The Central government has decided to exempt drugs required to be imported for clinical trials from import registration requirements. These drugs have also been exempted from Form 10 licenses.
The notification to this effect issued by the Drugs Controller General (India) on July 15, 2003 has also exempted drugs imported for product / formulation development and data generation and drugs that are not yet approved and marketed in the country but are meant for export purpose only from these mandatory requirements.
It has been decided that Form 9 required for issuance of Form 10 License can be issued by authorized agent of a Registered Manufacturer in India or the registered manufacturer himself. However, in the latter case, the Form 9 issued by the registered manufacturer will have to be authenticated by the Indian Embassy where the registered manufacturer is located.
The notification has also clarified that the three categories indicated above will require NOC / test licences on case-to-case basis from the central government.
The DCGI clarification has come in the wake of repeated requests from various industry quarters for a clarification on the issue of new registration. The notification has been forwarded to all port officers.
The Indian Drugs Manufacturers Association (IDMA), The Basic Chemicals, Pharmaceuticals & Cosmetics Export Promotion Council (Chemexcil), Organisation of Pharmaceutical Producers of India (OPPI) were some of the organizations who had been seeking clarification on this front.