New Delhi: More than 15% of medicines produced by small companies in India failed to meet quality standards compared with the national average of about 2%, says a government report on a recent survey.
In the government’s latest risk-based inspections of micro, small and medium enterprises (MSMEs), which have been on since December 2022, of the 271 samples analysed, 41 (15.1%) were declared to be not of standard quality (NSQ), says the report, which has been reviewed by ET.
A person in the know said 30% of the MSME units inspected were issued a stop production order (SPO).
“A strong correlation has been seen between the NSQ and MSME units,” the person said.
The Central Drugs Standard Control Organisation (CDSCO), along with state drug inspectors, has been carrying out inspections as part of a nationwide crackdown on spurious and substandard drugs.
At present, phase IV of risk-based inspections is on.
“Monthly NSQ data shows repeat failures for a company with the same product, and same product with multiple companies month-on-month,” another person said.
India’s drug regulator had earlier pointed to an urgent need to review the good manufacturing practices (GMP) regulations and quality management systems being followed by pharmaceutical companies during the inspections.
In August last year, 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 that fail to follow the timeline may be penalised as per the provisions of the law.
