FOPE: Impact of revised Schedule M on Pharma and Nutraceuticals

The FOPE letter highlights a disparity between the Schedule M amendment and international standards.

February 23, 2024

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Last Updated on March 7, 2024 by The Health Master

Schedule M

Schedule M: In the ever-evolving landscape of the pharmaceutical and nutraceutical industry, regulatory changes can send ripples of concern throughout the sector.

Recently, the Federation of Pharma Entrepreneurs (FOPE) has penned a letter to the Ministry of Health & Family Welfare, expressing deep apprehensions about the implications of the new Schedule M amendment.

This amendment mandates that manufacturing premises be exclusively dedicated to drug production, excluding any other manufacturing activities. In this article, we delve into the details of this amendment and its potential ramifications.

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Understanding the Schedule M Amendment

The Restriction on Manufacturing Activities

The crux of the matter lies in the amendment’s stipulation that manufacturing premises must exclusively cater to drug production.

This restriction applies to both existing and new facilities, presenting a significant challenge for the pharmaceutical and nutraceutical industry.

International Standards vs. Schedule M

Comparative Analysis of International Regulatory Bodies

The FOPE letter highlights a disparity between the Schedule M amendment and international standards.

Regulatory bodies such as the USFDA, EU, MHRA, MCC, and TGA allow facilities to manufacture both pharmaceutical products and dietary supplements, provided they adhere to stringent standards.

Contributions to Employment and Economy

Many Indian facilities, holding approvals from local and international regulatory bodies, currently produce both pharmaceutical products and dietary supplements.

This not only contributes significantly to employment but also bolsters foreign exchange earnings and enhances consumer satisfaction.

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Potential Implications of the Amendment

Dilemma in Exports

The FOPE letter forewarns that the amendment may force companies to choose between manufacturing drugs or dietary supplements, leading to potential business standstill.

This could result in losses, disruptions in exports, and damage to India’s supply chain credibility, thereby jeopardizing the “Make In India” philosophy.

Risk to India’s Global Supply Source Status

The potential fallout of the amendment extends to India’s role as a key global supply source.

The article explores how this regulatory change could hinder India’s opportunity to maintain a prominent position in the global market.

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Domestic Impact of the Amendment

Disruption to Existing Facilities

FOPE’s letter outlines the impact on the Indian market, emphasizing that existing facilities, approved for both drugs and dietary supplements, may face significant disruption.

This disruption could affect the supply chain, leading to potential shortages in the Indian market.

Timeframe for Establishing New Facilities

Establishing new facilities exclusively for drug production could take up to four years.

This extended timeframe poses a risk of consumers being deprived of regularly consumed products during the transition period.

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FOPE’s Plea: High Standards Deserve Continued Recognition

Adherence to Quality Standards

The industry association asserts that existing facilities, complying with high drug manufacturing standards, possess the necessary infrastructure and protocols to prevent cross-contamination.

Hence, they should be allowed to continue the production of both drugs and dietary supplements.

Urgent Call for Amendment Revocation

In a strong plea, FOPE urges the government to reconsider the amendment.

The letter underscores the industry’s commitment to maintaining high standards while emphasizing the need for flexibility in manufacturing processes.

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.