Putting an end to a long-drawn legal battle with drug manufacturers, the Union Health Ministry has banned the manufacture, sale and distribution of 328 fixed dose combinations (FDCs) of drugs with immediate effect and restricted another six. The ministry has been trying for the past two years to get these “irrational” and “unsafe” drugs banned, said media reports on Thursday.
Among the about 6,000 brands to be affected by the ban are popular drugs like the painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG and antibiotic Lupidiclox. 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 Decembler, the SC asked for the matter to be examined by the Drugs Technical Advisory Board (DTAB).
The DTAB report said there was no therapeutic justification for the ingredients in 328 of the FDCs and recommended banning them. It recommended restricted manufacture and sale subject to certain conditions of six FDCs. On 15 drugs, the SC ruled that the Government could not use the DTAB report to prohibit them. This exception covered several popular cough syrups, painkillers and cold medication with sales amounting to over Rs 740 crore annually. But it also told the ministry that it could still look into the safety of these 15 drugs with a fresh investigation if it still wanted to ban them.
Meanwhile, The All India Drug Action Network, a civil society group which was one of the petitioners in the Supreme Court case, 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 said in a statement. Reacting to the ban, several drug companies have claimed that they have anyway either phased out such
drugs or changed the combination.