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Delhi HC sets aside ban on 344 combination drugs( thehindu)



The Delhi High Court on Thursday set aside the Centre’s ban on 344 fixed dose combination (FDC) drugs, including Corex cough syrup and Vicks Action 500 extra, saying the decision was taken in a “haphazard manner” without consulting the statutory bodies as mandated under the law.

Justice Rajiv Sahai Endlaw said Section 26A of the Drugs and Cosmetics Act, which gives the power to stop manufacture of drugs and cosmetics in public interest, does not vest the government with carte blanche to regulate, restrict or prohibit the manufacture, sale or distribution of a drug. The court said the “power of regulation, restriction or prohibition under Section 26A cannot be exercised in public interest, for any reason other than the drug posing a risk to consumers thereof or having no therapeutic value or no therapeutic justification.” These aspects should be considered by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC), a process which was not done.

It said the March 10, 2016 decision banning the 344 FDCs was based on the recommendations of the Kokate Committee and without consulting the DTAB, the DCC and the Central Drugs Laboratory, the bodies set up under the Drugs and Cosmetics Act. The judge said that from the facts in the 454 petitions filed by pharma majors like Pfizer, Glenmark, Procter and Gamble and Cipla, it emerged “there was a total exclusion of the DTAB, the DCC and the Central Drugs Laboratory, and which in my view cannot be permitted.” — PTI
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