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Several drugs banned in US, Europe freely marketed in India
Ramesh Shankar, Mumbai | Monday, August 31, 2009, 08:00 Hrs  [IST]

Several drugs, banned for their serious side effects in developed nations like US, Canada and European Union, are freely available in the country. Though the list of such drugs is long, the latest among them is a combination drug of flupenthixol and melitracen, sold under the brand name of Deanxit.

The product has been banned in the above countries for its serious adverse drug reactions. According to sources, though melitracen, one of the two ingredients in Deanxit is not approved in India, the Drug Controller General of India (DCGI) is learnt to have cleared the combination reportedly without mandatory clinical trials.

The sources said that the drug is being aggressively promoted for a wide range of known and unknown disorders such as psychogenic depression, depressive neuroses, masked depression, menopausal depression, dysphoria in alcoholics and drug addicts etc without mandatory clearance from the DCGI.

Incidentally, Deanxit is banned in Denmark which is the country of its origin and other developed countries like US, UK, Canada, Australia and Japan have also not allowed to market the product in those countries.

Similar is the case with use of placenta extraction. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data. However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.

But in India, human placenta extract sold as Placentrex lotion, gel, and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.

According to MIMS journal, other medicines which were discarded globally but are available in India are thioridazine, tegaserod, phenylpropanolamine and nimesulide, to name only a few. Due to 10-fold increased risk of heart attacks and stroke, tegaserod used in the short term treatment of irritable bowel syndrome in females and chronic constipation in men and women has been banned globally, but the drug is available in India under different brand names like Ibsinorm (Sun Pharma), Tegibs (Torrent), Tegaspa (Lupin), Tagon (Intas), Tegod (Cipla) Tibs-6 (Hetero), Irbez (Emcure), etc, as there has been no action against the medicine by the concerned authorities.

Due to its potential to cause stroke, phenylpropanolamine used in cold and cough remedies was banned in all North America including US and western Europe. But in India, phenylpropanolamine-containing cough and cold remedies such as DCold, Vicks Action-500, Wincold, etc are available in the market.

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