M/S Laborate Pharmaceutical India Ltd vs State Of J&K And Others

The present petition has been filed by the petitioner-Company under section 561-A Cr.P.C. (now 482 Cr.P.C.) for quashing the proceedings in case

No. 70-Complaint of 2010 under section 18(a)(i) read with section 27 of the Drugs and Cosmetics Act, 1940 (for short the Act), titled, ""Drug

Inspector vs Shiva Medicine Traders"" and all orders passed therein, pending before the learned Excise Magistrate, Jammu.

The brief facts as they emerged from the complaint are that on 07.10.2008 the respondent No. 1-the Drug Inspector went for a routine inspection

along with his team members and visited the premises/shop of M/s Shiva Medicine Traders, respondent No. 2 herein situated at Reshamghar Colony,

Jammu and lifted the samples of various drugs from the shop of aforesaid trader. The drugs lifted for test/analysis for Government analysis included

the tablet Labchlor-250, Batch No. RDC 016, date of manufacturing 06/2018, expiry date 05/2010 manufactured by the petitioner and the Form No.

17 was filled in this regard. After preparing the samples, the Drug Inspector has also filled Form No. 18 for the purpose of sending the samples in

question to the Government Analyst, C. F. D. L. Jammu for test/analysis on 10.10.2008. The Drug Inspector received the certified test report vide

No. CFDL/LS/Act/tests/170/08 dated 06.12.2008 from the Government Analyst under section 25(1) of the Act vide communication dated 26.12.2008

and No. CFDL/432-433 through the office of the Controller Drugs and Food Control Organization, Jammu and Kashmir with the finding that the

samples of the drug in question i.e. Tablet Labchlor-250 was not of standard quality as defined in the Act and further stated that the sample fails in

assay of dissolution test and uniformity of weight of capsule content. The report of the Government Analyst is annexed as annexure D and D-1 to the

complaint. Thereafter, the Drug Inspector vide letter dated 21.01.2009 directed the dealer/retailer respondent No. 2 herein to submit the details of the

dealer from whom the drug has been purchased along with relevant record. The Drug Inspector has also submitted the report of the Government

Analyst to the respondent No. 2. The respondent No. 2 vide letter dated 29.01.2009 disclosed that the respondent No. 2 purchased the drug in

question from the respondent No. 3 and thereafter, the Drug Inspector sought requisite information even from respondent No. 3 vide letter dated

2.09.2009 and the respondent no:3 submitted the requisite information to the respondent No. 1 vide communication dated 03.09.2009. The Drug

Inspector yet again pursuant to the information disclosed by respondent No. 3 sought information from respondent No. 4 with regard to the

manufacturing of the drug in question vide letter dated 31.12.2009 who in turn vide letter (annexure-K) informed that the petitioner is the manufacturer

of the drug in question and also produced the relevant record. It is further stated in the complaint that the Drug Inspector when came to know about

the name of the petitioner, issued letter dated 06.03.2010 to the petitioner and directed him to produce sale and purchase record and total quantity of

the drug in question manufactured within seven days. He also annexed the report of Government Analyst along with aforesaid letter. As the

petitioner-company failed to reply the communication dated 06.03.2010 (supra) within 28 days as stipulated under section 25(3) of the Act and did not

provide the requisite record as sought by the Drug Inspector, so after obtaining the sanction from the competent authority, a complaint was filed

against the petitioner-company as well as other accused. It is submitted by the petitioner that in response to the letter dated 06.03.2010 dispatched on

08.03.2010 and received by the petitioner-company on 22.03.2010, the petitioner vide letter dated 10.04.2010 intimated the respondent No. 1 that the

petitioner has conducted the in-house test in the laboratory and found the medicine to be of a standard quality and it was also stated in the letter that

no sample as required under section 23 (4)(iii) of the Act was sent to the petitioner and without examining the sample it was not possible for the

petitioner to ascertain whether the drug in question was manufactured by the petitioner or not. It was also stated in the letter that the petitioner does

not accept the Government Analyst report and want to adduce the evidence in contravention of the findings of the Government Analyst report and

further it was stated that the product be sent to appellant’s laboratory i.e. Central Drugs Laboratory, Kolkata and the petitioner was ready to pay

the reanalysis charges. The petitioner reiterated the same vide another letter dated 19.05.2010. The petitioner has placed on record the copies of letter

dated 10.04.2010 and 19.05.2010 along with the postal receipts dated 12.04.2010 and 22.05.2010. It is further stated by the petitioner that respondent

No. 1 deliberately concealed the letter from the court and filed the complaint.

The petitioner has sought the quashing of the criminal proceedings primarily on the ground that the petitioner’s right of retesting the drug in

question has been violated by the Drug Inspector concerned by not complying the provisions of section 25(4) of the Act and further due to belated

filing of the complaint just few days before the expiry of the sample has resulted in to denial of right of testing as envisaged under sec. 25(3) and 25(4)

of the Act.

Mr. Sachin Gupta, learned counsel for the petitioner has vehemently argued that the respondent No. 1 deliberately did not send the sample to the

petitioner and also has laid much stress that the complaint was filed few days before the expiry of the shelf life so as to further deny the right of

retesting as provided under sec 25(4) of the Act. Learned counsel has placed reliance judgments of the Supreme Court in Medicamen Biotech Limited

and anr. v Rubmina Bose, Drug Inspector, (2008) 7 SCC 196 and Laborate Pharmaceuticals India Ltd. v State of Tamil Nadu, 2017 AIR SC 2423.

Per contra, Mr. H. A. Siddiqui, learned Sr. AAG has vehemently argued that the complaint has been filed by the respondent No. 1 after complying

with all provisions of the Act, as such, the present proceedings cannot be quashed.

Heard learned counsel for the parties.

Before appreciating the rival contention of the parties, it would be appropriate to extract the relevant part of the sections Nos. 23 and 25 of the Act

and the same are reproduced as under:

“23 Procedure of Inspectors.

(1)…………

(2)………..

(3)…………

(4) The Inspector shall restore one portion of a sample so divided or one container, as the case may be, to the person from whom he takes it, and shall

retain the remainder and dispose of the same as follows:â€

(i) one portion or container he shall forthwith send to the Government Analyst for test or analysis;

(ii) the second he shall produce to the Court before which proceedings, if any, are instituted in respect of the drug [or cosmetic]; and

(iii) the third, where taken, he shall send to the person, if any, whose name, address and other particulars have been disclosed under section 18A.]

(5)…………..

Reports of Government Analysts.

(1) The Government Analyst to whom a sample of any drug [or cosmetic] has been submitted for test or analysis under sub-section (4) of section 23,

shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken [and another copy to the

person, i f any, whose name , address and other particulars have been disclosed under section 18A], and shall retain the third copy for use in any

prosecution in respect of the sample.

(3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence of the facts stated therein, and such

evidence shall be conclusive unless the person from whom the sample was taken [or the person whose name, address and other particulars have been

disclosed under section 18A] has, within twenty-eight days of the receipt of a copy of the report, notified in writing the Inspector or the Court before

which any proceedings in respect of the sample are pending that he intends to adduce evidence in controversion of the report.

(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his

intention of adducing evidence in controversion of a Government Analyst’s report, the Court may, of its own motion or in its discretion at the

request either of the complainant or the accused cause the sample of the drug[or cosmetic] produced before the Magistrate under sub-section (4) of

section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the

authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein.

(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4)shall be paid by the complainant or accused as the Court

shall direct.

A perusal of section 23(4) of the Act reveals that the Inspector shall send the third sample to the person, if any, whose name, address and other

particulars have been disclosed under section 18-A of the Act. Further section 25(3) of the Act provides for that any document purporting to be a

report signed by the Government Analyst shall be the evidence of the fact stated therein unless the person from whom the sample was taken or the

person whose particulars have been disclosed under section 18-A of the Act, has within 28 days of the report receipt the copy of the report, notified in

writing the inspector or the court where any proceedings in respect of the samples are pending that he intends to adduce evidence in controversion of

the report. Further section 25(4) of the Act obliges the Magistrate on the request of the complainant or the accused or on his own motion to send the

sample produced before the Magistrate under section 23 (4) of the Act for fresh testing to the Director of the Central Drugs Laboratory.

Now coming to the facts of the instant case, it is evident from the record that no sample as envisaged by section 23 (4) (iii) of the Act has been

sent to the petitioner as there is no reference of sending the sample in the letter dated 06.3.2010 by virtue of which the report of Government Analyst

was sent to the petitioner and the petitioner in response to the letter dated 06.03.2010 has categorically stated vide letter dated 10.04.2010 that no

sample has been sent to the petitioner and the respondent No. 1 was also intimated that the petitioner-company want the sample to be retested. The

respondent No. 1 has not been able to demonstrate that the sample was sent to the petitioner and also has not controverted the issuance of letter dated

10.04.2010. Thus the petitioner has been deprived of its valuable right of retesting under sections 25(3) and 25(4) of the Act. Reliance is placed upon

the judgment of the Apex Court in Laborate Pharmaceuticals India Limited and others v State of Tamil Nadu"", 2017 AIR (SC) 2423 and the relevant

paragraph Nos. 6 to 8 are reproduced as under:

“6. A reading of the provisions of Sections 23(4) and 25 of the Act would indicate that in the present case the sample having been taken from the

premises of the retailer had to be divided into four portions; one portion is required to be given to the retailer; one portion is required to be sent to the

Government Analyst and one to the court and the last one to the manufacturer whose name, particulars, etc. is disclosed under Section 18-A of the

Act. In the present case, admittedly, one part of the sample that was required to be sent to the appellant (manufacturer) under Section 23(4)(iii) of the

Act was not sent. Instead, what was sent on 22-3-2012 was only the report of the Government Analyst. When the part of the sample was not sent to

the manufacturer, the manufacturer could not have got the same analysed even if he wanted to do so and, therefore, it was not in a position to contest

the findings of the Government Analyst. In the present case, the sample was sent to the appellant manufacturer on 10-8-2012 and on 13-9-2012 the

appellant had indicated its desire to have another part of the sample sent to the Central Laboratory for reanalysis. This was refused on the ground that

the aforesaid request was made much after the stipulated period of 28 days provided for in Section 25(3) of the Act.

The cognizance of the offence(s) alleged in the present case was taken on 4-3-2015 though it appears that the complaint itself was filed on 28-11-

2012. According to the appellant the cough syrup had lost shelf life in the month of November 2012 itself. Even otherwise, it is reasonably certain that

on the date when cognizance was taken, the shelf life of the drug in question had expired. The Magistrate, therefore, could not have sent the sample

for reanalysis by the Central Laboratory.

All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analysed in the Central Laboratory has been

denied by a series of defaults committed by the prosecution; firstly, in not sending to the appellant manufacturer part of the sample as required under

Section 23(4)(iii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4-3-2015 though the same was filed on

28-11-2012. The delay on both counts is not attributable to the appellants and, therefore, the consequences thereof cannot work adversely to the

interest of the appellants. As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to

the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution.â€​

Otherwise also, the instant complaint was filed on 21.04.2010 and admittedly the shelf life of the Drug in question was having expiry as 05/2010

and within such a short period, it would have been impossible to get the sample tested before its expiry, even if the petitioner had appeared before the

Magistrate even on the date of institution of the complaint i.e. 21.04.2020. Incidentally in the similar situation, when the complaint was filed on

02.07.2002 and shelf life was having expiry of 08/02, the Hon'ble Apex Court in Medicamen Biotech Ltd. v. Drug Inspector, (2008) 7 SCC 196 has

held:

“18. ..........It is also clear that the complaint had been filed on 2-7-2002 which is about a month short of the expiry date of the drug and as such

had the appellant-accused appeared before the Magistrate even on 2-7-2002 it would have been well-nigh impossible to get the sample tested before

its expiry.

In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the

delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided service of summons on it till 9-5-2005. This

is begging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf

life of the drug and concededly the filing of the complaint had nothing to do with the appearance of the accused in response to the notices which were

to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the

appellant in August/September 2001 as would be clear from the facts already given above and there is absolutely no reason as to why the complaint

could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case

suggest that the appellants have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of

the proceedings against them.â€​

So it is evident that the petitioner has been deprived of valuable rights under section 25(3) and (4) of the Act, and as such, this Court has no other

option but to quash the proceedings and as such, the criminal proceedings arising out of case No. 70-Complaint of 2010 under section 18(a)(i) read

with section 27 of the Drugs and Cosmetics Act, 1940 pending before the learned Excise Magistrate, Jammu are quashed.