Several small pharma units told to halt operations over quality

Feb 23,2024

Several drug manufacturing units are under the scanner for quality with the drug regulatory authority carrying out risk-based inspections.

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.

Source: Pharma