Supreme Court asks drugs advisory body to decide fate of over 334 banned combination medicines
NEW DELHI: The Supreme Court has asked the country's technical advisory body on drugs to decide on the fate of more than 300 combination medicines banned by the government between March 2016 and June 2017. The order is a potential relief to drug makers who have argued that the government did not consult statutory bodies provided for in the country's drug regulations before banning these drugs.
Companies can make and sell the 349 contested fixed dose combination drugs (FDCs) while Drugs Technical Advisory Board (DTAB) deliberates on the issue.
At the same time, the court also clarified that this order is specific to two of the government's ban notifications due to "peculiar facts" of the cases.
In an order dictated in open court on two government notifications banning these FDCs, a Supreme Court bench of Justices Rohinton Fali Nariman and Sanjay Kishan Kaul on Thursday said it was setting aside the ban on 15 such drugs which were manufactured in India before 1988.
However, if it chooses to, the government can carry out further inquiry on whether these drugs should continue to be marketed in the country, the court suggested.
For the remaining 334 FDCs, the court suggested that DTAB should decide whether the manufacture and sale of these drugs should be regulated, restricted or outright banned, and submit a report with its recommendations to the government within six months.