Single Window Clearance For Recombinant Drugs

Biotech companies will now be able to get a single window clearance for the manufacture and sale of genetically modified therapeutic products (recombinant drugs). A committee of experts will be set up under the health ministry to clear applications in the area.

These firms are presently required to get clearances from the department of biotechnology, the ministry of health as well as the environment ministry for the manufacture and sale of recombinant drugs.

Since the final licence for manufacturing medicines or vaccines is given by the health ministry, the committee will be set up in the health ministry, said Dr VK Vinayak, advisor in the department of biotechnology.

This committee will further consult the Genetic Engineering Approval Committee (GEAC), the Review Committee on Genetic Material (RCGM) or the environment ministry if required.

At the first meeting of the committee yesterday, it was decided to coopt the chairmen of GEAC or RCGM as members of the committee as and when required. The establishment of a unified regulatory commission for biotechnology has been a long standing demand of the Indian industry.

Companies wanting to introduce biotech products presently have to take the circuitous route of obtaining a biosafety clearance, collecting data on toxicology and other related areas and then applying to RCGM in the department of biotechnology (DBT) for clearance.

Then RCGM allows them to go ahead with pre-clinical toxicology trials and phase I and phase II clinical trials. For conducting phase III clinical trials, RCGM has to recommend the matter to GEAC and the DCGI's approval is also required. Further, for manufacturing the drug on a commercial scale, companies have to get clearances from the environment ministry.

The industry had been raising the issue of procedural impediments coming in the way of sustained growth of the sector. At a recent CII conference on regulatory issues in the biotech sector, it was said that one of the major hurdles facing the industry is excessive regulations of testing and approval of biotech products. Calling for the need for rationalisation of procedures, transparency and reduction in the number of agencies involved in regulation, people from the biotech sector had said that a single regulatory agency with adequate funding and expertise is important for streamlining the development of the sector.

Guljit Chaudhri, Sr VP, Vam Organic Chemicals said that clearance of applications within a definite time frame is a major necessity. Right now, there is no certainty about how long applications will take to be cleared, he said.