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In a high-level review meeting today, Union Health Minister Shri J P Nadda underscored the necessity for India to adopt a world-class regulatory framework to solidify its global reputation as the “Pharmacy of the World.” The meeting was attended by key figures including Union Health Secretary Shri Apurva Chandra, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi, and senior officers from the Central Drugs Standard Control Organization (CDSCO) and the Union Health Ministry.

Emphasizing Global Standards and Transparency

Shri J P Nadda emphasized the critical importance of achieving global regulatory standards to maintain the quality and safety of drugs, cosmetics, and medical devices produced in India. He highlighted that the regulatory framework should focus on transparency within the CDSCO and the industry at large. “Our focus needs to be on transparency of procedures at CDCSO and within the drugs and medical devices industry,” stated Shri Nadda. By adhering to the highest principles of transparency, the industry can ensure that products meet global quality standards.

Continuous Dialogue with Industry Stakeholders

The Union Health Minister stressed the need for continuous dialogue between CDSCO and the drugs and medical devices industry. This collaboration aims to understand industry challenges and support them in meeting the regulatory expectations. Shri Nadda called for the development of user-friendly mechanisms within CDSCO to facilitate ease of business while maintaining stringent regulatory standards. “CDSCO needs to be a user-friendly organization with state-of-the-art facilities matching global standards,” he asserted.

Supporting the MSME Sector

Acknowledging the challenges faced by the Micro, Small & Medium Enterprises (MSME) sector in adhering to quality standards, Shri Nadda highlighted the importance of addressing their issues and supporting them to enhance their capacity and product quality. He stated, “Let us understand the issues faced by the MSME sector and support them to strengthen their capacity and quality of products, and encourage them to meet regulatory requirements.”

Strengthening State Drug Regulatory Systems

Shri Nadda was briefed on the ongoing activities and future plans of CDSCO, including the progress of the scheme for strengthening state drug regulatory systems, which was launched in 2016 with a budget of Rs. 850 crores. He emphasized the necessity of aligning the skills and capacities of state regulatory bodies with the quality standards of the Central Government. “It is important to work in tandem with the States to enhance their skills and capacities and encourage them to align with the quality standards of the Central Government,” he added.

Conclusion

The meeting highlighted India’s commitment to maintaining its status as a leading producer and exporter of pharmaceuticals. By focusing on transparency, continuous dialogue with industry stakeholders, and supporting the MSME sector, India aims to achieve a regulatory framework that matches its global aspirations. As Shri Nadda concluded, “For India to become the global leader in drugs regulation to match our global reputation of ‘Pharmacy of the World,’ we need to have a world-class regulatory framework matching our scale of operations and international expectations.”

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