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Time of India
3 days ago
- Business
- Time of India
With no upgradation plan, several small drug companies may shut operations
New Delhi: Thousands of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector face the grim prospect of closure, having passed the May-end deadline for submitting plans to the government for upgrading their manufacturing facilities. Only a fraction of such units, 1,700 out of an estimated 6,000, have submitted plans for upgradation as per the newly-notified Good Manufacturing Practices ( GMP ), people in the know told ET. Industry executives said they anticipate many units to shut down and thousands of job losses as these units struggle with high costs needed to make the necessary infrastructure improvements. The government, meanwhile, is likely to initiate site audits and kick-off regulatory action against those not complying with the new standards, the people said. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 혈압, 혈당, 고지혈로 고민이 많으신 분들만 읽어주세요. 메디셜 더 읽기 Undo Experts noted that if the government takes stringent action, it may cause drug shortages in areas like cancer, where there are fewer manufacturing units. Live Events "Next few months will see a lot of small sector units getting closed, resulting in increased unemployment. The upgradation requirement to Schedule M has created challenges for small and medium units potentially leading to closures and unemployment," said an industry executive, raising concerns about the future of these units. Some executives believe that 'stop production notices' will be issued to units not complying with the newly-notified standards, which may inflate drug prices. "These units require hand holding by the government and if they do not get further support, then production will stop, resulting in escalation of drug prices," a second executive said. Health ministry officials however stressed that sufficient time has been given to the industry for complying with the new norms. Earlier the ministry had received several representations from pharma associations with annual revenues of less than '250 crore for extension of timeline for the implementation of revised Schedule M. Schedule M of the Drugs and Cosmetics Act outlines quality standards for pharma products. To address their concerns, in February, the ministry issued another notification for extension of implementation of revised Schedule M whereby manufacturers with less than Rs 250 crore revenues were required to file an application to the Central License Approving Authority within three months, along with the plan of upgradation.
Time of India
08-05-2025
- Business
- Time of India
New Schedule M rules: Most drug companies not yet ready for upgrade
With the revised Schedule M deadline approaching, only a fraction of small and medium pharmaceutical companies have submitted facility upgrade plans. The health ministry, concerned about the slow response, has urged state health secretaries to engage with local drugmakers. This aims to ensure broader compliance with the updated quality standards outlined in Schedule M of the Drugs and Cosmetics Act. Tired of too many ads? Remove Ads Only a small number of pharmaceutical companies have submitted plans for upgradation of facilities even as a revised deadline for implementation of revised Schedule M ends on Monday. Health ministry officials said out of about 10,000 medium and small manufacturing enterprises, just about 100 have submitted secretary Punya Salila Srivastava has now written to state health secretaries, asking them to issue necessary directions to state drug regulators to discuss the matter with drugmakers in their own M of the Drugs and Cosmetics Act outlines quality standards for pharmaceutical February, the ministry issued a notification extending the deadline for implementing revised Schedule M, whereby manufacturers with revenues of less than ₹250 crore were required to submit applications to the Central License Approving Authority within three months, along with their upgradation plans "However, as per the data available, very few firms have submitted their application requesting extension of timelines for implementation of revised Schedule M," said the health secretary in her letter to states.
