India: Supreme Court Asks Drug Technical Advisory Board To Decide Fate Of 349 Banned Fixed Drug Combination (FDCs) Medicines

The Supreme Court, in its judgment on December 15, 2017, on the matter of fixed drug combinations, has asked the Centre to make arrangement for experts to examine 349 fixed dose combination (FDC) medicines to first determine if there is any "therapeutic justification" to make these FDCs.

The Supreme Court bench of Justice Rohinton Fali Nariman and Justice Sanjay Kishan Kaul, was considering a special leave petition filed by the Union of India and the All India Drug Action Network, and a batch of transfer petitions, challenging an order of the Delhi High Court that quashed the ban of 344 FDCs in December 2016 on the ground of lack of mandatory consultations with the Drug Testing Advisory Board (DTAB) and the Drug Consultative Committee (DCC), statutory requirements under Section 26A.

The present appeals and transfer petitions relate to the interpretation of Section 26A of the Drugs and Cosmetics Act, 1940. By the impugned judgment of the learned single Judge of the Delhi High Court dated 1.12.2016, the learned Judge has held that the mandatory condition precedent for the exercise of the power by the Central Government under Section 26A of the Drugs Act is the prior consultation of the DTAB set up under Section 5 of the said Act.

Whereas, the FDCs, which contain two or more therapeutic ingredients, packed into a single dose, were banned on the recommendation of the government-appointed Kokate committee, which was set up to look into safety and efficacy of FDCs that lacked regulatory approval from the Central Government. The Kokate committee had deemed these FDCs irrational; and accordingly, the Government notified a ban on them.

About Kokate committee:

The Kokate committee was an expert committee set up by the Ministry of Health and Family Welfare (MoHFW) for examining and listing in categories, the safety and efficacy of FDCs as per the following terms of reference:

  1. FDCs which are considered grossly irrational/unsafe based on pharmacokinetic and pharmacodynamic interaction, dosage compatibilities of FDCs vis-a-vis that of single ingredients present in the FDC and available literature/evidence.
  2. FDCs which the Committee may consider necessary for further deliberation by any of the 10 Expert Committees already constituted.
  3. FDCs which are considered as safe and effective based on pharmacokinetic and pharmacodynamics interaction, dosage compatibilities of FDCS vis-a-vis that of single ingredients present in the FDC, available literature/evidence, clinical experience and other data available.
  4. FDCs which may be considered as rational, based on present data and knowledge available. However, data in post market scenario is required to be generated within a period of 1 to 2 years to confirm the same.

The Kokate committee had reviewed over 6300 fixed dose combination products and classified them in the four categories as described above: a) irrational, b) require further deliberations, c) rationale and d) require additional generation.

The Supreme Court Verdict -

The Supreme Court, in its verdict, stated that for the exercise of powers under Section 26 (A) of the Drugs and Cosmetics Act, the DTAB need not be mandatorily consulted by the Government in order to be convinced of reasons for banning a medicine. The Court remarked that the Government could be justified in declaring a ban even if it finds that the drug has been banned in other countries.

Insofar as the 15 drugs that have been banned by Central Government notifications and which were manufactured before September 21, 1988 are set aside, as these cases were never meant to be referred to Kokate Committee. However, it will be open for the Central Government, if it so chooses, de novo, to carry out an inquiry as to whether such drugs should be the subject matter of a notification under Section 26A of the Drugs Act.

Insofar the cases of 349 FDCs that have been banned Including 5 FDCs that banned recently 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.

Supreme Court (SC) directions to DTAB:

In order that an analysis be made in greater depth, the DTAB and/or a Sub-Committee formed by the DTAB for the purpose of taking a re-look into these cases, will not only hear the petitioners/appellants before SC, but they will also hear submissions from the All India Drugs Action Network.

The DTAB/Sub-Committee set up for this purpose will deliberate on the parameters set out in Section 26A of the Drugs Act, as follows.

  1. First and foremost, in each case, the DTAB or the Sub-Committee appointed by it, must satisfy itself that the use of the Fixed Dose Combinations (FDC) in question is likely to involve any one of the aforesaid three things:

    1. That they are likely to involve any risk to human beings or animals; or
    2. That the said FDCs do not have the therapeutic value claimed or purported to be claimed for them; or
    3. That such FDCs contain ingredients and in such quantity for which there is no therapeutic justification.
  2. The DTAB/Sub-Committee must also apply its mind as to whether it is then necessary or expedient, in the larger public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs. In short, the DTAB/Sub-Committee must clearly indicate in its report:

    1. As to why, according to it, any one of the three factors indicated above is attracted;
    2. Post such satisfaction, that in the larger public interest, it is necessary or expedient to (i) regulate, (ii) restrict, or (iii) prohibit the manufacture, sale or distribution of such FDCs.
  3. The DTAB/Sub-Committee must also indicate in its report as to why, in case it prohibits a particular FDC, restriction or regulation is not sufficient to control the manufacture and use of the FDC1.

Note - The SC suggested to DTAB/Sub-Committee to be set up for this purpose to afford the necessary hearing to all concerned, and thereafter decide whether the manufacture and sale of these drugs should be regulated, restricted or outright banned, and submit a report with its recommendations to the government within six months from the date on which this judgment is received by the DTAB.

The SC also suggested that the Central Government, thereafter, must give due regard to the report of the DTAB and to any other relevant information, and ultimately apply its mind to the parameters contained in Section 26A of the Drugs Act and, accordingly, either maintain the notifications already issued, or modify/substitute them or withdraw them.

Conclusion:

The Supreme Court judgment on the issue of Fixed Dose Combinations is a landmark judgment, as this now gives a clear direction to the government and regulator to look into this long- standing issue of fixed dose combination products in the country. The apex court has referred the issue of prohibition of 349 FDCs to the union health ministry's expert body on technical matters, the Drugs Technical Advisory Board (DTAB). The court has further asked the DTAB to submit a report with its recommendations to the government within 6-month.

Case Citation: Union of India Anr. (Appellants) vs Pfizer Limited and Ors. (Respondents), Supreme Court of India, Civil Appeal No. 22972 of 2017 (arising out of SLP (C) No. 7061 of 2017), D/d 15.12.2017.

Footnote

1. http://sci.gov.in/supremecourt/2017/3271/3271_2017_Judgement_15-Dec-2017.pdf

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