Govt bans 328 fixed-dose combination drugs

The Union Health Ministry has banned manufacture, sale and distribution of 328 fixed-dose combination (FDC) drugs following the recommendation on an expert panel that was set up on the advice of the Supreme Court.

“The Ministry of Health and Family Welfare has prohibited manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated September 7, 2018. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect,” the ministry said in a statement.

These concoctions of medicines, though clinically irrational, are used to manufacture hundreds of medicines under different brand names for sale in Indian retail medicine market, where FDC sale amounts to thousands of crores.

The decision comes after more than two years of legal battle between the government and pharmaceutical companies that challenged the Health Ministry's March 2016 decision to ban 344 FDCs as their manufacture is not clinically justified.

Giving its ruling on a bunch of petitions from the pharma firms, the apex court in December 2017 asked the central government to make arrangement for experts to examine the 349 FDC medicines once again to find out if there is any “therapeutic justification” to make these FDCs in the first place.

The 2016 decision was also on the basis of a recommendation by an expert panel.

The second expert committee that was set up after the Supreme Court order recommended banning 343 irrational FDCs after reviewing the health ministry's previous order.

“The committee noted that most appellants (companies manufacturing these medicines) had not generated safety and efficacy data of their own for their FDC. The published literature they provided to justify the FDC was not relevant because epidemiological data is not from India. They also relied on a few biased studies,” it stated in the report.

It also found that indications (symptoms indicative of a disease) mentioned by the pharmaceutical companies were too broad, absurd and vague and using such FDCs would lead to unnecessary overuse of a drug and the patients would be exposed to the risk of multiple ingredients when one would suffice.

“The central government considered the recommendations of the Expert Committee and Drugs Technical Advisory Board, and based on such consideration, it was concluded that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of these 328 FDCs in the country,” the health ministry said.

On the remaining 15 FDCs, there is no decisions yet as the legal procedures are yet to be completed.