DCGI warns of stern action against cos which change contents of formulations without changing existing brand names
The Drugs Controller General of India (DCGI) has warned of
stern action against those manufacturers and marketers of pharmaceutical
formulations who change the contents of the formulations without changing the
existing brand names.
In a circular, the national drug regulator has directed the
state drug controllers and the zonal & sub-zonal officers of the Central
Drugs Standard Control Organisation (CDSCO) to consider legal measures to
discourage the unethical practice of marketing formulations by changing their
contents without changing the existing brand names by the pharma companies.
The DCGI wants the enforcement officers and drug controllers
to ensure that contents changed formulations are not marketed in the country in
the old brand names as it confuses both the prescribers and patients. He wanted
the licensing authorities not to permit to sell formulations with changed
compositions without changing the old brand names.
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 drug
formulation, still continuing with marketing the products in the old registered
brand names. The formulations in old brand names were being manufactured with
different APIs. The DCGI asked the regulatory officers to curb this unethical
tendency of the manufacturers because it confuses both the prescribers and
patients.
Dr. Reddy reminded the drug controllers that this issue was
discussed repeatedly in three Drugs Consultative Committee (DCC) meetings held on 10.12.2008, 20.10.2010 and 15.02.2011. In all the three meetings, the
experts found that this practice of the manufacturers was a serious issue and
needed 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 DCs should ensure that the same brand name is not retained by the
manufacturers after changing the composition of the APIs in the new formulation.
Responding to the circular of the DCGI, S Sivabalan, Tamil
Nadu state drug controller said his department is giving permission for
manufacturing only for generic products, no trade name is permitted in Tamil
Nadu at present. However, he added that as per the national regulator's order,
he will try to discourage if any unethical practice is found on the side of
manufacturers.
Subhash Mondal, chairman of Regulatory Affairs Division of
the Indian Pharmaceutical Association said it is a fact that some companies in
various parts of the country are retaining the same brand name after they have
changed the APIs of the product. He also said such practice will confuse the
doctors and the patients.
“Sometimes this practice of the manufacturers may lead to
serious health problems. To solve this tendency the department needs proper
legislation in place,” he added.
Medical Device Rules, 2017 came into force in January 2018 and devices are regulated by the Central Drugs Standard Control Organization (CDSCO Approvals Services)
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