Last Updated on August 1, 2024 by The Health Master
Schedule M
The pharmaceutical manufacturing landscape in Telangana is on the verge of a seismic shift due to revised Schedule M compliance.
Over a hundred Micro, Small, and Medium Enterprises (MSMEs) in the state are poised to shutter their operations within the next three months, as the stringent requirements of the Revised Schedule M prove insurmountable.
Schedule M Compliance: A Mountain to Climb
The Revised Schedule M, a set of Good Manufacturing Practices (GMP) guidelines for pharmaceutical production, has been a game-changer for the industry.
While larger pharma companies have managed to adapt to the new norms, smaller players are struggling to keep their heads above water.
- Massive Investment: Upgrading facilities to meet Schedule M standards requires a hefty investment of Rs. 5 to 10 crore per unit.
- Revenue Crunch: MSMEs are facing a dire financial situation, with many unable to generate the minimum Rs. 50 crore annual turnover necessary to sustain operations after compliance.
Industry in Distress: A Cry for Help
Faced with an uncertain future, the Telangana chapter of the Indian Drug Manufacturers Association (IDMA) has sounded the alarm.
President J Rajamouli led a delegation to the Director-General of Drugs Control Administration, seeking a temporary reprieve from inspections.
- Intense Scrutiny: Drug control officials have been conducting frequent inspections, adding to the industry’s woes.
- Temporary Relief: While the DG has agreed to halt inspections until December 2024, the long-term outlook remains bleak.
No Extension in Sight: A Do-or-Die Situation
The Central Drugs Standard Control Organization (CDSCO) has shown no inclination to extend the deadline for Schedule M compliance.
This leaves MSMEs with a stark choice: adapt or perish.
- High Failure Rate: A staggering 36% of inspected manufacturing units have been forced to close due to non-compliance.
- Industry-Wide Plea: Pharmaceutical associations across India have urged the CDSCO for a one-year extension, but their requests have fallen on deaf ears.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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