The Association of Biotechnology Led Enterprises (ABLE), a representative body of the Indian biotech industry, has proposed to establish an autonomous 'Biotechnology Regulatory Authority' comprising experts to facilitate timely clearances of biotech products for testing and marketing.
"The authority is to be set up for a cause, and not for a case and will reflect and address the industry's needs at large," Varaprasad Reddy, vice-president of the Association told Pharmabiz.
The authority should strive to avoid delay and uncertainty in approvals of biotech products. It should also find a solution to cut down excessive regulations in this sector. There is a strong feeling that procedures should be rational and the number of agencies or departments involved in the regulatory process should be reasonable.
Regulatory approvals for rDNA products in India have become more complicated and time consuming. On the contrary, countries like US and Japan have centralized systems and one umbrella committee looks into bio-pharmaceuticals and evaluates initial data generated by the company and gives approval for clinical trials. The clinical data is thus evaluated for marketing approvals in the final stage.
Import of microorganisms has also been a major hurdle to the industry, as there are multiple bodies involved in the clearance, such as DCGI, RCGM, GEAC and Institutional Bio-safety Committee.