SC recommends sending of 349 Fixed Drug Combinations to Drugs Technical Advisory Board for examination

The Supreme Court of India bench consisting of Justices R.F.Nariman and Sanjay Kishan Kaul in the matter of Union of India & Anr. v. Pfizer Limited & Ors. have interpreted Section 26A of the Drugs and Cosmetics Act, 1940 (“Drugs Act”) and held that consultation with the Drugs Technical Advisory Board (“DTAB”) is not mandatory in way of exercise of power under Section 26A of the Drugs Act.

The dispute in the case arose when, after a detailed report from the Kokate Committee which found Fixed Dose Combination (“FDC”) as irrational and potentially risky, the Government of India banned several FDCs under various categories.

Around March 2016, number of Writ Petitions were filed in the Delhi High Court (“High Court”) against such notifications which banned the FDCs which disposed off the writ petitions. A Letters Patent Appeal was filed before the High Court whereas the Union of India (“Respondents”) filed transfer petitions to the Supreme Court. This is how the matters reached the Supreme Court in civil appeals arising out of Special Leave Petitions against the judgment of the single Judge of the High Court dated 1.12.2016 and 10 Letter of Patent Appeals pending before the High Court were transferred to the Supreme Court.

After hearing the counsel of the Appellants (Pinky Anand, Additional Solicitor General of India) and Pfizer Limited and Ors. (C.S Vaidyanathan and Vashisht, Advocates),  the Court took into account the various materials placed on record and analyzed them arrive at its final conclusion.

In words of the Court,

“Under Section 26A, the Central Government must be “satisfied” that any drug or cosmetic is likely to involve (i) any risk to human beings or families; or (ii) that any drug does not have the therapeutic value claimed or purported to be claimed for it; or (iii) contains ingredients in such quantity for which there is no therapeutic justification. Obviously, the Central Government has to apply its mind to any or all of these three factors which has to be based upon its “satisfaction” as to the existence of any or all of these factors. The power exercised under Section 26A must further be exercised only if it is found necessary or expedient to do so in public interest. When the power is so exercised, it may regulate, restrict or prohibit manufacture, sale or distribution of any drug or cosmetic. Undoubtedly, Section 26A has to be read with the rest of the Drugs Act. So read, it is clear that unlike Section 6(2), Section 8(2), second proviso to Section 10, proviso to Section 12(1), Section 16(2), proviso to Section 18(2), Section 33 and Section 33N, there is no explicit requirement to consult the DTAB set up under Section 5 of the Drugs Act. The question is did the Parliament do so deliberately or is it something that the Court should read into the provision?”

The Court considered the fact that Section 26A was brought in by an amendment in 1982. The amendment specifically made changes in Sections 33 and 33N in which it added the words “on the recommendation of the Board”. From this, it is clear that Parliament in the very Amendment Act which introduced Section 26A made certain changes which involved the DTAB under Section 5 of the said Act. It is clear that the additional power that is given to the Central Government under Section 26A does not refer to and, therefore, mandate any previous consultation with the DTAB. On the contrary, the Central Government may be “satisfied” on any relevant material that a drug is likely to involve any risk to human beings etc. as a 32 result of which it is necessary in public interest to regulate, restrict or prohibit manufacture, sale or distribution thereof. So long as the Central Government’s satisfaction can be said to be based on relevant material, it is not possible to say that not having consulted the DTAB, the power exercised under the said Section would be non est.

It is also pertinent to note that the Court held that the position of law laid down in the two  judgments of Macleods Pharmaceuticals Limited v. Union of India & Ors (Madras High Court) and Lundbeck India Pvt. Ltd. v Union of India (Karnataka High Court) was correct as far as the interpretation of the said section was concerned.

Taking into account the peculiar facts of the case, the Court suggested the following course of action:

“On the facts of these cases, a suggested course of action was stated by learned counsel appearing on behalf of the petitioners/appellants. This course is that instead of now remitting the matter back to the Delhi High Court for an adjudication on the other points raised in the writ petitions, the case of 344 FDCs that have been banned, plus another 5 FDCs that have been banned, which comes to 349 FDCs, (barring 15 FDCs that are pre 1988 and 17 FDCs which have DCG(I) approval) pursuant to the Kokate Committee report, by notifications of the Central Government under Section 26A of the Drugs Act, should be sent to the DTAB, constituted under Section 5 of the Drugs Act, so that it can examine each of these cases and ultimately send a report to the Central Government. We reiterate that only on the peculiar facts of these cases, we think that such a course commends itself to us, which would obviate further litigation and finally set at rest all other contentions raised by the petitioners. We say so because we find that the Kokate Committee did deliberate on the 344 FDCs plus 5 FDCs and did come to a conclusion that the aforesaid FDCs be banned, but we are not clear as to what exactly the reasons for such conclusions are, and whether it was necessary in the public interest to take the extreme step of prohibiting such FDCs, instead of restricting or regulating their manufacture and supply. In order that an analysis be made in greater depth, we, therefore, feel that these cases should go to the DTAB and/or a Sub-Committee formed by the DTAB for the purpose of having a relook into these cases. It is important, however, that the DTAB/Sub-Committee appointed for this purpose will not only hear the petitioners/appellants before us, but that they also hear submissions from the All India Drugs Action Network.”

Read the judgment below:

Drugs Act-watermark


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