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 notification released by the Central Drugs Standard Control Organisation (CDSCO), 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 in three separate meetings held between 2008 and 2011.
According to CDSCO, 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.”
“DCC further recommended that such type of practice needs to be discouraged and State Drugs Controllers 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 changed,” stated the notification.
“In view of the above, you (the state drug control regulators) 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.
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