Author(s): Vishal Vennu, Prem Saini

Email(s): ,

DOI: 10.5958/0974-360X.2020.00738.6   

Address: Vishal Vennu1, Prem Saini2
1Ph.D. Scholar, SOP, Lingaya’s Vidyapeeth, Faridabad, Haryana, India & Department of Rehabilitation Sciences, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.
2 Head, School of Pharmacy, Lingaya’s Vidyapeeth, Faridabad, Haryana, India. *Corresponding Author

Published In:   Volume - 13,      Issue - 9,     Year - 2020

Studies have examined possible problems regarding previous clinical trial regulations. However, no study studied the knowledge and views of Indian researchers about the current new rules. Therefore, the study aimed to address this gap. In this cross-sectional web-based online survey, a total of 106 male and female researchers were chosen randomly from various sources over India between July 2019 and September 2019. Google form was used to develop the survey questionnaires, which had already been validated. A web link was created for participants to perceive the survey. The demographic characteristics, knowledge, and views of Indian researchers were described in numbers (percentages) and means (standard deviations). Of 106 researchers, 75 (70.8%) knew the new regulations. The modification in the timeline, open post-trial drug passage, and welcoming equality was accepted by 36 (63.2%), 32 (53.1%), and 31 (54.5%), respectively. The new advances in severe adverse effects and compensation were accepted by 37 (64.9%). Overall, 34 (59.6%) agreed on the new rules, and 71 (67%) answered that the new regulations would often influence on profit clinical trial investigations. Generally, 91 (87.5%) researchers believed that the new rules are incredibly beneficial to the development of clinical research in India. The study results suggest that most researchers know and agree with the modifications. The current new rules force to extend clinical research and the pharmaceutical industry in India. Overall, this study strengthens the aim of the new regulations that promote clinical trials, accept new drugs, and enhance the country's moral norms.

Cite this article:
Vishal Vennu, Prem Saini. The knowledge and views of Indian researchers concerning India’s current drugs and clinical trial regulations. Research J. Pharm. and Tech. 2020; 13(9):4179-4184. doi: 10.5958/0974-360X.2020.00738.6

1.    Davis S., et al. Ethics committees and the changed clinical research environment in India in 2016: A perspective! Perspect Clin Res. 8(1); 2017:17-21.
2.    Kadam R., et al. Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators. Perspect Clin Res. 7(2); 2016:81-87.
3.    Ramalingam S., Bhuvaneswari S.and SanKaRan R. Ethics workshops-are they effective in improving the competencies of faculty and postgraduates? J Clin Diagn Res. 8(7); 2014:XC01-XC03.
4.    Burt T., et al. Clinical research environment in India: Challenges and proposed solutions. J Clin Res Bioeth.5(6); 2014:1-8.
5.    Rake B. and Haeussler C. Did relaxing clinical trial regulation enhance the stock of scientific knowledge in India? Not necessarily. PLoS One.14(1); 2019:e0210163.
6.    Chatterjee P. India tightens regulation of clinical trials to safeguard participants. BMJ. 346; 2013:f1275.
7.    Evangeline L., et al. Regulatory process and ethics for clinical trials in India (CDSCO). Phar Innov. 6(4); 2017:165-169.
8.    Kondal A., Krishna G.M. and Bansal D. 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).  Pharmaceu Med. 30; 2016:1-13.
9.    Imran M., et al. Clinical research regulation in India-history, development, initiatives, challenges and controversies: Still long way to go. J Pharm Bioallied Sci. 5(1); 2013:2-9.
10.    Lahiry S., et al. Paradigm shift in clinical trial regulations in India. Ind J Rheum. 13(1); 2018:51-55.
11.    Clinical trials in India: ethical concerns. Bull World Health Organ. 86(8); 2008:581-582.
12.    Gulhati C.M. Needed: closer scrutiny of clinical trials. Indian J Med Ethics. 1(1); 2004:4-5.
13.    Yee A. Regulation failing to keep up with India's trials boom. Lancet. 379(9814); 2012:397-398.
14.    Shivayogi P. Vulnerable population and methods for their safeguard. Perspect Clin Res. 4(1); 2013:53-57.
15.    Subramanian S. Thousands of Indians die in unethical clinical trials. Available from:
16.    Acharya K. HEALTH-INDIA: Prime Destination for Unethical Clinical Trials. Available from:
17.    Kahn J. A Nation of Guinea Pigs. Available from:
18.    Ramamurthy N.V. Inept media trials of clinical trials. Perspect Clin Res. 2012; 3(2); 2012:47-49.
19.    Drishtiias Drugs and Clinical Trials Rules, 2019. Available from:
20.    Vaidyanathan G. India’s clinical trials rules to speed up drug approvals. Nature. 2019.doi:10.1038/d41586-019-01054-4
21.    Jesani A. and Srinivasan S. New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights. IndianJ Med Ethics. 4(2); 2019:89-91.
22.    Associates S  Mondaq Ltd. India: The New Drugs And Clinical Trial Rules, 2019. Available from
23.    Eysenbach G. and Wyatt J. Using the Internet for surveys and health research. J Med Internet Res. 4(2); 2002:e13.
24.    Ritter P., et al. Internet versus mailed questionnaires: a randomized comparison. J Med Internet Res. 6(3); 2004:e29.
25.    Eysenbach G. Improving the quality of Web surveys: the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). J Med Internet Res. 2004; 6(3); 2004:e34.
26.    Vennu V. and Dahiya S. Awareness and Opinions of Research Professionals on India's New Drug and Clinical Trials Regulations: Protocol of a Cross-Sectional Online Survey Study. JMIR Res Protoc.9(1); 2019: e14744.
27.    Nijhawan L.P., et al. Informed consent: Issues and challenges. J Adv Pharm Technol Res. 4(3); 2013:134-140.
28.    Travis L. One of many free survey tools: Google docs. J Electr Res Med Libra. 7(2); 2010:105-114.
29. The New Drugs and Clinical Trial Rules, 2019 India: research professionals awareness and opinions. Vailable from:
30. India's new drugs and clinical trials rules, 2019. Available from:
31.    Krumpal I. Determinants of social desirability bias in sensitive surveys: a literature review Quality & Quantity. 47; 2013:2025-2047.
32.    Nederhof A.J. Methods of coping with social desirability bias: A review Eur J Soc Psychol.15(3); 1985:263-280.

Recomonded Articles:

Author(s): Nimbalkar V.V., Pansare P.M., Nishane B.B.

DOI: 10.5958/0974-360X.2015.00310.8         Access: Open Access Read More

Author(s): Umesh Kumar, Rakesh Narang, Surendra Kumar Nayak, Sachin Kumar Singh, Vivek Gupta

DOI: 10.5958/0974-360X.2017.00425.5         Access: Open Access Read More

Author(s): Ravindranath S. Misal, Vishawas R. Potphode, Vijay R. Mahajan

DOI: 10.5958/0974-360X.2017.00218.9         Access: Open Access Read More

Author(s): Niharika, Navneet Verma

DOI: 10.5958/0974-360X.2016.00182.7         Access: Open Access Read More

Author(s): Rakhi Mehra, Renu Makhija, Neera Vyas

DOI: Not Available         Access: Open Access Read More

Author(s): A. S. K. Sankar, B. Datchayani, N. Balakumaran, Mohammed Rilwan, R. Subaranjani

DOI: 10.5958/0974-360X.2017.00047.6         Access: Open Access Read More

Author(s): Jino Elsa Thomas, Usha Y Nayak*, Jagadish PC, Koteshwara KB

DOI: 10.5958/0974-360X.2017.00007.5         Access: Open Access Read More

Author(s): R. Narayana Charyulu, P. Parvathy Devi, Jobin Jose, A. Veena Shetty

DOI: Not Available         Access: Open Access Read More

Author(s): Ahmed Hilal Sheriff, Preetham Prasad Nittla

DOI: 10.5958/0974-360X.2019.00968.5         Access: Open Access Read More

Author(s): U.S Mahadeva Rao, Khamsah Suryati Mohd, Abdurrazaq Muhammad, Bashir Ado Ahmad, Mohaslinda Mohamad, Rosmawati Mat Ali

DOI: Not Available         Access: Open Access Read More

Author(s): Niha Naveed, Karthikeyan Murthykumar, Subasree Soundarajan, Sripradha Srinivasan

DOI: Not Available         Access: Open Access Read More

Author(s): Sonte Sushmitha, Sedimbi Revathi Priyanka, L. Mohan Krishna, M. Srinavasa Murthy

DOI: Not Available         Access: Open Access Read More

Author(s): Raj Kumar R, Praveen D, Palani Shanmugasundaram

DOI: 10.5958/0974-360X.2016.00164.5         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

56th percentile
Powered by  Scopus

SCImago Journal & Country Rank

Recent Articles