The Hindu Business Line : New regulatory body for recombinant pharma products

New Delhi/ Mumbai, June 27 Drug companies planning to launch recombinant biologics, DNA vaccines and similar genetically modified (GM) pharma products may come under the lens of the proposed National Biotechnology Regulatory Authority (NBRA).

Currently, the approval for these drugs – right from their clinical trials to market authorisation – is vested in the Drug Controller General of India (DCGI). The Department of Biotechnology’s (DBT) draft NBRA Bill, 2008 seeks to amend the Drugs and Cosmetics Rules (8th Amendment), 1988 to exclude recombinant pharmaceuticals from the DCGI’s purview and transfer it to the proposed new regulator.

Thus, vaccines containing living genetically engineered organisms, recombinant blood and plasma derived products such as clotting factors (used for treating haemophilia patients and produced using GM fish) and gene therapy products would come under the NBRA’s scanner.

Besides ‘pure’ biotech firms like Biocon and Shanta Biotech, pharma companies from Dr Reddy’s Laboratories, Wockhardt and Intas Biopharmaceuticals are also eyeing the growing market for biologics. Biocon and Wockhardt have already launched recombinant human insulin, while Dr Reddy’s and Intas have introduced genetically engineered granulocyte colony-stimulating factor products that treat loss of toxicity-fighting white blood cells due to administering chemotherapy in cancer patients.

Officials, however, clarified that the NBRA’s regulatory role will be confined to only drugs with ‘living’ GM organisms. That would, for example, include live vaccines used for polio, tuberculosis and measles, but not human insulin or the recombinant hepatitis-B vaccine (whose active ingredients are products derived from GMOs, but not themselves living GMOs).

The NBRA will accordingly take over not only some of the functions of the DCGI, but even that of the newly created Food Safety and Standards Authority (FSSA). The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests, which currently authorizes the testing and commercial release of GM crops, would also become redundant.

“It is good idea to have a single contact point for all matters concerning modern biotechnology. Also, the NBRA being given statutory status through an Act of Parliament and headed by a professional biotechnologist will give it more teeth and enable independent functioning,” said Mr R.K. Sinha, Executive Director, All India Crop Biotechnology Association (AICBA).

Turf wars

But the NBRA Bill could also set off regulatory turf-wars. To illustrate, in the proposed framework, GM wheat would be under the purview of the NBRA, but biscuits or flour made from GM wheat are to be regulated by the FSSA. The underlying logic here is to treat products that expose humans and animals to ‘live’ genetic modifications on a different plane.

“If the proposal is to use the NBRA for GM crops, live vaccines, cell and gene therapies, while excluding recombinant protein therapeutics, that is fine. However, I have concerns if products have to straddle two regulatory agencies, viz, DCGI and NBRA. We need to have clarity in who regulates what and any blurred boundaries will introduce inefficiencies and inconsistencies,” according to Dr Kiran Mazumdar-Shaw, CMD, Biocon.

There should be more clarity in definitions like ‘genetic engineering’ to prevent lawyers from having a field day, noted Dr K.K. Narayanan, President, Association of Biotechnology Led Enterprises (ABLE).

More Stories on : Pharmaceuticals | Regulatory Bodies & Rulings

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page