The drugs control officers across the country are planning to oppose the Centre's move to create a separate Biotechnology Regulatory Authority. They are of the view that there should not be a separate regulatory authority for biopharmaceutical sector as the existing drug control administration in the country is capable of regulating biotech sector also and the jurisdiction should remain with it.
Drugs Control Officers from different states have raised serious objections against the proposal as it threatens the existence of the state drug departments. The proposal to centralise issue of manufacturing licenses as a part of the drug regulatory reforms has already rattled state drug control officials.
The officials feels that the drug control department can train the staff in conducting inspections in biotechnology units, hire specialized drugs inspectors having exposure to biotechnology industry or seek expert advice whenever need arises.
The officials pointed out that creation of a separate Biotechnology Regulatory Authority might lead to further fragmentation of the functions of drugs departments. The All India Drugs Control Officers' Confederation (AIDCOC) is likely to take up the issue with the Centre, soon.
The Central Government is keen to set up a Biotechnology Regulatory Authority for clearing biotech products. A committee of secretaries has been constituted to work out modalities for creation of the Authority and rationalization of the legislative and regulatory regime, it is learnt.
Creation of a national level Biotech Regulatory Authority is being discussed and reviewed, Dr MK Bhan, secretary, Department of Biotechnology, Government of India, said during the second week of February 2006.