Last Updated on June 29, 2024 by The Health Master
Nutraceutical
Following the implementation of the revised Schedule M, which mandates dedicated areas for nutraceutical and pharmaceutical production, the Indian government has established a committee to examine the feasibility of allowing nutraceutical manufacturing within existing drug manufacturing facilities.
This move comes amidst ongoing industry discussions regarding the potential benefits and challenges associated with this practice.
Committee members
The committee comprises esteemed members, including:
- A Visala, Joint Drugs Controller (I) CDSCO
- Ranga Chandrashekar, Joint Drugs Controller CDSCO (HQ)
- AK Pradhan, Advisor, CDSCO (HQ)
- Arvind Kumar Bansal, NIPER, Mohali
- SM Mudda, Industry Expert
The CDSCO (HQ)’s enforcement division will provide secretariat support to the committee, with a deadline of three weeks to submit their report.
Strict confidentiality principles will be observed by all committee members.
Weighing the Advantages and Disadvantages of Integrated Production
India’s pharmaceutical industry, known as the “pharmacy of the world,” has traditionally manufactured multivitamins and minerals alongside medicines within the same facilities.
This practice aligns with global trends in nutraceutical and pharmaceutical production.
However, the formation of this committee suggests a deeper examination of the potential advantages and disadvantages of integrated production.
Benefits of Integrated Production:
- Operational Efficiency: Combining production lines could potentially streamline operations and reduce costs.
- Product Diversification: Manufacturers can expand their product offerings by leveraging existing infrastructure.
Challenges of Integrated Production:
- Increased Regulatory Requirements: Meeting stricter quality standards for both product lines may necessitate additional regulatory compliance measures.
- Specialized Equipment Needs: Separate production lines and specialized equipment might be required for nutraceutical production.
- R&D Cost Pressures: Ensuring compliance and quality for both pharmaceuticals and nutraceuticals could lead to increased research and development expenses.
Industry Perspectives
Sanjaya Mariwala, executive chairman of OmniActive Health Technologies and president of the Association of Herbal and Nutraceutical Manufacturers of India, welcomes the focus on stricter quality standards.
However, he emphasizes concerns regarding the potential costs and disruptions associated with segregating production lines.
Mariwala proposes a solution that prioritizes quality while considering industry limitations:
- High-Standard Pharmaceutical Plants: Allowing facilities with high existing quality standards to produce both product types.
- Collaborative Approach: Open communication between regulators and manufacturers to develop practical solutions.
Moving Forward
Mariwala underscores the importance of:
- Rigorous Quality Control: Implementing robust quality control measures across both production lines.
- Premarket Reviews with Clinical Trials: Ensuring product safety and efficacy through thorough premarket reviews and clinical trials for nutraceuticals.
- Accurate Labeling: Providing consumers with clear and transparent product information.
- Incentives for Compliance: Encouraging adherence to regulations through appropriate incentives.
Unified Regulatory Body
Mariwala envisions a unified regulatory body streamlining processes and addressing unethical practices.
This comprehensive approach, he believes, would foster a globally competitive Indian nutraceutical industry built on compliance and sustainable growth.
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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