By P.T. Jyothi Datta

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).
www.checkbiotech.org