Several controversial drugs, which are banned in the developed nations like US, Canada and European Union nations for adverse health effects and are freely available in India, will be re-examined by the Drugs Technical Advisory Board (DTAB) in its meeting on November 9.

Drug Controller General of India (DCGI) Dr Surinder Singh said that his office has asked the DTAB to re-examine these controversial drugs which included the popular non-steroidal anti-inflammatory drug Nimesulide, anti-depression drug Deanxit, decongestant phenylpropanolamine, antibiotic drug gatifloxacine, etc.

The DCGI's decision to put these controversial drugs under the radar of the DTAB comes in the wake of serious concern raised by the medical experts in the country over the side-effects of these drugs.

Top on the list is Nimesulide, a non-steroidal anti-inflammatory drug, which has been banned in many countries but is being marketed in India aggressively by prominent drug companies. It was put under focused surveillance in the National Pharmacovigilance Programme by the drug authorities. However, the drug regulatory authorities claimed that no adverse drug reaction report had been received on the use of Nimesulide in the country so far to necessitate a review.

After the US, countries like Ireland and Singapore also banned this drug following information suggesting an increased risk of liver toxicity compared to other drugs in the same class. The European Medicines Agency has also taken up an independent assessment of the liver toxicity risk following safety concern by the Irish authority. However, the authorities in India said the oral suspension of Nimesulide was still permitted to be marketed in many countries including India. It may be noted that the drug is not approved for use in Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries. However, it is available in India under the brand names Nise (Dr Reddy's) and Nimulid (Panacea Biotech). The same is used in a number of fixed dose combination drugs too and experts have felt that many of them were irrational as the efficacy was not assessed fully.

Another drug in the list for review is the fixed-dose combination of flupenthixol and melitracen, sold under the brand name of Deanxit, which has been banned in advanced countries due to the health hazards. Though melitracen, one of the two ingredients in Deanxit is not approved in India, the DCGI is learnt to have cleared the combination drug reportedly without mandatory clinical trials in India.

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 both in Denmark which is the country of its origin and other developed countries like US, UK, Canada, Australia, Japan, etc.

Another drug which will be reviewed is phenylpropanolamine. Due to its potential to cause stroke, phenylpropanolamine used in cold and cough remedies was banned in all North American countries including US and western Europe. But in India, phenylpropanolamine-containing cough and cold remedies such as D’Cold, Vicks Action-500, Wincold, etc are freely available in the market.

Similar is the case with several other drugs and some of them will be re-examined by the DTAB on November 9.