India's Drug Regulator Intensifies Pharma Quality Checks Under Revised Schedule M

India's top drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has issued a directive to state drug regulators, emphasizing the urgent need for strict adherence to the revised Schedule M. This mandate requires state authorities to conduct thorough inspections of pharmaceutical manufacturing facilities to ensure they meet the stringent requirements of Good Manufacturing Practices (GMP). The goal is to guarantee the quality and safety of pharmaceutical products manufactured in India.

Any manufacturing unit found to be non-compliant during these inspections will face "strict action" as per the provisions of the Drugs and Cosmetics Act and its rules. State drug regulators are required to submit monthly reports detailing their inspection findings and any actions taken to the CDSCO.

Schedule M of the Drugs and Cosmetics Rules, 1945, lays down the GMP standards for pharmaceutical products, including essential systems for prompt product recalls when defects are identified. The revised Schedule M, notified in January 2022, introduces enhanced quality norms. Initially, companies with an annual turnover exceeding Rs 250 crore were required to comply by July 1, 2023. Micro, Small, and Medium Enterprises (MSMEs) had a deadline of January 1, 2024. However, recognizing the challenges faced by MSMEs, the government extended their compliance deadline to December 31, 2024.

Impact: This move is expected to significantly boost the perceived quality and reliability of Indian pharmaceutical products globally. Companies that have invested in upgrading their facilities will benefit from enhanced market reputation and potentially increased export opportunities. However, non-compliant MSMEs might face operational disruptions or penalties if they fail to meet the extended deadline. Impact Rating: 7/10

**Explanation of Difficult Terms:** **Schedule M:** A part of the Drugs and Cosmetics Rules, 1945, in India, which specifies the mandatory Good Manufacturing Practices (GMP) that pharmaceutical companies must follow to ensure the quality, safety, and efficacy of their products. **Good Manufacturing Practices (GMP):** A system for ensuring that products are consistently produced and controlled according to quality standards. It covers all aspects of production, from the starting materials, premises, and equipment to the training and personal hygiene of staff. **Central Drugs Standard Control Organisation (CDSCO):** India's national regulatory body for pharmaceuticals and medical devices, responsible for the approval of drugs, clinical trials, and setting standards for quality. **Drugs and Cosmetics Act:** The principal legislation in India that governs the import, manufacture, and distribution of drugs and cosmetics. It also provides for the regulation of the quality of drugs and cosmetics sold through various outlets. **MSMEs:** Micro, Small, and Medium Enterprises. These are businesses categorized based on their investment in plant and machinery, and annual turnover, forming a significant part of India's economy.