1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>India

India Proposes Safeguards For Gene Therapies

 
• By Vibha Sharma

India has proposed establishing a Gene Therapy Advisory and Evaluation Committee that will comprise independent experts to monitor all GTP clinical trials.

Gene Therapy
India Wants To Streamline Regulatory Processes For Gene Therapies • Source: Shutterstock

The deadline is nearing for stakeholders to comment on India’s proposal to establish a national guideline to support the research and development of gene therapy products (GTPs). The proposal clarifies that any GTP of foreign origin, or its modified variants, that is first-in-human use is not permissible for direct first-in-human trials in India.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from India

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.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By Vibha Ravi

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 
• By Urtė Fultinavičiūtė

As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.

More from Asia