Law:

Section:

(a) Drug Regulatory Authority of Pakistan Act (XXI of 2012)--- ----S. 3---Drug Regulatory Authority of Pakistan (DRAP), establishment of--- Object and Scope--- DRAP has been established to provide for effective coordination and enforcement of Drugs Act, 1976 and to bring harmony in inter-provincial trade and commerce of therapeutic goods. (b) Drug Regulatory Authority of Pakistan Act (XXI of 2012)--- ----S. 7, Sched. Paras. 1 & 6---Drugs Act (XXXI of 1976), S. 7---Specific Relief Act (I of 1877), Ss. 42 & 54---Civil Procedure Code (V of 1908), O. XXXIX, Rr. 1 & 2---Suit for declaration and injunction--- Interim injunction, grant of---Registration of drugs---Plaintiff company sought quashing of decision of DRAP to register 'Reditux' injection as a similar bio-therapeutic product was ultra vires the World Health Organization (WHO) Guidelines and Drug Regulatory Authority of Pakistan Act, 2012---Plaintiff sought prohibition order against authorities to issue letter of registration to defendant---Validity---Question of public admittance at large to Life Saving Drugs presupposed vast magnitude---Inimical effect on such access due to grant of injunction would cause disadvantages manifold to larger public interest---Same injection was being vended in several other countries and in Pakistan, it would be marketed on import and not through a license to manufacture---Such was not intention of legislature that for each import and on each moment in time separate exercise should be carried out by DRAP to match bioequivalence or bio-similarity under WHO Guidelines---Research reports and dossier submitted by originator could serve the purpose which had already been considered by the experts---Responsibility of issuing license to manufacture and/or registration of drugs was entrusted and devolved on DRAP---While according license or registration to any drug it was inherent and intrinsic responsibility of authorities to ensure best satisfaction with conscientiousness and trustworthiness and if something was found wrong, then naturally DRAP was required to act in furtherance of correction and ratification---Experts had recommended 'Reditux' generic bio-similar…

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