Friday, February 18, 2011

3 popular drugs face ban for serious side-effects

Kounteya Sinha, TNN, Feb 8, 2011, 12.16am IST

NEW DELHI: After the recent ban on nimesulide, India is looking to clamp down on three other controversial drugs -- Gatifloxacine, Tegaserod and Deanxit. All these drugs are used extensively in the country, under different brand names, and they cumulatively do a business of around Rs 70 crore annually. 

A meeting of Drug Technical Advisory Board's (DTAB) sub-committee, headed by Dr Y K Gupta from AIIMS, could take place next week to decide on the fate of these three drugs.

Speaking exclusively to TOI, 
Drug Controller General of India, Dr Surinder Singh, said, "these drugs are under the scanner. We are finalising a date with the DTAB sub-committee to meet and take a final call. It will happen soon."

Though a meeting was slated to be held on January 27, it got postponed. 
Gatifloxacine is used as an antibiotic. But according to Dr Singh, "this drug is known to shoot up and also dip blood sugar levels".

Dr Anoop Misra, former head of department of medicine at AIIMS, told TOI, "In the past one year, I have seen six cases of blood sugar shooting up to abnormal levels -- almost 500% among patients after taking Gatifloxacine. Gatifloxacine induced diabetes or worsening of blood sugar has been well documented."

Drug expert Dr C M Gulati told TOI, "It is known to cause heart movement abnormality."
Deanxit, which alone does Rs 35 crore of business in India, is used for depression. "It's a fixed dose combination drug, having flupenthixol and melitracen. Interestingly, melitracen is not approved in India. So how can you approve a combination of which one of the ingredients is not approved?" Dr Gulati asked.

"Also, this drug is made in Denmark. However, it is not approved for use in Denmark itself. According to rule 30 B in the drugs act. Any drug not approved in the country of origin cannot be used in India. It's sale is prohibited in the UK, US, 
Canada, Australia and Japan," he added.

Tegaserod is used in India for irritable bowel syndrome and chronic constipation.

According to Dr Gulati, "This drug is banned all over the world after it showed a 10-fold increased risk of heart attacks and stroke. The most popular Indian name of this drug is Ibsinorm and Tegibs.

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