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TN pharma fully prepared for audit of drug control department as per revised Schedule M: TN IDMA
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Peethaambaran Kunnathoor Chennai
January 06 , 2025
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Pharmaceutical companies in Tamil Nadu are now fully prepared for the revised Schedule M audit of the drug control department as all the small scale units have upgraded their manufacturing facilities to the standards prescribed in the new Schedule M of the D&C Act, says TN IDMA chairman, J Jayaseelan in the wake the deadline set for the MSME units with less than Rs. 250 crore turnover ended on January 4, 2025.
He said, very few manufacturing units are in the middle of the upgrading work in their facilities, but they will be completed in another few days.
“Here there is no problem, all the industrial units under the MSME sector are in the process of upgrading to ensure compliance with quality standards as per the new GMP, and majority of the units have already completed the work. The remaining companies are engaged in the process and they will complete it in a few days. So, the drug regulatory department can start the audit at any time. We are ready to welcome the officers,” said Jayaseelan.
The director of the TN DCA, M Sridhar said the department will gear up for inspections soon after the deadline set by the union health ministry ends in the first week of this month. However, he said, the department will give a few more days to the industry on humanitarian ground. But he has to implement the law as the head of the department. The industry says that they are expecting an extension of the period by the union health ministry as the pharma MSMEs across the country have requested the union government for getting the date extended.
The director said the union health ministry is likely to announce a further date as desired by the industry within one or two days.
Sridhar said in the first phase of the regulatory inspections conducted in 46 pharmaceutical manufacturing companies in the state in the month of November last year, only four companies were found 100 per cent compliant with the norms of the revised Schedule M. He said it 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.
Meanwhile, the president of the Tamil Nadu MSME Pharma Manufacturers Association (TN PMA), S Varadarajan said a team of MSME leaders will meet the drug control director M Sridhar and inform him about the progress in the upgrading work in the units. He said he got some information from Delhi that the union health ministry is seriously considering giving a further date for the small-scale players, and it could be a minimum period of six months. This will be discussed with the state DCA director and request for extension of inspections. However, he said most of the units have already upgraded to the new standards as prescribed by the revised Schedule M.
Varadarajan informed Pharmabiz that, the PMA, in September last year, gave one memorandum to the union health minister and the secretary through the state health secretary demanding for extension of the deadline to comply with the revised GMP norms. Besides, one letter was sent to the Drug Controller General of India (DCGI) through the state drug controller. The association wanted one year for the full compliance of the revised Schedule M.
Talking to Pharmabiz, the small scale industry leader said the pharmaceutical industry in Tamil Nadu is a key contributor to the state’s economy and healthcare, and their contribution to exports is also high. There are 367 pharmaceutical formulation companies operating in the state, out of which 85 companies are WHO-cGMP. These companies are already complying with all the Schedule M norms, but the remaining 282 companies needed modifications and development of infrastructure and other facilities in the production units. He said financial constraint was the major reason for the delay in the upgradation process.
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