R. Rajendra Babu, J.

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 under S.26-A of the Drugs and Cosmetics Act, 1940 thereinafter 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 S.26-A punishable under S.28(3) of the Act.

2. The 1st petitioner is a proprietary concern 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:

"Metronidazolel. P. 200 mg. D1- iodohydroxy quinoline IP-250 mg Dl Cyclomine Hydrochloride bp.smg Colour-Tartrazine"

The 1st respondent by Ext. P1 notification dt. 30.12.95 prohibited 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. Ext. P1 notification was issued without applying the mind and without getting the opinion of an expert committee as envisaged under S.26-A of the Act and it was only a verbatim reproduction of S.26A of the Act. There was no consultation by the Drugs Technical Advisory Board or the Drugs Consultative Committee or any sub committee appointed by the 1st respondent before Ext. P1 notification was issued and Ext. P1 was issued without constituting any expert committee and the entire matter has been dealt with perfunctorily and in an abrupt manner and as such Ext. P1 was illegal, arbitrary and violative of natural justice and is liable to be set aside. Ext. P2 complaint was filed by the 4th respondent alleging violation of Ext. P1 notification and as Ext. P1 notification is nonest and void, the complaint also is liable to be quashed.

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 under S.26A of the Act after a thorough examination by the 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 our 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 S.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/ disentry 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 submiss