New Delhi: The Supreme Court on Monday lifted a ban on the manufacture and sale of Piramal’s painkiller Saridon and two other drugs – Piriton and Dart – for now. A bench of Justice Rohinton Fali Nariman and Justice Indu Malhotra sought the Centre’s response to the pleas by affected pharmaceutical companies against the order to ban FDCs manufactured before 1988.
The bench is hearing cases on the validity of fixed-dose drug licences. Questioning the ban, the companies had earlier said that the only reason given in the government’s notification was that the combinations had “no therapeutic value”.
It is to be noted here that the Health Ministry had banned the manufacture, sale, and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect and restricted another six. The list of such drugs includes Piramal’s painkiller Saridon, Macleods Pharma’s Panderm Plus skin cream, Alkem Laboratories’ antibacterial Taxim AZ and combination diabetes drug Gluconorm PG.
In 2016, the Government had banned 344 FDCs but their manufacturers contested the ban in various high courts and the Supreme Court. Last year in December, the SC asked for the matter to be examined by the Drugs Technical Advisory Board (DTAB).
The All India Drug Action Network, a civil society group which was one of the petitioners in the Supreme Court case, had welcomed the ban and sought swift action from the Government on the 15 excluded FDCs. “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” it had said in a statement.