New Delhi: In a major setback to pharmaceutical companies, the Supreme Court on Thursday held that asthma medicine Doxofylline is a bulk drug whose price is to be fixed by the Centre.
"We hold that Doxofylline is derivative of Theophylline, a bulk drug, and Doxofylline in any formulation comes within the definition of scheduled formulation. We hold that it is well within the jurisdiction of the government to fix the ceiling price of Doxofylline formulation," a bench of justices G S Singhvi and S J Mukhopadhaya said.
The apex court set aside the Delhi High Court`s verdict which had quashed the Centre`s notification by which the government had fixed the prices of Doxofylline formulations.
It held that Doxofylline is a derivative of Theophylline, which is a bulk drug.
Bulk drug means a drug specified in the First Schedule of Drugs (Prices Control) Order whose price is fixed by the Centre.
"In view of our finding that Doxofylline is a derivative of Theophylline, we hold that Doxofylline comes within the meaning of bulk drug as defined in para 2(a) of DCPO," the bench said.
The court passed the order on an appeal filed by the Centre challenging the high court order which had said that the government cannot fixed the price of the drug as it was not bulk drug.