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KDPMA feels selling changed compositions under old brand name should be patient centric
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Nandita Vijay, Bengaluru
June 11 , 2019
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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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