The Central Government must comply with the provisions of Section 26A of the Drugs and Cosmetics Act, 1940, and provide a reasonable opportunity of hearing to the manufacturers of the drug in question before imposing a ban on the manufacture, sale, or distribution of a drug.

( 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

( 4 ) MR. Chakraborty urged that in the instant case no material had been disclosed to show as to how the Central Government had arrived at such satisfaction before issuing the impugned notification Mr. Chakraborty also pointed out that neither had any affidavit been filed on behalf of the Central Government nor had the records been produced which might have thrown some light on the matter

( 5 ) MR. Chakraborty then submitted that neither the petitioners and/or their members had been given a reasonable opportunity of hearing before the impugned notification was issued nor had an Expert Committee been appointed to make a proper assessment of the combination drugs in question upon consultation with the manufacturers thereof.

( 6 ) MR. Chakraborty next urged that significantly no adverse report had been received from any quarter regarding the use of such combination drugs or that its use was injurious to human beings. In fact, the American Medical Association had in its Drug Evaluation Annual, 1995, observed that in treating invasive intestinal amebiosis, metronidazole is the drug of choice in combination with idoquinol or paromycin

( 7 ) MR. Chakraborty also referred to a report published in Current Therepeutic Research, volume 56, No. 7, in its July 1995 issue, in respect of a research, undertaken by Searle (India) Ltd. , a well-known manfuacturer of the combination drug, wherein it was observed that the combination of the two above-mentioned drugs complement each other effectively to eradicate intestinal amebebiosis

( 8 ) MR. Chakraborty submitted that Sections 5, 6 and 7 of the 1940 Act provided for the constitution of a Drugs Technical Advisory Board, the establishment of a Central Drugs Laboratory and an Advisory Committee to be called the "drugs Consultative Committee", to advise the Central Government, State Governments and the Drugs Technical Advisory Committee on any matter tending to secure uniformity in administration of the Act throughout India

( 9 ) IN support of his submissions, Mr. Chakraborty firstly referred to a Single Bench decision of the Bombay High Court in the case of Unichem Laboratories Ltd. Bombay v. Union of India, reported in AIR 1988 8 Bombay 134, where the total ban imposed by the Central Government on Anabolic Steroid with a combination of vitamins was under consideration. In the said case, although an affidavit was affirmed on behalf of the Central