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CDSCO needs to take on onus to approve, permit drug brand names in India: Dr BR Jagashetty
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Nandita Vijay, Bengaluru
June 10 , 2019
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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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