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SMPMA highlights FSSAI licensing and BP, USP reference standards challenges among others to DCGI
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Shardul Nautiyal, Mumbai
December 06 , 2023
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The Small & Medium Pharma Manufacturers Association (SMPMA) has raised Food Safety and Standards Authority of India (FSSAI) licensing challenges for food supplements and export market challenges related to British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) standards among other festering issues with the Drugs Controller General of India (DCGI) Dr. Rajiv Singh Raghuvanshi in a recent meeting in New Delhi.
IP Reference Standards are specific substances or materials used as benchmarks for testing and ensuring the quality and consistency of pharmaceutical products. These standards help pharmaceutical companies and regulatory authorities maintain uniformity and quality in the production of medicines.
SMPMA members have received communications from the Indian Pharmacopoeia Commission (IPC) regarding the availability of ready stock of IP Reference Standards. Considering that its members predominantly operate in export markets following BP and USP standards, the SMPMA has proposed that IPC analyses its stock of IP Reference Standards and provides an affordable alternative for BP/USP Working Standards. This would alleviate the burden on Indian companies, reducing costs and delivery timelines, and minimizing forex remittances.
According to Nipun Jain, chairman, SMPMA, “We have urged the DCGI to consider the SMPMA’s suggestion to analyse the stock of IP Reference Standards vis-a-vis Reference Standards of other pharmacopoeias like BP and USP. This was also proposed to provide an alternate source of affordable working standards for BP/USP to Indian companies that are involved in exporting pharmaceutical products.”
Jain further informed members companies holding FSSAI licenses for manufacturing tablets, capsules, and liquid formulations, face challenges with simultaneous drug manufacturing. Central Drugs Standard Control Organisation (CDSCO) restriction on manufacturing multivitamin formulations under FSSAI licenses in the same premises as drug manufacturing has posed a dilemma. SMPMA has requested permission to manufacture multivitamin products under the food supplements category within drug manufacturing premises, ensuring no GMP violations or cross-contamination.
Concerns have also been raised about polyvinyl alcohol (PVA) in tablet coatings. “The increasing use of PVA in tablet coatings raises concerns about the use of technical-grade PVA instead of pharma-grade, posing potential health risks. We propose enforcing the use of coating materials only from registered drug manufacture license holders to ensure patient safety and maintain the integrity of India's pharmaceutical exports,” SMPMA members said.
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