Warning given to Chinese active pharmaceutical ingredients (API) manufacturer by USFDA-Indian Drug Manufacturers may be impacted

Chinese manufacturer Novacyl Wuxi Pharmaceutical has been given warning over basic manufacturing problems at its facility. According to the FDA letter 2013, USFDA investigator found significant cGMP deviations and violations for the manufacture of active pharmaceutical ingredients (APIs) which is the reason behind adulteration of APIs and drug products. The methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding did not conform to cGMP. The operational and administration activities also did not pertain to cGMP.

India is heavily dependent on China for API ingredients as they are cheaply available from China. India’s dependence on China for API imports was also raised by the Opposition in the Lok Sabha in November. The essential drugs for which import is done includes Paracetamol, Ranitidine, Metformin, Amoxicillin, Ciprofloxacin, Acetyl Salicylic Acid, Ofloxacin, Cefixime, Ibuprofen, Ampicillin, and Metronidazole. Chinese manufacturers also control the pricing of such drugs. According to the trade estimates China accounts for 58 percent of such imports by value and 80 per cent by volume for India.