
of corticosteroids with other drugs for use in asthma should be banned because asthma therapy is a long term therapy and corticosteroids in
dosage when administered for longer periods are reported to cause more harm than good to the patients. While examining the reasonableness of
the prohibition against manufacture and sale of the said drugs the harmful potentialities of the drugs have to be considered in the context of the
conditions as prevalent in the country where, on account of illiteracy, people are not aware of the ill effects of the drugs available in the market and
are often misled and misguided by quacks and inexperienced doctors. The less drastic course of permitting manufacture and sale of the drugs with
a warning about its use, suggested by the Learned Counsel for the Petitioner, would, in our opinion, not be adequate to protect the general public
from the harmful consequences. It is, therefore, not possible to hold that the prohibition which has been imposed by the impugned notification on
the manufacture and sale of the drug in question imposes an unreasonable restriction so as to be violative of the right guaranteed under Article
19(1)(g) of the Constitution.
In the result, the appeals, the special leave petitions as well as the transferred cases and writ petition are dismissed. The judgment of the High
Court of Punjab and Haryana, under appeal, is affirmed subject to the direction that it would be permissible for the Petitioners in these cases and
other manufacturers whose writ petitions are pending in the High Courts to approach the Board and place before the Board any fresh material in
support of their claim within a period of one month and any such representation as well as the material produced in support thereof shall be
considered by the Board along with representation submitted in pursuance of the direction given by the Court in order dated January 6, 1992 in
SLP (C) No. 15382 of 1991. This shall be done within three months of the filing of the representations. No order as to costs.
In M.P. No. 3 of 2011, three Companies have sought to implead them as Respondents 3 to 5 to the above proceedings. They are (i) Low Cost
Standard Therapeutics (LOCOST), a nationally reputed public Trust and NGO based at Vadodara, Gujarat, which is active in the field of health
care, low cost drugs, transfer of pharmaceutical technology to LDC''s, issues of disadvantaged children and human rights and relief in disaster
situation for the last 30 years; (ii) All India Drug Action Network (AIDAN), an internationally well regarded and reputed All-India network of
socially concerned consumer and health action groups, medical and health professionals and academics from medical colleges, active since 1982 in
advocating a rational drug policy based on essential generic drugs, weeding out harmful, irrational, wasteful and useless drugs in the market and (iii)
Medico Friend Circle, a network, recognized nationally and internationally for their contribution to public health policy and pharmaceutical policy.
Their grievance is that the drug in question has harmful adverse effects on human beings and therefore the Central Government has rightly
prohibited the drug u/s 26-A of the Act on the advice of the expert committee and therefore they may be permitted to be impleaded in the Writ
Petition and subsequent to such impleadment the writ petition be dismissed.
Similarly, M.P. No. 4 of 2011 is filed to implead Citizen, Consumer and Civic Action Group, a registered public and charitable Trust and a
public interest group, founded in the year 1985, located in Chennai dealing with issues of public health, safety, performance of public utilities,
consumer and environmental protection, as party Respondent, with a similar prayer as that of the other impleading Petitioners.
On behalf of the proposed Respondents, the following decisions are relied on by the Learned Counsel:
(i) Chandra Bhavan Boarding and Lodging, Bangalore Vs. The State of Mysore and Another, :
9....The legislature has prescribed two different procedures for collecting the necessary data, one contained in Section 5(1)(a) and the other in
Section 5(1)(b). In either case it is merely a procedure for gathering the necessary information. The Government is not bound by the advice given
by the committee appointed u/s 5(1)(a). Discretion to select one of the two procedures prescribed for collecting the data is advisedly left to the
Government. In the case of a particular employment, the Government may have sufficient data in its possession to enable it to formulate proposals
u/s (5)(1)(b)....
(ii) Mr. Cooper on Vincent Panikurlangara v. Union of India and Ors., (1987) 2 SCC 165 :
The legislation in the field is the Drugs and Cosmetics Act, 1940 (hereinafter referred to as ""the Act""). The Act was amended in 1982 and the
definition of ""drug"" was amended and Sections 10-A and 26-A were inserted into the Act conferring power on the Central Government to prohibit
import of drugs and cosmetics in public interest as also to prohibit manufacture, sale or distribution thereof. The amended Act came into force with
effect from 1-2-1983, but on account of proceedings taken in court by manufacturers challenging the vires of Section 26-A of the Act and interim
directions given by the court, the benefit of the new power conferred on the Central Government is not yet available. According to the Petitioner,
Article 21 of the Constitution guarantees right to life and this Court has interpreted the guarantee to cover a life with normal amenities ensuring
good living which include medical attention, life free from diseases and longevity up to normal expectations. On account of both want of
appropriate enforcement of the law as also strict measures necessary to eradicate the existing evils, the fundamental right to life is not available to
the citizens of the country.
8....Challenge in these writ petitions is to the vires of Sections 10-A and 26-A of the Act. The counter-affidavit further points that some of the
medicines which are alleged to have been banned in some developed countries are allowed to continue in the market of the other developed
countries and there is no uniformity.
The issues raised in this petition are of vital importance as they relate to maintenance of approved standards of drugs in general; the writ
petition involves the claim for withdrawal of 7000 fixed dose combinations and withdrawal of licences of manufacturers engaged in manufacture of
about 30 drugs which have been licensed by the Drugs Control authorities; the issues that fall for consideration are not only relating to technical and
specialised matters relating to therapeutic value, justification and harmful side effect of drugs but also involve examination of the ectness (sic) of
action taken by the Respondents 1 and 2 on the basis of advice; the matter also involves the interest of manufacturers and traders of drugs as also
the interest of patients who require drugs for their treatment.
A healthy body is the very foundation for all human activities. That is why the adage ""Sariramadyam Khaludharma Sadhanam"". In a welfare
State, therefore, it is the obligation of the State to ensure the creation and the sustaining of conditions congenial to good health....
Section 5 of the Act authorises constitution of a Central Drugs Technical Advisory Board as also a State Board for each State. The object of
setting up of such Boards is to advice the respective Governments on technical matters arising out of the administration of the Act and to carry out
such other functions as are assigned to the Boards by the Act. Sub-section (2) provides for the manning of the Central Board. We are of the view
that adequate representation should be provided to consumers and at least two capable representatives from out of their category should be
nominated by the Central Government. The manning of this Board should be such that in its functioning it would be in a position to effectively
advise the Central Government on all technical matters.
We have no doubt that the existing Drug Consultative Committee is a useful body but the Central Government should consider whether it
requires to be broad-based and confined (sic conferred) with larger scope of operation or it is necessary to constitute another high powered
authority, as prayed for by the Petitioner so that such a vital matter like public health does not go without adequate attention.
The objection raised by the Petitioner with reference to specific medicines has not been examined by us mainly for the reason that we have
found this proceeding not an appropriate one for such purpose. We, however, hope that the Central Government shall take into consideration the
objections raised by the Petitioner and have the same referred to the Consultative Committee or to such other body as it considers expedient for
immediate examination and a decision in that regard shall be taken, not later than six months.
The Petitioner has indeed done a commendable job in bringing the matter before the Court. We appreciate his move and are inclined to think
that he should be suitably compensated with a view to reimbursing him for the expenses. We direct the Ministry of Health of the Central
Government to deposit a sum of Rs 5000 (Rupees Five Thousand only) in this Court within two months hence which the Petitioner will be at liberty
to withdraw.
(iii) Systopic Laboratories (P) Ltd. v. Prem Gupta (Dr), 1994 Supp (1) SCC 160:
1.....The said notification has been issued in exercise of the power conferred by Section 26-A of the Drugs and Cosmetics Act, 1940 (hereinafter
referred to as ''the Act''). In the said notification, it has been stated that the Central Government is now satisfied that long term use of steroids in
fixed dose combinations for treatment of asthma is likely to involve risk to human beings and such formulations do not have therapeutic justification
and further that it is necessary and expedient in public interest to prohibit the manufacture and sale of the said drugs.
Having considered the submissions made by the Learned Counsel for the Petitioners and the learned Additional Solicitor General in this regard,
we must express our inability to make an assessment about the relative merits of the various studies and reports which have been placed before us.
Such an evaluation is required to be done by the Central Government while exercising its powers u/s 26-A of the Act on the basis of expert advice
and the Act makes provision for obtaining such advice through the Board and the DCC.
The learned Additional Solicitor General has pointed out that in view of the observations made by this Court in its order dated January 6, 1992
in SLP (C) No. 1588 of 1989, the matter is being considered by the Technical Advisory Board in the light of the fresh material that has been
placed before the Board. Having regard to the aforesaid observations in the order dated January 6, 1992, the Petitioners as well as other
manufacturers who have filed writ petitions in the High Court and whose writ petitions are pending in the High Court can also approach the Board
and produce any fresh material in support of their claim for revocation of the ban on manufacture and sale of fixed dose combination of
corticosteroids with any drug for internal use for treatment of asthma. The Board, while considering the matter would take into account the said
material which is placed before it. The Petitioners and other manufacturers desirous of availing this opportunity of reconsideration of the matter may
submit the material in pursuance of this order before the Board within a period of one month.
Heard Learned Counsel appearing for the parties and perused the records and the relevant provisions of law.
CIPLA, a pharmaceutical company in India having a turnover of more than Rs. 5,000 crores per annum, started research design in 1952 with
a view to attain self-sufficiency in technological development, particularly in the pharmaceutical, medicine and drug development fields. They claim
that they have 31 world-class manufacturing facilities spread across the country with dedicated plants for oncology products, hormones, inhalers,
carbapenems and cephlosporins among others. The manufacturing facilities of the Petitioner-Company are with the approval of Food and Drug
Administration (FDA, USA), Medicines and Healthcare Products Regulatory Agency (MHRA), UK, Therapeutic Goods Administration (TGA),
Australia, Medicines Control Council (MCC), South Africa, National Institute of Pharmacy (NIP), Hungary, Pharmaceutical Inspection
Convention (PIC), Germany, World Health Organisation (WHO), Department of Health, Canada, State Institute for the Control of Drugs, Solvak
Republic and ANVISA, Brazil.
The Petitioner''s Active Pharmaceutical Ingredients (API) manufacturing plants are amongst the most sophisticated plants in the world, capable
of complex multi-storage synthesis producing over 120 API''s from high potency actives in grams to those made in several tonnes. It is also
claimed by the Petitioner that their products are one of the widest range of products and dosage forms in the world today, including metered-dose
inhalers, pre-filled syringes, trans-dermal spray patches, lyophilized injections, nasal sprays, medical devices and thermolabile foams. The petitioner
is one of the companies in the world to offer triple drug AIDS cocktail for less than $1 a day to patients in several countries.
Phenylpropanolamine (PPA) is a synthetic sympathomimetic amine which is commonly used in cough and cold preparations and is also used as
a nasal decongestant and respirator. The Petitioner has been selling products with PPA for the last 10 years and the products containing PPA have
been duly approved by the relevant authorities under the Act without any objection or complaint of after/side adverse effects. PPA is openly sold
in USA, UK, Japan and in neighbouring Asian countries. PPA has been in the world market for more than 50 years and in the Indian market for
20 years.
In the said situation, the ban on the sale of products containing PPA by the Respondents, vide impugned notification dated 10.2.2011, is
assailed by the Petitioner as illegal and contrary to law on the ground that there has been no mandatory consultation whatsoever with the DTAB or
the Expert Committee under the Act and the Union of India has not invited suggestions or representations from the stake-holders for consideration
of the Board or the Committee. Further, there is no Board in existence since February 2010 and u/s 5 of the Act, the tenure of the Board
constituted thereunder is only for a period of three years, which has expired on 2.2.2010. Therefore, the impugned notification is not only ultra-
vires the Act and the Rules made thereunder, but also is clearly and completely vitiated on account of non-application of mind.
It is further submitted by the Petitioner that there is no subjective satisfaction of the Central Government to the effect that it is likely to involve
risk to humans and animals and it does not have a therapeutic value as claimed or purported to be claimed for it and it contains the ingredients in
such quantity, for which there is no therapeutic justification and also necessary or expedient in public interest to do so.
To the above challenge, the Respondents have come out with a reply stating that the impugned notification dated 10.2.2011 was issued by the
Central Government prohibiting certain drugs in public interest on the recommendations of the Expert Committee constituted for that purpose. The
notification issued u/s 26-A of the Act is on the satisfaction of the Central Government that it is necessary and expedient to prohibit the
manufacture, sale and distribution of certain drugs in public interest and the drugs for which harmful effects are reported in the published literature
or in the media or if therapeutic justification is considered inadequate in the context of current medical evidence, are examined by the Expert
Committee on a continuous basis and therefore, the use of the drug is assessed on the basis of available technical information benefit ratio-risk
ratio, local needs and availability of safer alternatives etc. The action to prohibit the drug is taken by the Government on the basis of the
recommendations of the Expert Committee set up to examine issues relating to safety and effectiveness of the drug. Accordingly, the Central
Government prohibited the PPA in public interest, as its continued use is associated with harmful effects. The safety of the drug formulations
presently permitted to be marketed in the country are examined by the Expert Committee in the context of the present scientific knowledge about
the use of the drug and the risk associated with use.
u/s 26-A of the Act, there is no provision for issuance of any prior notice before banning of a drug. It gives power to the Central Government
to ban a drug upon it satisfaction that the drug is likely to cause risk and harm to the public. Therefore, the ban is within the ambit of the power
provided u/s 26-A of the Act. Further, taking into account the recommendations of the Expert Committee, the Respondents have prohibited the
said drug and issued the impugned notification.
In the above facts and circumstances of the case, the following questions arise for consideration:
(i) Whether the prohibition is violative of Article 19(1)(g) of the Constitution of India?
(ii) Whether the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human-beings or that any drug
does not have the therapeutic value claimed or purported to have been claimed or it contains the ingredients in such quantity, for which, there is no
therapeutic justification and that in the public interest, it is necessary or expedient so to do, to prohibit such drug u/s 26-A of the Act?
(iii) To arrive at such a satisfaction, whether the Central Government consulted the statutory authorities constituted under DTAB u/s 5 of the Act
and have the recommendation or opinion from the Expert Committee constituted for the purpose of Sub-section (5) of Section 5 of the Act?
(iv) Whether the opinion of the Expert Committee alone is enough to prohibit the drug without the recommendation of the DTAB?
(v) Whether this Court can exercise the power of Judicial Review to interfere with the order of the Respondents ?
Let me now deal with the above points one by one:
(i) Article 19(1)(g):
Right to carry on trade and commerce is a fundamental right guaranteed under Article 19(1)(g) of the Constitution. However, this right is
subject to reasonable restriction under Article 19(6). The law enjoins upon it an act in a particular manner as contemplated in respect of carrying
on a business or trade. The instant case is manufacturing and selling of a drug. Such guaranteed is to be restricted only in the manner as provided
for. Clause (6) of Article 19 provides that nothing in Sub-clause (g) of the said clause shall affect the operation of any existing law in so far as it
imposes or prevents the State from making any law imposing, in the interests of the general public, reasonable restrictions on the exercise of the
rights conferred by the said sub-clause, and, in particular, nothing in the said sub-clause shall affect the operation of any existing law in so far as it
relates to, or prevent the State from making any law relating to (i) the professional or technical qualifications necessary for practising any profession
or carrying on any occupation, trade or business, or (ii) the carrying on by the State, or by a corporation owned or controlled by the State, of any
trade, business, industry or service, whether to the exclusion, complete or partial, of citizens or otherwise. Reasonable restriction would be
substantive and procedural. The reasonableness in the context covers the substantive reasonableness as well as procedural reasonableness. In
applying the test of reasonableness, the broad criterion is whether the law strikes a proper balance between social control on the one hand and the
rights of the individual on the other hand. The Court shall take into account the following aspects viz., (a) nature of the right infringed; (b) underlying
purpose of the restriction imposed; (c) evils sought to be remedied by the law, its extent and urgency; (d) how far the restriction is or is not
proportionate to the evil; and (e) prevailing conditions at the time.
If we apply the reasonable restriction imposed by the Government in the instant case, the drug is in existence as claimed by the Petitioner for
about 20 years and there was a decision by DTAB to allow such a drug to continue in use unless the evil sought to be remedied by the law and its
extent and urgency and the underlying purpose of restriction imposed taking into the circumstances under which the Government has to proceed to
impose ban on the particular drug in ordinary circumstances. It would be followed by the law in existence and only by following a substantive and
procedural aspect of reasonableness in making the restriction, the Government can make such things to impose ban on the particular drug.
It is contended by the learned Senior Counsel for the Petitioner that the act of the Government with a colourable exercise of power was done
in a mechanical and whimsical manner in violation of the statutory provision, by giving a go-bye to the mandatory procedure, set down in the
relevant provisions of the Act and hence the same cannot be sustained and it deserves to be quashed.
In this context, it is to be stated that Section 5 contemplates what kind of expert advice and consultation is to be taken before going for the
restriction. If the law provides and enjoins on a particular trader or businessman, that right cannot be infringed upon by an unreasonable restriction.
of course, the Government is empowered to take into account the public interest with subjective satisfaction to impose such a restriction,
considering the urgency involved and the evil sought to be remedied in the prevailing conditions at the time. Therefore, the reasonable restriction, as
contemplated u/s (6) of Article 19 could be exercised by the Government with a subjective satisfaction at the prevailing circumstances and in the
manner as provided for.
The right guaranteed by Clause (g) of Article 19(1), namely, freedom of profession, trade or business is intended to ensure that citizens'' right
to business does not depend on grant by the State and that the State cannot prevent a citizen from carrying on a business, except by a law
imposing a reasonable restriction in the interest of the general public. If by a statutory provision the right of an agent to carry on his business is
affected, he may, in his own right, maintain an action. A person must be held to have access to justice if his right in any manner whether to carry on
business is infringed or there is a threat to his liberty. This has been held by the Supreme Court in Tashi Delek Gaming Solutions Ltd. and Another
Vs. State of Karnataka and Others, .
An analysis of the entire factors in this regard gives a clear impression to this Court that the sub-committee namely expert body constituted
under Sub-section (5) of Section 5 alone has been taken into account without the proper advice and consultation, as contemplated u/s 5, which
contemplates the highest expert body, in which the expert committee members cannot be a part of it. If that is so, the right of the Petitioner can be
infringed only in the manner as provided for and not otherwise. Therefore, there is an infringement of the right guaranteed under Article 19(1)(g) in
this case.
(ii) Prohibition of drug u/s 26-A of the Act - Public Interest:
A healthy body is the very foundation for all human activities. In a welfare State, it is the obligation of the State to ensure the creation and the
sustaining of conditions congenial to good health. In a series of pronouncements during the recent years, the Supreme Court has culled out from the
provisions of Part IV of the Constitution several obligations of the State and called upon it to effectuate them in order that the resultant pictured by
the Constitution Fathers may become a reality. Maintenance and improvement of public health have to rank high as these are indispensable to the
very physical existence of the community and on the betterment of these depends the building of the society of which the Constitution makers
envisaged. Attending to public health, therefore, is of high priority - perhaps the one at the top.
Health care of citizens is a problem with various facets. It involves an ever-changing challenge. There appears to be, as it were, a constant
competition between Nature, which can be said to be responsible for new ailments, on one side and human ingenuity engaged in research and
finding out curative processes. This being the situation, the problem has an ever-shifting base.
The issue raised in this petition is of vital importance as it relates to maintenance of approved standards of drugs in general. The issue that falls
for consideration not only relates to technical and specialised matters relating to therapeutic value, justification and harmful side effect of drugs but
also involves examination of the correctness of action taken by the Respondents. The matter also involves the interest of manufacturers and traders
of drugs as also the interest of patients, who require drugs for their treatment.
The World Health Organisation, in its report, on the basis of expert advice, is of the view that human ailments can be treated effectively with
285 basic drugs. While we are cognizant of the position that the problem is a shifting one and one cannot have a fixed process to deal with the
situations that would arise from time to time, the Central Government on the basis of the expert advice can indeed adopt an approved national
policy and prescribe an adequate number of formulations which would on the whole meet the requirement of the people at large. Obviously, instant
attention has to be bestowed to keep abreast of the changing situations and make proper and timely amends. While laying the guidelines on this
score, injurious drugs should be totally eliminated from the market. Great care in this regard has to be taken.
Such drugs as are found necessary should be manufactured in abundance and availability to satisfy every demand should be ensured. Undue
competition in the matter of production of drugs by allowing too many substitutes should be reduced as it introduces unhealthy practice and
ultimately tends to affect quality. The State''s obligation to enforce production of qualitative drugs and elimination of the injurious ones from the
market must take within its sweep an obligation to make useful drugs available at reasonable price so as to be within the common man''s reach.
That would involve regulating the price. It may be that there may be an improved quality of a particular medicine which on account of its cost of
production will have to sell at a higher price but for every illness which can be cured by treatment, the patient must be in a position to get its
medicine. This is an obligation, found in the relevant articles of Part IV of the Constitution.
Research in this field is of vital importance. Constant attention has to be devoted to get the best of results at the laboratories and put to use all
useful findings. The traditional indigenous system of treatment in India had once upon a time made a lot of advancement. There is, therefore,
sufficient scope for research on the basis of our own knowledge. Herbal preparations, as far as practicable, should be encouraged and appropriate
laboratories should be set up, both in the public and the private sector to continue the system of research into every branch in this field relevant to
gathering of knowledge and proper utilisation thereof in the field of treatment and manufacture of drugs. It is not for the court to lay down the drug
policy of the Government. This Court is aware of the fact that the State is concerned and anxious to improve the general condition and is willing to
exercise adequate control; Parliament has in several legislations in recent years enhanced the penalties with a view to ensure elimination of injurious
drugs and maintenance of the quality and standard of drug preparations. There is, however, no scope for complacency in this field and constant
and regular attention has to be bestowed in order that the flow into the market may be only of acceptable drugs. Therefore, this question is also
answered in favour of the Petitioner.
(iii) Objects sought to be achieved under the Act - Consultation and advice:
The preamble of the Act has underlined the object and reasons. The Act has been enacted to regulate the import, manufacture, distribution and
sale of drugs and cosmetics.
Chapter-II of the Act contemplates the Drugs Technical Advisory Board, the Central Drugs Laboratory and the Drugs Consultative
committee.
Section 5 of the Act provides for constitution of the Drugs Technical Advisory Board (DTAB) by the Central Government to advise the
Central Government and the State Governments on technical matters arising out of administration of the Act and to carry out other functions
assigned to it by the Act.
Section 7 of the Act empowers the Central Government to constitute an Advisory Committee to be called ""the Drugs Consultative Committee
to advise the Central Government, State Government and the Drugs Technical Advisory Board on any other matter tending to secure uniformity
throughout India in the administration of this Act.
Chapter-IV of the Act contemplates manufacture, sale and distribution of drugs and cosmetics, under which Section 26-A of the Act was
introduced by Amendment Act 68 of 1982, providing the powers of the Central Government to regulate, restrict or prohibit the manufacture, etc.,
of the drug and cosmetic in public interest.
The object and reasons of the Amendment Act is to regulate the import into the manufacture, distribution and sale of drugs and cosmetics in
the country. The problems of adulteration of drugs and also of production of spurious and sub-standard drugs are posing serious threat to the
health of the community and it is therefore considered necessary to amend the Act so as to impose more stringent penalties on the anti-social
elements indulging in the manufacture or sale of adulterated or spurious drugs or drugs not of standard quality which are likely to cause death or
grievous hurt to the user. This opportunity is also being availed of to incorporate certain other provisions on the other aspects of effective control
on the manufacture, distribution, sale of drugs and cosmetics on the basis of the experience gained in the working of the Act. It has also aimed to
widen the definition of the expression ''drug'', to be extended to enable control being exercised over the components of drugs including the empty
gelatine capsules and also devices which are intended for internal or external use in the diagnosis or treatment of diseases in human beings or
animals. Accordingly, the Amendment Act has provided Section 26-A, which reads as follows:
Section 26-A: Powers of Central Government to regulate, restrict or prohibit manufacture, etc., of drug and cosmetic in public interest--Without
prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to
involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or
contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so
to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such
drug or cosmetic.
In this regard, it is seen that the DTAB in its meeting held on 21.6.2002, examined the issues related to continued marketing of products
containing PPA in India, recommended that the PPA could be used with the maximum dose restricted to 50 mg/day for children and 100 mg/day
for adults, as had been recommended by Medicines Safety Committee of UK for Great Britain. The matter was again examined by the Expert
Committee, in its meeting held on 8.11.2010, and it deliberated upon the issue about the continued use of PPA and made the following
observations:
(i) PPA is a non prosecution drug available in various combinations as decongestant for cough and cold.
(ii) PPA is not a drug of choice to be used as decongestant in cough and cold preparations, because, its association with hypertensive episodes
and there are relatively safer alternatives available, such as Pseudoephedrine & phenylepherine. Alternatives as nasal drugs and spray for use as
nasal decongestants are also available.
(iii) It is also noted that PPA has been progressively replaced by other alternatives by the manufacturers themselves in cough and cold preparations
in other countries as well as India.
The Committee, after deliberations recommended that all the PPA containing formulation should be discontinued for use in the country.
To contradict and counteract the Expert Committee''s recommendations, the Petitioner contended that the setting up of the Expert Committee
and the statutory basis for the same have not been set down in the counter affidavit filed during April 2011. However, in the subsequent affidavit
filed during July 2011, it was made known that the SubCommittee/Expert Committee was constituted by the DTAB in its meeting held on
9.11.2009 and the Government in paragraph 14 of the counter affidavit has stated that there is no mandate to consult the DTAB before invoking
the power u/s 26-A of the Act and they have also filed the relevant papers for their support. It is seen from the records that a portion of the drug
reference manual and two letters issued by the competitors of the Petitioner, namely Bayer Pharmaceuticals Limited, dated 12.4.2011 and Glaxo
Smithkline Pharmaceuticals Limited, dated 20.4.2011, have been filed in the typed set of papers, and no other material was placed by the
Government along with the first counter affidavit. It is claimed by the Petitioner that the above letters are obtained by the Respondents after the
filing of the Writ Petition, and therefore, it cannot be treated as a material for satisfaction of the Central Government in banning the drug in question.
A perusal of the minutes of the meeting of the Expert Committee held on 8.11.2010 would show that the members of the Expert Committee
sat at 3 p.m. and deliberated for a short period of time and decided in favour of banning the drug. The question raised by the Petitioner is as to
whether the scientific reliable material and information has been relied on for such recommendation to ban the drug. In support of the Petitioner''s
contentions, it is stated that the PPA was nothing save the general information and the allegation in respect of high dosage, namely 150 mg PPA
and as such, in USA, it was used as appetite suppressant which was in existence even before 2002 when the DTAB recommended not to decide
for being banned. Therefore, whether this allegation can be material for the satisfaction of the Committee for recommendation of the ban of the
drug, has to be examined.
The Respondents on 4.7.2011 filed affidavit, wherein, it was pointed out that in the Agenda No. 8 of the 58th meeting of the statutory DTAB
held on 9.11.2009, the DTAB has categorically come to the conclusion that in the present context of scientific knowledge, the continued marketing
of certain drug formulations including PPA were required to be reviewed and accordingly, nominated an Expert Committee of seven members as
set out therein. Therefore, the mandate of Expert Committee constituted by the DTAB was to review the marketing of drugs including the PPA in
the present context of scientific knowledge and it is the specific case of the Respondents that the Expert Committee''s finding as set out therein in
the meeting held on 8.11.2010, was pursuant to the mandate of the DTAB. On a perusal of the records filed by the Respondents, it is seen that
pages 22 to 27 relate to document No. 2, the Expert Committee''s notes are found at pages 28 to 34, and the minutes of the meeting held on
5.5.2010 is also available. The Expert Committee held its first sitting on that day to discuss two drugs, namely Rosiglitazone and Nimesulide only
and PPA was not discussed.
Further, in the minutes of the meeting held on 8.11.2010, it was discussed in single meeting within short time and the decision was taken in
favour of the banning the drug. In the present context of the scientific knowledge as mentioned by the DTAB, without any new reliable scientific
material or clinical trial information duly documented by the Expert Committee of the DTAB, it cannot be a proper recommendation without
consulting the DTAB in over-ruling the earlier decision of the DTAB itself. Therefore, the Ministry of Health and Family Welfare decided to ban
the drug on the urgency based on the report submitted by the Parliamentary Standing Committee of the Ministry of Health and Family Welfare.
The decision is based on the recommendation of the Expert Committee dated 8.11.2010. The Ministry of Health and Family Welfare decided on
the urgency of banning the drug based on the report submitted by the Parliamentary Standing Committee of the Ministry of Health and Family
Welfare, but to the satisfaction of this Court, it does not find place on record before this Court, as to what is the decision of the Standing
Committee.
In this context, the urgency invoked was only based on the recommendation of the Expert Committee without consultation of the DTAB by
over-ruling the earlier decision dated 21.6.2002, wherein, the DTAB recommended that the PPA may be used with maximum dose restricting 50
mg/day for children and 100 mg/day for adults as had been recommended by the Medicine Safety Committee of U.K.
Section 5(1) of the Act mandates that the Central Government, shall, as soon as may be, constitute a Board (to be called the Drugs Technical
Advisory Board--i.e. DTAB) to advise the Central Government and the State Governments, on technical matters arising out of the administration
of the Act, and to carry out the other functions assigned to it by the Act. For this purpose, as per Section 5(5) of the Act, the Board may constitute
Sub-Committees and may appoint to such Sub-Committee for such periods, not exceeding three years, as it may decide, or temporarily for the
consideration of particular matters, persons who are not members of the Board. A conjoint reading of Section 5(1) as well as Section 5(5) reveals
that the DTAB is a Board and the Sub-Committees are under it for a particular purpose.
It is admitted position that there was no DTAB during the period commencing from 2.2.2010 to 7.4.2011. It is also not disputed by the
Respondents that the issue of drugs and matters relating thereto including the ban and prohibition, are matters involving high technical subject,
expertise and experience and are not matters within the expertise or domain of the civil servants and it is for this reason that the Act provides for
constitution of the DTAB. Therefore, the Sub-Committee would comprise of persons who are not the members of the DTAB and this clearly
shows that the Sub-Committee shall carry out certain specific mandate of the DTAB and to report back to DTAB for final decision. Then the
DTAB will advise the Government and only thereafter, the Government will have satisfaction to go on further decision to prohibit the drugs. The
Sub-Committee is neither a substitute to DTAB, nor independent of DTAB, nor a delegate of the DTAB in exercise of the powers of the DTAB,
and therefore, the Sub-Committee''s opinion alone is not a material before the Government to arrive at the subjective satisfaction. The Act is a self-
contained code provided for the mechanism and procedure to regulate the drugs, and since the drugs are highly specialised in technical field, the
DTAB has been established. Section 5(2) of the Act provides for various individuals to man the Board and the range of experts provided under
the Act would show that they are high skilled persons who have absolute intellectuals authority on the said issue. The Board u/s 5(2) of the Act
consists of the following members:
(i) the Director General of Health Services, Ex-officio, who shall be the Chairman;
(ii) the Drugs Controller of India, Ex-officio;
(iii) the Director of the Central Drugs Laboratory, Calcutta, Ex-officio;
(iv) the Director of the Central Research Institute, Kasauli, Ex-officio;
(v) the Director of the Indian Veterinary Research Institute, Izatnagar, Ex-officio;
(vi) the President of the Medical Council of India, Ex-officio;
(vii) the President of the Pharmacy Council of India, Ex-officio;
(viii) the Director of the Central Drug Research Institute, Ex-officio;
(ix) two persons to be nominated by the Central Government from among persons who are in-charge of drugs control in the States;
(x) one person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical
chemistry or pharmacognosy on the staff of an Indian University or a college affiliated thereto;
(xi) one person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the
staff of an Indian University or a college affiliated thereto;
(xii) one person to be nominated by the Central Government from the pharmaceutical industry;
(xiii) one pharamacologist to be elected by the Governing Body of the Indian Council of Medical Research;
(xiv) one person to be elected by the Central Council of the Indian Medical Association;
(xv) one person to be elected by the Council of the Indian Pharmaceutical Association; and
(xvi) two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government.
The above reading of the provisions of the Act and the persons who constitute the Committee, indicates clearly that the range of experts
provided under the Act, would show that they are highly skilled persons who have absolute intellectual authority on the said issue to take decision
and advise the Government properly.
When Section 5 is very specific that the Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical
Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of the Act and
to carry out the other functions assigned to it by the Act, in the instant case, the Respondents, without resorting to such an advice from the Board,
took a decision to ban the drug in question.
The requirements of the applicable enactment, namely, the Act have not been complied with by the Government while effecting the ban u/s 26-
A. DTAB was not in existence after 02.02.2010. Therefore, the satisfaction of the Central Government for banning the drug was not ensued on the
advice or recommendation of DTAB
The stand of the Respondents is that there is no mandate to consult DTAB before invoking the power u/s 26-A. It is true, as per the said
Section, the Central Government is empowered to regulate, restrict or prohibit, manufacture etc., of a drug in public interest. In this context, it is
significant to mention that the said Section 26-A cannot be read in isolation, but it should be read together with Section 5. A combined reading of
Sections 26-A and 5 would make it mandatory for the Central Government to take the advice of DTAB before taking any decisions with regard to
technical matters, such as the one in question.
In the given situation, in the case on hand, it is clear that the necessary ingredients as contained in Section 26-A viz., satisfaction of the Central
Government; satisfaction to the effect that the use of the drug, namely, Phenylpropanolamine is likely to involve risk to humans and animals, or it
does not have a therapeutic value as claimed or purported to be claimed for it, or contains ingredients and in such quantity for which there is no
therapeutic justification and that, in public interest, it is necessary or expedient so to do, have not been adhered to by the Respondents before
taking the impugned action. In addition, no opportunity was also given to the Petitioner, before issuing the impugned notification.
All government actions are meant to be performed by individual persons to further the objectives set down in the Constitution, the laws and the
administrative policies to develop democratic traditions, social and economic democracy set down in the Preamble, Part III and Part IV of the
Constitution. The intention behind the government actions and purposes is to further the public welfare and the national interest. Public good is
synonymous with protection of the interests of the citizens as a territorial unit or nation as a whole. It also aims to further the public policies. The
limitations of the policies are kept along with the public interest to prevent the exploitation or misuse or abuse of the office or the executive actions
for personal gain.
The public policy cannot be a camouflage for abuse of the power and trust entrusted with a public authority or public servant for the
performance of public duties. Misuse implies doing of something improper. The essence of impropriety is replacement of a public motive for a
private one. When satisfaction sought in the performance of duties is for mutual personal gain, the misuse is usually termed as corruption. The
holder of a public office is said to have misused his position when in pursuit of a private satisfaction, as distinguished from public interest, he has
done something which he ought not to have done.
It is well settled that public authorities must have liberty and freedom in framing policies. No doubt, the discretion is not absolute, unqualified,
unfettered or uncanalised and judiciary has control over all executive actions. At the same time, however, it is well established that courts are ill-
equipped to deal with these matters. In complex social, economic and commercial matters, decisions have to be taken by governmental authorities
keeping in view several factors, and it is not possible for courts to consider competing claims and conflicting interests and to conclude which way
the balance tilts. There are no objective, justiciable or manageable standards to judge the issues nor such questions can be decided on a priori
considerations.
The State and its instrumentality has also power to change policy. The executive power is not limited to frame a particular policy. It has
untrammelled power to change, rechange, adjust and readjust the policy taking into account the relevant and germane considerations. It is entirely
in the discretion of the Government how a policy should be shaped. It should not, however, be arbitrary, capricious or unreasonable. In other
words, every action of a public authority must be based on utmost good faith, genuine satisfaction and ought to be supported by reason and
rationale. It is, therefore, not only the power but the duty of the court to ensure that all authorities exercise their powers properly, lawfully and in
good faith. If powers are exercised with oblique motive, bad faith or for extraneous or irrelevant considerations, there is no exercise of power
known to law and the action cannot be termed as action in accordance with law.
It is true, the Government has every power to frame policies in public interest, but such policies should not be arbitrary, capricious,
unreasonable and violative of the provisions of the Acts and the Rules.
In the instant case, as it was stated that the Parliamentary Standing Committee, Ministry of Health and Family Welfare, by its order dated
08.11.2010, recommended for banning of PPA, this Court intended to see the material of that recommendation and, accordingly, directed the first
Respondent to produce the same before the Court. But, the said material is not placed by the Union of India. Instead, it is stated that the report of
the Committee is confidential. No doubt, the Parliamentary Standing Committee opinion will have some consideration for the Union of India to go
for the banning of the particular drug, but that opinion also has to be acted upon as per the law provided.
In a system of governance, it is specifically provided the manner in which it is to be done in the ordinary circumstances and also the system
contemplates the particular method of advice and consultation and hence it is to be acted upon by the Government in the manner as provided.
Therefore, this Court is of the considered opinion that after having the expert body opinion and also the opinion of the Parliamentary Standing
Committee, the same have to be placed before the appropriate body constituted for that purpose and then to arrive at a subjective satisfaction,
since the matter involves a fundamental right of a trade or business under Article 19(1)(g).
In the case on hand, DTAB is the competent body for such an opinion and advice and hence it has to be consulted by the Government for a
decision to be taken. In the absence of any such material placed before this Court, it cannot be construed that the Government has done its duty
and discharged its responsibility in accordance with law.
It is also to be noted that in Chapter IV of the Act, Section 26-A was introduced, which contemplates that without prejudice to any other
provision contained in this Chapter, if the Central Government is satisfied that the use of the drug or cosmetic is likely to involve any risk and it is
expedient to do so to prohibit such a drug in a larger public interest, it can give a go-bye to the advice and consultation, as contemplated in Section
5 under Chapter II of the Act.
No doubt, the power of Union of India is wide in exercising the right in public interest in alarming situations, prevailing in particular
circumstances. The Government is also empowered to invoke such a power in those circumstances to go for immediate prohibition of a particular
drug. But, in the instant case, it is not made out before this Court the circumstances available to the Government to go for prohibition of the drug
without recalling the earlier decision of DTAB. The contingency and emergent situation coupled with prevailing circumstances are the matters for
the Government to act in matters of this nature. On going through the totality of facts and circumstances of this case, it is not revealed that such
emergent situation was available for the Government to dispense with the procedure contemplated under the Act.
DTAB is a statutory body to advise the Central and State Governments on technical matters arising out of the administration of the Act and to
carry out the other functions assigned to it by the Act, consisting of experts as indicated above. When DTAB consists of so many experts in the
field, its consent is very much required for the Government before taking the decision u/s 26-A. Further, the DTAB, in its earlier decision on
21.06.2002, recommended for Regulation of the product PPA, restricting the maximum dose to 50 mg/day for children and 100 mg/day for adults
as had been recommended by the Medicine Safety Committee of UK, and not for banning the product in toto. The said position continues even as
on today and the product is being used for several decades. But, all of a sudden, the Respondents have taken a unilateral decision to ban the
product PPA even without giving an opportunity to the stakeholdlers, including the Petitioner. In such view of the matter, the issuance of impugned
notification in so far as it relates to PPA is concerned is arbitrary, unjust, unreasonable and not in public interest, as envisaged in the Act, coupled
with violation of principles of natural justice.
The Central Government, u/s 7 of the Act, may constitute an advisory committee to be called ""the Drugs Consultative Committee"" (DCC) to
advise the Central Government, State Governments and the DTAB of any matter tending to secure uniformity throughout India in the administration
of the Act. u/s 7(2) of the Act, the DCC shall consist of two representatives of the Central Government to be nominated by that Government and
one representative of each State Government to be nominated by the State Government concerned. Section 7(3) of the Act provides that the
DCC shall meet when required to do so by the Central Government and shall have power to regulate its own procedure.
On a reading of the above provisions of the Act, it is crystal clear that the DCC is constituted to advise the Central Government, the State
Governments and the DTAB on any matter tending to secure uniformity throughout India in the administration of the Act. Therefore, it is manifestly
provided that the constitution of the DTAB and DCC under Chapter-II of the Act, prescribes the methodology and procedure by which the
Central Government can take advise and come to a decision and hence, it is mandatory on the part of the Government to take a comprehensive
consultative process and advise from the DTAB, which is essential for the Central Government to come to a satisfaction on prohibition or ban of a
drug in public interest.
A perusal of the records as well as the stand of the Respondents would clearly make out a case that the Central Government has not
constituted a Board which was not in existence during the relevant point of time between 2.2.2010 and 7.4.2011. Therefore, it could be concluded
that the Government of India has come to the satisfaction only based on the Expert Committee and not on the advise of the DTAB.
(iv) Elements for subjective satisfaction and the power of Union of India to impose ban:
It is to be next decided regarding the Government''s power to regulate, restrict or prohibit the manufacture, sale, distribution of drugs and
cosmetics in public interest, and as to under what circumstances, how that power is to be exercised to prohibit a drug. Section 26-A of the Act
deals with the power of Central Government to regulate or restrict, manufacture, etc., of drug in public interest and Section 26-A of the Act
mandates that, ""without prejudice to any other provision contained in this Chapter (i.e. Chapter-IV relating to manufacture, sale and distribution of
drugs and cosmetics), if the Central Government is satisfied that the use of any drug or cosmetic is likely to involve any risk to human beings or
animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity
for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by
notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic.
In the absence of the consultative process and the advise of the DTAB, it is to be seen as to whether the Central Government has satisfaction
to prohibit a drug, in this case, PPA. The Supreme Court, in the case of Systopic Laboratories (Pvt.) Ltd. v. Dr. Prem Gupta (1994 Supp (1)
SCC 160), considered about the satisfaction of the Central Government. In paragraph 19 of the said case, the Supreme Court held as follows:
Having considered the submissions made by the Learned Counsel for the Petitioners and the learned Additional Solicitor General in this regard,
we must express our inability to make an assessment about the relative merits of the various studies and reports which have been placed before us.
Such an evaluation is required to be done by the Central Government while exercising its powers u/s 26-A of the Act on the basis of expert advice
and the Act makes provision for obtaining such advice through the Board and the DCC.
Further, in a decision of the Delhi High Court reported in M/s. E. Merck (India) Ltd. and another Vs. Union of India and another, , in
paragraph 18, it was held as follows:
18.... Before imposition of such ban following ingredients as contained in Section 26-A of the Act are to be fulfilled: (i)Satisfaction of the Central
Government; (ii)Satisfaction has to relate to: (a) likely to involve risk to humans and animals or (b) it does not have a therapeutic value as claimed
or purported to be claimed for it; or (c) it contains ingredients and in such quantity for which there is no therapeutic justification; (iii) it is necessary
or expedient in public interest to do so.
The ratio laid down in the above decisions would manifestly makes it clear that it is mandatory that the Central Government, while exercising its
power u/s 26-A of the Act, shall act on the basis of the expert advise through the DTAB and DCC and in examining this case, on a perusal of the
entire records, it would reveal that it is admitted fact that the Government of India was not having the DTAB during the relevant period of time and
only based on the Expert Committee''s opinion, they have to come to such a conclusion without taking the necessary advise from the expert body
as constituted u/s 5(2) and 5(5) of the Act. This Court has no other option except to hold that it is no doubt true that the Government is
empowered to prohibit any drug which is likely to involve any risk to human-beings and that any drug does not have a therapeutic value claimed or
purported to be claimed for it or contains the ingredients and in such quantity, as there is no therapeutic justification and that in public interest, it is
necessary or expedient to do so, and it can be done only with the satisfaction and for that purpose it is mandatorily provided that the DTAB is an
advisory body to take such a decision.
It is to be mentioned that the Expert Committee members are not the members of the DTAB and when the Expert Committee members are
not the members of the DTAB, it is obligatory and incumbent on the part of the Respondents, after recommendation by the Sub-Committee, to
place before the DTAB and then it will form an opinion to arrive at the subjective satisfaction.
The Act was passed in the year 1940 with the purpose to regulate the import, manufacture, distribution and sale of drugs and cosmetics. By
the Amendment Act 68 of 1982 apart from other provisions, Section 26-A was incorporated by way of amendment to the Act. The purpose
behind introduction of such a provision is obvious. Central Government is empowered, by the Parliament, to prohibit the manufacture, sale or
distribution of a drug or cosmetic. Before imposition of such ban, the following ingredients as contained in Section 26-A of the Act are to be
fulfilled: (i) Satisfaction of the Central Government; (ii) Satisfaction has to relate to:(a) likely to involve risk to humans and animals, or (b) it does
not have a therapeutic value as claimed or purported to be claimed for it; or (c) it contains ingredients and in such quantity for which there is no
therapeutic justification; (iii) it is necessary or expedient in public interest to do so.
A bare reading of Section 26-A discloses that the powers conferred on the Central Government is general in nature. It provides for prohibition
of any drug which does not have therapeutic value claimed or purported to be claimed. The word ''any drug'' refers to a particular drug. A
particular drug in turn refers to a particular person who manufactures the said drug or group of persons which manufacture particular drug. In
addition, the Central Government has to be satisfied that ingredients u/s 26-A do exist. Such satisfaction has to be objective and relevant material
must exist before the Government can issue notification. Consequently, to arrive at such satisfaction, there has to be cogent material. In other
words, the exercise of powers depending on the existence of circumstances to be so determined is an administrative action. The notification under
the Act is not of general application but applies to specific medicine manufactured by specific manufacturers.
The intention of the Legislature is that the drugs, which are hazardous or without therapeutic value or without any therapeutic justification
should not be allowed to be manufactured, sold or distributed. The provision made has a laudable objective and it is clearly a reasonable restriction
on the freedom of carrying business by any person. In fact, in Union of India (UOI) and Another Vs. Cynamide India Ltd. and Another etc., ,
challenge to vires of Section 26-A of the Act was repelled by Supreme Court. Further, the ingredients mentioned above clearly spell out that the
power given to the Central Government is neither uncontrolled nor unguided. A particular drug would be banned only if the Government is satisfied
about the hazardous nature of the drug or its nil therapeutic value or no therapeutic justification. Above all, the Government is also to be satisfied
that public interest warrants such prohibition. All these factors constitute definite guidelines to the Central Government before it acts to issue the
Notification u/s 26-A of the Act, prohibiting manufacture, sale or distribution of a drug or cosmetic and, therefore, removes the element of
arbitrariness.
For such a provision to sustain, it is not necessary that statutory appeal has to be provided. Even in the absence of statutory appeal, the
aggrieved person has the constitutional remedy of challenging the Notification by filing Writ Petition under Article 226 of the Constitution to the
High Court or under Article 32 to the Supreme Court. The scheme of the Act further provides for constitution of Drugs Technical Advisory Board,
Central Drugs Laboratory and Drugs Consultative Committee for the purpose of carrying out the functions assigned to it by the Act. Before the
Government records its satisfaction to prohibit the manufacture, sale, distribution etc., of a particular drug, opinion of DTAB or DCC is to be
obtained. Though the stand of the Respondents is that the drug in question was prohibited on the advice of the expert committee, the same is not
reflected in the impugned notification. Therefore, the said stand is not correct. Also, though the Government has filed a typed set of papers showing
a portion of a drug reference manual and two letters issued by competitors of the Petitioner namely Bayer Pharmaceuticals Limited dated
12.04.2011 and Glaxo Smithkline Pharmaceuticals Limited, dated 20.04.2011, the said material from other pharmaceutical companies have been
obtained by the Respondents after the filing of the writ petition and cannot be treated as material taken into account for the satisfaction of the
Central Government in banning the drugs.
(v) Judicial Review:
Whenever a decision of the Central Government taken u/s 26-A of the Act is challenged, while exercising the power of judicial review of such
a decision, the Court can go into the questions as to whether the satisfaction was based on material, which was relevant and germane to the issue
and that it was not an arbitrary exercise of power. Once the Court comes to the conclusion that the ingredients of Section 26-A are fulfilled; that
the satisfaction is based on material on record after considering all possible views in the matter and relevant material germane to the issue was
considered and the action was not ultra vires the powers of the Central Government, no further scrutiny of the matter is required, while exercising
the power of judicial review over such a decision and this Court cannot sit in appeal against the decision of the Government. Judicial review of such
a decision is available on limited grounds. While the Court cannot sit on appeal over the decision-making authority, it has to preserve democratic
values of rule of law. From this angle, the Court is to ensure that the authority who has taken the decision acts within the boundaries of law and its
power.
Over a period of time, grounds have been evolved on which judicial review of administrative action is permissible. The administrative decision
can be interfered with if it lacks in fairness or is mala fide, it is ultra vires, or abuse of power or colourable exercise of power and passed for
improper purpose or it is based on irrelevant considerations or relevant material is not taken into consideration. Once the Court is satisfied that a
particular decision taken was within the power of the authority and it is not an abuse of such power and has not been taken with improper motive
and is based on relevant material, it is not within the purview of a Court to substitute its own decision over a decision of the appropriate authority
as if sitting in appeal. On this point, the Supreme Court in S. Pratap Singh Vs. The State of Punjab, , has observed in the following words:
The Court is not an appellate forum where the correctness of the order of the Government can be canvassed and, indeed, it has no jurisdiction to
substitute its own view.... for the entirety of the power, jurisdiction and discretion... is vested by law in the Government.
Similarly, in Asif Hameed and others Vs. State of Jammu and Kashmir and Others, , the Supreme Court enumerated the power of judicial review
of administrative action in the following words:
While exercising the power of judicial review of administrative action, the Court is not an appellate authority. The Constitution does not permit the
Court to direct or advise the executive in matters of policy or to sermonize qua any matter which under the Constitution lies within the sphere of
legislature or executive, provided these authorities do not transgress their constitutional limits or statutory powers.
It is well settled that the matters which are to be decided by the experts are to be left for them to decide and once such expert bodies take
decisions in technical and specific matters, it is not for the Court to interfere with the evaluation made by those expert bodies.
However, in the instant case, it is conspicuous that the opinion of the expert bodies such as DTAB or DCC was not obtained by the
Respondents before issuing the impugned notification. The subjective satisfaction, which has to be objective, and relevant material must exist
before the Government to issue a notification and, consequently, to arrive at such a satisfaction, there has to be cogent material and, while
exercising such powers, the existing circumstances are to be determined in an administrative action. When the notification issued under the Act is
not of general application but applies to a specific medicine manufactured by a specific manufacturer, it results in civil consequences on the
manufacturer. Therefore, before imposing the ban, the Government must have satisfaction and the essential ingredients of Section 26-A are to be
fulfilled and the satisfaction of the Government must be based on substantive material and other circumstances and, therefore, while analysing the
entire background circumstances and the issues involved and also the way in which the Government has acted without having subjective
satisfaction, this Court cannot be restrained from exercising the extra-ordinary jurisdiction under Article 226 of the Constitution, in which case, it
can very well make a Judicial Review of the impugned notification.
Conclusion:
While arriving at a decision by the Government to prohibit drugs in general and, PPA in particular, u/s 26-A of the Act, even assuming that its
continued use will harm public, it is paramount consideration for the Government to arrive at a subjective satisfaction in public interest. In the
present case, in the absence of the same, the prohibition of the drug in item No. 3 alone of the impugned notification in GSR. No. 82(E), dated
10.02.2011, is unsustainable and ultra-vires of the provisions of the Act, and, therefore, the impugned notification to such extent has to be
quashed. Accordingly, the impugned notification, insofar as it relates to the particular drug, i.e. PPA, in item 3 of the impugned notification of the
first Respondent in GSR.82(E) dated 10.02.2011, is quashed and, as far as the other drugs in the impugned notification are concerned, this Court
is not expressing any opinion, as they are not the subject matters of challenge in the present Writ Petition. In view of the same, the matter requires
serious re-consideration by the Central Government to arrive at the satisfaction as contemplated under the provisions of the Act. Hence, the matter
is remanded to the first Respondent for deciding the matter afresh as per the provisions of the Act and also taking into account the larger public
interest involved in the matter and for passing appropriate orders, after giving an opportunity of being heard to the Petitioner, as expeditiously as
possible.
Writ Petition is allowed with the above direction. No costs. Consequently, the connected M.P. No. 2 of 2011 is closed.
As regards the impleading petitions viz., M.P. Nos. 3 and 4 of 2011 are concerned, as the proposed parties are before this Court for a public
cause and since this Court is not competent to deal with any public interest litigation, they may also go before the Central Government when the
matter is decided afresh as indicated above, in which situation, their grievances shall be looked into by the Respondents/Central Government,
before taking any decision. This Court is not inclined to implead them as parties, but gives them liberty to approach the Respondents, as observed
above. Accordingly, the impleading petitions are also disposed of.