Center orders new standards for drug manufacturing after deaths abroad

New Delhi: India’s pharmaceutical companies will have to comply with new manufacturing norms this year, according to a government notification published on Saturday, although smaller companies have sought a delay, citing their debt burden. Shocked by a series of deaths abroad related to drugs manufactured in India since 2022, Prime Minister Narendra Modi’s government has stepped up scrutiny of drug factories to clean up the image of this $50,000 million industry. “The manufacturer must take responsibility for the quality of pharmaceutical products to ensure that they are suitable for the intended use, comply with the requirements of the license They say companies should market a finished product only after achieving “satisfactory results” in material testing and should retain sufficient quantities of samples of intermediate and final products to allow repeated testing or validation. . The health ministry said in August that inspections of 162 pharmaceutical factories from December 2022 had found “lack of testing of raw materials used”. That is, less than a quarter of the 8,500 small pharmaceutical factories in India comply with international standards of drug manufacturing set by the World Health Organization (WHO). The notification states that large drug manufacturers should address these concerns within a period of six months and smaller manufacturers within 12 months. Smaller companies had sought an extension, warning that almost half of the investment needed to meet the standards would be put on hold because they are too indebted. OMS and other health officials have linked the rabbits to the deaths of at least 141 children in Gambia, Uzbekistan and Cameroon.