The Central Drugs Standard Control Organisation (CDSCO) has issued draft guidelines on the approval of clinical trials and new drugs with a view to put in place general requirements for approval of different phases of trials and different categories of new drugs, as the requirements usually vary depending on nature of new drugs.

The draft guidelines, published for the comments from the stakeholders, are expected to help industry to submit the required documents in a 'more realistic manner which in turn will also help reviewer of CDSCO to review such applications in systematic manner.' The CDSCO has asked the industry to send in comments by August 24, 2011 in this regard, ahead of finalising the guidelines.

The guidance document also has laid down guidelines for different categories of new drugs like investigational new drugs, new drug substances, additional strength, additional indication, modified release form etc. “It is apparent that this structured application with comprehensive and rational contents will help CDSCO to review and take necessary action in a better way and would ease the preparation of electronic submissions, which may happen in the near future at CDSCO,” according to the document.

“These guidelines apply to approval of clinical trial and approval of manufacture/import for marketing of various categories of new drugs in the form of API and finished formulation which are considered as new drug as per Rule 122E of Drugs and Cosmetics Rules. This guideline describes requirements for approval of clinical trials and new drugs and the procedure for review of technical dossiers of such applications by CDSCO under Rule 122 A, 122B, 122DA, 122DAA, 122E and Schedule-Y of Drugs and Cosmetics Rules,” it said.

“This guideline is based on regulatory requirement for drug approval in India as prescribed under Drugs and Cosmetic Act and Rules made there under and its various amendments. For development of any new drug the applicant is required to obtain license in Form-29 from 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, it added.