As the country's biotech regulatory environment has not yet matured enough to accommodate the ground realities and often turns hostile to budding industry projects, the growth of this sector is suffered severely. Since many of the projects gets really hampered with procedural hurdles and unnecessary delays, the industry is now seeking for a grievance cell to sort out pending issues and the recurring tussles for the prospect of the sector.

The existing regulations for biotech sector, especially, bio-pharmaceuticals sector are more stringent and unwelcome than any other sectors as the people who frame the regulatory policies for the industry are often unaware of ground realities, says a senior official dealing with regulatory affairs at a Hyderabad-based bio-pharmaceuticals company.

The industry sources said that it was very surprising that the DCGI office, which was responsible for approval bio-pharmaceutical products and related projects, did not have a biotechnologist at all. "No clear-cut checklist or format has been developed for biotech products for registration of products. If the regulatory system in India does not improve, biotech companies have dim future," they added.

The US and UK have framed national policies which enable companies to comply and follow certain formats and timelines. In these countries, a company may wait for the product approval from regulatory authorities for 90 days only. In case if the company has not received any communication, the company has right to proceed further. Whereas in India, companies have to wait until they get a formal approval from regulatory bodies and they are never sure when they will get it.

Shantha Biotechnics' Streptokinase and Biocon's Insulin were victims of such delays in the past. IPR violations also pose a big challenge to biotechnology industry today. India needs biotech committees that understand the industry needs and biotech policy that guides and supports them in developing new products that meet demands of both domestic and overseas markets. The Indian biotech industry needs a grievance cell, which can know the grievances of the industry and find out solutions for them, said the source.

There have been many research institutes in India that have been conducting quality chemical research which has helped the pharmaceuticals industry but there have been few institutes that carried out biotech research, thus biotech companies have to solely depend on their indigenous research capabilities, the sources opined.