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).
"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.
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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.
"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.
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".
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