The document summarizes current regulations for conducting clinical trials in India. Key changes under the new 2019 rules include expanding ethics committee membership, increasing the validity of ethics committee registration to 5 years, and deemed approval of clinical trials for indigenous drug development within 30 days. The new rules aim to improve ethical standards and access to new drugs in India by streamlining processes for clinical research.

1. CURRENT REGULATIONS FOR CONDUCTING
CLINICAL TRIALS IN INDIA
Vasundhra Kakkar
INTODUCTION
• The Central Drugs Standard Control Organization and its chairman Drug Controller general of India are committed to
protect the citizens from the marketing of unsafe medication.
• Discovery of new drugs and devices through clinical research helps to fight with affliction of mankind. Because of this
sustained demand to develop a new therapeutic agent, biomedical research is conducted to enable discovery of more
effective and safer medication and discovery of new therapeutic uses of already established drugs.
Figure-1 Drug Development Process
• Clinical trials are important link between pre-clinical discovery of a new lead and their use.
• Over the last couple of years, Indian regulatory and business processes have gone through several enhancements to
harmonize with the rest of the world with the goal of making it easier for India to participate in global trials.
• The new rules aim to promote clinical research in India by providing for a predictable, transparent and effective
regulation for clinical trials and by ensuring faster accessibility of new drugs to the Indian population.
BASIC
RESEARCH
PROTOTYPE
DESIGN OR
DISCOVERY
PRECLINICAL
DEVELOPMENT
CLINICAL
DEVELOPMENT
(PHASE1,
PHASE2,
PHASE3)
DRUG
APPROVAL
AND
LAUNCH
METHEDOLOGY
New Drugs and Clinical Trial Rules, 2019 by Indian Society for Clinical Research were studied.
RESULT AND DISCUSSION
CHAPTER III: ETHICS COMMITTEE FOR CLINICAL TRIAL, BA-BE STUDY
RULE TITLE CHANGE
7 Constitution of Ethics
Committee for clinical trial
Significant changes in the constitution of Ethics Committee :
• Minimum of seven members from medical, nonmedical, scientific and non-
scientific areas with at least, one lay person; one woman member; one legal
expert; one independent member from any other related field such as social
scientist or representative of non-governmental voluntary agency or
philosopher or ethicist or theologian.
• At least 50% of members not affiliated with the institute or organization in
which EC is constituted. Every member of the EC shall be required to undergo
such training and development programs
9 Validity period of registration of
ECs for clinical trial
Validity of registration increased to 5 years
10 Renewal of registration of ECs
for clinical trial
Application for renewal of registration to be made 90 days prior to the date of
the expiry of the registration
12(4) Proceedings of ECs for clinical
trials
Any change in the membership or the constitution to be intimated to DCGI
within 30 days
13 Maintenance of records by ECs
for clinical trial
More comprehensive requirements for maintenance of records by ECs – Five
years after completion of clinical trial.
RESULT AND DISCUSSION
CHAPTER V: CLINICAL TRIAL, BA/BE STUDY OF NEW DRUGS & INDs
PART A: CLINICAL TRIALS
RULE TITLE CHANGE
21 Application for permission to conduct clinical
trial of a new drug or investigational new drug
Form CT-04 (in place of Form 44) with revised application fee
as per Sixth Schedule (Central/State Gov. sponsored projects
are exempt from application fee)
22(2) Grant of permission to conduct clinical trial Decision on application will be taken within 90 working days
22 (3) (ii) Grant of permission to conduct clinical trial In case of rejection, the applicant can request the DCGI to
reconsider the application within a period of 60 working days
from the date of rejection of the application, on payment of fee
23 Permission to conduct clinical trial of a new
drug or IND as part of discovery, research &
manufacture in India
For products being developed indigenously, the applications to
conduct clinical trials will be considered approved within 30
days of the application.
25 Conditions of permission for conduct of
clinical trial
Clinical trial sites that do not have their own EC, can use
registered EC of another trial site; or an (registered)
independent EC.
28 Academic clinical trial No permission for conducting an academic clinical trial by
DCGI, if it is intended solely for academic research purposes.
Only EC approval is mandatory.
RULE SUBJECT INR
21 Phase-1 3,oo,ooo
Phase-2, Phase-3,Phase4 2,00,000
FEE PAYABLE FOR CONDUCTING CLINICAL TRIAL
Figure-2 Trend of number of clinical trials being approved by regulators in India as per Central
Drugs Standard Control
CONCLUSION
The Rules are comprehensive, well balanced policy and will improve the ethical and quality standards of clinical trials in the
country, which will further benefit patients. The conditions of waiving local clinical trial under these Rules will help early
access to drugs for patients in India. Where the deemed approval for clinical trials in 30 working days for indigenous drug
will speed up the trial process and also encourage local drug development
REFERENCES
1. Imran M, Nazmi AK, Tabrez S, Shah MA, Clinical research regulations in India-history, Development, initiatives,
challenges and controversies, J Pharm Bioallied Sci2013 Jan –Mar; 5(1) : 2-9.
2. New Drugs and Clinical Trial Rules, 2019 by Indian Society for Clinical Research
3. Manavalan S, Sinfield C, Conducting Clinical Trials In India : Opportunities and challenges,August8, 2017.