Indian biotech firms can rejoice. Worrisome environmental regulations for biotech pharma products are finally being liberalised.
The most ardent of sundry regulators in the sector - the genetic engineering approval committee (GEAC) - has decided to waive its approvals for imported biotech pharma products, if they are not significantly processed in the country before domestic marketing or exports.
The GEAC, which has to vet the genetically modified biotech pharma products for clinical trials, manufacture and marketing to determine how safe they are from the perspective of environmental safety, would be confining itself to regulating only those products which are manufactured and marketed in the country.
For India's biotech-driven pharma firms, the GEAC's move means a lot, as they import biotech products from countries like Cuba , Russia and China, for domestic marketing and exports. Sources from the environmental ministry said that a high-level consultative group with strong industry participation would be soon set up to find out ways to "rationalise" biotech pharma products regulation. The aim of the move, the sources said, is to avoid multiple and multi-layered regulatory processing that are found to be hindering not only biotech business but also domestic biotech research.
The regulatory process would be simplified and expedited. The group would comprise the ministry of environment which houses the GEAC, as well as health, food processing, agriculture and science and technology ministries. "We have decided to take a liberal view concerning export of biotech drugs," a senior official from the environment ministry said.
Although regulation of biotech pharma products (therapeutic proteins, vaccines, diagnostic materials) are the current issue, the committee would also give suggestions on regulating genetically modified food and food products that too are to hit the markets in the coming months.
At the same time, that is , while planning to be lenient, the GEAC has upped the ante on ensuring compliance of biotech firms with the existent rules. Sources said Biocon and Biological Evans (BE), two leading biotech firms of the country, now require to explain to the GEAC as to why they had avoided getting the committee's permit when they proceeded to carry out clinical trials in two of their R&D products - insulin and hepatitis vaccine respectively. The GEAC is understood to have served notices to Biocon and Biological Evans, for violation of the environment protection act.
Sources from the environment ministry said that Biocon and BE should have obtained the GEAC's clearance before they could begin phase III clinical trials in the products. It may be recalled that the GEAC had earlier warned Shantha Biotechnics, another domestic biotech company for doing phase 3 clinical trials in streptokinase, a recombinant DNA biotech product with use as a cardiac cure, without the committee's prior approval.
There is, in fact, differences among regulators of biotech products. The DCGI and the Department of Biotechnology (DBT) - which has the Review Committee on Genetic Materials with it - feel that the GEAC should not intervene in regulation of pharma products that do not involve a living genetically modified organism. When there is no scope for release of a genetically engineered living material to the environment, the GEAC should not have a role, they feel.
While it is RCGM's mandate to validate a genetically engineered biotech product for its purity and molecular structure, the DCGI evaluates pharma products including biotech-driven ones from its criteria of safety and efficacy to the patients who take them. Of course, the biotech products involving gene alteration technologies such as recombinant DNA products need to be evaluated in terms of geno toxicity and auto immunity also, unlike chemistry-driven drugs and herbal medicines.
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