Last Updated on June 21, 2024 by The Health Master
Multivitamin
The Small and Medium Pharma Manufacturers Association (SMPMA) is making a strong case for increased industry involvement in regulatory decision-making and streamlining processes for multivitamin production in India.
In a recent letter to the Drug Controller General of India (DCGI), SMPMA Chairman Nipun Jain outlined key concerns impacting the industry, including:
Restrictions on Multivitamin Production under Food Supplement Category:
Jain urged the DCGI to allow the manufacturing of multivitamin products under the food supplements category within existing drug manufacturing facilities.
He emphasized that this wouldn’t violate Good Manufacturing Practices (GMP) or lead to cross-contamination, as the ingredients used in both drugs and food supplements are often identical.
Regulatory Conflict & Export Challenges:
A current regulatory hurdle exists where the Central Drugs Standard Control Organization (CDSCO) restricts the production of food supplements under FSSAI licenses in facilities also used for drug manufacturing.
This creates a significant roadblock for exports, as products registered as food supplements overseas cannot be labeled as drugs domestically.
Need for Industry Representation in Consultative Committees:
Jain highlighted the importance of including SMPMA in existing and future advisory and consultative committees set up by the DCGI.
“Our association boasts a nationwide presence with a substantial member base actively contributing to the Indian pharmaceutical sector,” stated Jain.”
“SMPMA’s inclusion will ensure a more holistic view, guaranteeing that the broadest range of industry concerns are addressed.”
High Costs and Delays in Obtaining Reference Standards:
Another challenge faced by Indian pharmaceutical manufacturers is the high cost and extended delivery times associated with acquiring BP/USP reference standards, which are crucial for exports.
Jain proposed that the Indian Pharmacopoeia Commission (IPC) analyze their existing stock of IP Reference Standards against BP/USP standards and provide affordable working standards to Indian companies.
Reduced Costs, Improved Efficiency Through Collaboration
By offering working standards alongside IP standards, the IPC can significantly benefit Micro, Small and Medium Enterprises (MSMEs) in the pharmaceutical industry.
This initiative would not only reduce testing costs but also enhance efficiency, leading to a win-win situation for both the government and the pharma MSME sector, as Jain emphasized.
Commitment to Collaboration and Growth
The SMPMA has consistently emphasized its commitment to working hand-in-hand with regulatory authorities to address these pressing issues and foster the growth of the Indian pharmaceutical sector.
“We express our sincere gratitude and pledge our unwavering cooperation in working together for the best interests of the pharma industry,” concluded Jain.
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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