A large number of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector have been identified by the government as producing substandard drugs.
More than 65% of MSME firms have been found to be manufacturing drugs that are not of standard quality (NSQ), during risk-based inspections of pharma companies conducted since December last year, said a person with knowledge of the matter.
Out of the total MSME units inspected, 30% were issued stop production orders (SPO), the person cited above told ET. “Samples of 68% MSME companies have failed. This is alarming,” the person said.
Currently, Phase IV of the risk-based inspections is being conducted. During this process, the inspectors withdrew samples from 22 companies. Out of the total 446 samples drawn, 271 were analysed. “While 230 samples were found to be of standard quality and 41 were NSQ,” the person said.
The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and was last amended in 2005. Schedule M sets out the requirements for drug plants.
However, in September, several industry associations representing the MSME sector wrote to the health ministry and the drug regulator citing that the move will impact competition and will have a drastic impact on the availability of medicines.
