NEW DELHI: The country’s drug regulator has warned manufacturers and marketers of pharmaceutical formulations against changing the contents of drug formulations without changing the brand name.
In a circular, the Central Drug Standard Control Organisation has directed the state drug controllers and its zonal and sub-zonal officials to consider legal measures to discourage the unethical practice of pharma companies marketing formulations after changing their contents without changing the existing brand name.
In the circular, the Drug Controller General of India said that it wanted the enforcement officers and drug controllers to ensure that formulations with changed contents were not marketed in the country with the old brand names as it confused both, the prescribers and the patients.
The circular also said that the licensing authorities should not permit sale of formulations with changed compositions without a change in the brand name.
The initiative follows complaints that some drug manufacturing companies, after changing the active pharmaceutical ingredients (APIs) of a drug formulation, were continuing with marketing the products with the old, registered brand name.
“This (the practice) confuses both, the prescribers and the patients, and must stop,” the circular read.
The issue has been discussed in the drug consultative meetings in the past. In the meetings, the experts suggested that the practice followed by the manufacturers was a serious issue and needed to be stopped with legal measures.
The communiqué noted that the change of composition of formulations without changing the brand name was not only misleading but also resulting in undesirable pharmacological effects as the consumer would take the formulation assuming that it was made with the earlier composition.
Dangerous drugs?
There have been complaints that some pharma companies are marketing drugs with their old, registered brand names even after changing their active pharmaceutical ingredients.
The practice is resulting in undesirable pharmacological effects on those taking the drugs.
The Central Drug Standard Control Organisation has directed state drug controllers and its zonal and sub-zonal officials to consider legal measures to discourage the unethical practice.