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Guidance For IndustryBiologicals3

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Guidance For IndustryBiologicals3

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ksvnewdelhi
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Guidance for Industry (Biologicals)

Central Drugs Standard Control Organization Page 3

OBJECTIVE
This Guidance has been developed in conformity with New Drugs and Clinical Trials
Rules, 2019 under Drugs and Cosmetics Act 1940 and GCP Guidelines of India for the
purpose of submission of Clinical Trial application. The clinical trial sponsor is required
to submit application (Form CT-04) for the purpose of conducting clinical trial in India
and submit documents as per New Drugs and Clinical Trials Rules, 2019 there in. The
sponsor is also responsible for implementing and maintaining Quality Assurance
system to ensure that the clinical trial is conducted and data generated, documented
and reported in compliance with the protocol and Good Clinical Practice Guidelines
issued by CDSCO, Directorate General of Health Services, Govt. of India as well as
all applicable statutory provisions of New Drugs and Clinical Trials Rules, 2019 under
Drugs and Cosmetics Act,1940. Standard operating procedures should be
documented to ensure compliance with GCP and applicable regulations.

Sponsors are required to submit a status report on the clinical trial to the Licensing
Authority at the prescribed periodicity. In case of studies prematurely discontinued for
any reason including lack of commercial interest in pursuing the new drug application,
a summary report should be submitted within 3 months. The summary report should
provide a brief description of the study, the number of patients exposed to the drug,
dose and duration of exposure, details of adverse drug reactions, if any, and the reason
for discontinuation of the study or non-pursuit of the new drug application. Any
expected serious adverse event (SAE) occurring during a clinical trial should be
communicated promptly (within 14 calendar days) by the Sponsor to the Licensing
Authority and to the other Investigator(s) participating in the study.

The manufacturer / sponsor has to submit application in Form CT-04 for permission of
Clinical Trial under the provisions of New Drugs and Clinical Trials Rules, 2019 under
Drugs and Cosmetic Act, 1940.
The requirements in respect of Chemistry and Pharmaceutical information has been
elaborated for Biologicals in this document while requirement for conduction of Clinical
trial and other requirements remains the same as per New Drugs and Clinical Trials
Rules, 2019.

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