[india-drug] RE: Letrozole for Inducing Ovulations(3)

["Reji K Joseph" <rejikjoseph55@hotmail.com>]

   Dear Group,

   This  is  in  response to the questions raised by Dr. Weerasuriya. The
   first  question  is how  does  a  specific  indication  for a drug get
   approved?

   The  approval  for  marketing  a  drug in India is granted by the Drug
   Controller  General of India (DCGI). DCGI grants approval on the basis
   of  the  test  data submitted by the applicant. The nature of the data
   required  would  depend on the status of that particular drug in other
   countries.  If  the  drug  is  discovered  in  India, the applicant is
   required  to furnish data on clinical trials from phase 1. Whereas, if
   the  drug  is  approved  in any other country, data on only phase 3 is
   required.  However,  if the drug is developed in any other country and
   has  not yet gained approval, trials are required at one phase earlier
   to  the  phase  of trials in the other country. Approval for different
   dosage  forms would require studies on bioavailability and dissolution
   studies.

   Section 122 A to 122 E and schedule Y of the Drugs and Cosmetics Rules
   1945 deals with these issues.

   Regards,
   Reji K Joseph
   ---------------------------------------------------------------
   
   Reji K Joseph
   Research Scholar
   Centre for Economic Studies and Planning
   Jawaharlal Nehru University
   New Delhi, 110067
   INDIA
   Telephone: 0113500735