Government bans sale of 328 fixed-dose combinations

Health Ministry has prohibited the manufacture and sale of 328 fixed-dose combinations (FDCs) for human use with immediate effect observing that they may involve risk to patients.

The restriction comes after the central government published a notifications in March, 2016 prohibiting the manufacture, sale and distribution of 344 FDCs drug under section 26A, Drugs and Cosmetics Act, 1940. In response to this, manufacturers had contested the matter in High courts and the Supreme Court, which directed the Drugs Technical Advisory Board to look into the matter. The board found no therapeutic justification for the ingredients used in 328 FDCs brought to its notice. Another six FDCs are also restricted subject to certain conditions. An Expert Committee appointed by the government also made similar recommendations on these FDCs.

In-line with these observations by the Drugs Technical Advisory Board and the Expert Committed the Ministry of Health and Family Welfare has prohibited 328 FDCs through a gazette notifications on September 7.

Reacting to this development, the stock of several pharma companies focused on the Indian market tanked including Granules, Caplin Point, Opto Circuit, Unichem Labs and HesterBio were down more than 3 per cent. While Shalby, Vivimed Lab and Astrazeneca Pharma were down more than 2 per cent.