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.
