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TN DC dept soon to begin preliminary inspections to ensure compliance of revised Schedule M
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Peethaambaran Kunnathoor, Chennai
September 27 , 2024
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On completion of the two-day training programme conducted by the Tamil Nadu drug control department for the drug inspectors, the department is now gearing up for the preliminary inspections at the manufacturing sites of the pharma companies in a phased manner.
This preliminary inspection will last for a minimum period of six months, and primarily it is aimed to give awareness to the manufacturers about the compliance of the revised Schedule M norms. The final round of inspections will start soon after finishing the preliminary check, said M Sridhar, drug controller, Tamil Nadu.
“We are planning to conduct the preliminary inspections in the month of October, and we will probably start it in the third week of the month. This is mainly aimed to take stock of the preparedness of the new Schedule M upgradation. With this, we will educate the manufacturers about the importance of the upgrading, and secondly the department wants to know how far the industry is getting ready for the new Schedule M. There will be a final round of inspections once this preliminary check is over,” Sridhar told Pharmabiz.
He said, this preliminary inspection will be conducted in a phased manner, and to make the inspections more transparent and more prospective separate inspectors will be assigned in each zone. In Madurai zone, inspectors from some other zone will be assigned to, and in Chennai zone 1, inspectors from either Salem or Tanjore or Namakkal will be deputed. He said the concerned inspectors of any specific zone may give some concessions to the industries, so different inspectors are used for. To a specific question, he said this is quite a state inspection and not involving regulators from the central department.
According to Sridhar, the department has shortlisted 46 companies for the first phase of the preliminary inspections. This inspection will be conducted in all the companies irrespective of big or small in terms of their turnover. But the second round of the inspections will be strictly based on the turnover as mandated by the drug controller general of India. There are 346 formulation companies in the state.
To strengthen the process of inspections, the department conducted a two-day training program for the drug inspectors to provide awareness on how to conduct inspections in manufacturing plants. Along with the inspectors were given awareness about how to investigate the counterfeit drugs. The retired joint commissioner from the FDA of Maharashtra, Om Prakash Sadhwani, took the class on investigation skills for counterfeit drugs. In another session, he delivered a lecture on ‘Revised Schedule M – Regulation Perspective’. Out of the total 137 drug inspectors, 126 drug inspectors attended the two-day workshop.
The inspections would have been started two months earlier, but the Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA) sent one memorandum to the union government through the state health secretary seeking extension of the timeline for compliance of the Revised Schedule M norms. So, the department did not conduct the inspections in large companies also. As per the direction of the DCGI, the timeline given for compliance of the new GMP norms for the large companies with an annual turnover of Rs. 250 crore ended on July 5, 2024. But the government gave exemptions to the companies and did not conduct inspections even after the date was over.
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