Govt to amend New Drugs and Clinical Trials Rules 2019

Amendment - New Drugs and Clinical Trials Rules, 2019

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Govt India
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The Union health ministry is planning to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019 for compassionate use of any new unapproved drug based on Drugs Technical Advisory Board (DTAB) recommendations.

DTAB considered the draft notification regarding the same dated June 05, 2020 and after detailed deliberation recommended to amend the NDCT Rules, 2019 to include the provisions for compassionate use of unapproved new drugs.

The Central Government, in consultation with the DTAB, had issued a draft gazette notification on June 5, 2020, about making an amendment in NDCT Rules, 2019 for compassionate use of any new unapproved drug. It had also invited suggestions, objections on the draft guidelines from the industry.

DTAB was apprised that representation of Cure SMA Foundation of India had been received to frame the rules and guidelines for compassionate use of unapproved drugs in India.

In the representation, it was mentioned that the medical treatment of patients with chronic, life-threatening or seriously disabling rare diseases can be very disappointing both for the suffering patients, their families and physicians in cases where patients cannot be treated satisfactorily with currently authorized medicines.


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Market authorization of new pharmaceuticals in developing countries like India can take several years during which valuable time is lost from the patient’s perspective.

Further, it was mentioned in the representation that the way to tackle this problem was to allow patients with chronic, life-threatening or seriously disabling rare diseases to obtain the medicines under “compassionate use” for new pharmaceuticals under clinical development for which phase-II/III studies provide an acceptable safety profile in clinical trials.

It was also suggested to develop a framework for compassionate use of unapproved new drugs.

As per the draft gazette notification, it is proposed that in chapter XI, after rule 96, the following shall be inserted:

“96A: Application for import of unapproved new drug for Compassionate use for the treatment of patients by hospitals or and medical institution,

96B: Grant of licence for import of new drug for compassionate use, 96C: Conditions of licence,

96CA: Suspension or cancellation of license to import new drug for the purpose of compassionate use,

96D: Application for the permission to manufacture new drug for Compassionate use,

96E: Grant of the permission to manufacture new drug for Compassionate use, 96F: Condition of permission,

96G: Inspection of manufacturing site of new drug for the purpose of compassionate use,

96H: Suspension or cancellation of permission to manufacture new drug for the purpose of compassionate use and

96I: Licence to manufacture new drug for compassionate use under the Drugs and Cosmetics Rules, 1945.

It will come into force on the date of final publication in the Official Gazette in the NDCT Rules, 2019.


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