IN THE HIGH COURT OF ALLAHABAD
Binod Kumar Roy and A. K. Yog, JJ.
D.K.JOSHI - Appellant
Versus
STATE OF UTTAR PRADESH - Respondents
C. M. W. P. 13620 Of 1993
Decided On : 12/20/2000
Drugs and Cosmetics Act - Licencing Authority - Rules 49a, 50a, 59, 65 - The court directed the respondents to restrain Chief Medical Officers who did not possess the requisite qualifications from acting as Licencing and Controlling Authorities under the Drugs and Cosmetics Act, and to cancel the licences issued to unqualified persons after 12th April, 1989.
Fact of the Case:
The petitioner sought to restrain unqualified Chief Medical Officers from acting as Licencing and Controlling Authorities under the Drugs and Cosmetics Act, citing the potential harm to public health and the breach of legislative intent.
Finding of the Court:
The court found that unqualified Chief Medical Officers were appointed as Licencing and Controlling Authorities, endangering public health and breaching the legislative intent of the Act and Rules.
Issues: The main issue was whether unqualified Chief Medical Officers should be allowed to act as Licencing and Controlling Authorities under the Drugs and Cosmetics Act.
Ratio Decidendi: The court held that the appointments of unqualified Chief Medical Officers as Licencing and Controlling Authorities should be restrained to safeguard public health and uphold the legislative intent of the Act and Rules.
Final Decision: The court directed the respondents to restrain unqualified Chief Medical Officers from acting as Licencing and Controlling Authorities and to cancel licences issued to unqualified persons after 12th April, 1989.
BINOD KUMAR ROY, A. K. YOG, JJ.
( 1 ) THE prayer of the petitioner is to command the respondents (i) to restrain the Chief Medical officers of this State to act as Licencing and Controlling Authority, who are not qualified under the Drugs and Cosmetic Rules, 1945, framed under the Drugs and Cosmetics Act, 1940 (hereinafter referred to as the Rules and the Act respectively for the sake of brevity) ; (ii) to cancel the licences issued to such persons who are not qualified under the Rules after 12th April, 1989 ; and (iii) to award costs to him.
( 2 ) THE petitioner claims to be a social worker and having interest in the welfare of the public at large specially for those of the district Agra who arc being subjected to consumption of drugs distributed by such persons who are not authorised to distribute the same under the law ; he has no rivalry-direct or indirect-against the respondents nor is connected in any manner with them ; the Act contemplates to regulate the import, manufacture, distribution and sale of Drugs and cosmetics and for maintenance of their high standard and its main object is to prevent import, etc. of the sub-standard drugs and intends to eradicate such drugs ; in the year 1945 the Rules were framed under the Act ; our State Legislature passed an Amendment Act No. 47 of 1975 amending the provisions of (i) the Indian Penal Code, (ii) the Code of Criminal Procedure, (iii)the Prevention of Food Adulteration Act and (iv) the Drugs and Cosmetics Act for providing deterrent punishment for offences relating thereto ; the State Government while exercising its power under sub-rule (1) of Rule 59 of the 1945 Rules vide notification No. 1022/xvi-X-XII (67)-76 dated March 24, 1977, was pleased to appoint all the Chief Medical officers of the State in respect of whole of the district in which they were posted including nagar Maha Palikas, Nagar Palikas, Notified Areas and Town Areas as Licencing Authority as per Part VI of the Rules, as also the Controlling Authority under Rule 50 of the Rules ; Vide rule 49a the qualifications for the Licencing Authority were laid down to the effect that no person shall be qualified to be a Licencing Authority under the Act unless he is a graduate in pharmacy or Pharmaceutical Chemistry or in Medicine with specialisation in clinical pharmacology or Microbiology from a University established in India by law and has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years provided that the requirements as to the academic qualification shall not apply to those Inspectors and Government Analysts, who were holding those positions on the 12th day of April, 1989 : vide Rule 50a the qualification of a Controlling Authority was prescribed laying down that no person shall be qualified to be a Controlling Authority under the act unless he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law and has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years provided that the requirements as to the academic qualification shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989 ; Rules 49a and 50a aforementioned came into force with effect from 12th April, 1989 ; the aforesaid Rules have been accepted by our State as no amendment to the contrary has been made till date ; Part VI of the Rules lays down provisions for the sale of drugs other than homeopathic medicines, conditions for grant or renewal of the licences to sale, stock, exhibit or offer for sale, or distribute drugs other than those included in Schedule X which shall be made in Form 19 or form 19a, as the case may be, or in the case of drugs included in Schedule X, shall be made in form 19c to the Licencing Autho
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