The Central Drug Standards Control Organisation has amended its earlier notification dated October 29, 2002 banning two anti-allergic drugs, terfinadine and astemizole, effective from August 2003 and now made the ban effective from April 1, 2003.

The new notification issued February 26, 2003, was following the Delhi High Court order to put the ban with immediate effect instead of August 2003. The CDSCO has taken this decision subsequent to a notice from the Delhi High Court directing them to file a reply on prohibiting the drugs from human use from August 2003, ten months after finding it unsafe for use.

The DCGI office, subsequent to the court notice, reviewed the matter at the highest level and amended the order now to take effect from April 1, 2003.

In view of the concern shown by the High Court of Delhi, during course of hearing of a public interest litigation filed by Social jurist, A Lawyers Group about safety of these formulations, Ministry of Health & Family Welfare, Govt. of India, has decided to amend the above Gazette Notification as to prohibit the manufacture of these drugs for human use with immediate effect and sale and distribution thereof with effect from 1st April 2003.

With this, the Department has asked manufacturers to stop forthwith manufacture of formulations of these drugs and make arrangements to withdraw the stocks from the market in such a way that these drugs are not offered for sale with effect from the date mentioned above.

It may be recalled that the court had directed CDSCO to examine the matter that as 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 the withdrawal should not to be postponed further actual withdrawal from the market."