HOECHST PHARMACEUTICALS Vs. C V S MANI

JUDGEMENT

(1.) The import, manuFacture,distribution and sale of drugs and cosmetics are, inter alia,regulated by the Drugs and cosmetics Act, 1940, hereinafterreferred to as the Act. Sections 6, 12 and 33 of the Actempower the Central Government to frame rules in themanner and to the extent mentioned in the said sections.Such rules have been promulgated and are known as theDrags and Cosmetics Rules, 1945, hereinafter referred toas the Rules.

(2.) The Central Government by a notification No. O.S.R.27(E) dated 17/01/1981 made certain amendmentsto the Rules. The amended rules partly came into force on 1/08/1981 and partly on the date of the publication ofthe amended rules in the Official Gazette.' The challengebefore us is to these amendments, the contention being thatthe amendments contained in the notification dated 17/01/1981 are illegal, invalid, ultra vires and unenforceable.The consequent prayer is to quash the said notification andrestrain the Central Government and its officers and authorities from taking action in consequence of the amendmentspostulated by the aforesaid notification amending the Rules.

(3.) The four group of petitioners before us in the fourpetitions are M\s. Hoechst Pharmaceuticals Ltd. and others(C.W. No. 1605 of 1981), Pfizer Limited (C. W. No. 1719of 1981), Cyanamid India Limited (C.W. No. 1724 of1981), and Cosme Farma Laboratories (C.W. No. 1951 of1981). The respondents before us are Mr. C. V. S. Mani,Additional Secretary to the Government of India in theMinistry of Health and Family Welfare, New Delhi (underwhose signatures the impugned notification has been issued),the Union of India, The Drug Controller, and the Organisation of Pharmaceutical Producers of India. The petitionersare respectively the manufacturers of single ingredient drugsknown as "Novalgin" (Hoechst), "Vermex" (Pfizer), "Verban" (Cyanamid) and''Mejoral" (Cosme Farma). The effectof the amendments in the rules by virtue of the impugnednotification is that the petitioners can no longer market theiraforesaid drugs under or by giving in any manner upon thelabels and containers the trade or brand names under whichthese drugs have been marketed till the issue of the impugnednotification and if the petitioners want to market their saiddrugs the same can only be marketed if these are labelledonly with their respective proper names, namely, the scientific name by which the respective drug would be known invarious pharmacopoea. The impugned amended rules,inter alia, postulate that preparations containing any newdrug as the single active ingredient and approved underRules 30A, 69B or 75B by the licensing authority shall belabelled and marketed under a generic name only. Withregard to some other drugs the amended rule provides thatthe proper name of the drug shall be printed or written in amore conspicuous manner than the trade under the properwhich shall be shown immediately after or under the propername. The dispute really is whether respondents 1, 2 and3, as above-mentioned, can acting within the scope of thepower conferred by the Act and the Rules, compel the petitioners or the other manufacturers of drugs to either not usethe brand name or trade name at all in marketing the drugsrespectively produced by them or can compel manufacturersof drugs to market the drugs by giving proper name or thescientific name more prominently than the brand name orthe trade name on the labels or containers. During thecourse of hearing the second point was not much pressed andthe petitioners said that they may even comply with thismandate of the amended rules if otherwise the rules as promulgated are within the power of the rule making authorityand the rules were not ultra vires the Act or the Constitutionof India. But on the first point, namely complete.prohibition to use the brand name or trade name, the contention isthat such prohibition is ultra vires the petitioners' rightsunder Articles 13, 14 and 19 of the Constitution. Inasmuchas the arguments in all the four petitions were identical andthe facts are not very different for the purposes of enunciatingthe law, we shall primarily notice the facts in the Hoechstmatter, C.W. No. 1605 of 1981.