This document summarizes the current regulatory challenges for conducting clinical trials in India. It outlines the evolution of India's clinical trial regulatory framework over time in response to incidents of malpractice. Key recommendations from an expert committee include accrediting clinical sites and investigators, establishing expert review committees, and providing compensation for injuries from trials. Regulatory actions by Indian authorities aim to implement these recommendations. The pharmaceutical industry desires further clarity on issues like liability and access to drugs post-trials. Overall improvements are expected in areas like accreditation, compensation policies, and transparency of the regulatory system.

1. Current Regulatory Challenges in
conduct of Clinical Trials –India​
Prabhat Kumar
November 2014

2. AGENDA
• Clinical Trial current regulatory framework
• Current regulatory challenges
• Background of evolution of current regulatory
framework
• Recommendation of the expert committee
• Actions from the CDSCO
• Industries expectations
• Positive developments….!
• Way forward

3. Clinical Trials: Current Regulatory Framework 1
• Drugs and Cosmetics Act,1940 & Rules,1945
• ICMR Ethical guidelines,2000/2006
• Indian GCP Guidelines, 2001
• National Pharma.Vig. Programme, 2004
• Revised Schedule Y (Drugs & Cosmetics Rules),
2005

4. Clinical Trials: Current Regulatory Framework 2
• BA/BE Study Guidelines, 2005
• Notification on Devices,2005
• Amendment to Drugs and Cosmetic Act,2008
• Notification on Clinical trial registration, 2009
• Amendment to D and C Act, CRO Regn,Sch.Y-
1,2009
• Proposed Clinical establishment Bill,2010
• Amendments in 2012 and 2013
• CDSCO official order/notifications………..

5. Background of evolution of current
regulatory framework
• NHRC orders probe into southern state drug trial scandal – several
women were as used as human subject for breast cancer drug trial by a
pharmaceutical company.
• Unauthorised clinical trial of vaccine against cervical cancer were
conducted by an NGO on 25,000 minor girls in one of the southern
states and in western state.(HPV Vaccine Trial) A government funded
hospital in Bhopal was conducting clinical trials on unwitting patients.
• A Medical College in Indore enrolled children for illegal drug tests for
nearly ten years.
• Health activists are concerned about the way many clinical trials are
conducted in this country.
• There have been a series of incidences involving alleged malpractices in
recent past, health minister in last govt. talked in Parliament about
patient deaths during clinical trials.

6. Background of evolution……framework .Cont..
Expert Committee by MoH under Dr. Ranjit Roy choudhury
Term of reference : To formulate policy and guidelines for
–Approval of new drugs including biologicals
–Approval of clinical trials including global CTs, BA/BE studies for export
–Functioning of the 12 NDACs (now replaced with SEC and TEC)
–To identify experts for the CDSCO
–Any other matter related to CDSCO

7. Recommendation of the expert committee
• Total 25 recommendations were suggested by this
committee which includes…
• CTs can be conducted only at accredited Clinical sites by accredited PIs after
approval by accredited ECs.
• Roster of experts (SEC) from all over India and selection of experts by random
tables.
• Roster of accredited sites from which Pharma co.s can select the Sites and PIs.
• A technical review Committee to be set up to take uniform, unbiased ,final
decision on approvals.
• Audio-visual recording wherever necessary in vulnerable groups.
• Compensation (Financial) to be paid to legal nominees in case of Death or
Disability
• All SAEs to get equal treated whether due to test drug, placebo or Standard
treatment.
• Provision of Ancillary care during trial period.

8. Actions from the CDSCO
• CDSCO office released a series of orders (total 14) with
regard to requirements for conduct/ approval of clinical
trials and new drug approval based on the
recommendations of R.R. Committee Report.
Which includes mainly…….
• CT Compensation in case of injury or death discerned at
a later stage.
• Providing Ancillary Care to the Clinical Trial subjects
• Limiting Number of Clinical Trials an investigator can
undertake at a time

9. Action…… continued…
• Requirement for filing of application to market
new Chemical
• Waiver of CT in Indian Population for approval of
New Drugs
• Requirement for filing of application to market
new Chemical Entities

10. Industries expectations
Need of the clarity
• Expectation to have consolidated guidance
documents providing the current interpretation
of the regulations related to the EC functioning,
(similar to USFDA, EMEA etc. )

11. Industries expectations Cont..
Clinical trial liabilities
• Recently DCGI has been instructing sponsors /CROs to
include the wording in ICF that sponsor or CRO will provide
complete medical care as well as compensation for the injury.
• The injury may either arise out of the ‘study’ i.e. as specified
in the Protocol and the ICF or may arise out of any act,
omission, negligence or misconduct of the CRO or the
investigator / institution.
• Who would primarily be liable to compensate the study
subject, whether the sponsor or the CRO or the investigator /
institution in connection with the study?

12. Industries expectations Cont..
Access to drugs
• Another issue that arises is the liability of the
sponsor to provide access to drugs and treatment
post termination of the trial. Depending upon the
study protocol, availability of the drug and stage
of the trial, this issue needs to be addressed.

13. Positive developments….!
In the recent(Oct14) DIA conference, where some
of the regulatory challenges were discussed and
thoughts from the stake holders
There are upcoming positive changes in the near
future in the areas of:
Clinical trial conduct:
• Accreditation will be required for Investigators/Study sites
to conduct clinical trials.
• Accreditation of Ethics Committee/Institutional Review
Board to approve/oversee clinical trials.

14. Positive developments….! Conti……
• Compensation clause for any injury to subjects participating
in trials: This is being re-visited (no compensation for
ineffective therapy or adverse events not related to drug, or
adverse events for patients in placebo arm are being
discussed).
• Audio-visual recording of informed consent (IC) is being
revisited.
– Regulatory system: Transparency and possibility of
online tracking of regulatory application are being
worked up on.
– Changes in medical/nursing education system.
– Affordable health: Health assurance for all patients at
primary health centers; health insurance for

15. Way forward
• There are encouraging sentiments of upcoming positive
changes in the regulatory environment will lead to more
clinical trial work in India.
• With the advent of globalization, it is important to
adhere to global standards and best practice respecting
local norms and value at the same time look at
innovative ways to provide affordable healthcare to
patients in India.
• Collaborative work is required between regulators,
industry and academia to support innovation .
• Regulatory frame work must be rational and evidence-
based; rather mere opinion based.

16. Over Regulation?

17. Controlled regulation: Win-Win situation !!!

18. DISCLAIMER
The views and opinions expressed in the following PowerPoint slides are those of
the individual presenter and should not be attributed to my organisation, its
directors, officers, employees, volunteers, members, committee, or affiliates, or
any organization with which the presenter is employed or affiliated.

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