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Judgment
S.S. Sodhi, J.—The matter here concerns the production, sale and distribution by the appellants of pharmaceutical products known as Dizlagin and in the other case Parapam. The challenge being to the withdrawal thereof as recommended by the Sub-Committee of the Drugs Consultative Committee for weeding out harmful/irrational/ineffective Fixed Dose (hereinafter referred to as ''the Consultative Sub-Committee'') culminating in the ban on the manufacture of these products by the impugned notification of the Central Government of December 6, 1990.
It was apparently in pursuance of directions of the Supreme Court in Vincent v. Union of India that the fixed dose combination of various drugs including Dizlagin and Parapam were considered by the Consultative Sub-Committee. It was after due publicity and after hearing representatives of the Drug Manufacturers Associations, that it considered the matter and made its recommendation.
The controversy now raised before us lies within a narrow compass, namely, that it is only in terms of Section 26A of the Drugs and Cosmetics Act, 1940 (Abbreviated hereafter to ''the Act'') that the Central Government is empowered to prohibit the manufacture, sale and distribution of drugs. This provision of law reads as under :-
"26A. Power of Central Government to 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, prohibit the manufacture, sale or distribution of such drug or cosmetic."
It was the contention of the counsel for the appellants that the withdrawal of the fixed dose combination drugs Dizlagin and Parapam was not in terms of Section 26A of the Act as it was founded merely upon the view of the Consultative Sub Committee to the effect that no substantial evidence has been produced by the representatives of the manufacturers to prove rationality of the combination of drugs comprised in Dizlagin and Parapam whereas the burden lay upon the Central Government to record its satisfaction as required thereunder before proceedings to prohibit their manufacture, sale or distribution.
A plain reading of the recommendations of the Consultative Sub-Committee does indeed lend credence to the contention raised. Due care and caution has no doubt to be exercised in allowing drugs into the market and it is also the obligation of the State to ensure that harmful drugs are not put within reach of an unsuspecting public, but at the same time, it must be appreciated that manufacture of drugs involves considerable expense and effort and particularly, as in a case like the present, where the manufacture was approved by a license having been granted for the purpose, by the appropriate authority, the order directing the withdrawal of such drug must fall within the four corners of the legal frame work as set forth in Section 26A of the Act. As this does not appear to be so is the present case, we hereby dispose of this writ petition with a direction to the respondents to re-examine the drugs Dizlagin and Parapam afresh within three months, taking into account all relevant factors and to thereafter pass appropriate orders in accordance with law keeping in view particularly the provisions of Section 26A of the Act. When the Consultative Sub-Committee meets for this purpose, let an opportunity of hearing also be afforded to the appellants. Counsel for the respondents has on our direction undertaken to inform the counsel for the appellants of the date that the Consultative Sub-Committee may fix for this purpose.
Before parting with this matter, it may be clarified that the ban on the manufacture of Dizlagin and Parapam shall ensure till the matter is decided afresh and further that it shall be subject to such modification, if any, as may be made by the Central Government in pursuance of the directions as contained in this order, namely, on the matter being examined afresh.
This appeal is disposed of accordingly. There will, however, be no order as to costs.