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India Signals ‘Systemic Changes’ In CGT Regulatory Approach

 
• By Anju Ghangurde

India is pressing ahead with “big shifts” in its regulatory approach for cell and gene therapies. Reduced “layers of review”, tighter internal timelines, upcoming guidelines to facilitate CGT development and reforms in the constitution of expert committees are some of the key changes.

India CGT regulation
Big shifts in India's CGT regulatory approach (Shutterstock)

India’s regulatory apparatus is implementing a range of “systemic changes” to support and keep pace with advances in cell and gene therapy (CGT), a sunrise sector where the government sees huge promise.

Key Takeaways
  • Indian government apparatus to provide significant support/impetus to sunrise CGT space
  • Layers of regulatory review for CGT pruned, internal timelines revised

Dr Rajeev Raghuvanshi, Drugs Controller General of India (DCGI), at a recent summit, said that CGT is a segment has been taken up on “mission mode” and the government is...

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