New Delhi, March 27: An Indian ayurvedic company has got into trouble by surreptitiously lacing its anti-impotence drug with Viagra.

Viagra can “by no stretch of imagination” be said to be ayurvedic, the Supreme Court has said, ruling that Hyderabad-based Fizikem Laboratories Pvt Ltd should be prosecuted.

Fizikem was found to have added 33.9 to 46.82 milligrams of sildenafil citrate — the active chemical in the male performance-enhancing drug Viagra — to its own ayurvedic formulations Ozomen and Ozomen Forte.

The company neither had a licence to manufacture medicines using sildenafil citrate, nor did it mention putting the drug in its own brands, the court observed.

Viagra, the “little blue pill” that has been a wonder drug against erectile dysfunction, can have various side-effects including vision and hearing problems, bloody urine, headache and dizziness. One other reason why users must know they are taking the drug — and use it only after consulting a physician — is that it can cause complications in heart patients taking nitroglycerin for angina.

The inspector of drugs had taken samples of both Ozomen and Ozomen Forte from Fizikem’s premises, where they were on sale, and sent them for chemical analysis.

After receiving the report, the official ordered that the company be prosecuted under the Drugs and Cosmetics Act, 1940, which bans manufacture and sale of drugs and cosmetics that are misbranded, spurious or substituted wholly or in part by another chemical.

Fizikem challenged the order in Andhra Pradesh High Court, arguing an allopathic drugs inspector is not empowered to initiate action against an ayurvedic drugs manufacturer.

The high court upheld the claim and quashed the proceedings. But on appeal, the Supreme Court ruled that the inspector was within his rights to order the company’s prosecution.

“The brand name is Viagra and generic name is sildenafil citrate. This is an allopathic drug and by no stretch of imagination can it be said to be an ayurvedic drug. Since it is an allopathic drug, it cannot be used… (without) a licence,” a two-judge bench said.

“It is an admitted position that the accused (the company) does not possess the licence. Therefore, the very fact of selling this drug as one of the ingredients in the Ozomen capsule and not displaying the name in the prescribed manner will constitute an offence.”

Sildenafil citrate, an off-white crystalline power, is sold under various brand names of which Pfizer’s Viagra is the best-known. A diamond-shaped Viagra pill contains doses of 25mg, 50mg or 100mg of the drug.

Apart from that, each tablet has various other ingredients such as microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate and hypromellose.