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The Indian pharmaceutical industry has received a twelve-month extension to comply with the revised Schedule M of the Drugs and Cosmetics Act, a crucial step in upgrading Good Manufacturing Practices (GMP) to international standards. This extension, announced by the Union Health Ministry on January 4th, 2025, provides much-needed breathing room for pharmaceutical manufacturing units, particularly Micro, Small, and Medium Enterprises (MSMEs), who faced challenges in meeting the initially set deadlines. The revised Schedule M, notified in December 2023, aims to align India's pharmaceutical manufacturing standards with global best practices, particularly those of the World Health Organization (WHO). This is a vital step for India, a major exporter of medicines to Low and Middle-Income Countries (LMICs), many of which require WHO GMP certification for import.
The initial implementation timeline, set to begin in July 2023 for larger manufacturers (annual turnover exceeding ₹250 crore) and January 2025 for MSMEs (annual turnover below ₹250 crore), proved too stringent for many smaller firms. The primary concerns raised by industry associations centered around securing the necessary finances for facility upgrades and managing the complexities of implementing the changes within the original timeframe. The government responded to these concerns by issuing a draft notification offering a three-month grace period for registration with the Central Drugs Standard Control Organisation (CDSCO) and submission of upgrade plans. Following this period, a comprehensive audit of facilities will be conducted to ensure that committed upgrades are underway. Failure to meet the revised deadline of December 31st, 2025, will likely result in penalties and regulatory action.
The decision to extend the deadline reflects a pragmatic approach by the Indian government, balancing the need to enhance manufacturing standards with the realities faced by the pharmaceutical industry. The extension offers a crucial opportunity for MSMEs, which represent a significant portion of India's pharmaceutical manufacturing sector (approximately 8,500 out of 10,500 units), to undertake the necessary upgrades without jeopardizing their operations. The government’s proactive measures, such as the launch of the Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS), aim to provide financial support to these smaller firms, ensuring a smoother transition to the revised GMP standards. The extension also acknowledges the progress already made, as evidenced by the more than 800 manufacturing units and 252 public testing labs inspected by CDSCO. These inspections have revealed a growing awareness and implementation of the revised GMP standards among many MSMEs.
The long-term benefits of aligning with global GMP standards are substantial. Improved manufacturing practices translate to higher quality medicines, increased patient safety, and greater international competitiveness for Indian pharmaceutical companies. This alignment is particularly significant for India’s export market, enhancing its reputation as a reliable supplier of quality medicines to LMICs. The successful implementation of the revised Schedule M will not only boost India's pharmaceutical industry but also contribute to improved healthcare outcomes globally. The twelve-month extension reflects a commitment to facilitating a smooth and effective transition, ultimately benefiting both the domestic pharmaceutical sector and global health security. While the extension provides a crucial reprieve, ongoing monitoring and support for MSMEs will be essential to ensure the successful implementation of the new standards by the extended deadline.
Source: Pharma units get 12-month extension to implement revised Schedule M of Drugs and Cosmetics Act