- (1.) THE instant appeal is directed against a Judgment and order dated 14-2-97 reported in AIR 1997 Cal 186 passed by a learned Single Judge in C.O. No. 5043 (W) of 1996 whereby and whereunder the Notification No. G.S.R.-793 (E), issued under Section 26A of the Drugs and Cosmetics Act, 1940 (in short the Act) and published in the Gazette dated 13th December, 1995 was quashed and set aside.
(2.) BY the impugned Notification dated 13th December, 1995 a prohibition on manufacture, sale and distribution of fixed dose combination of Hydroxyquinoline group of drugs with any other drug, except for preparations meant for external use, was imposed. The impugned Notification has been issued in exercise of the power vested in the Central Government under Section 26A of the Act which reads as under :- "Power of Central Government to prohibit manufacture, etc. of drug and cosmetic in public interest.- Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic." The contention of the respondents-writ petitioners assailing the impugned notification was that except reproducing the language of Section 26A of the Act, the impugned Notification does not specify the ground on which the Central Government arrived at a satisfaction that 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 was required to be prohibited in the public interest.
(3.) THE above contention found favourwith the learned single Judge in quashing the impugned notification. THE Ld. single Judge observed that there was nothing on record to show that any expert committee was constituted to examine the matter in consultation with the manufacturers of the drugs in question and directed that the order under appeal shall remain in abeyance for a period of two months from the date thereof to enable the Central Government to consider the matter afresh in accordance with the principles of natural justice and administrative fair play. It was further directed that while reconsidering the matter, the Central Government should take the assistance of a committee of experts which should give the representative of the manufacturers of the drug in question, including the petitioners a reasonable opportunity of hearing and placing relevant research papers and documents. While giving directions for hearing the appeal expeditiously an interim order staying the operation of the Judgment under appeal was passed on 3-2-99.;