The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance for industry on requirement of chemical & pharmaceutical information including stability study data before approval of clinical trials/ BE studies.

These guidelines apply to approval of clinical trial and BA/BE study of various categories of new drug formulations which are considered as new drug as per Rule 122E of Drugs and Cosmetics Rules. However, this guideline does not apply to biologicals and vaccines.

This guideline is based on regulatory requirements for approval of clinical trial of new drugs in India as prescribed under Drugs and Cosmetic Rules. For manufacture of trial batches of new drug for clinical trials in India, the applicant is required to obtain license in Form-29 from the concerned State Licensing Authority based on NOC obtained from CDSCO. Test batches of new drugs for development and generation of data of any new drug should be manufactured only after obtaining the license in Form-29.

The CDSCO has prepared this guidance document to specify the requirements for submission of chemical and pharmaceutical information including stability study data for approval of clinical trial/BA-BE studies. It will ensure that sufficient data is submitted to CDSCO to assess the safety as well the quality of the proposed clinical trials from chemical and pharmaceutical information perspective.

The CDSCO has clarified that chemical and pharmaceutical data required to be submitted for BA/BE studies of an unapproved new drug will be same as required for phase III clinical trial. However, in case of application for BE permission of a drug already approved in the country, chemical and pharmaceutical data required to be submitted include dosage form and its composition, master manufacturing formula, stability study data (as required for phase III clinical trial).

The CDSCO has mentioned that this guidance document is for feedback purposes only and it has invited comments and suggestions regarding this draft document from the various stakeholders within 30 days.