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Pharmaceutical clinical trials and time limit

The government has recently put up a proposal to change the time limit required for attaining drug regulatory approvals from State government from four-year to 10 years. The Indian Pharmaceutical Alliance has taken up the issue with what it considers to be a kind of backdoor approval for extension of data exclusivity norms in India. It argues that this will result in lengthy and potentially damaging data exclusivity. A type of intellectual property protection, in data exclusivity, data pertaining to clinical trial and other data which is submitted by an originator or parent drug/pharmaceutical company cannot be used by a drug regulatory authority to authorize a generic version of an established drug for certain duration of time. The prevalent perception is that without such exclusive time period, there isn t much incentive for the drug companies to make investments in conducting expensive experiments, clinical trials and marketing a drug.
India has resisted the efforts of U.S. and EU to make data exclusivity norms as it considers it to be potential barrier to the growth of its generic drugs industry and more affordable drug prices for the country. Generally the trend is that globally generic drugs are authorized by simply establishing bio-equivalence of claimed drug with that of drug already tested and approved. A number of State-level regulators, drug manufacturers and the Central authority that is the Drugs Controller General of India (DCGI) simply opt to wait for four years and after that they approach State authorities. Moreover, the Drugs Controller General of India, the Central regulator, doesn t even ask for a separate local clinical trial data for new pharmaceutical drugs under the broad exception of “public interest”. The court routinely decline to hear and entertain PILs on Drug regulatory standards although they both know lax regulation with regards to drugs is far more dangerous. It is the responsibility of the government to assess the negative effects of drug clinical trials, their recording and understand it before its too late.

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