Last Updated on December 25, 2024 by The Health Master
Revised Schedule M
The Telangana pharmaceutical industry is urging the Department of Pharmaceuticals (DoP) and the Central Drugs Standard Control Organization (CDSCO) to provide greater clarity on the provisions of the revised Schedule M and the production of nutraceuticals in drug manufacturing facilities.
These areas currently present significant ambiguity and pose challenges for drug manufacturers.
During a seminar organized by the DoP in Hyderabad, J Rajamouli, Chairman of the Telangana Indian Drug Manufacturers’ Association (IDMA), expressed concerns about the lack of clarity in certain provisions of the revised Schedule M.
Mandatory vs. Guidelines:
Some provisions are explicitly stated as mandatory, while others are presented as WHO guidelines.
As guidelines are voluntary, the industry seeks clarification on whether these specific provisions are mandatory requirements.
Nutraceutical Production:
The industry also awaits a definitive response from the government regarding the production of nutraceuticals in drug manufacturing facilities.
Given the high drug manufacturing standards maintained by Telangana’s pharma industry, the association urges the authorities to permit this practice.
Uneven Implementation and Cost Implications
Rajamouli highlighted the uneven implementation of revised Schedule M across the country.
While stringent regulations and high compliance costs are enforced in southern states like Telangana, Tamil Nadu, and Karnataka, other regions have less stringent enforcement.
This disparity leads to variations in product quality and significant cost differences for manufacturers.
Impact on MSMEs:
The implementation of the new GMP standards necessitates substantial investments from small and medium-sized enterprises (MSMEs).
With many MSMEs acting as contract manufacturers for larger players, their survival hinges on the ability to upgrade their facilities.
Rajamouli emphasized the need for government support, including interest-free soft loans, to enable these crucial players to meet the new requirements.
Conversion and Packing Charges
Rajamouli also called for a revision of the Conversion Charges and Packing Charges (CC&PC), which have remained unchanged since 2012.
Currently, contract manufacturers receive only Rs 2500 to Rs 3000 for the production of one lakh tablets.
This amount is insufficient and needs to be significantly increased to ensure the viability of these businesses.
Key Demands of the Telangana Pharma Industry:
- Clarity on revised Schedule M provisions: Specifically, clarification on the mandatory nature of guidelines.
- Permit nutraceutical production in drug manufacturing facilities.
- Ensure uniform implementation of revised Schedule M across the country.
- Provide financial support to MSMEs for facility upgrades.
- Revise the Conversion and Packing Charges.
- Extend the timeline for revised Schedule M implementation.
In conclusion, the Telangana pharma industry has clearly articulated its concerns and demands to the DoP and CDSCO.
Addressing these issues is crucial for the continued growth and sustainability of the industry, ensuring the availability of high-quality medicines for the Indian population.
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What is Schedule M?
Schedule M is a set of guidelines for Good Manufacturing Practices (GMP) in the pharmaceutical industry in India.
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What are the concerns raised by the Telangana pharma industry regarding revised Schedule M?
Lack of clarity on mandatory provisions, uneven implementation across the country, and high compliance costs.
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How can the government support the pharma industry in implementing revised Schedule M?
By providing financial assistance, extending the implementation timeline, and revising the Conversion and Packing Charges.
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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