In Chennai the capital city of southern Indian state Tamil Nadu, the Madras High Court has refused to direct the Central Government to halt the manufacture and sale of controversial drug Nimesulide.
Nimesulide is prescribed for fever and body pain among children and touted to bring down a fever more rapidly than other drugs. It is an anti-inflammatory, analgesic and anti-pyretic drug. Its patient information sheet gives that the use is contraindicated in children under 12 years of age as in rare cases it could cause damage to the liver and kidneys. It has never been filed for FDA approval in the US where it is not marketed.
The Division Bench led by Justice S.J. Mukhopadhaya and Justice K. Suguna, while laying aside a public interest litigation petition filed by the Tamil Nadu Health Development Forum, opined that in view of the stand taken by the Centre, coupled with the dismissal of a similar petition by the Delhi High Court, there was no plausible cause to issue any direction.
The Forum meanwhile had noted that the drug was not approved for use even for adults in the U.S., Canada, England, Australia and other developed countries; being said to could cause serious side effects which could affect the liver and kidney.
The petitioner described the Center's decision not to ban Nimesulide as unreasonable and unfair.
Meanwhile the Drugs Controller-General of India, represented by Assistant Solicitor-General P. Wilson says the safety profile of the drug is similar to other drugs in its category used for pain and fever.
"It is not possible to determine the question whether Nimesulide is toxic, harmful and its general use on patients will affect kidney or liver of a person.
That is a question that can be determined by expert bodies having knowledge of pharmacology and medicine. The court cannot deliberate on the issue under Article 226 (jurisdiction of the High Court) of the Constitution", he was quoted.
A similar litigation was filed before the Delhi High Court. Here too, it was dismissed following an enquiry by the Drug Technical Advisory Board .