Pharma & Healthcare Update

December 15, 2005

New Bill to regulate scientific research on humans

A new Bill titled as - “The Biomedical Research on Human Subjects (Promotion & Regulation) Bill”, has been proposed by the Government to regulate and enforce ethical practices in scientific research on humans. It is likely to be introduced in the next session of Parliament.

The need for the Bill arose as currently only the commercial aspects of research on humans through clinical trials was being regulated under the Drugs and Cosmetics Act,1945, more specifically Schedule Y. Further, concerns were being raised as to the unethical practices in the industry. The current bill which relies heavily on the “ethical guidelines for biomedical research on human subjects” issued by the Indian Council of Medical Research (ICMR), aims to plug the holes and encompass all kinds of research on humans. This would include clinical trials - both commercial and academic, as well as the entire range of research, including genomics, gene mapping, foetal tissue transplant, and stem cell research.

The Bill is driven by “ethical considerations” in research and its schedules contain the principles and processes , such as:

  • ethical considerations
  • ethical review procedures
  • clinical trials
  • clinical evaluation of devices
  • diagnostics
  • vaccines
  • epidemiological studies
  • stem cell research (including human genetics research)
  • transplant research
  • assisted reproductive technologies

It also covers stem cell research,a very controversial area of research which has been opposed in many countries. A further need to regulate this kind of research in India was felt as there are many cases of forced uniformed consents and clinical research on the illiterate and poor, which could lead to unregulated abortions, and the general flouting of medical ethics and scientific principles by doctors.

Currently the only regulator on human research in India is the Drug Controller-General of India who regulates commercially conducted clinical trials. The Bill proposes that the ethics committee of ICMR be designated as the national ethics committee, which will also be the technical adviser to the biomedical regulator. It also prescribes fines up to Rs 1 lakh and imprisonment of up to a year for norm violations.

Though, the Bill has been seen by some as a right move in the direction of bringing in more regulation into a much needed space, others feel that it would be causing a multiplicity of regulation, as there is the Drugs and Cosmetics Act already regulating clinical trials. Hence, it is felt that such a move would actually hinder the burgeoning market for clinical trials in India.

 

Nithya Reddy Dr. Milind Antani


Disclaimer

The contents of this hotline should not be construed as legal opinion. View detailed disclaimer.

This Hotline provides general information existing at the time of preparation. The Hotline is intended as a news update and Nishith Desai Associates neither assumes nor accepts any responsibility for any loss arising to any person acting or refraining from acting as a result of any material contained in this Hotline. It is recommended that professional advice be taken based on the specific facts and circumstances. This Hotline does not substitute the need to refer to the original pronouncements.

This is not a Spam mail. You have received this mail because you have either requested for it or someone must have suggested your name. Since India has no anti-spamming law, we refer to the US directive, which states that a mail cannot be considered Spam if it contains the sender's contact information, which this mail does. In case this mail doesn't concern you, please unsubscribe from mailing list.

 

 

 

Proud Moments

Benchmark Litigation Asia-Pacific: Tier 1 for Government & Regulatory and Tax
2020, 2019, 2018

Legal500 Asia-Pacific: Tier 1 for Tax, Investment Funds, Labour & Employment and TMT
2020, 2019, 2018, 2017, 2016, 2015, 2014, 2013, 2012

Chambers and Partners Asia Pacific: Band 1 for Employment, Lifesciences, Tax and TMT
2020, 2019, 2018, 2017, 2016, 2015

IFLR1000: Tier 1 for Private Equity and Project Development: Telecommunications Networks.
2020, 2019, 2018, 2017, 2014

AsiaLaw Asia-Pacific Guide 2020: Tier 1 (Outstanding) for TMT, Labour & Employment, Private Equity, Regulatory and Tax

FT Innovative Lawyers Asia Pacific 2019 Awards: NDA ranked 2nd in the Most Innovative Law Firm category (Asia-Pacific Headquartered)

RSG-Financial Times: India’s Most Innovative Law Firm
2019, 2017, 2016, 2015, 2014

NDA Connect

Connect with us at events, 
conferences and seminars.