New Delhi: Minister of Health and Family Welfare; Chemicals and Fertilizers, Dr. Mansukh Mandaviya had a meeting with stakeholders from pharmaceuticals MSMEs, today.
During a meeting with representatives from pharma companies in the MSME sector, Dr. Mansukh Mandaviya, emphasized the crucial role of self-regulation in the industry to maintain India’s position as the “Pharmacy of the World”. Mandaviya stressed the importance of quality in pharmaceutical products and the need for Good Manufacturing Processes (GMP) through self-regulation.
To this end, the industry has agreed on the phased implementation of Schedule M to improve quality assurance and reduce compliance burden. Mandaviya has also directed the Drugs Controller General of India (DCGI) to act against all pharmaceutical manufacturing companies that produce spurious drugs, emphasizing the government's zero-tolerance policy towards non-adherence to quality compliance.
To ensure the highest quality of pharma products, the regulatory authorities have started risk-based inspections and audits of plants, with action being taken against non-compliant firms. This includes suspension of production, cancellation and suspension of licenses, and show-cause notices issued to those who fail to comply.
He stated that 137 firms were inspected, and action has been taken against 105 firms. Production has been stopped at 31 firms and Cancellation & Suspension of Product/Section Licenses have been issued against 50 firms. In addition, show cause notice has been issued to 73 firms, and warning letters have been issued against 21 firms.
The meeting was attended by senior officers from the Department, as well as representatives from the Indian Drug Manufacturers’ Association.
