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India Regulatory Reform: ‘Redeliberation’ At SECs Tightened, ‘Unnecessary Load’ Reduced

 
• By Anju Ghangurde

India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.

L to R: Anil Matai, Director General OPPI; Vinod Kotwal Member Secretary, NPPA; Bhushan Akshikar, MD, GSK Pharmaceuticals; Anupriya Singh Patel, Union Minister Of State For Health And Family Welfare, Dr Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers; DCGI Dr Rajeev Raghuvanshi; and Amitabh Dube, country president and MD, Novartis in India.

India’s drugs regulator continues to implement reforms to improve systems and procedures as part of its thrust towards simplifying regulation, while ensuring execution is “intense”.

Addressing the annual summit of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), outlined certain initiatives that the regulator is implementing...

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