With the health ministry all set to ban valdecoxib formulations, a COX II inhibitor known for its serious side-effects, doctors seem to be favouring alternatives like paracetamols for treating arthritis and other serious rheumatoid problems.
The National Pharmaco Vigilance Advisory Committee (NPVAC), formed by the Union health ministry, has recently recommended to the government that all valdecoxib formulations be banned.
The panel has observed that prolonged exposure to the drugs could have a telling effect on the body.
The controversy over COX II inhibitors, a group of non-steroidal, anti-inflammatory drugs, kicked off when the Food and Drug Administration pulled out the roficoxib formulation and its brand from the US market a few weeks ago.
In India, too, roficoxib was banned after the NPVAC reported that the drug had links with serious skin reactions, including Stevens Johnson?s syndrome and toxic epidermal necrolysis (TEN).
It has also been established that patients using the drug for a long time are vulnerable to cardiovascular risks.
As for the proposed ban on valdecoxib formulations, drugs controller-general Ashwini Kumar said officials were working on the notification, which would be issued as soon as the Union health ministry approved it.
?We have been informed about the NPVAC report and the moment we get the green light from the government, we will stop manufacture and sale of valdecoxib,? said deputy drug controller (Calcutta) Abhijit Chakraborty.
The move threatens the entire Rs 85-crore market of valdecoxib and the Rs 250-crore-plus market for all COX II inhibitors.
According to a rough estimate, around 35-40 per cent of Calcuttans who have crossed 60 are suffering from arthritic problems and consuming COX II drugs.
?It is dangerous to prescribe COX II inhibitors and we have been advocating for their ban for some time now,? said Tapas Bannerjee, head of neuromedicine at the National Neurosciences Centre of Peerless Hospital.
The ban move has prompted doctors to look for alternatives. Most doctors in Calcutta now prefer paracetamols for pain relief. The medicine is considered the safest.
?Ban or no ban, we are not taking any chances and have been prescribing alternatives to arthritic patients,? said Buddhadeb Chatterjee, orthopaedic surgeon at Apollo Gleneagles Hospital.
Chatterjee has also conducted a survey, which revealed that most Indians have a weak knee, compared to westerners who suffer more from hip problems. ?I had examined 1,000 Americans and 1,000 Indians, mostly Calcuttans,? he said.
The companies that will be hit by the ban include Glenmark Pharma, Nicholas Piramal, Torrent, Candila Pharma, Zydus, RBX Croslands, Macleods, Alembic and Lyka Hetero.
The firms have the products in the form of Valdecoxib Solid and Valdecoxib Gel.
