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Shardul Nautiyal, Mumbai June 11 , 2019
State drug controllers from across the country have sought legal action under trademark law against pharma manufacturers who are marketing new formulations by tweaking composition without changing the existing brand names.

In the interest of patient safety, Drugs Controller General of India (DCGI) had issued a circular to all the state drug controllers to ensure that changed formulations are not marketed in the country with the old brand names as it confuses both the doctors and patients.

It has been brought to the notice of Central Drugs Standard Control Organisation (CDSCO) that some manufacturers while changing the API of a drug formulation are still retaining the brand name of old formulation.

In the circular sent to all central and state regulators’ offices on May 16, DCGI Dr S Eswara Reddy said that his office has received information from across the country that some drug manufacturing companies, after changing the active pharmaceutical ingredients (APIs) of a formulation are still continuing with marketing the products in the old registered brand names.

Responding to the circular, Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr HG Koshia however said that state licencing authority is authorised to give approval for generics and not for brand names under the Drugs and Cosmetics (D&C) Act, 1940.

However, according to a state drug controller from Rajasthan on conditions of anonymity said that earlier state licensing authorities approved brand names but the practice was discontinued as per the central regulator's directive. He further said that brand names for drugs fall under a separate category 5. Retaining the same brand name or changing the brand name in case composition of drug is changed is the subject matter of trademark.

On the issue of changed composition with same brand name, industry sources say that the physicians and medical fraternity are being apprised about the changes made in composition in case the brand name is retained.

In the circular, Dr. Reddy reminded the drug controllers that this issue was discussed repeatedly in three Drugs Consultative Committee (DCC) meetings held on December 10, 2008, October 20, 2010 and February 15, 2011. In all the three meetings, the experts found that this practice of the manufacturers was a serious issue and need to be stopped with legal measures.

He informed them that the change of formulation compositions without changing the brand names is not only misleading but also resulting in undesirable pharmacological effects as the consumer would take the formulations assuming that it was made with earlier compositions.

The DCGI said such kind of practice needs to be discouraged and state drug controllers should ensure that the same brand name is not retained by the manufacturers after changing the composition of the APIs in the new formulation.

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