1,600 combination drugs under govt lens, may face ban over safety issues

The government is planning another clampdown on fixed-dose combination (FDC) drugs, following a ban on more than 300 such medicines over safety issues last month. 

For the next round of the ban, the government is looking at combinations that were recommended for further investigation by the Chandrakant Kokate committee. Of the 1,600 FDC drugs that are under watch now, around 600 are learnt to be vitamins. 

The experts' panel had in 2016 recommended curbs on "irrational combinations" falling under the FDC category. The Kokate committee had observed that while there were some combination drugs that definitely lacked therapeutic value, the rationality of a few others needed more research to give a final decision. 
 

The Drugs Technical Advisory Board (DTAB) is judging the efficacy of 1,600 combination drugs to decide how many of these should be banned. In the past round, where more than 300 FDC drugs were banned by the government, the Supreme Court had provided relief for some. In the same order, the apex court had restrained the central government from acting on a panel recommendation to restrict the sale of FDCs approved prior to 1988. 

The SC order came in response to pleas by Abbott and others, which argued that the recommendation to include 15 pre-1988 approved FDCs in the ban list was against the court verdict.

The DTAB in July had accepted the recommendations of the experts' panel, which was appointed to probe the efficacy of 349 FDCs. While a ban was proposed on 343 drugs, the board suggested restricted use with respect to six drugs. 

Aggrieved by the government decision, companies had moved the court. Abbott manufactures Phensedyl and Tixylix, which have annual sales worth Rs 2.8 billion and Rs 560  million, respectively. Phensedyl is the largest selling fixed-dose combination drug in the domestic market.

The companies argued that the Supreme Court in its December 2017 order had referred 329 drugs to the DTAB for further review. Fifteen pre-1988 approved drugs were not in the review list as the court had set aside government notifications banning their sale.