New Delhi: The Supreme Court has held that Sildenafil Citrate (a Viagra-like drug) was an allopathic formulation and only companies holding a valid licence can manufacture and sell it.
A bench headed by Justice A K Mathur while quashing the Andhra Pradesh High Court order said Sildenafil Citrate, a patented and proprietary medicine used for erectile dysfunction, is an allopathic medicine.
"This is an allopathic drug and by no stretch of imagination it can be said to be an ayurvedic drug," it said.
The court further said the drug inspector and others (appellants) appear to be justified that since Viagra (brand name) or sildenafil citrate (generic name) was an allopathic drug and cannot be sold by a person unless he hold a license for it.
The judges said the selling this drug as one of the ingredients in an ayurvedic capsule, Ozomen, and not displaying its name among the capsule's ingredients would also constitute an offence.
It also held that the inspector appointed under the Chapter IV was competent to launch prosecution against the accused drug manufacturers.
The decision came on an appeal challenging the Andhra High Court's judgement that held that the drug inspector appointed under Section 21 of the Drugs and Cosmetics Act, 1940 had no jurisdiction to launch prosecution in connection with manufacture and sale of ayurvedic drugs Ozomen capsules and Ozomen forte.
While the accused (Fizikem Laboratories) in this case was holding an allopathic as well as ayurvedic licence, it did not have a license to manufacture Sildenafil Citrate.
The drug inspector after inspecting the premises of Fizikem and others had found that each Ozomen capsule contained 45.2 mg.
He had booked the lab for contravening the Act and held it liable for manufacturing and mislabelling the ayurvedic medicine.
The accused had challenged the action initiated by the inspector in the high court.
Source :
PTI