New Drug Approval in India

The Drugs & Cosmetic Act & Rules have laid down guidelines under certain sections for approval of new drugs. The clinical trials are specified in this act. This is imperative for the safety of human health and well being.

CDSCO provides the guidelines in the act for approval under varied conditions. This is applicable for both the manufacturers and the importers. The clinical trials have to be conducted in the manner prescribed. In certain clinical trials have to be conducted about five hundred time in different centers.

CDSCO formally examines applications and then passes it to various committees under its purview. Important committees are Investigational New Drugs and New Drug Advisory Committee.

Small quantities of drugs are allowed to be imported or manufactured conditionally. For this purpose formalities prescribed in the act have to be fulfilled.

We at Rifa Pharma provide full guidance and assistance in appraisal of new drug registration application.

We also provide services for
  • Blood Bank and Blood Product Registration
  • NOC for Import of Half finished or Raw materials
  • Loan Licensing
  • Legalization of Export/Import documents
  • Neutral Code Licensing