India’s small drugmakers in the micro, small, and medium enterprises (MSME) sector will soon be required to adhere to the good manufacturing practices outlined in Schedule M of the Drugs and Cosmetics Act. Health Minister Mansukh Mandaviya announced this decision after engaging with industry representatives, emphasizing the need for quality assurance and reducing compliance burdens. The move aims to uphold India’s reputation as the world’s pharmacy by ensuring the highest standards in drug manufacturing.
Phase-wise Implementation of Schedule M:
- The adherence to Schedule M practices will be implemented gradually in MSME pharma firms.
- Schedule M covers various aspects, including shop floors, quality control systems, labs, production, equipment cleaning, and housekeeping.
Enhancing Quality Assurance and Reducing Compliance Burden:
- The mandatory compliance with Schedule M will improve quality assurance in the production of medicines.
- Health Minister Mandaviya believes that self-regulation and adherence to good manufacturing practices are crucial for MSME pharma companies.
Safeguarding India’s Pharmaceutical Reputation:
- India’s position as the “pharmacy of the world” must be upheld.
- The health ministry is taking measures to prevent compromises in the quality of medicines produced in India.
- Recent incidents of deaths allegedly caused by drugs made in India highlight the importance of maintaining high standards.
Workshops and Stringent Actions:
- The central government conducted a workshop in Hyderabad with state drug regulators to expedite policy implementation.
- The Drugs Controller General of India has been instructed to take strict action against manufacturers of spurious drugs.
- The government has zero tolerance for non-compliance and the production of substandard medicines.
Risk-based Inspections and Regulatory Measures:
- Regulatory authorities have initiated risk-based inspections and audits of pharmaceutical manufacturing units.
- Actions have been taken against firms found to violate quality compliance.
- Production has been halted at certain firms, while licenses have been canceled or suspended.
- Show cause notices and warning letters have been issued to other non-compliant companies.