The Madras High Court has upheld the validity of a notification issued by the Union Ministry of Health and Family Welfare on March 16 last year banning the manufacture, sale and distribution of Gatifloxacin, a drug used for treating acute bacterial exacerbation of chronic bronchitis, acute sinusitis and community acquired pneumonia, among other ailments. Justice V. Ramasubramanian dismissed writ petitions filed by the Federation of South Indian Pharmaceutical Manufacturers Association as well as Macleods Pharmaceuticals, a private manufacturer of the drug, challenging the Central notification and claiming that the ban order was arbitrary, unjust and illegal. Rejecting the petitioners' arguments, the judge said that he did not find any reason to interfere with the ban order imposed on the basis of a report of a 10-member expert committee, which took into consideration a study published in the New England Journal of Medicine in March 2006 reporting disturbances in blood glucose levels associated with the use of Gatifloxacin in patients. He pointed out that the drug was withdrawn from the market in the United States, Canada, Indonesia, Malaysia, Philippines, Singapore, Thailand, Brazil, Mexico and other countries in 2006 by the original manufacturer. In 2008, the United States Food and Drug Administration removed the drug from the list of approved ones. According to the expert committee, which recommended the ban in India in February 2011, the risks associated with systemic use of Gatifloxacin either in the form of tablet or injection overweighed the benefits. It also took into account the fact that there were equally efficacious and safer antimicrobial drugs as an alternative to the banned drug. On the petitioners' argument that the members of pharmaceutical industry were not given an opportunity to explain their stand before imposition of the ban, the judge said there was no need to follow principles of natural justice as the government had imposed the ban by exercising its legislative power and not by way of an administrative action. When pointed out that the industry representatives were allowed to express their views before banning Nimesulide, another drug, the judge referred to official notes and said such an opportunity was given not on the basis of a statutory requirement but at the instance of a Union Minister before whom a representation had been made by a Member of Parliament. “It was given on account of some extraneous reason, if not for extraneous considerations. Hence, the same cannot be cited as a precedent… Rather than throwing public interest to the winds and exposing the community at large to risks associated with drugs that are potentially harmful, the court could even choose to err on the wrong side.” The judge rejected the petitioners' other argument that the Centre need not have shown urgency in banning Gatifloxacin, used in India since 2001, even before the reconstitution of Drugs Technical Advisory Board (DTAB) in April 2011. “In matters concerning public health, the court cannot allow time to run on the specious plea that we have already waited or suffered for ten years. If a drug is likely to be harmful or likely to involve any risk to human beings, the withdrawal of the same from the market, should happen instantaneously, upon the acquisition of knowledge about such potentially harmful effects.