India Ends Bulk Drug Industrial Licensing

The Department of Industrial Development at India's Ministry of Industry has abolished industrial licensing for all bulk drugs, formulations and intermediates.

The notification follows the new drug policy's recommendations on industrial licensing, foreign investment and foreign technology agreements. It says a more liberal regime for the granting of industrial approvals will give production the necessary impetus to meet future demands, as well as ensuring adequate availability of drugs at reasonable price.

However, licensing will continue for bulk drugs reserved for the public sector, such as vitamins B1 and B2, tetracycline, oxytetracycline and their salts and derivatives, and folic acid. Licensing is also required for bulk drugs involving the use of recombinant DNA technology, those requiring the use of nucleic acids and their active principles, and formulations based on the use of specific cells and tissue-targeted formulations.