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NEW CLINICAL TRIAL RULES SUMMARY – IMPORTANT CHANGES
(1) Orphan drugs:
For orphan drugs, used in the treatment of rare diseases (drug intended to treat conditions which
affects not more than five lakh persons in India), No fee shall be chargeable in respect of
application for conduct of clinical trial for orphan drugs, Moreover the Rules exempt local clinical
trials for orphan drugs permitted to be imported for sale or distribution.
(2) Permission to conduct clinical trial of a new drug or investigational new drug as part of
discovery, research and manufacture in India-
This is applicable to only IND applications i.e., a firm who has not received Clinical trial NOC
within 30 days of filing the application will get an automatic approval, i.e., the permission to
conduct clinical trial shall be deemed to have been granted by the Central Licencing Authority,
but needs to give a notification/intimation to Licensing authority in Form CT 4A.
(3) Waiver of CT:
The DCGI can waive of the Clinical trial requirement in India if the drug is approved in key
developed countries such as UK, US Europe etc, subject to the condition that if the regulator had
already granted permission to conduct a global clinical trial which is ongoing in India and has
been approved for marketing in those identified country.
(For example: if a US-based company conducted clinical trials that also included Indian patients
and the drug is marketed in the US, there will be no need for conducting local clinical trials to
prove its efficacy in India)
Also the regulator can give CT waiver based on following points
 If there is no probability or evidence, on the basis of existing knowledge, of difference in

Indian population of the enzymes or gene involved in the metabolism of the new drug or
any factor affecting pharmacokinetics and pharmacodynamics, safety and efficacy of the
new drug; and
 If the applicant has given an undertaking in writing to conduct Phase IV clinical trial to
establish safety and effectiveness of such new drug as per design approved by the Central
Licensing Authority
 Provided that the Central Licensing Authority may relax this condition, where the drug is
indicated in life threatening or serious diseases or diseases of special relevance to Indian
health scenario or for a condition which is unmet need in India such as XDR tuberculosis,
hepatitis C, H1N1, dengue, malaria, HIV, or for the rare diseases for which drugs are not
available or available at a high cost or if it is an orphan drug.
(4) Timelines:
 Ninety working days approval timelines for Global Clinical Trials (GCTs).
 A clinical trial application filed in Form CT- 4 will be approved or rejected within a 90
days’ timeline for domestic players.
 In case of rejection of application by DCGI, the provisions for approaching Health
Ministry for appeal have been given in new CT rules.
 The validity of clinical trial approval received in Form CT 06 has been determined as two
years to initiate a study (extendable by one year). This ensures initiation of approved
studies and quicker access to new treatment for patients.
(5) Increase in Fee:

The application Fee has been increased 10 folds.
(For example: an earlier application for M&M of a drug product was Rs 50,000; which is now
increased to Rs 5 lac per application).
 In case of application received from Micro Small Medium Enterprises (MSME) firms
for conduct of clinical trial, approval of new drug and pre and post submission meeting,
the fee payable shall be half of the fee specified above
(6) Post trial access:

Conditions for providing post-trial access of drugs to patients who require after the study has
been completed have been defined for the first time.
(For example: Patients who have participated in a clinical trial for an investigational new drug
may also receive access to the drug “free of cost” by the sponsor after the trial is concluded, but
with certain riders)
 This applies to cases where the clinical trial is being conducted for an indication “for
which no alternative therapy is available” and the investigational new drug has been
found to be “beneficial” to the trial subject by the investigator. The trial subject or his or
her legal heir has to have consented “in writing” to the use of this drug on the subject and
has to declare in writing that the sponsor shall have “no liability” for this post-trial use.
(7) Removal of clause to pay 60% interim compensation:

The government removed a clause in the clinical trials rules that mandated the sponsor to pay
60% of compensation upfront in case of death or permanent disability of a patient. This removal
of the clause is because of the objections received from stakeholders. (The earlier proposal said
the interim compensation will not be recoverable even if investigations prove that the death or
disability did not occur because of the trial.)
(8) Medical management to trial patients:
The government also made it mandatory for firms to provide medical management as long as
required, or till such time it is established that the injury is not related to the clinical trial.
(9) Miscellaneous:
There are no changes in the rules for safety reporting process and timelines and in the process
and requirement for compensation payout. The Set formulae to determine the quantum of
compensation presently followed under administrative orders has been incorporated as a
Schedule to the rules.

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NEW CLINICAL TRIAL RULES SUMMARY – IMPORTANT CHANGES

(1) Orphan drugs:

(3) Waiver of CT:

Also the regulator can give CT waiver based on following points

 If there is no probability or evidence, on the basis of existing knowledge, of difference in

(5) Increase in Fee:

(6) Post trial access:

(7) Removal of clause to pay 60% interim compensation:

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