An employee inspects a handful of tablets inside a drug making facility. (Photographer: Martin Leissl/Bloomberg)

Supreme Court Refers 349 FDC Medicines To Drug Advisory Board For Relook

The Supreme Court today referred 349 fixed dose combination medicines, including brands like Corex cough syrup, Vicks Action 500 extra and several anti-diabetes drugs to the Drugs Technical Advisory Board for re-examining.

The apex court set aside the order of the Delhi High Court which had quashed the Centre’s decision to ban these drugs on the ground that the procedures prescribed in the Drugs and Cosmetics Act, were not followed.

A bench of justices RF Nariman and Sanjay Kishan Kaul said that the 349 FDCs were banned pursuant to the Kokate Committee report, by notifications of the central government under Section 26A of the Drugs Act.

“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 said.

The bench said that DTAB or its sub-committee appointed for this purpose will hear the drug manufacturers. It would also hear submissions from non-government organisation All India Drugs Action Network.

The top court said that the DTAB or the sub-committee will deliberate on the parameters set out in section 26A - which gives the power to prohibit manufacture of drugs and cosmetics in public interest - of the Drugs Act in each case. It must satisfy itself that the use of the FDCs in question is likely to involve any risk to human beings or animals.

Secondly, it said that FDCs do not have the therapeutic value claimed or purported to be claimed for them.

The bench said that the DTAB or its sub-committee must:

  • Decide whether it is then necessary in the larger public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs.
  • Clearly indicate in its report the reasons why any of the three actions are warranted.
  • Indicate why, in case it prohibits a particular FDC, restriction or regulation is not sufficient to control the manufacture and use of the FDC.
We request the DTAB/Sub-Committee to be set up for this purpose to afford the necessary hearing to all concerned, and thereafter submit a consolidated report, insofar as these FDCs are concerned, to the central government within a period of six months from the date on which this judgment is received by the DTAB
Supreme Court Bench

It indicated that the central government must then regard the DTAB’s report to modify its notification or withdraw it.

The Delhi High Court had on Dec. 1, 2016, allowed the petitions of various pharma and healthcare majors, like Pfizer, Glenmark, Procter and Gamble and Cipla, challenging the government’s March 10 notification banning the FDCs, saying the decision was taken by the Centre without following procedure prescribed in the Drugs and Cosmetics Act.

Some of the well-known medicines on which the ban on sale was lifted by Delhi High Court include Pfizer's Corex cough syrup, Glaxo's Piriton expectorant and Crocin Cold, P&G's Vicks Action 500 extra, Reckitt’s D’Cold, Piramal's Saridon, Glenmark’s Ascoril and Alex cough syrups, Abbott’s Phensedyl cough syrup and Alembic’s Glycodin cough syrup.