Hundreds of Fixed Dose Combinations (FDCs) drugs continued to be sold in the market in the country, the Drug Controller General of India (DCGI) has admitted in a recent order. It has now directed the concerned drug manufacturers to prove the safety and efficacy of such medicines within the next two months.
But what is more intriguing is that the drug regulator itself seems to be unaware of the names of such Fixed Dose Combinations (FDCs) being illegally sold as both the orders do not specify names of such drugs except mentioning those 294 FDCs whose fate lies presently under the jurisdiction of the Madras High Court.
Moreover, it will be interesting to see how much and how many drug firms will fall in line to the DCGI instructions given that its similar order issued six months ago has failed to evoke any response from the sector so far.
As per the DCGI directive, the manufacturers need to submit documents proving the safety and efficacy of the FDCs.
“In case they are unable to do so, they will be either asked to conduct the clinical trial or stop the sale. In case of multiple applications for the same FDC, all such applicants will have option to conduct one such study (wherever necessary) sponsored by the firm, if required,” said a senior official from the DCGi.
The move follows observations from a Parliamentary Standing Committee of the Ministry of Health and Family Welfare that some of the State licencing Authorities have issued manufacturing licenses for a large number of Fixed Dose Combinations (FDCs) without prior clearance from the DCGI.
“This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk,” noted the panel.
The drug controller in early January too had asked the State Governments to ask the concerned manufactures to prove the safety and efficacy of such Fixed Dose Combinations (FDCs) before it within a period of 18 months, failing which such FDCs would be considered for being prohibited for manufacture and marketing in the country.
“However, so far hardly any manufacturer has approached us to prove the safety and efficacy of such FDCs,” the official said.