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Nandita Vijay, Bengaluru June 14 , 2019
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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