SC for relook into 349 FDC medicines by drug advisory board

Pharmaceutical firms have suffered a setback as the Supreme Court has favoured re- examination of 349 fixed dose combination (FDC) medicines, a ban on which was set aside by the Delhi High Court.
The FDC medicines, including well-known brands such as Corex cough syrup and Vicks Action 500 Extra and several anti-diabetes drugs, were banned by the Centre on the grounds that they involved "risk" to humans and safer alternatives were available.
Deciding the appeals of the Centre, a bench of justices R F Nariman and S K Kaul yesterday set aside the high court order, saying that the requisite procedure prescribed in the Drugs and Cosmetics Act were not followed and ordered that these medicines be re-examined by the Drugs Technical Advisory Board (DTAB).

The Centre had on March 10, 2016 banned the FDC medicines on the recommendations of the Kokate Committee.
"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," the apex court said in its verdict.
It said that THE DTAB or its sub-committee appointed for this purpose would hear the drug manufacturers and also the the submissions from NGO All India Drugs Action Network.

The top court said that the DTAB/sub-committee will deliberate on the parameters set out in section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of the drugs Act like first and foremost in each case, it must satisfy itself that the use of the FDC in question is likely to involve any risk to human beings or animals.

Secondly, it said the FDCs do not have the therapeutic value claimed or purported to be claimed for them and whether such FDCs contain ingredients and in such quantity for which there is no therapeutic justification.
It said that 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.
The bench said that the board or committee must clearly indicate in its report as to why, according to it, any one of the three factors are attracted and post such satisfaction, that in the larger public interest, it is necessary or expedient to regulate, restrict, or prohibit the manufacture, sale or distribution of such FDCs.

The top court said that the DTAB/Sub-Committee must also indicate as to 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," it said.
The Delhi High Court had on December 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 the high court included 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.
The apex court, however, said that "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".