SUPREME COURT OF INDIA
Sujata v. Manohar and R.P. Sethi, JJ.
C.A. No. 3369 of 1997 with C.A. No. 4835/99 @ S.L.P. (C) No. 3685/1998
Decided On: 25.08. I 999
Bhagwan Singh and Anr. Appellants
versus
State of Punjab and Ors. Respondent
DRUGS AND COSMETICS ACT, 1940 - RULE 50-A - QUALIFICATIONS OF CONTROLLING AUTHORITY - EXPERIENCE IN TESTING OF DRUGS - EXPERIENCE AS CHEMICAL EXAMINER - NOT RELEVANT - APPOINTMENT OF CONTROLLING AUTHORITY SET ASIDE.
Fact of the Case:
The appellants, who were Assistant Drugs Controllers, challenged the appointment of respondent No. 3 as the State Drug Controlling Authority under the Drugs and Cosmetics Act, 1940, on the ground that he did not possess the requisite qualifications and experience.
Finding of the Court:
The Court held that respondent No. 3 possessed the requisite academic qualifications, but did not have the requisite experience in testing of drugs or in the enforcement of the Drugs and Cosmetics Act, 1940. The Court also held that respondent No. 3's experience as a Chemical Examiner was not relevant experience.
Issues: Whether respondent No. 3 possessed the requisite qualifications and experience to be appointed as the State Drug Controlling Authority under the Drugs and Cosmetics Act, 1940.
Ratio Decidendi: The Court held that the term "drugs" in Rule 50-A(II) of the Drugs and Cosmetics Rules, 1945 must be understood as defined in the Drugs and Cosmetics Act, 1940. The Court also held that the relevant experience must be the experience of testing medicinal or other preparations for internal or external use of human beings or animals, as such, and not incidentally isolating such preparations in the course of analysis for other purposes.
Final Decision: The Court allowed the appeals, set aside the impugned judgment and order of the High Court, and set aside the appointment of respondent No. 3 as the Controlling Authority.
ORDER
1. Delay condoned, looking to the facts and circumstances of the case.
2. Application for arraying proforma respondent Nos. 5 & 6 as appellant Nos. 3$4 is allowed.
3. Leave granted in S.L.P. (C) No. 3685/ 1998.
4. Both these appeals challenge the appointment of respondent No.3, Dr. Harpal Singh. as the State Drug Controlling Authority under a Notification dated 18.3.1996.
5. Rule 50-A of the Rules framed under the Drugs and Cosmetics Act, 1940 prescribes qualifications of a Controlling Authority. Rule 50-A of the Drugs and Cosmetics Rules, 1945 is as follows:
"Rule 50-A: Qualifications of Controlling Authority :_
(I) No person shall be qualified to be a Controlling Authority under the Act unless:-
(i) 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
(ii) he 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 qualifications shall not apply to those Inspectors and the Government Analysts who were holding those positions on 12th day of April, 1989.
6. Respondent No. 3 is a qualified Doctor and he possesses M.D. in Pharmacology. The appellants who were at the relevant time, holding the post of Assistant Drugs Controller and had also applied for the said post, contend that the qualification prescribed is, inter alia, a degree in Medicine with specialisation in Clinical Pharmacology. They contend that respondent No.3 does not possess a specialisation in Clinical Pharmacology and hence, he is not qualified to be appointed to the post of Controlling Authority under the Drugs and Cosmetics Act, 1940. It is, however, pointed out by learned counsel appearing for the State as also by respondent No.3 that a Post Graduate Course in Pharmacology also contains the subject of Clinical Pharmacology. They also contend that a specialisation in Clinical Pharmacology is available only at the stage of super-speciality and not at the stage of Post-Graduate studies in Medicine. This, however, is contested by the appellants who have contended that atIeast in some Universities, there is a Post Graduate specialisation in Clinical Pharmacology. We have, however, to read the academic qualification prescribed in its entirety. The first part prescribes only the qualification of a graduate degree in Pharmacy or Pharmaceutical Chemistry. In the alternative, a graduate degree in Medicine with specialisation in Clinical Pharmacology is prescribed. Therefore, a super-speciality qualification is not contemplated in this context. If the Expert Committee which selected the candidate has found the possession of an M.D. in Pharmacology by him as an adequate compliance with the academic qualification prescribed, we would not like to take a different view. The High Court has also, in the impugned judgment, come to the conclusion that the academic qualifications of the respondent No.3 can be said to conform to the qualifications prescribed under Rule 50-A. Therefore, respondent No. 3 can be considered as possessing the requisite academic qualifications.
7. The problem, however, relates to the prescribed requisite experience for holding the post of a Controlling Authority. Rule 50-A (II) requires experience in (I) the manufacture or testing of drugs or (2) enforcement of the provisions of the Act, for a minimum period of five years. Therefore, we have to examine whether the respondent No.3 posses five years experience in any of these areas. Respondent No.3, after he completed his M.B.B.S. degree and intership in 1968 obtained employment in May, 1968 as a Medical Officer in the State of Punjab. In September, 1978, he was appointed as a Demonstrator in the Medical College. Amritsar and he worked in this post upto January, 1982. During this period the third respondent has stated that as a Demonstrator, he w
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