By K.G. Narendranath

It is good news that the government is expediting the process of setting up
the national biotechnology regulatory authority, which is envisaged as a
dextrous, one-stop facility.
Even after a fair degree of streamlining of the regulation of modern biotech
products?medicinal and agricultural- in recent years, the regulators tend to
overreach their jurisdictions, causing a lot of hardship to applicants. At
the same time, regulatory laxity and incompetence are posing a serious
enough threat to nature including the humans therein.

The regulators in this domain are many. The Genetic Engineering Approval
Committee (GEAC) attached to the environment ministry has the mandate to
assess the compatibility with the natural environment of the genetically
re-engineered product for which manufacturing/marketing approval is sought.

The Review Committee on Genetic Manipulations (RCGM) in the department of
biotechnology which is part of the ministry of science and technology is
empowered to ask the applicant to produce the bio-safety data related to the
genetically modified organisms and products derived there from, besides
overseeing the process of creating the data.

The Drugs Controller General of India (DCGI) is entitled to give/deny
approval for indigenous manufacture/ import as well as marketing of
therapeutic proteins and vaccines involving generic re-engineering such as
recombinant DNA technology. DCGI also ensures that clinical trials (on
humans) of these substances in three phases are done and the data produced
is validated before the approval for manufacture/ marketing is given.

DCGI, along with GEAC, is also responsible for maintaining post-marketing
surveillance on these products as hazards could show up when the exposure to
the nature/ human body is widespread and prolonged.

The complexity of regulatory regime does not end there. There is the lower
tier of Institutional Bio-safety Committees (IBSCs), which do the job of
assessing the risk profile of these substances at the level of the
researcher/ potential commercial operator and recommend what kind of
regulatory scrutiny the substance and the process of making it should be
subjected to.

The IBSCs also oversees the conduct and examines the results of the animal
toxicity studies prior to clinical trials, in coordination with another
regulator, the institutional animal ethics committee. That the
approval-giving mechanism is quite cumbersome is evident from the very fact
the applicants need to produce clinical trials data, one of the many
requirements for getting the approval, before three regulators ? GEAC, DCGI
and RCGM.

It is common that GEAC often which gives the go-ahead for release of the
substance to the environment, implements more exacting standards than other
regulators, causing the applicant to stumble at a fairly advanced stage. It
is not uncommon for GEAC to ask the applicant to do clinical trials afresh
as per a changed protocol, after DCGI approval is given.

Since the regulators perform under different Acts of Parliament - GEAC under
the Environment Protection Act, DCGI under the Drugs and Cosmetics Act and
Institutional Animal Ethics Committees under the Prevention of Cruelty to
Animals Act- the problem is exacerbated.

India is an emerging force in the area of biotech research. Many of its
publicly funded institutions as well as a few private companies have made
headway in this area. We have at least few recombinant DNA biotech products
developed predominantly indigenously (if not totally) like human interferons
(used for cancer cure), streptokinase (a clot-dissolving substance),
erythropoitein (for blood regeneration) and a few vaccines. Competent and
reasonable regulation is a pre-requisite for the industry to grow.
International trade in this area also holds tremendous growth potential, as
endorsed by several studies by professional agencies.

Another area that will need to come under the regulatory gaze of the
proposed national biotechnology regulatory authority is stem cell research.
Currently, over a dozen institutions are publicly undertaking some activity
or the other in the field of stem cells in India while scores of others are
believed to be doing the same secretly. Yet, there is no formal regulation
of the sector with necessary legal sanction and diligence.

The existing set-up comprising the Indian Council of Medical Research?s
National Guidelines for Stem Cell Research and Therapy, 2006, and a draft
stem cell policy published by the department of biotechnology is devoid of
proper legal backing. Also, DCGI, which is required to approve clinical
trials of stem cell therapy, obviously need to harness expertise in the
area.

Stem cell research which comprises creation of cell lines from multiple
sources, including human embryo, adult cells and umbilical cord blood and
therapy is therefore undertaken in the country in the absence of competent
monitoring and this is obnoxious. It is evident that the regulatory agencies
involved don?t even coordinate properly.

Even while giving policy support to stem cell research, a promising area
because of its potential to find cure for diseases caused by degeneration of
cells, developed countries bar or restrict morally hazardous activities such
as creation of human embryonic stem cell lines or hES lines (derived from
blastocysts, which, in turn, are sourced from surplus embryos in IVF
clinics).

Regulators across the globe see the prospect of trade (even international)
in human embryos, given the demand from stem cell researchers. The proposed
national regulatory authority should therefore have an all-encompassing
mandate in this area with necessary resources, technical and legal.

For biotechnology research and business to flourish in India (which offer
immense benefits to patients, the farming community and consumers in
general), mature regulation is a must.
www.checkbiotech.org