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Time bound action needed to identify brand names with tweaked APIs: Kaushik Desai
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Nandita Vijay, Bengaluru
June 14 , 2019
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The Central Drugs Standard Control Organisation (CDSCO) needs to fix a
specific time line for pharmaceutical companies to take actions on all
drug brands marketed by them with altered APIs in their compositions but
using the same brand name, said Kaushik Desai, a pharma consultant.
This
will be the only way to further reinforce and toughen the stand
clarified in the circular issued by the CDSCO on May 16, 2019 to all
drug controllers on this subject, he added.
The earlier order was
in 2012 and companies did adhere to it. But now in 2019, we see that
companies are seen to selling the old brands with a different API
composition which does not require permission from the state drugs
control authorities.
Instead of raking the past, a more strategic
approach would be to commence discussions with industry heads and
pharma manufacturers associations to understand the ground reality and
back it with a final order so that such drugs have new brand names on
mutually agreed timelines, pointed out Desai.
The phase wise
actions for all such products could start with stoppage of production,
careful scrutiny while renewals or new approvals, fix timelines for
exhausting inventory, approval of products with new brand name, build a
strong mechanism of actions for defaulters, enforce uniformity of
implementations of measures across pan-India and simultaneously initiate
changes in requisite drug laws.
Another point of the circular,
noted by Desai, was that advising the state drugs controllers to take
suitable measures is not seen as an imperative attempt. Instead actions
like providing a specific guideline is suggested and seen to be a more
practical approach. This will bring in uniformity of actions by all
state drug regulating authorities.
Although this action may take
a toll on the revenues of some pharma companies, it will put the system
in place and safeguard interest of patients, he said.
As a first
step, dispatching the circular of May 16 to all state drugs controllers
was right as they are the licensing authority and this is just a
reinforcement of decision taken during several meetings of Drug
Consultative Committee (DCC). Therefore, in order to ensure that the
DCGI is serious on this, rigorous steps need to be spelt out.
Now,
CDSCO which approves all brand names will automatically have its reigns
on the issue. In an age of digitization and smart technology,
information can be gathered instantly. Similarly, all state drugs
control departments too can interface with the CDSCO to reconfirm
duplication of brand names as this mechanism does not exist.
There
is urgent need to have a central repository and if needed this project
can be outsourced under CDSCO guidance considering the workload and
priority, noted Desai adding that this practice of selling in the old
brand name with a different API composition is a serious issue and needs
to be one of the top items on the list of actions in streamlining
regulations.
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