The Central Drugs Standard Control Organisation (CDSCO), along with state drug authorities, have inspected more than 25 units at Baddi in Himachal Pradesh and in Punjab so far this year. The regulator has issued show-cause notices to several of them, and some have been ordered to stop production, a person in the know told ET.
Most of the units facing action are micro, small and medium enterprises (MSMEs).
The regulator has been conducting risk-based inspections since December 2022 as part of a nationwide crackdown on spurious and substandard drugs. The inspections have found that the share of nonstandard quality medicines manufactured in the micro, small and medium enterprises is seven times more than the national average.
Out of the 271 samples analysed last year, 41 (15.1%) were declared to be not of standard quality (NSQ).
Another person in the know said 30% of the MSME units inspected till last year were asked to stop production. “A strong correlation has been seen between the NSQ and MSME units,” the person said.The CDSCO had earlier pointed to an urgent need to review the manufacturing practices and quality management systems followed by pharmaceutical companies.The health ministry had also notified the revised Schedule M for pharma companies in a bid to improve the quality of drugs. Under this, health minister Mansukh Mandaviya announced in August last year, companies with a turnover of ₹250 crore or more will have to implement the revised good manufacturing practices (GMPs) within six months. Medium and small-scale enterprises with a turnover of less than ₹250 crore will have to do so within a year. Companies that fail to follow the timeline could be penalised.
The GMP system was 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 manufacturing plants.
Last September, several industry associations representing the MSME sector wrote to the health ministry and the drug regulator, saying that the move would wipe out competition and have a drastic impact on the availability of medicines.
According to a person associated with an industry association, at present only about 20% of the country’s drug manufacturers comply with World Health Organisation’s GMP standards. Most of the others could face closure if the revised Schedule M is implemented without providing them adequate time and handholding, this person said.
“We had estimated in 2019 that MSMEs will require a minimum of ₹3 crore to ₹5 crore per manufacturing unit and a minimum of three years to comply with the revised Schedule M requirements,” he said. “The government should consider three years from the date of final notification as the date of final compliance. These three years are required for improving infrastructure, additional manpower recruitment and training, and implementation of revised SOPs (standard operating procedures).”
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