The Drug Controller General of India (DCGI) has directed drug controllers of all states and union territories to take action against manufacturers who are changing the active pharmaceutical ingredients (APIs) in a drug formulation but retaining the brand name of the old formulation.
"..,the Drug Consultative Committee (DCC) unanimously 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," said Eswara Reddy, DCGI in a note on May 16 to state drug controllers.
Moneycontrol has seen a copy of the note.
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.
"In view of above, you are required 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 manufacturers, if the composition of the APIs in the new formulation is changed.
Tweaking formulation
Many drug makers tweaked their formulations and relaunched their products retaining the same brand name following government ban on 343 FDC drugs, citing it irrational and having no therapeutic justification.
Many companies such as Glenmark, MacLeods and Piramal relaunched their products.
The implications of the note is also not clear for some brands such as Pfizer's Corex, a codeine-based cough syrup, which was banned in 2016. The company sells a different composition cough syrup under brand name Corex DX, which was approved in 1996, and has been in market for over two decades.
In the domestic pharmaceutical industry, brand recall among doctors and patients is extremely important as companies invest significant money, time and human resources to build them. Companies launch line extensions of the same brand, tweaking formulation to expand sales.
Correction: A previous version of this article erroneously said Corex DX was launched after Corex was banned. This has been corrected after Pfizer pointed it out.
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