Union ministry bans 328 fixed dose combinations of drugs considered unsafe
After a long drawn fight led by health activists against pharmaceutical companies, the Union Health Ministry recently banned the manufacture, sale and distribution of 328 fixed-dose combinations (FDCs) of drugs with immediate effect. These include widely popular drugs like Saridon, and skin cream Panderm, antibiotic Lupidiclox and combination diabetes drug Gluconorm PG, among others. It also restricted another six.
The notification, issued on March 10, read “On the basis of recommendations of an expert committee, the central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale distribution for human use of said drugs in the country.”
The health ministry had been trying to ban these drugs for the past two years, on the grounds that they are ‘irrational’ and ‘unsafe’. This comes after the SC asked for the matter to be examined by the Drugs Technical Advisory Board (DTAB) in December 2017. The report of DTAB recommended the ban of the 328 FDCs, as there was no therapeutic justification for their ingredients. It also suggested restricted manufacture and sale of the six FDCs. The Supreme Court said it would look into the safety of another 15 drugs with a fresh investigation, as it could not use the DTAB report to ban them.
In 2016, the government had banned over 300 FDC drugs on the ground that they involve ‘risk’ to humans and safer alternatives were available. However, this decision was later overturned by the court. This fact was brought about as an argument by the drug companies during the Delhi High Court hearing.
On the other hand, the government contended that the FDC medicines are ‘new drugs’ and, therefore, would require license from Drugs Controller General of India (DGCI) for sale and manufacture. The fact that the banned drugs lacked approval was a secondary issue, and the primary focus was that they ‘lacked safety and efficacy’. The government also said that it was difficult to implement any action at state level, as there were no valid licences for making any of the banned FDCs. Thus, the government believed that ban of these drugs was the only option left.
The All India Drug Network, a civil society group welcomed the decision. They mentioned that the banned FDCs account for Rs. 2500 crore, but represent only a small part of the actual amount. According to their 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.
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