The Delhi High Court directed the government to file an affidavit explaining steps taken by it for complying with the order of the High Court on December 20, 2002 on banning Astemizole and Terfinadine eight months after finding it unsafe for use and also to reply on why it issued a simultaneous notification permitting the manufacture and sale of the two drugs till August 2003.
The High Court, in December 2002, had directed the Centre to examine the matter at the highest level holding that it was prima facie of the view that in case the government felt satisfied that one particular drug deserved to be prohibited from being marketed and used, “the same ought to have been done with immediate effect and not postponed for eight months”.
While hearing the matter the bench observed that it has perused the minutes of the meeting of Drug Technical Advisory Board held on April 11, 2002, that the two drugs were withdrawn in several countries much earlier.
The court also pleaded the Department of Chemicals and Petrochemicals as a respondent in the matter, issued notice to it on the plea of petitioner seeking direction for strictly following the statutory provisions in respect with the Drug Price Control Policy of 1994.
The court had also sought reply from the Drug Controller General of India (DCGI) and three pharmaceutical companies - Panacea Biotech, Dr Reddy's Laboratories and Ranbaxy India - on a petition seeking immediate ban on these drugs.
A public interest litigation (PIL) by NGO, Social Jurists, had sought a ban on the drug and a probe on its efficacy at the hands of an independent expert body. The petitioner had submitted that the drugs had been banned in developed countries about 30 years ago after they were found harmful for humans.