# \[e-drug\] Unethical drug promotion in India **URL:** \ **Category:** e-drug\ **Created:** [April 1, 2004, 10:52am UTC](https://talk.edrugplus.org/t/e-drug-unethical-drug-promotion-in-india/19259 "2004-04-01T10:52:21Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![seeemgee](https://avatars.discourse-cdn.com/v4/letter/s/aca169/32.png) [@seeemgee](https://talk.edrugplus.org/u/seeemgee)\ **Post date:** [April 1, 2004, 10:52am UTC](https://talk.edrugplus.org/t/e-drug-unethical-drug-promotion-in-india/19259/1 "2004-04-01T10:52:21Z")
E-DRUG: Unethical drug promotion in India ----------------------------------------- [HAI Europe had a campaign in the 1980's to get rid of "braintonics" like piracetam and "appetite stimulants" like buclizine. There is hardly any evidence that these work. However, there is also little evidence that they don't work. The latter was needed to clean them from the European market due to their status as "old" drug under European drug legislation. It is a scandal that such drugs are wasting people's meagre resources in India! What companies are involved? Local or international ones? WB] Dear E-druggers, India: Illegal, Unethical Promotion Hits New Highs Indications Increased, Side Effects Suppressed   In clear violation of India's drug laws and medical ethics, two medicines are being promoted aggressively for unapproved indications. At the same time information on side effects is being suppressed.   Piracetam is being promoted for unimaginably 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." The recommended duration of treatment for the last indication is "entire school year" in a dose of "3g per day" i.e. 7-8 capsules of 400mg daily. If the drug is administered for the entire school year as recommended, it will mean parents buying at least 2,700 capsules every 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 unending claims of the drug's efficacy include "the treatment of sickle cell anaemia," stroke and vertigo.   In Britain, piracetam (Nootropil) is permitted for use in just a single indication, a rare disorder called cortical myoclonus, that too only as an adjunctive therapy (Reference: British National Formulary). While in India, the drug is being promoted for use in young children, in Britain its use is contraindicated 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.   Another drug, buclizine under the brand name of Logifene is illegally and aggressively being promoted as an appetite stimulant in very young children. It was approved only as an antihistamine by Drugs Controller General, India (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 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!   Why do some companies in India openly resort to illegal and unethical promotion of medicines? Because they are neither fearful of law nor the law enforcers. Even if 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. In the absence of new molecules, pharma companies do the next best thing: invent diseases, increase indications and underplay side effects. Dr. Chandra M. Gulhati, Editor, MIMS INDIA (Monthly Index of Medical Specialities) 90 Nehru Place, New Delhi 110019. India. Tel: 91 11 26433115/26234875 Fax: 91 11 26463720/26424016 e-mail: seeemgee@yahoo.co.uk -- To send a message to E-Drug, write to: e-drug@healthnet.org To subscribe or unsubscribe, write to: majordomo@healthnet.org in the body of the message type: subscribe e-drug OR unsubscribe e-drug To contact a person, send a message to: e-drug-help@healthnet.org Information and archives: [http://www.essentialdrugs.org/edrug](http://www.essentialdrugs.org/edrug)