BRIEF—India bans 328 fixed-dose combination drugs over safety grounds

The Indian health ministry on Wednesday notified a ban on 328 fixed-dose combination (FDC) drugs on safety grounds, Business Standard reports.

The ban follows the recommendation of the drug technical advisory board (DTAB). The manufacture and sale of six FDCs will be restricted. These include anti-diabetic drugs, antibiotics, and analgesics.

The DTAB had in June originally recommended against 349 drugs, but 15 drugs, approved prior to 1988, have been kept outside the purview of the ban. This follows a Supreme Court (SC) order last week, which restrained the government from banning those 15 drugs. The 15 drugs, which include cough and cold medicines Phensedyl and Tixylix, have a market size of over 7 billion rupees ($97.4 million).

The ban could impact overall sales of around Rs 15 billion, but the exact number could not be immediately ascertained.