The Union Ministry of Health and Family Welfare is likely to curb the number of ‘combination drugs’ that are sold in India, often with no discernible benefit to consumers.
It may withdraw licences given to some 200 fixed dose combinations (FDCs) which are deemed irrational, industry sources said. (An FDC combines two or more medicines which will be sold under a new brand name; they cost three to four times individual drugs.)
The government action may come in spite of a pending case in the Madras High Court regarding withdrawal of licences to some 294 FDCs.
Health experts say many FDCs are unnecessary products that often combine totally unrelated drugs just to increase sales for their manufacturers.
Estimates suggest that in the Rs66,000 crore domestic pharmaceuticals market, FDCs account for over Rs15,000 crore.
Gopal Dabade, co-convenor of the All India Drug Action Network, said medical representatives (MRs) of drug-makers promote FDCs as new products before doctors.
“Some FDCs have drugs like nimesulide that are banned globally due to adverse side-effects. FDCs carry no special benefits for patients,” said C M Gulhati, editor of the Monthly Index of Medical Specialties, a medical reference journal.
“State-level drug controllers had issued licences for these irrational combinations without prior approval from the Drugs Controller General of India (DCGI). The government has been talking of a ban for quite some time now,” said an expert who works closely with the health ministry.
The government is said to be preparing to withdraw some FDCs containing multivitamins, paracetamol and anti-cholesterol drug atorvastatin from the market. But there are no clear indications from the DCGI yet, said the expert. “It might be a few months or so before the withdrawal of licences actually happens."