In a major setback to pharmaceutical companies, the Supreme Court today held that asthma medicine Doxofylline is a bulk drug whose price will have 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 Supreme Court 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.

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