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Monday, 29 April 2013 00:00
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Pharma quality system needs urgent overhaul


If the Merck case where local authorities gave a rival pharma firm permission to produce a generic version of a drug for which Merck had a valid product patent wasn’t bad enough, India’s pharmaceuticals regulatory system just got another poke in the eye. Not only does the latest Parliamentary Standing Committee on health continue where it left off last year—pointing to serious flaws in the procedure for granting approvals for new drugs—it accuses the ministry of coming up with “half measures, vague and dilatory responses”. It goes onto say that the government agreeing with its recommendations in the past was nothing but “mere platitude … (and) … confirms the intent of the Government in staggering decisions and actions on vital matters either by way of referring matters to committees after committees or evolving time-consuming policies.”

After noting the Central Drug Standard Control Organisation (CDSCO) was hugely understaffed—it has only 124 of its 327 sanctioned posts—the Committee points to several banned drugs still being available in India, cases are also cited of new drugs being approved despite the fact that the mandated clinical trials have not been carried out. In a number of cases, the Committee talks of expert opinion being flaky—either the opinions are identical or they are not backed with any test results—and in some others, it recommended the government report such doctors who look like they’ve colluded to the Medical Council of India. If this wasn’t enough, in some cases, the Committee talks of approvals being given by the CDSCO’s non-medical staff. Sadly, no action has been taken despite so many months of the Committee’s last report. Apart from taking action on this, the Committee has done well to suggest a more transparent system of operations. In the US, it cites the example of one drug where 37 experts drawn up by the US FDA gave different opinions on whether the drug should be banned or made a prescription one or whether the dosage should be reduced—all opinions are available on the FDA website. If the same procedure was followed in India, independent experts would be able to examine the ministry’s actions.


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