The new Drugs and Clinical Trials Rules 2019 aim to promote clinical research in India by making the regulation of clinical trials more predictable, transparent and effective. Key features include reduced timelines for approving clinical trial applications to 30 days for drugs developed in India and 90 days for foreign drugs. The rules also provide for automatic approval if no communication is received within these timelines. They mandate medical management of subjects injured during trials as determined by investigators and allow waiver of local clinical trials for drugs approved in specified foreign countries. However, some criticize that the rules do not adequately address issues like ensuring drug suitability for India's diverse populations through bridging trials.

1. New Drugs and Clinical Trials
Rules, 2019
Mr Dilip Namdev Kawane
M Pharm Pharmacology

2. Definition: Clinical Trials
 A clinical trial is a systematic study to generate data for
discovering or verifying the clinical and pharmacological profile
(including pharmacodynamics and pharmacokinetic) or adverse
effects of a new drug on humans.
 It is the only way of establishing the safety and efficacy of any
drug before its introduction in the market for human use and is
preceded by animal trials where the efficacy and side effects are
observed in animals and an estimated drug dose is established.
 It is important for anyone preparing a trial of a new therapy in
humans that the specific aims, problems and risks or benefits of a
particular therapy be thoroughly considered and that the chosen
options be scientifically sound and ethically justified.

3. Features of New Rule 2019
 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.
 New rules have reduced the time for approving
applications, which has now come down to 30 days for drugs
manufactured in India and 90 days for those developed outside
the country.
 In case of no communication from Drugs Controller General of
India, the application will be deemed to have been approved

4. Features of New Rule 2019
 Drug Controller General of India will decide the compensation in
cases of death and permanent disability or other injury to a trial
subject.
 The requirement of a local clinical trial may be waived for approval
of a new drug if it is approved and marketed in any of the
countries specified by the Drugs Controller General with the
approval of the government.
 Ethics committee will monitor the trials and decide on the
amount of compensation in cases of adverse events.


5. Features of New Rule 2019
 It has been mandated that in case of injury to the clinical trial
subject, medical management will be provided as long as required
as per the opinion of the investigator.
 New drugs approved for use in select developed markets will be
automatically allowed in India provided global trials includes Indian
patients.
 This waiver would also extend to drugs that receive these
marketing approvals even while a trial is underway in India.
 New rules has removed regulations on tests conducted on
animals in case of drugs approved and marketed for more than
two years in well-regulated overseas drug markets.

6. AIM:
 The Union Ministry for Health and Family Welfare has notified the
Drugs and Clinical Trials Rules, 2019 with an aim to promote
clinical research in the country.
 The new rules will change the regulatory landscape for the
approval of new drugs and conduct of clinical trials in the country.
 These rules will be applicable to all new drugs, ethics committee
and investigational drugs applicable for human use,
bioequivalence studies and clinical trial in India.

7. Significance of New Rules
 Near 70 million population in India suffer from rare disorders and
many of which still not curable and their treatment is also very
high.
 Moreover, the research in India is more skewed towards non-
communicable diseases. So, clinical trials in this field will bring
much anticipated balance.
 The new rules state that any drug discovered in India, or research
and development of the drug has been done in India, and which is
proposed to be manufactured and marketed in the country, will be
deemed approved for clinical trials within 30 working days
by Central Licensing Authority (CLA).

8. Significance of New Rules
 In the event that there is no communication from the CLA to
applicant within the stipulated time, then the permission to conduct
clinical trial shall be assumed to have been granted.
 Removal of the compensation clause should be considered as a
welcome move for all the subjects participating in clinical trials in
India. Earlier there was no clarity and there were long and
cumbersome legal hassles which created a question mark on the
safety of trials.
 The DCGI would now accept the data generated outside the
country thereby making the process easier and application time
shorter.

9. Significance of New Rules
 Apart from this the new rules will end the unnecessary repetition of
trials and speed up the availability of new drugs in the country,
lower the cost of drugs and will improve the ease of doing
business for drug makers.

10. Criticism of New Regulations
 Monopolistic tendencies in the CRO market remains unaddressed.
 As India has the vast ethnic diversity the need of bridging trials for
ethnically diverse populations to check drug suitability population
is not addressed.
 Waiver should be only for drugs required urgently for national
emergency.
 To prove a injury due to the trial is problematic and it is prone to
manipulation.

11. Key Highlights
 New Drug and Clinical Trial Rules, 2019 are applicable from
date of release, 25th Mar 2019, except Chapter 4 [Ethics
Committee for Biomedical and Health Research], which will come
into force after 180 days (i.e. 21st Sep 2019)
 Rule 97 (Rule 122DAA): New Rules supersede existing Part XA
and Schedule Y of D&C Rules, 1945
 All existing licenses, orders, directions will continue to remain
valid

12. Key Highlights
 Defined timelines for review and approval of CT applications:
90 days for global clinical trials
30 days for INDs being developed in India - If no response from
DCGI, “automatic approval” to proceed, by notification to DCGI via
Form CT-4A
 Application fee for Phase 1 to 4 clinical trials increased 6-8 folds

13. Key Highlights
 Validity of Clinical Trial approval for two years to “initiate the
study” (extendable by one year)
 Two types of Ethics Committees (EC) defined:
for Clinical Trials & BA/BE studies
for Biomedical & Health Research
 Validity of EC registration increased to 5 years (from 3 years)
 DCGI to be informed about the approval granted by the EC within
15 working days of the grant of such approval

14.  In case of rejection of CT application, the applicant may request to
reconsider the application within a period of 60 days from the date
of rejection of the application
 Quarterly report of enrolment status to be submitted DCGI
 Six monthly status report (in place of annual status report) of
each clinical trial
 Termination of study to be notified within 30 days

15. Key Highlights
 Provision of Pre- and Post-submission meeting with DCGI
 Provision of waiver of local clinical trials, if drug is approved and
marketed in certain countries
 No change in process and requirement for Payment of
Compensation
 Onus of providing medical management to the subject on the
Investigator
 Conditions for post-trial access of study drug to trial participants
outlined

16. Key Highlights
 EC Accreditation is not mandatory
 SAE reporting timeline changed for sponsor : 14 calendar days
from “awareness of SAE/Death” and not “Occurrence/onset of
SAE.”
 PSUR content & structure is aligned with EU PBRER (ICH) format
which is very detailed & exhaustive but timeline is retained as per
old regulation as “30 calendar days” from data lock point.
 Free medical care – PI can decide to continue medical care Or
until it is decided as not related