“We will make a framework (for the risk-based inspection). We will switch the checklist and the questions which we look at when we go there (for audits),” Raghuvanshi said on the sidelines of an Indian Pharmaceutical Alliance (IPA) event.
Raghuvanshi said there would be surprise inspections, which would take 3-4 days.
India has around 10,000 pharmaceutical manufacturing units, of which more than 80% are MSMEs.
Raghuvanshi said it’s not possible to audit all of them. “We have to do risk-based (inspections), which we are doing,” he said.
The revised Schedule M, which is considered more stringent than the World Health Organization’s (WHO) good manufacturing practices (GMP) in certain areas, was notified on December 28, 2023.Companies with turnover of over ₹250 crore will have to comply with the upgraded version of Schedule M, starting July 1, and the remaining others, which are largely micro, small, and medium enterprises (MSMEs), have been given a year’s time to comply. Inspections on those firms will begin from January 1, 2025.Raghuvanshi, who took over the charge as DCGI in February 2023, is trying to restore the reputation of made-in-India medicines, battered by scores of child deaths in Uzbekistan and The Gambia, linked to the consumption of tainted cough syrups by Indian manufactures.
As part of the massive crackdown, Central Drugs Standard Control Organisation (CDSCO) teams have inspected 400 manufacturing units, most of them MSMEs, leading to the shutdown of dozens of units. The teams also audited drug testing laboratories that were making substandard and poor quality drugs.
Raghuvanshi said inspections have found lapses in process validation , poor documentation, many smaller units didn’t have full fledged quality control labs, and were using external labs.
“(I am) not very happy to say that more than 36% of them have to be closed,” Raghuvanshi said.
“Some of them decided to move out (of manufacturing), they have realised that they can not meet the expectations of the regulator,” Raghuvanshi added.
Raghuvanshi was also instrumental in bringing revised and upgraded Schedule M. There has been a major internal shake up as well.
