In a major setback to many pharma companies in the country, the government is reported to have directed state drug controllers to prevent pharmaceutical companies to sell new drugs under old brand names.
This comes in response to the practice of the companies that have built a particular brand name and go ahead to use the brand name for a different API (active pharmaceutical ingredient) altering API.
The government has come up with the move after the expert panel is of the view that such drugs wherein the ingredients are changed or altered by the companies while retaining the same brand name is misleading.
Besides, such practices may result in undesirable effects as the consumer would take the formulation under the impression that it is the earlier composition.
‘The Drugs Consultative Committee (DCC) anonymously resolved that the change of formulation composition 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 practise needs to be discouraged and State Drugs Controllers should ensure that the same brand name should not be permitted to retain by the manufactures, if the composition of the API(s) in the new formulation changed,’ said Eswara Reddy, DCGI in a letter dispatched on May 16 to state drug controllers.
DCCI also recommended that this practice needs to be discouraged and State Drugs Controllers should ensure that the same brand name should not be permitted to be retained by the manufacturers if the composition of APIs in the new formulation is changed.