Clinical Trials and Regulatory Framework in India

The Supreme Court of India is examining the regulations surrounding clinical trials, especially those conducted by multinational pharmaceutical companies in poorer countries.

Key Points

• Supreme Court Involvement: The court allowed a petitioner to submit objections to the existing rules concerning clinical trials. 
• Regulations Overview:
  • In 2019, the Indian government framed new rules for drugs and clinical trials.
  • Amendments to these rules were notified in 2024 to improve patient safety and align with global standards.
• Concerns Raised by NGO:
  • Swasthya Adhikar Manch, an NGO, filed a PIL in 2012, highlighting the misuse of Indian citizens in clinical drug trials conducted by multinational firms.
  • Allegations include exploitation of poor citizens as "guinea pigs" without adequate compensation.
• Legal Proceedings:
  • The court granted four weeks for objections to be filed against the existing rules.
  • The Centre's additional solicitor general argued that the PILs had become irrelevant due to the 2019 and 2024 rule updates.
• Historical Context:
  • In 2013, the Supreme Court found the existing norms "deficient" and pushed for the introduction of new protective rules.

Conclusion

The Supreme Court's intervention aims to ensure that clinical trials in India prioritize the welfare of Indian citizens and adhere to stringent safety protocols, rather than merely serving the interests of multinational companies.