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Pharmaceutical Medicine

, Volume 30, Issue 1, pp 1–13 | Cite as

Clinical Trial Regulations in India: Progress and Challenges Arising from Recent Amendments to Schedule Y of the Drugs and Cosmetics (D&C) Act 1940 (D&C Rules 1945)

  • Amit Kondal
  • G. V. Murali Krishna
  • Dipika BansalEmail author
Current Opinion
  • 118 Downloads

Abstract

The Central Drugs Standard Control Organization, which is the drug regulatory authority in India, has recently amended the regulatory framework surrounding the conduct of clinical trials in the country. In 2005–2009, India witnessed mammoth growth in the field of clinical research; however, recent years have seen a series of controversies and issues, publicized by various non-governmental organizations wishing to shine a light on the deficiencies in the clinical trial regulatory milieu in India. As a result, the regulatory environment has undergone dramatic changes, with the passage of new laws to recognize and fill these lacunae, thereby bringing transparency and accountability to the clinical trial process. Important amendments have been made to serious adverse event reporting, remittance to trial participants, audiovisual recording of informed consent, Ethics Committee registration and the accreditation process of clinical sites throughout the country. Although the spirit of these new laws is a welcome move, some changes are insufficient to fill the lacunae. This article summarizes these amendments and highlights the significant threats and challenges to various stakeholders involved in clinical research in complying with them. The laws should be framed for regulating clinical trials, not for constraining human research in the country.

Keywords

Informed Consent Process Investigational Product Compound Annual Growth Rate Ethic Committee Serious Adverse Event 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

The contents of this article are based on the authors’ personal opinions. None of the authors are associated with any regulatory staff or pharmaceutical company. This work is purely an academic activity.

Compliance with Ethical Standards

Funding

The authors certify that they have received no financial compensation/support from any sources in any form for preparation of this manuscript.

Conflicts of interest

Dr. Amit Kondal, Dr. Dipika Bansal and Murali Krishna declare that they have no conflicts of interest that are directly relevant to the content of this article.

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Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  • Amit Kondal
    • 1
  • G. V. Murali Krishna
    • 1
  • Dipika Bansal
    • 1
    Email author
  1. 1.Clinical Research Unit, Department of Pharmacy PracticeNational Institute of Pharmaceutical Education and ResearchMohaliIndia

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