Mumbai based UCB Pharma Ltd is being accused of aggressively promoting two pharmaceutical products namely, Piracetam and Buclizine, for unapproved indications without disclosing their possible adverse side effects.

While Piracetam is being promoted under the brand name " Nootropil" for vague conditions like "intellectual decay," "social maladjustment," "lack of alertness," "changes of mood," "deterioration in behaviour "and "learning disabilities" in children associated with the written word, Buclizine (brand name: Longifene) is promoted as an appetite stimulant in very young children.

However, the drugs were not approved by the Drugs Controller General of India for these indications while issuing the marketing approval.

The allegations, raised in the forthcoming issue of Monthly Index of Medical Specialties (MIMS), are seen as yet another instance of increasing violation of nation's drug laws and medical ethics.

UCB is recommending Piracetam as a treatment for learning disabilities for children for the "entire school year" in a dose of 3 gram per day which is 7 to 8 capsules of 400 mg daily. MIMS notes that if the drug is administered for the entire school year as recommended, it will mean parents buying at least 2,700 capsules at a cost of Rs. 12,775 year after year.

There cannot be a more ingenious, albeit unethical method of increasing sales even though it hurts the pockets of parents without any benefit to children. The claims of the drug's efficacy include "the treatment of sickle cell anaemia," stroke and vertigo also.

With Reference to British National Formulary, MIMS points out that Piracetam (Nootropil) is permitted in Britain for use in just a single indication, a rare disorder called cortical myoclonus and that too only as an adjunctive therapy. While the drug is being promoted for use in young children in India, the British has contra-indicated the drug for adolescents under the age of 16 years.

If the Indian company marketing Piracetam is to be believed, the drug is nothing short of nectar. "It has no contraindications, no need to observe any precautions, no interactions and no adverse drug reactions". In Britain, the drug is contraindicated in hepatic and renal impairment, during pregnancy and lactation. It is to be used cautiously in elderly. Its side effects include: diarrhoea, weight gain, insomnia, nervousness, depression, hyperkinesia and rash. It can interact with warfarin and result in bleeding. Piracetam is not marketed in the United States.

The other drug, buclizine is illegally and aggressively being promoted as an appetite stimulant in very young children. It was approved only as an antihistamine by DCGI. In January 1993, the manufacturer decided on its own to discontinue its use as an antihistamine and instead promote it as an appetite stimulant without regulatory approval.

Buclizine's use has been restricted worldwide to the treatment of migraine only in combination with analgesics in patients over the age of 10 years. In the United States, the molecule was discarded in 1999. Before being withdrawn in Switzerland in 1998, the drug was indicated for use in motion sickness, nausea and vomiting but contraindicated for use in adolescents below 16 years. Internationally reported adverse effects include: drowsiness, blurred vision, diarrhoea, difficulty in passing urine, dizziness, dryness of mouth, tachycardia, headache, nervousness, restlessness, hallucinations, skin rash and upset stomach. Bottles of Longifene, the only brand of buclizine being sold in India do not contain either the package insert or the patient information leaflet. Thus Indian consumers are being deliberately deprived of safety information. However the words "for increase in appetite and weight gain" are boldly printed on the bottle's carton!

Lack of strict regulatory control has been pointed out for the recurrence of such illegal activities. Companies openly resort to illegal and unethical promotion of medicines as they are neither fearful of law nor the law enforcers. Even when an erring company is caught red-handed indulging in illegal activities, it is let off, for reasons best known to regulators, with a light warning as happened in the case of letrozole, MIMS notes.