Schedule M, API-CF, PTUAS & PMPDS

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries (SPI).

• The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

• APICF (Assistance to Pharmaceuticals Industry for Common Facilities) scheme will help in strengthening of clusters and ensure better compliance of various regulatory requirements.

• PTUAS (Pharmaceuticals Industry Technology Upgradation Assistance Scheme) scheme will help the MSMEs in technology upgradation and meeting global standards, he underlined in his address.

• Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS) would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry.

• Schedule M is a part of Drug and Cosmetic act 1940.

• Good Manufacturing Practices (GMP) under Schedule M were made mandatory conditions for manufacturing operations of pharmaceutical formulations.

• The quality of drug formulations is the sole responsibility of the manufacturer. He has to ensure the production of desired quality formulations and their stability until, the formulation reaches the consumer across the retailing counter.

• GMP certification is a standard defined by WHO for ensuring products are produced and controlled as per the quality standard.

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