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Nandita Vijay, Bengaluru June 10 , 2019
The CDSCO needs to take on the onus to approve and permit brand names for marketing in the country. A dedicated cell should be set up to look into this with immediate effect. This would be the only way to regulate the use of brand names of medicines pan-India, said Dr. BR Jagashetty, former National Adviser (Drugs Control) to MoHFW, CDSCO and former Karnataka Drugs Controller.

Such an effort would immediately help curb duplication of drug names and also prevent the sale of look-alike and sound alike drugs (LASA) which is major problem confronting medical professionals, pharmacists and patients in the country, he added.

The reality is that when various brand or trade name drugs are being marketed in the country, it is not possible to keep track on the same. Rule 96(1) (i) of the Drugs and Cosmetics Rules, 1945 provides to print proper name of the drug in a more conspicuous manner than the trade name.

The trade name has to be printed just below the proper name on its label. However, contrary to this rule, in 2012 the Union government issued an order directing all state licensing authorities (SLAs) to give permission for drugs only in generic names but not in the brand names. It also permitted manufacturer to assign brand or trade name as per their whims and fancy without any control. The same was raised in various meetings of DCC and others. Currently, this permission to market and register the brand comes falls under the purview of MRTP under the aegis of the Consumer Protection Act, Dr. Jagashetty said.

Legally too, if brand names are not permitted to be approved by SLAs, the Union government should have thought of ways to streamline and control the same by assigning to some authority so that culprits can be brought to book by proper investigation for any violation, Dr Jagashetty told Pharmabiz.

Further Rule 75(5) of DCR, 1945 provides for collection of additional fee of Rs. 300 for each additional item of drugs. Accordingly, prior to 2012 directions, SLAs including Karnataka used to collect the amount for each brand or trade name drug approval along with an undertaking from manufacturer as suggested in the latest proposed draft amendment to various rules vide G.S.R.152 (E) dated February, 26, 2019. The said revenue was also lost by states in view of direction issued by GOI during 2012. Now various brands or trade name drugs are available in the market without any permission by drugs control authorities thereby making drugs control enforcement team difficult to proceed in the investigation for any violation of such branded drugs in its quality or otherwise. In view of the 2012 directions, such an amendment will not serve any purpose, said Dr. Jagashetty.

Therefore, it would be pertinent for the Union government to authorize the CDSCO to take stock of brand names and permit trade or brand names in future. It should re-look into the 2012 directions either to withdraw or modify suitably so that drugs control administration will be in full control to oversee any violations and also suitable revenue be generated to states. This is because state drugs controllers only have an idea of brands circulated in their jurisdiction and it is impossible to keep tabs on other locations with similar brands names. Hence, India needs a single authority to verify the drug brand names which is on similar lines that of Patent Office that authenticates an innovative process or product, pointed out Dr. Jagashetty.

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