THE SUPREME Court has exempted the sale of steroid-antihistamine drug combinations for treatment of asthma from a ban until the next hearing in August. In 1981, the Drug Technical Advisory Board had recommended a ban on all steroid combinations, excluding asthma drugs. The ban was extended to asthma five years later.
A number of drug manufacturers filed suit challenging the extension of the ban, contending the action was arbitrary and a violation of the fundamental right of freedom to trade. They noted such combinations were sold throughout the world. "In any case, if the drugs are available singularly, what is the use of banning their combinations?" asked P K Dutta, managing director of one of the appellants, Systopic Laboratories Ltd. The petitioners argued the ban only forced people to buy drugs individually and prepare the combinations. This was not only costlier, but also hazardous.
However, Amit Sengupta, a doctor working with the Delhi Science Forum, refuted these arguments as specious. He contended steroid-based fixed-combination drugs have been banned because the dosages are pre-set though these live-saving drugs must be given to suit each patient and must be individually prescribed. "By prescribing a combination drug," Sengupta argued, "doctors are actually giving two drugs though the patient may need only one. The patient must therefore suffer the side effects of both," Sengupta said.
Furthermore, WHO, which has a list of rational fixed-dose, combination drugs, has not approved steroids to be included as a combination with any drug. The case promises to be a contentious one.
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