The Drug Controller General of India (DCGI) has listed a new set of 1200 fixed-dose combinations(FDCs) which was sent for investigation of the panel that eradicated nearly 350 drug combinations last week. FDC is a combination of more than two drugs in a single pill. According to experts various drugs from a single therapeutic group can result with resistance. Most pharma companies in India get their license from a state to sell the FDC’s without the Central government’s recognition. The DCGI has been taking constant steps to assure patient safety. One recent expected change on the medical device sector is the new regulation of medical devices is being drafted.
Under the category of irrational, 350 have been listed among the 963 FDC’s, the final listing is yet to be generated in a time period of six months. A famous P&G product, Vicks Action 500 fell into the list and the company has stopped its manufacturing and sale.
Over the 1,200 listed FDCs, 120 drugs would be categorized as ‘banned’ in the list given by DCGI to the Kokate committee, a DCGI official stated. “Each FDC possess about more than 5 brands in the market which implies approximately 1.200 could be banned”. Banning about 350 FDCs could be disastrous to about 2,700 branded drugs causing a loss of nearly Rs 7,000 crore to the industry.
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