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CENTRALISING DRUG LICENCES
P A Francis | Wednesday, February 1, 2006, 08:00 Hrs  [IST]

Multiplicity of drug brands and the resulting confusion amongst the medical practitioners and patient community have been engaging the attention of the regulatory authorities for some time. As the state health departments are empowered to issue drug manufacturing licences, there has been a steady rise in the number of drug brands marketed in the country over the years leading to several prescription and dispensing errors. Currently there is no mechanism of assessing the magnitude of such errors in the country. And these errors must be inflicting serious injuries to the patients for no fault of theirs. Indiscriminate licensing of drug products by the state drug authorities has also led to emergence of a large number of irrational combinations and similar sounding brand names in the market. The office of the DCGI has been trying its level best to put an end to the granting of licences for irrational and harmful combinations for some time now but with little success. DCGI had directed all state drug authorities in 2002 not to issue manufacturing licences for any drug combinations as they are classified as new drugs and approval for them has to be issued by DCGI only. Not all states, however, are abiding by this directive and most of the irrational combinations for which licences have been issued, are still in the market. According to an industry estimate, over 60,000 drug brands are in circulation in the country. Current lack of coordination between the state drug authorities and the DCGI office is also resulting in availability of certain unsafe drugs in the market. Pharma companies can easily obtain a manufacturing licence for any product even after the application for same product is rejected by another state drug authority. A recent case is that of Crocin quik of GSK. Even after Gujarat and Maharashtra FDA objecting to the marketing of the product, the same is licensed by Karnataka drug control authority and is being marketed in most parts of the country. Many such cases will come to light if one scrutinizes the drug licensing records in the country. The initiative took by the Union health minister, Dr Ambumani Ramdoss, to streamline the entire operation of granting drug licences by deciding to centralise this activity, therefore, needs to be appreciated. This reform in drug licensing will form a part of the new drug policy which is being finalised now. There are certain objections coming up from drug control officials of certain states against the move. That should be expected. But, the Central health ministry should go ahead with its plan to centralise the manufacturing licences without any delay.

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