Last Updated on June 19, 2024 by The Health Master
Schedule M
The Indian pharmaceutical industry, a global leader in generics, is facing challenges due to the recently implemented Schedule M.
This regulation by the government mandates that drug manufacturing units can only produce drugs and not any other products.
Financial Burden on Small and Medium Enterprises (SMEs)
The Federation of Pharma Enterprises (FoPE), representing medium and small-scale pharmaceutical companies, has expressed concerns about the financial strain this puts on their members.
Setting up a separate plant solely for cosmetic production is not feasible for many SMEs.
FoPE proposes a solution: allowing them to manufacture cosmetics in the designated area for topical drugs (creams, lotions, etc.).
This leverages existing facilities and ensures continued compliance with Good Manufacturing Practices (GMP).
Precedent for Co-Manufacturing
The pre-2001 exemption in Schedule M permitted these units to manufacture allied products like nutraceuticals and ayurvedic medicines alongside drugs.
Additionally, cosmetic production within the topical product section was allowed.
The concern lies with companies licensed between 2001-2011.
These companies, previously following compliant practices for both drugs and cosmetics, now face a significant financial hurdle to establish separate cosmetic production units.
Safety and Quality Not Compromised
FoPE emphasizes that for over 3 decades (1988-2024), these manufacturers have maintained high-quality standards for both drugs and cosmetics.
They highlight the stringent measures taken to prevent cross-contamination, ensuring product safety.
Proposed Solution: Leveraging Existing Infrastructure
FoPE proposes a practical solution: allowing the continued production of cosmetics within the existing topical product section.
They argue that:
- Similar Products: Most cosmetic products (creams, lotions, suspensions) closely resemble topical drugs in form and function.
- External Application: Both product categories are applied externally, with cosmetics primarily for aesthetic purposes.
- Enhanced Quality Control: Manufacturing cosmetics in the designated section would subject them to stricter GMP requirements compared to the Cosmetics Rules.
By implementing this suggestion, the government can ensure both industry growth and consumer safety.
Related article: Nutraceuticals in Drug Units: Panel to examine the issue
Conclusion
The new Schedule M, while aiming to enhance quality control, presents a financial challenge for small and medium pharmaceutical companies in India.
FoPE’s proposed solution offers a practical approach that leverages existing infrastructure and maintains stringent quality standards for both drugs and cosmetics.
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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