The Small and Medium Pharma Manufacturers Association (SMPMA) has appealed to the Drug Controller General of India (DCGI) to allow the production of multivitamins as food supplements within drug manufacturing facilities. In a letter to DCGI Dr. Rajeev Singh Raghuvanshi and SMPMA chairman Nipun Jain emphasized that this change would not violate GMP standards or cause cross-contamination, as the same ingredients are used in both drugs and supplements.
Jain pointed out a regulatory conflict where the Central Drugs Standard Control Organization (CDSCO) prohibits manufacturing under FSSAI licenses in premises also used for drug production. This restriction, he argued, negatively impacts the export business since products registered as food supplements abroad cannot be labeled as drugs domestically.
Jain also called for SMPMA’s inclusion in advisory and consultative committees to ensure a comprehensive industry perspective is considered in regulatory decisions.
Addressing another issue, Jain highlighted the high costs and long delivery times for BP/USP reference standards required for exports. He proposed that the Indian Pharmacopoeia Commission (IPC) should compare their stock of IP Reference Standards against BP/USP standards and offer affordable working standards for Indian companies, which would save costs, reduce delivery timelines, and conserve foreign exchange.
As reported by Pharmabiz, Jain suggested that IPC provide working standards alongside IP standards to assist MSMEs in reducing costs and enhancing testing efficiency. He reiterated SMPMA’s commitment to collaborating with regulatory authorities for the growth of the pharma sector.