To uphold India’s reputation as the global “pharmacy of the world,” the micro, small, and medium enterprises (MSME) in the pharmaceutical sector will soon be required to adhere to the good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Act. This decision, announced by Health Minister Mansukh Mandaviya after engaging with industry representatives, aims to prioritize quality assurance and alleviate compliance burdens for MSME drugmakers. By gradually implementing Schedule M practices, the Indian government aims to ensure the highest standards of drug manufacturing, reinforcing the country’s position as a leader in the global pharmaceutical industry.
The mandatory compliance with Schedule M practices will encompass various aspects of the manufacturing process, including shop floors, quality control systems, laboratories, production, equipment cleaning, and housekeeping. By adopting these practices, MSME pharma firms will enhance quality assurance in the production of medicines, contributing to the overall safety and efficacy of the healthcare system.
Health Minister Mandaviya emphasizes the importance of self-regulation and adherence to good manufacturing practices for MSME pharma companies. By proactively implementing these measures, the sector can maintain the highest standards of quality, fostering trust among consumers and global partners. This move is particularly crucial in light of recent incidents where deaths were allegedly caused by drugs manufactured in India, underscoring the significance of upholding stringent quality standards.
The central government has taken proactive steps to expedite the implementation of these measures. A workshop was conducted in Hyderabad with state drug regulators to streamline policy implementation and ensure effective enforcement. The Drugs Controller General of India has been instructed to take strict action against manufacturers of spurious drugs, demonstrating the government’s commitment to eradicating substandard medicines from the market. Zero tolerance for non-compliance and the production of substandard drugs is a key principle driving these initiatives.
Regulatory authorities have initiated risk-based inspections and audits of pharmaceutical manufacturing units to assess compliance with quality standards. Action has been taken against firms found to violate these standards, including halting production, canceling or suspending licenses, and issuing show cause notices and warning letters to non-compliant companies. These measures aim to create a robust regulatory framework that ensures the production of safe and effective medicines in India, further bolstering the country’s reputation as a trusted global pharmaceutical hub.