SC refers 344 fixed dose combination medicines to Drug Advisory Board for Re-examination

New Delhi: The Supreme Court referred 344 fixed dose combination (FDC) medicines, including well- known brands like Corex cough syrup, Vicks Action 500 extra and several anti-diabetes drugs to the Drugs Technical Advisory Board (DTAB) for re-examining.

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

Read also: Big Relief to Pharma Companies: Delhi HC quashes ban on FDC drugs

A bench of justices R F 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.

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

The top court said that 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 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 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 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.

It indicated that "the central government, thereafter, must have 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".

The bench said it is not going into the issue of whether section 26A is legislative in nature and therefore excludes natural justice and was only concerned with the verdict of single judge of Delhi High Court which was being set aside.

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.

Read also: List of Banned Fixed Dose Composition drugs

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 DCold, Piramal's Saridon, Glenmark's Ascoril and Alex cough syrups, Abbott's Phensedyl cough syrup and Alembic's Glycodin cough syrup.

The bench said that insofar as the drugs that were banned and which were manufactured before September 21, 1988, it set aside the central government notifications banning them as these cases were never meant to be referred to the Kokate Committee.

It, 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".

The bench said that the view taken by the Karnataka and Madras High Court on a similar issue was a correct one by which it was held that consultation with the DTAB is not mandatory before the exercise of power under Section 26A.