Government bans Saridon, 327 other fixed-doze combination drugs due to health risks

In a major setback to both domestic and foreign pharmaceutical companies, the Indian government has banned 328 fixed-doze combination or FDC drugs to stop their irrational use. The order has been implemented with immediate effect and bans the selling, marketing and manufacturing of several common cough syrups, painkillers and flu and cold drugs. The ban has been cheered by several health activists concerned about the increasing dependency on antibiotic medicines or the misuse of it. Justifying the ban, the health ministry stated that the ingredients of these drugs do not add to the benefits that people can get from taking them. The ministry has also informed that about 15 FDCs have been kept out of the apprehension of the recent ban. “No therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings,” news agency Reuters quoted the health ministry as saying. Though these medicines have been banned with immediate effect, but the ministry did not gave the name of drugs or brands in particular. The president of the Indian Drug Manufacturers’ Association, Deepnath Roychowdhury, told Reuters that the order would have an impact on a market worth an estimated 16 billion rupees ($222 million) a year for such drugs, which are produced by both small and large pharmaceutical companies. “Combination drugs are used to improve patients’ compliance, as it is easier to get patients to take one drug rather than several. But inconsistent enforcement of drug laws in India has led to a proliferation of such medicines based on state approvals, rather than from the federal government,” Roychowdhury added further. Even in 2016, the government had banned about 350 such drugs, referred to as fixed-dose combinations (FDCs), but the industry came out with several legal obligations which forced the Supreme Court to call for a review by an advisory board.