Updated on 27 September 2012
In cases of life threatening or serious diseases, it is desirable to expedite the development, evaluation, and marketing of new therapies intended to treat persons, especially where no satisfactory alternative therapy exists. In such cases patients or clinicians are generally willing to accept greater risks or side effects from products that treat life-threatening or serious diseases, than they would accept from products that treat less serious illnesses.
CDSCO will initially examine such applications, and if any particular data is lacking it will be informed to the applicant or else the applications will be forwarded to the members of IND committee in case of investigational new drugs (INDs) or to the members of New Drug Advisory Committee (NDAC) in case of new chemical entities other than IND and new fixed dose combinations.
However, in case of applications for grant of approval of new dosage form, new indication, new route of administration etc. of approved drugs, the application will be examined by CDSCO. Wherever required, such applications may also be examined in consultation with expert or expert committees. Further, all requests for exemption of toxicological & clinical data requirements will be considered on the basis of examination and scrutiny of the adequacy of data and in consultation with experts.
A legal undertaking in the form of an affidavit should be submitted by the applicant (competent person from the company) stating that the data submitted along with the application is scientifically valid and authentic.
(To know more about regulatory-related issues in India, visit www.cdsco.nic.in)