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Nandita Vijay, Bengaluru June 11 , 2019
Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) has observed that practice of selling of Drug Formulations with changed composition under the existing brand name is a matter of concern. Since trademarks and brand names are out of the purview of the Drugs and Cosmetics Act, the Association sees the need for some level of oversight on the issue by the drugs control authority.

Referring to the communication note issued by the CDSCO on May 16, 2019, the Association feels that the circular is more of an advisory in nature. “As an industry, we should take it positively and should ensure only ethical practices prevail for the benefit of the patients. We are in the business of pharmaceuticals only because of the prescribers and the patients . Therefore the industry needs to be sensitive to the interest of the patients and prescribers,” Harish K Jain, secretary Karnataka Drugs and Pharmaceutical Manufacturers Association and Director, Embiotic Laboratories told Pharmabiz.

As far as trademarks or brand names are concerned , it is out of the purview of the D&C Act. Instead it is covered under the Intellectual Property Rights. Therefore the drug controllers do not have any mandate for control of the brand names. No doubt this is an area of apprehension. So the Union government is now trying to bring in some legislation which is much desired, he added.

There are various companies having products with different molecules but manufacturing and marketing it under the same brand name with suffixes and prefixes. This has been an industry practice. But this creates a confusion in the minds of prescribers, patients and pharmacists. Therefore some level of control is required by the drugs control authority.

For instance, if there is an antihistamine drug which due to some reason gets banned but being a big brand the survival of the company depends on that product. Now what happens is that the company tries to bring in another molecule with a similar therapeutic activity profile and markets it using the same brand with a prefix or an suffix. Such affixing of brand names currently do not require the approval from the state drugs control department, he said.

If a company is patient centric, it should adhere to the rules enforced by the regulatory authority. “In Karnataka too, we are not sure if there are companies tweaking existing formulations using different molecules but manufacturing and marketing it in the same brand name. But irrespective of regulations, all pharma companies have a moral obligation not to harm patient interest, said Jain.

“For chronic health conditions like a cardiovascular disease, if a particular brand is prohibited, in the interest of the patient’s health, pharma companies will bring in another new molecule which is equally safe and efficacious like the earlier banned one and will manufacture it under the same brand name. This is because the patients relate his health condition to that drug brand rather than the molecule. We need to take on decisions based on patient centric benefits,” said Jain.

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