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MP DCA forms team of regulatory officers to assist pharma units in upgrading plants as per revised Schedule M
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Peethaambaran Kunnathoor, Chennai
January 13 , 2025
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The drug control administration under the Food and Drug Administration in Madhya Pradesh has formed one team of regulatory officers to provide support and guidance to the pharmaceutical manufacturing units in converting the manufacturing facilities to the standards prescribed under the revised Schedule M of the Drugs and Cosmetics Act.
The team will visit the companies and guide the manufacturers in the process of the upgrading work to comply with the new schedule, said Shobhit Koshta, deputy drug controller at the drug control administration.
Speaking to Pharmabiz, he said all the drug manufacturing units in the state have started submitting applications for extension. As per the draft notification issued on January 4 this year by the union health ministry, the companies have to submit applications within three months seeking extension for full compliance work for the new manufacturing standards. He said the department will provide all help to the industries in the state.
Meanwhile, Dr Darshan Kataria, president of the Madhya Pradesh Small-scale Drug Manufacturers Association (MP SDMA) informed that the small and medium level pharmaceutical industries in Madhya Pradesh are busy preparing to complete the upgrading work in their manufacturing facilities and they will complete it within the stipulated period.
“The conversion and improvement work has been continuing for the last one year and it will be completed very soon. Actually, we would have completed the work within the earlier specified time, but there were some technical hurdles that slowed down the conversion process. The machine suppliers, equipment suppliers and the consultants were busy and preoccupied with a number of units in many states. They had contracts with several manufacturers belonging to various states. Since they wanted more time, we requested the government to give us a few more months to complete the work,” he said.
Dr Kataria pointed out that the manufacturing units in Madhya Pradesh have taken the directions of the government in a favourable manner and they are engaged in the work that the government is expecting of them. He said the illustrations given by the government are very good and supportive to the industry.
When asked how many companies are in the process, he said all the 150 MSME units are upgrading their plants, and no company will close down because of the revisions in the drug act. All the companies will continue and all of them will improve their facilities for the full compliance of the Schedule M.
The small-scale drug manufacturing units in Madhya Pradesh are mostly located in places such as Bhopal, Indore, Devas, Pitambur and Ujjain. About 10 companies in the state are having US FDA facilities, and above 50 companies are WHO-GMP compliant. Most of the units are engaged in the export business.
Madhya Pradesh IDMA chairman, Paresh Chawla said the industry has so far not been given any information from the special team of regulators of the drug control department on how to move on with the revised Schedule M process in the wake of the extension of the deadline.
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