- (1.) The petitioner Nos. 1 and 3 claim to be Associations of manufacturers of drugs and pharmaceuticals in West Bengal, some of whom are engaged in the manufacture of different combinations of Iodochlorohydorxyquinoline with diastase and metronodazole for treatment of diarrhoea and dysentery under different brand names for about the last forty years. In this writ application they have challenged a Notification No. G.S. R. 793(E) issued by the Union of India and published in the Gazette of India Extraordinary in its issue of 13th December, 1995, 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.
(2.) Appearing in support of the writ petition, Mr. Guatam Chakraborty submitted that the impugned notification dated 13th December, 1995, was a more or less verbatim reproduction of Section 26A of the Durgs and Cosmetics Act, 1940, hereinafter referred to as the "1940 Act", and reveals complete non application of mind on the part of the Central Government authorities who were responsible for the issuance thereof
(3.) Mr. Chakraborty submitted that the powers under Section 26A of the 1940 Act could be invoked in the public interest only when the Central Government was satisfied that the use of the drug in question was likely to involve any risk to human beings or, animals or it did not have the therapeutic value claimed, or contained ingredients in such quantity for which there was no therepeutic justification;