Dr. Mansukh Mandaviya, Union Minister of Chemicals & Fertilizers, and Health & Family Welfare, emphasized the importance of quality and Good Manufacturing Processes (GMP) for MSME Pharma Companies. He met with representatives from the MSME sector and urged them to adopt self-regulation to maintain India’s position as the ‘Pharmacy of the World.’
The Union Minister acknowledged that India’s global standing in the pharmaceutical sector depends on the quality of its products. He stressed the need for self-regulation to strengthen this position and ensure value and quality.
As a result, the decision was made to gradually implement Schedule M, making it compulsory for the MSME pharma sector. This move aims to enhance quality assurance and reduce compliance burdens.
Dr. Mansukh Mandaviya instructed the Drugs Controller General of India (DCGI) to take strict action against pharmaceutical manufacturers producing spurious drugs. He emphasized that India will not compromise on the quality of drugs manufactured in the country. To address this issue, special inspection squads have been formed, and stringent actions have been taken against non-compliant manufacturers.
To ensure the highest quality standards in the pharma industry, regulatory authorities have initiated risk-based inspections and audits of manufacturing plants. So far, 137 firms have been inspected, and action has been taken against 105 of them.
Production has been halted at 31 firms, while licenses have been canceled or suspended for 50 firms. Additionally, show cause notices and warning letters have been issued to 73 and 21 firms, respectively.
The meeting was attended by Ms. S. Aparna, Secretary (Pharma), Dr. Rajeev Raghuvanshi, DCGI, senior officers from the department, Dr. Viranchi Shah, National President, and other office bearers of IDMA.
