|
State DCs seek action against pharma cos tweaking drug composition with same brand names
|
|
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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|