The crucial meeting of the Mashelkar Committee on Regulatory Reforms in Biotechnology, set up by the union environment ministry, is to take place in the first week of December. The committee is to finalise its recommendations in the meeting.

Informing this to pharmabiz, R A Mashelkar, director general, Council for Scientific and Industrial Research (CSIR) said that his tight schedule caused the delay in holding the final meeting. He said that the members of the committee, drawn from all concerned ministries like ministry of science and technology, ministry of health and ministry of environment, were all keen to see the preparation of the report at the earliest.

The report is expected to prescribe solutions to almost every 'regulatory' problem being faced by the biotech industry today. As per the draft recommendations prepared by the committee few months ago, the final report was supposed to relieve the Genetic Engineering Advisory Committee (GEAC) from the burden of issuing routine clearances for biotech products and restrict its role to specific products. The role of the DCGI in clearing biotech drug applications was to become more crucial. The decision however depends on the final view that is to be taken by the committee now. The report is also to call for the formation of a biotech regulatory authority as a long-term plan to integrate all regulatory activities undertaken by various departments at present.

The national task force was set up by the union ministry of environment & forests to analyse the regulatory issues before the biotech industry and recommend measures to streamline the regulatory process for recombinant products in the country.

The biotech industry is pinning much hope on the recommendations of the committee as they had been complaining of delays due to multiple regulatory hurdles that are in place today. The industry and apex organizations like Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI) had been pitching for an umbrella law to cover the entire approval process of r-drugs.