Nearly half of pharma industry may come under price control

Fixed-dose combinations (FDCs), drugs that include two or more therapeutic ingredients, comprise nearly 40 per cent of Indian drug market, say industry bodies that fear the move of National Pharmaceutical Pricing Authority (NPPA) putting them under price control. The drug pricing authority last month proposed to include FDCs under the Drug Price Control Order (DPCO) 2013. The proposal has been made to the Department of Pharmaceuticals (DoP).

DPCO 2013 that lists drugs under price control already includes 18 per cent drugs sold in domestic market, as per the industry bodies. It now fears that bringing FDCs in DPCO will put over half of Indian pharma industry under price control.

“FDCs were made so that a doctor can prescribe one drug instead of three different drugs,” says S V Veerramani, the past-president of the Indian Drug Manufacturers Association (IDMA). “This helps the consumer save considerable amount of money. However, if they are also brought under price control, companies will not be able to sustain. Companies will have to withdraw these drugs,” he says.

Apparently the government’s move to put FDCs under price control is also to make them affordable for patients. It is not for the first time that FDCs have come under regulatory stress. Early last year Central Drug Safety Control Organisation (CDSCO) banned 344 FDCs after Dr C K Kokate committee found them to be irrational. The ban had been issued after the committee's observations that the specified FDCs lacked therapeutic justification. This impacted several high-selling brands such as Corex, Phensedyl and Vicks Action 500 Extra. Later in the year the drug quality regulator again declared about 200 more drugs to be irrational. 

Dr S S Agarwal, immediate past president of the Indian Medical Association (IMA) argues in favour of bringing FDCs under price control. 

Bitter pill

March 2016: Govt bans 344 fixed-dose combinations 

Late 2016: Govt names 200 fixed-dose combinations as lacking therapeutic value

May 2017: Govt proposes to bring fixed-dose combinations under price control