Industry recommends prefix or suffix in existing brand name to be allowed on change in API formulation
Worried about the prospects of pharmaceutical business getting impacted, the Indian pharma industry has recommended that a prefix or suffix in an existing brand name to be allowed on change in active pharmaceutical ingredients (API) formulation in the same therapeutic segment towards patient safety.
The Indian Drug Manufacturers Association (IDMA) has proposed to the government that brand name of medicines be allowed to be retained if change of API formulation is in same therapeutic segment with suitable prefix or suffix in an existing brand name for patient safety.
In a circular sent to all central and state regulators’ offices on May 16, 2019 former Drugs Controller General of India (DCGI) Dr S Eswara Reddy had said that his office has received information that some drug manufacturing companies, after changing the APIs of a formulation are still continuing with marketing the products in the old registered brand names.
The drug regulator stated that the practice of changing the key therapeutic ingredients in a drug formulation without changing the brand name “is not only misleading but may also result in undesirable pharmacological effects as the consumer would take the formulation assuming that it has the earlier composition.”
In a circular, it has asked its officials to take “all measures” to prevent companies from retaining the same brand name for different formulations.
The apex drug regulator’s move aims at preventing patients from accidentally taking the wrong medicine in cases where pharmaceutical companies change the composition of their drug brands, but continue to sell the new formulation under the old brand name.
The notification comes nearly eight years after the issue was deliberated by the Drugs Consultative Committee (DCC) in three separate meetings held between 2008 and 2011.
“Drug Consultative Committee (DCC) has also recommended that such type of practice needs to be discouraged and State Drugs Controllers (DCs) should ensure that the same brand name should not be permitted to retain by the manufacturers if the composition of the API(s) in the new formulation is changed,” stated the circular.
“In view of the above, State DCs are requested to take all measures to discourage the practice of marketing of drug formulations with changed composition without changing the brand names and ensure that the same brand name is not permitted to be retained by the manufacturer, if the composition of the API(s) in the new formulation is changed,” it added.
DCGI had 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.
However some state licensing authorities have maintained that they are authorised to give approval for generics and not for brand names under the Drugs and Cosmetics (D&C) Act, 1940. 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.