The Chennai High Court has asked the Union Health Ministry and the Drug Controller of India (DCGI) to respond on a Public Interest Litigation (PIL) filed by a Chennai based NGO for complete ban of nimesulide in India.
Admitting the PIL filed by Dr.C.S.Rex Saragunam, Secretary of the Tamil Nadu Health Development Forum on 10th September 2003, the division bench consisting of Chief Justice B.Subhashan Reddy and A.Kulasekharan has asked the Government to respond on or thereafter 12th of October 2003.
Talking to Pharmabiz.com, the doctor and the petitioner counsel S.Ayyadurai said the Government's unwillingness to totally ban nimesulide drugs in the country despite the Delhi High Court's intervention amounts to infringement of Article 14 and 21 of the Indian constitution, which stands for equality before law, protection to life and liberty of the citizens. "India is a country with many millions of illiterate people, and in reality, many of the prescription drugs are bought by people as OTC drugs. The inaction of the Government to ban a drug that has been banned widely in many developed countries and even in Bangladesh, is a very serious matter. No one dies of fever, but dies when his liver and kidneys fail," said Dr.Rex.
In his petition, he has stated that nimesulide was a non-steroid anti-inflammatory drug, not an anti-pyretic drug, widely prescribed by doctors for its ability to bring down the temperature faster than paracetamol, available in brands like Crocin, Metacin, Dolopar etc. Studies show this drug is harmful to kidneys and liver on prolonged use. Even for minor fever related body pain, doctors prescribe it by going by the patient's psychology, without considering the long-term harmful impact of the drug. Nimesulide is among the most expensive drugs, offering the manufacturers profit margin of over 1300 percent, resulting in large-scale manufacturing and marketing by pharma companies. The drug is not approved in many countries including the U.S., U.K., Canada and Australia. It has been banned in Finland, Spain, Turkey and Bangladesh, said the PIL.
The petitioner noted that though the Government is armed with powers to ban this drug under 26-A of the Drugs and Cosmetics Act, 1940, it has so far not done so despite the Delhi High Court's intervention. It is unjust on the part of the authorities to remain inactive, putting the public, particularly children at risk. Hence, the court should intervene to ban the drug, contended the petitioner.
The Tamil Nadu Health Development Forum, an NGO registered as a trust in 1991, is led by Dr.Chandra, a leading Chennai based social worker and doctor of repute, and by Dr.Rex, its Secretary. The NGO mainly works for the upliftment of women and children, said the Secretary.