Last Updated on December 23, 2023 by Hitesh Goyal
Pharma Industry
In a recent meeting held in New Delhi, the Small & Medium Pharma Manufacturers Association (SMPMA) brought to light significant challenges faced by pharma industry, particularly in obtaining licenses from the Food Safety and Standards Authority of India (FSSAI) and complying with international standards for export.
SMPMA’s Dialogue with DCGI
Unlocking Export Potential
The SMPMA engaged with the Drugs Controller General of India (DCGI), Dr. Rajiv Singh Raghuvanshi, addressing issues that included licensing hurdles, export challenges related to British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) standards, and other pressing concerns.
IP Reference Standards
Delving into the realm of pharmaceutical quality assurance, SMPMA proposes a strategic analysis of IP Reference Standards by the Indian Pharmacopoeia Commission (IPC) to provide an affordable alternative for BP/USP Working Standards.
This move aims to streamline operations for Indian pharma industry operating in export markets.
Licensing Complexities
SMPMA Chairman, Nipun Jain, sheds light on the licensing complexities faced by member companies manufacturing tablets, capsules, and liquid formulations.
The plea to the DCGI seeks solutions to challenges related to simultaneous drug and multivitamin manufacturing, with a focus on maintaining Good Manufacturing Practices (GMP) and preventing cross-contamination.
Patient Safety First
Raising a red flag on the use of polyvinyl alcohol (PVA) in tablet coatings, SMPMA emphasizes the potential health risks associated with technical-grade PVA.
The association proposes stringent measures, including enforcing the use of coating materials exclusively from registered drug manufacturing license holders, to uphold patient safety and safeguard the reputation of India’s pharmaceutical exports.
Strengthening India’s Position
A glimpse into SMPMA’s proactive approach to not only address immediate challenges but also contribute to the overall enhancement of the Indian pharma industry.
The association’s vision encompasses streamlining licensing processes, improving product quality, and reinforcing India’s standing as a reliable player in the global pharmaceutical market.
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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