UNI SAN PHARMACEUTICALS Vs. UNION OF INDIA

JUDGEMENT

(1.) The petitioners Uni-San Pharmaceuticals, Hyderabad, and M/s. Pharma Trades, Jews Street, Ernakulam, filed this O.P. for quashing Ext. P1 notification issued by the 1st respondent u/S. 26-A of the Drugs and Cosmetics Act, 1940 (hereinafter referred as the Act) prohibiting the manufacture, sale and distribution of fixed dose combination of Hydroxyquinoline group of drugs with any other drug except for preparations meant for external use and also for quashing Ext. P2 complaint filed by the 4th respondent before the J.F.C.M. Court-II, Kochi, for violation of Sec. 26-A punishable u/S. 28(3) of the Act.

(2.) The 1st petitioner is a proprietory concerned engaged in the manufacture and sale of drugs by virtue of a licence issued by the Director of Drugs Control Administration, Government of Andhra Pradesh, Hyderabad, and the 2nd petitioner is engaged in the purchase, storage, sale and distribution of drugs. The 1st petitioner was manufacturing various drugs including "maxaquin" tablets with the following formula :

(3.) Respondents 1 and 2 filed a counter-affidavit contending that Ext. P1 notification was issued by the Central Government by virtue of the power conferred u/S. 26-A of the Act after a thorough examination by a technical sub committee constituted for the said purpose and by the Drug Technical Advisory Board. the decision taken by the above Board was informed to the Supreme Court in Writ Petition 698/1993 filed by Drug Action Forum for weeding out irrational and harmful drugs. Therefore, if at all aggrieved by Ext. P1 notification, the petitioners have to approach the Supreme Court in the above case. The business activities of the petitioners are carried out on the basis of a licence issued by the Director of Drugs Control Administration, Government of Andhra Pradesh, and the petitioner cannot claim protection under licence issued by the State Government for the manufacture and sale of Mexaquin tablets since the manufacture and sale are subject to the provisions of Sec. 26-A of the Act. Ext. P1 notification was issued on the basis of the recommendations made by the sub-committee for Drug Consultative Committee entrusted with weeding out of irrational and harmful drugs and with the approval of the Drug Technical Advisory Board (DTAB). The fixed dose combinations of Hydroxyquinoline group of drugs were banned in the year 1983 except for preparations which are used for diarrhoea/dysentry and for external use. The observations contained in W.H.,O. reports were also considered by the sub committee and the DTAB. A Public Interest Litigation under WP 698/93 was filed by the Drug Action Forum before the Supreme Court praying for the ban of drugs and combinations including Hydroxyquinoline in the country and after examining various submissions made by the intervenors and the Government, the Supreme Court by order dt. 17-11-94 directed the Government of India that the list of drugs that would be submitted by the petitioner therein be examined by the DTAB within a period of three months. The list of drugs submitted included Dy-Hydroxyquinoline. The reports were duly placed before the Supreme Court through affidavits filed by Government. Consequently Ext. P1 notification was issued banning the above combination of medicine. Respondents 3 and 4 are the agencies who are implementing the orders passed by the respondents. Ext. P1 notification was issued by virtue of the powers conferred u/S. 26-A of the Act and it is not liable to be set aside as violative of the fundamental rights as alleged.