Union Health Minister J P Nadda Calls for World-Class Regulatory Framework for India’s Drug Industry

New Delhi: Union Health Minister J P Nadda emphasized the need for India to develop a world-class regulatory framework to match its global reputation as the “Pharmacy of the World.” This call to action came during a high-level review meeting on the regulation of drugs, cosmetics, and medical devices held today. The meeting was attended by Union Health Secretary Apurva Chandra, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi, and senior officials from the Central Drugs Standard Control Organization (CDSCO) and the Union Health Ministry.

Minister Nadda highlighted India’s prominent position as a leading producer and exporter of drugs and stressed the necessity for the CDSCO to create a roadmap with clear timelines for achieving global standards. He called for a systems-based approach focusing on the highest standards of uniformity, technical upgrades, and a forward-looking strategy. Ensuring the quality of drugs for export, Nadda emphasized, is essential for maintaining India’s reputation.

Transparency within the CDSCO and the broader drugs and medical devices industry was another key point in Nadda’s address. “To achieve global standards, our focus needs to be on the transparency of procedures at CDSCO and within the industry,” he stated. He urged both the regulatory body and the industry to uphold the highest principles of transparency to ensure that Indian products meet global quality standards.

Minister Nadda also stressed the importance of continuous dialogue between CDSCO and the industry to understand and address their challenges, thereby supporting them in meeting regulatory requirements. “Our focus should be on developing mechanisms that ensure ease of doing business for the drugs industry within the regulatory requirements. CDSCO needs to be a user-friendly organization with state-of-the-art facilities matching global standards,” he added.

Regarding the Micro, Small & Medium Enterprises (MSME) sector in drug manufacturing, Nadda acknowledged the issues faced by small-scale industries in meeting quality standards. He called for understanding and supporting these sectors to enhance their capacity and product quality while encouraging compliance with regulatory requirements.

During the meeting, Minister Nadda was briefed on the mandated activities of CDSCO, its achievements, future plans, and the various challenges it faces. He was also updated on the progress of the Scheme for Strengthening State Drug Regulatory Systems, which has a budget of Rs. 850 crores and was launched in 2016 during his previous tenure.

The Union Minister underscored the importance of collaboration between central and state regulatory bodies, noting that states are an integral part of the regulatory value chain. He emphasized the need to enhance state skills and capacities and align them with central quality standards, particularly in light of CDSCO’s initiative to upgrade Good Manufacturing Practices to global levels.