Chennai: In the first phase of the regulatory inspections conducted in 46 pharmaceutical manufacturing companies in Tamil Nadu by the state drug inspectors, it was found that only four companies are 100 percent compliant with the norms of Revised Schedule M of the Drugs and Cosmetics Act 1940.
This was the first new GMP-focused inspection conducted by a state drug control department in India after the notification of the Revised Schedule M Guidelines by Government of India on January 6, 2024.
In Tamil Nadu, inspections were conducted on the 8th and 9th of this month, and the head office is awaiting the reports from the inspectors’ offices. Prior to the inspections, on September 20 and 21, the drug inspectors were given training on how to conduct inspections in manufacturing units. All the 132 drug inspectors attended in the upskilling programme.
According to sources from the drug control department, the remaining 306 companies will be inspected after January 4, which is the last date mandated for the small players to upgrade the facilities as per the new Schedule M. According to the statistical data available with the DCA, there are 352 pharmaceutical manufacturing companies in Tamil Nadu.
Sources informed Pharmabiz that the inspections conducted on November 8 and 9 were not risk-based inspections by joining with CDSCO officers, but were purely a state inspection based on the revised schedule. The drug control department prepared a checklist based on the new Schedule M norms and the inspectors used the list while inspecting the companies. The department had formed various teams of inspectors to conduct inspections in companies located in different parts of the state. One team consisted of two drug inspectors and one senior drug inspector. Inspections in each company continued for two days.
As far as the large companies are concerned, this was a belated inspection in their facilities as the last date mandated for them, those companies with a turnover above Rs. 250 crore, ended on July 5 this year. Within that period, the department did not conduct any inspection in those companies, but they were included in the inspections conducted at present. Out of the 46 companies inspected, the inspectors found that above 50 per cent of them were complying with 80 per cent of the norms. Very few companies were found complying with less than 70 per cent.
“It was a new GMP-focused inspection process we have just now completed, it will continue after one month. The timeline given for the small companies will end on January 4, 2025, after that we will initiate action if we find any anomaly. Right now, the department is preparing the industries on how to go forward complying with the provisions of the Revised Schedule M, and we are supporting the industry. We want the industry on one side, and on the other side we want regulations also. We are sure that all the drug manufacturers in Tamil Nadu will follow our advice and comply fully with the schedule,” said M Sridhar, drug controller.
The president of the Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), M Varadarajan said the industry is hoping for an extension of the timeline as all the industry associations in India have forwarded their requests to the Central government asking for some more time. He said the companies have already started the upgrading process, but it requires some more months’ time to complete the work.
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