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The Laghu Udyog Bharti (LUB) has sought inputs and detailed analysis from all pharmaceutical manufacturers on challenges related to compliance, infrastructure and training to further request the Union health ministry for revised Schedule-M extension till December 2026.
LUB has designed a digital form and has circulated it across all the industry to seek comments and inputs for needful compliances and request for the revised Schedule M extension.
According to Dr. Rajesh Gupta from LUB, “The inputs are required as industry is facing delayed machineries and instrument supply, validations, standard operating procedure (SOP) compliances, skill workforce shortages, mandatory training course of 30 hours to be designed and Revamped Pharmaceuticals Technology Upgradation Assistance (RPTUAS) scheme status among other pain points. LUB delegation will again be called by the Union health minister in coming days with the required factual submissions following two discussions on January 10 and 16, 2026.”
Dr. Gupta further stated, “A google form designed for such analysis needs to be filled and submitted on priority from those wanting revised Schedule-M extension upto December 2026 on genuine grounds and compliant stages. The same is urgently required for completion of required infrastructure, documentation and training of workforce with doable and non-doable submissions.”
The digital form requires pharma manufacturers to share company name, place, state, promoter name (only 1 required), mobile number, email ID, did the manufacturer apply for revised Schedule-M extension till May 2025? And brief reason for revised Schedule-M extension as per gap analysis required by the Central Drugs Standard Control Organisation (CDSCO) and respective State Food and Drug Administration (FDA).
Sharing updates on the matter, Dr. Viranchi Shah, national spokesperson, Indian Drug Manufacturers' Association (IDMA) said, “IDMA has made representations to the government regarding Schedule M, requesting certain simplifications, clarifications, and also an extension for those who have already begun the upgradation journey. For last two years, IDMA has made several efforts, along with CDSCO and State Licensing Authorities (SLAs) across India, to help pharma micro, small and medium enterprises (MSMEs) in their upgradation journey through training sessions and seminars. IDMA was also instrumental in working with the government in RPTUAS and other financial support for MSMEs. IDMA’s technical team is also available to guide MSMEs who need better understanding or more support.”
Industry sources stated that a hard deadline would lead to a shortage of supplies of commonly used medicines, may cause thousands of job losses and impact the medicine security of low and middle income countries that depend on imports from India.
While manufacturers with an annual turnover of more than Rs. 250 crore had to comply with revised Schedule M effective July 1, 2024, the implementation date for MSMEs was January 1, 2025. After MSMEs sought more time to make the necessary changes in their manufacturing processes, the union health ministry extended the deadline for them to December 31, 2025.
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