Advances in Pharmacology and Pharmacy Vol. 13(2), pp. 204 - 213
DOI: 10.13189/app.2025.130205
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Navigating the Regulatory Landscape: Key Transformations in India's Drug & Clinical Trials Regulations - A Comparative Analysis with the USA & Europe


Dhara Trivedi , Kashyap Thummar , Bhumika Maheriya *, Sanjay Chauhan
Graduate School of Pharmacy, Gujarat Technological University, India

ABSTRACT

Clinical trials are essential investigations that evaluate the safety and effectiveness of new medications, addressing modern health challenges. Typically lasting 10-12 years, these trials assess novel therapies to improve public health outcomes, which are critical in drug discovery. Historical landmarks such as the Nuremberg Code and Declaration of Helsinki set ethical guidelines, while incidents like the thalidomide tragedy prompted regulatory changes like the Kefauver-Harris Amendment, prioritizing safety in drug approvals. Regulations ensure ethical standards, participant safety, and trustworthy data, advancing medical research and patient welfare. India has a comprehensive regulatory framework governing clinical trials, evolving from historical challenges with drug regulation during British rule. Significant changes occurred post-independence, with the establishment of the Drugs and cosmetic act, of 1940. Amendments and updates, including the transition to TRIPS-compliant patent laws and the introduction of Ethical and Regulatory Guidelines, have enhanced India's clinical trial landscape. The Ministry of Health and Family Welfare oversees drug regulation in India through the CDSCO and NPPA. Recent rules, such as the 2019 Medicines and Clinical Trials Rules, aim to streamline and improve clinical trial processes in India. The 2019 rules introduce several key changes, including amendments to the ethics committee constitution, the validity of approved licenses, streamlined application processes, and accelerated approval mechanisms. India's recent regulations align with international standards and aim to improve efficiency and patient safety in clinical trials. The comparison demonstrates the complexity of clinical trial regulations and the efforts made by various countries to ensure the safety and efficacy of new medications while facilitating innovation and drug development. The 2019 New Drugs and Clinical Trials Rules represent a significant shift in India's clinical trial regulations, aiming to simplify processes, enhance patient safety, and maintain ethical standards. Aligned with global norms, these reforms aim to attract investments, foster innovation, and accelerate drug development. Collaboration among stakeholders is vital to address implementation hurdles, strengthen regulatory supervision, and ensure fair healthcare access, positioning India as a leader in clinical research while prioritizing patient welfare and public health.

KEYWORDS
CDSCO, Drug and Cosmetics Act - 1940, NPPA, New Drug and Clinical Trial Rules, 2019

Cite This Paper in IEEE or APA Citation Styles
(a). IEEE Format:
[1] Dhara Trivedi , Kashyap Thummar , Bhumika Maheriya , Sanjay Chauhan , "Navigating the Regulatory Landscape: Key Transformations in India's Drug & Clinical Trials Regulations - A Comparative Analysis with the USA & Europe," Advances in Pharmacology and Pharmacy, Vol. 13, No. 2, pp. 204 - 213, 2025. DOI: 10.13189/app.2025.130205.

(b). APA Format:
Dhara Trivedi , Kashyap Thummar , Bhumika Maheriya , Sanjay Chauhan (2025). Navigating the Regulatory Landscape: Key Transformations in India's Drug & Clinical Trials Regulations - A Comparative Analysis with the USA & Europe. Advances in Pharmacology and Pharmacy, 13(2), 204 - 213. DOI: 10.13189/app.2025.130205.