“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.