The Union Minister of Chemicals & Fertilizers, and Health & Family Welfare, held a productive meeting with representatives from pharmaceutical companies belonging to the Micro, Small, and Medium Enterprises (MSME) sector. This meeting was held on 11th July, 2023.
The meeting aimed to discuss various aspects of the industry and highlight the importance of self-regulation to maintain India’s esteemed status as the ‘Pharmacy of the World’.
During the meeting, the Union Minister strongly emphasized the need for self-regulation within the MSME pharma sector. By adhering to strict quality standards and taking necessary measures to combat spurious drugs, India can continue to be a global leader in pharmaceuticals. To this end, the implementation of Schedule M regulations will be made mandatory for the MSME pharma sector in a phased manner.
The Union Minister also shared updates on the regulatory actions taken to ensure the highest quality of pharmaceutical products. In pursuit of this goal, regulatory authorities have initiated risk-based inspections and audits of manufacturing plants. So far, 137 firms have undergone inspections, leading to actions against 105 firms. Out of these, production has been halted at 31 firms, and Cancellation & Suspension of Product/Section Licenses have been issued against 50 firms. Furthermore, show cause notices have been issued to 73 firms, and warning letters have been issued to 21 firms.
These stringent actions demonstrate the commitment of the government to uphold the integrity and safety of the pharmaceutical industry. By holding companies accountable for their practices, the Union Minister aims to ensure that consumers receive high-quality medications that meet the required standards.
The meeting between the Union Minister and the MSME pharma representatives signifies the government’s proactive approach to engaging with industry stakeholders and addressing critical issues. By working collaboratively, the government and the MSME sector can contribute to the growth and development of the pharmaceutical industry in India.
As India continues its journey as the ‘Pharmacy of the World’, self-regulation, quality assurance, and rigorous inspections will play pivotal roles in maintaining this prestigious position. The Union Minister’s interaction with the MSME pharma sector representatives reaffirms the government’s commitment to creating an environment conducive to the production of safe and effective pharmaceutical products for the global market.