Recent Changes to Clinical Trial Regulation in India: Focus on Serious Adverse Events, Compensation and Registration of Ethics Committees

Author:

Karwa Manoj,Arora Saurabh,Agrawal Shilpa Garg

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference23 articles.

1. Rule 122 DAC. Permission to conduct clinical trials. Available from: http://www.cdsco.nic.in/GSR%2063(E)%20dated01%20.02.2013.pdf . Accessed 18 Jun 2013.

2. Ramamurthy NV. Inept media trials of clinical trials. Perspect Clin Res. 2012;3(2):47–9.

3. Writ petition filed by NGO Swasthya Adhikar Manch. Available from: http://www.unethicalclinicaltrial.org/Downloads/Detail%20Chronology%20of%20Events.pdf . Accessed 18 Jun 2013.

4. Supreme Court issues notices on unethical drug trials. Available from: http://unethicalclinicaltrial.org/Downloads/Media%20News%206-2-2012%20PIL.pdf . Accessed 18 Jun 2013.

5. Pramesh CS, Badwe RA. Will the proposed compensation guidelines for research-related injury spell the death knell for clinical research in India? J Postgrad Med. 2012;58(2):156–8.

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