The Union Environment Ministry has decided to finalise the Mashelkar Committee report on Regulatory Reforms in Biotechnology after wider consultations with various stakeholders. The ministry is to host the final draft of the report on its website and invite comments from the public before moving on to implement its recommendations.
R A Mashelkar, Director General, Council for Scientific and Industrial Research (CSIR) said that the expert committee has already approved the zero draft of the report.
"The draft has been circulated among the committee members for fine-tuning. They are supposed to get back to us with their observations within two weeks. Once it is done, the entire report would be made available on the web to make it more transparent,'' he said.
The report is expected to prescribe solutions to almost every problem being faced by the biotech industry today.
Ninety per cent of biotech drug approvals that are currently going through the scrutiny of the Genetic Engineering Advisory Committee (GEAC) could be directly approved by DCGI once the recommendations are implemented, it is learnt. The time given by the ministry to the committee to submit its report is September 30, 2004.
The committee had met last week and finalized the draft recommendations prepared by the sub-committee.
The report is expected 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 Task Force is headed by Dr R A Mashelkar and has members from the Departments of Environment, Biotechnology, Health etc.
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 and Federation of Indian Chambers of Commerce and Industry had been pitching for an umbrella law to cover the entire approval process of r-drugs.