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... and the government's new set of rules to ensure safety standards in DNA-based drugs
FINALLY waking up to health hazards from genetically manipulated drugs, the Union government is trying to monitor their production and marketing by setting up a new safety-test system. The ministry of industries has recently issued a list of such drugs and formulations. These are used on humans and animals as therapeutics, prophylactics and immunostimulators, and can spell health problems.
A 3-tier system seeks to implement safety regulations in the production process. Justifying this, P K Ghosh of the Department of Biotechnology (DBT) says, "Biological manipulation of organisms by recombinant Deoxyribonucleicacids (DNA) technology could result in the secretion of harmful nucleic acids and proteins."
Only 6 drugs based on imported manipulation technology, and 2 based on indigenous technology, have been approved since the Drug Policy was formulated in 1986.
Under the new regime, marketing proposals will first have to be cleared by the DBT's Product and Industry Development Division. Next comes clinical tests under Indian conditions. The final products will have to leap a hurdles-race through the Institutional Biosafety Committee, the Review Committee on Genetic Manipulation and the Genetic Approval Committee of the Ministry of Environment and Forests.
The industry is grouching about "long-winded bureaucratic procedures" which will "deter foreign companies from entering the Indian market, or investing in technology development here". But the officials are cautious. Ghosh says, "Genetic manipulation for producing drugs is a relatively new field. We can never be too careful." And as the market burgeons, rules are likely to become gradually more stringent.
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