Government to remove CL provision for biotech imports

Jayashree Padmini - New Delhi

While relaxing the norms for import of biotech products, the Union government has proposed to amend the list of restricted technology and to categorise it under ITCHS classification in order to facilitate effective monitoring to thwart any chance of dual use of technology.

Consequently, the government has decided to take all biotech products out of Compulsory Licensing (CL) norms for imports into the country and the Cabinet note to this effect is already moved, informed sources said. This requires amendments to the Drug Policy, the Industrial Development and Regulatory Act 1951 and the list of restricted technology.

ITCHS classification is a safeguard to ensure that banned toxic or hazardous wastes are not imported.

Once the amendments are incorporated, products involving monoclonal antibodies, stem cell technology and nanotechnology can be imported with approval from the Project Approval Board under Department of Industrial Policy & Promotion (DIP&P).

All these products now fall under restricted technology and are not listed under ITCHS classification for exports and imports.

The government plans to outsource the listing out of products and technologies to be categorised under ITCHS classification, and most likely the Biotech Consortium India Ltd (BCIL), New Delhi, would be retained to undertake the task. Harmonising the system and bringing it under the Project Approval Board will ease import hurdles at the same time facilitate for monitoring of technology imports to avoid any duel use, said the source.

In accordance with this, the government has already moved Cabinet note to liberalise FDI norms and to allow foreign technology agreements through automatic route. The Pharmaceutical Policy 2002 will be amended to remove compulsory licensing provision for foreign technology agreements. According to the Policy, automatic approval for Foreign Technology Agreements are not allowed for use of recombinant DNA technology.

— jayashreep@expressindia.com