NEW DELHI: 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.