MSME Pharma companies under the lens over drug quality issues

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.

The Central Drugs Standard Control Organisation (CDSCO) along with state drug inspectors have been doing these inspections as part of a massive nationwide crackdown on spurious and substandard medicines. This followed controversy over alleged Made-in-India cough syrups being responsible for the deaths of children in Gambia.

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.

“There has been a strong correlation between NSQ and the condition of manufacturing set up. Monthly NSQ data shows repeat failures for a company with the same product and same product with multiple companies month on month,” a second person said.
India’s drug regulator had earlier pointed to an urgent need to review the current GMP regulations and Quality Management Systems being followed by pharma companies during the RBI.
In August, Union health minister Mansukh Mandaviya had announced that companies with a turnover of ‘250 crore and more will have to implement the revised GMP within six months. Medium and small-scale enterprises with a turnover of less than ‘250 crore will have to implement it within a year. He also said that companies which fail to follow the timeline may be penalised.

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.

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