The pharmaceutical industry in India is facing a major challenge as the deadline for upgrading manufacturing units according to the revised Schedule M of the Drugs and Cosmetics Act approaches.
Industry leaders estimate that nearly 5,000 of the country's 10,000 drug manufacturing units may struggle to meet the requirements, putting them at risk of potential closure.
Schedule M, which outlines quality standards for pharmaceutical products, was introduced by the health ministry in January last year and is set to come into effect on January 1, 2025.
As per industry insiders, about 2,000 of the country's pharmaceutical units are already compliant with Good Manufacturing Practices (GMP). Around 3,000 are in the process of upgrading their facilities to meet the new standards.
However, the remaining 5,000 units have yet to undertake the necessary upgrades to comply with the newly implemented Schedule M. Without an extension, these units may face significant challenges in maintaining operations, with closure looming as a real possibility.
The industry has been requesting a two-year extension to allow more time for infrastructure upgrades, recruitment, and staff training. However, despite these concerns, the government has not yet issued any notice regarding an extension.
This leaves the industry with little time to implement the required changes. A senior government official confirmed that, unless the deadline is extended, companies will be expected to meet the provisions or face action.
The government may soon begin audits and risk-based inspections of drug manufacturing units to ensure compliance with the new standards.
The revised Schedule M mandates that pharmaceutical companies adhere to strict guidelines regarding manufacturing practices, facility requirements, and quality management systems.
Among the new provisions are annual product quality reviews, quality risk management protocols, and the establishment of robust pharmaceutical quality systems.
Industry leaders had previously met with the health minister to discuss the challenges posed by the new regulations. They highlighted delays in procuring machinery and upgrading infrastructure as key issues that require additional time for resolution.
The industry has argued that micro, small, and medium enterprises (MSMEs) will be particularly affected without a grace period.
While the health minister has acknowledged the concerns raised by industry leaders and requested details from the Department of Pharmaceuticals (DoP) on initiatives to assist the sector in upgrading its quality standards, no decision on an extension has been made thus far. Another official noted that the minister has been closely monitoring the situation, but the issue remains unresolved.
Former DoP secretary Arunish Chawla reassured the industry by stating that the government is providing adequate support for the MSMEs. He mentioned that the government had liberalised its schemes to specifically help these smaller enterprises meet the revised Schedule M requirements.
These schemes include support for upgrading utilities, testing laboratories, stability chambers, and quality assessment systems, as well as the core production processes.
Chawla further highlighted that many companies have already registered for the scheme, and some have completed their gap analysis. Several companies have passed the technical committee's scrutiny and are receiving assistance to meet global quality standards, including those set by the World Health Organization (WHO).
Despite these initiatives, industry executives remain concerned about the tight timeline for upgrading infrastructure. They argue that they need until December 2026 to complete the necessary changes.
Companies are facing challenges in securing loans, procuring machinery, and implementing required upgrades. Additionally, staff training and machinery validation are crucial components of the process, and these steps require considerable time and resources to ensure proper operation.
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