Wednesday, March 2, 2011

Banned drugs still in circulation--medical experts | TheMedGuru

by Varma.gbsnp - March 2, 2011



The drugs banned by the Union health ministry recently continue to be prescribed, sold, and purchased in Pune. This is due to lack of awareness, medical experts say.


In a notification on Feb. 10, the health ministry banned the sale of some drugs prescribed for common problems such as cold, cough, fever, pain, and stomach upset etc.

Among the drugs banned, four of the most controversial drugs are:
nimesulide suspension(anti-inflammatory drug),
cisapride (gastroprokinetic agent),
phenylpropanolamine (decongestant drug) and
human placenta extracts.

Boasting of the ban, Sanjay Patil, Food and Drug Administration’s joint commissioner, Pune, said, “The union government's notification is clear. Certain drug formulations have been banned with immediate effect. The health ministry had issued a notification on February 10."

The use of these drugs may pose certain risks to humans and safer alternatives are available. It is necessary and expedient to prohibit the manufacture, sale and distribution of these drugs in public interest, the ministry's notification has said.

What is galling about the notification is that why it so long for the government to prohibit such drugs. The evidence of ill-effects of the drugs have been documented and moreover, when foreign countries banned these drugs, Indian manufacturers also stopped their manufacturing of these drugs.

Banned drugs
The decision by the ministry comes after the Drugs Technical Advisory Board (DTAB) recommended their banning. The DTAB, a part of the union health ministry, is the final arbiter on technical matters.

Nimesulide has already been banned in many countries including the U.S., Britain, Japan, Canada, Australia, Denmark, and 168 other countries. All the while the drug was freely available in India.

Nimesulide suspension was routinely prescribed to treat fever and pain in children. It was also callously prescribed for inflammation.

One of the side effects of nimesulide is permanent liver damage. The WHO recommends paracetamol for fever, and the next choice is ibuprofen.

Cisapride’s side effects include intestinal motility leading to spasm and intestinal paralysis. Its notoriety extends to cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, and QT prolongation.

The less said about placenta extracts, the better. In some countries, human placenta extracts were never allowed for want of safety data.

However, the human placenta extracts have been used in India for a veritable laundry list of disorders: female infertility, scarring, post-phlebitic ulcers, scars, vitiligo, wounds, prevention of adverse effects due to radiotherapy, fallopian tube blockage, skin problems and many more. The extracts were sold as gels, lotions, and injections.

Ban effect may take longer
Letters have been sent to chemists, retailers, wholesalers, manufacturers to stop the manufacture, sale, and distribution of the banned drugs.

R.B.Joshi, the assistant commissioner (drugs), said, “FDA will initiate stern action against those involved in the sale, distribution and manufacturing."

Chemists allege that doctors themselves prescribe the banned drug formulations. The stocks of the banned drugs are still available, and how long it will take for their complete disappearance can't be said.


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