1. Delay condoned, looking to the facts and circumstances of the case.

2. Application for arraying pro forma Respondents 5 and 6 as Appellants 3 and 4 is allowed.

3. Leave granted in S.L.P. (C) No. 3685 of 1998.

4. Both these appeals challenge the appointment of Respondent 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 :

"50-A. Qualifications of a Controlling Authority. for the (1) 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 the 12th day of April, 1989." *

6. Respondent 3 is a qualified doctor and he possesses MD 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 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 3 that a postgraduate 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 superspeciality and not at the stage of postgraduate studies in Medicine. This, however, is contested by the appellants who have contended that at least in some universities, there is a postgraduate 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 superspeciality qualification is not contemplated in this context. If the Expert Committee which selected the candidate has found the possession of an MD 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 Respondent 3 can be said to conform to the qualifications prescribed under Rule 50-A. Therefore, Respondent 3 can be considered as possessing the requisite academic qualification.

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 (1) 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 Respondent 3 possesses five years' experience in any of these areas. Respondent 3, after he completed his MBBS Degree and internship 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 Medical College, Amritsar and he worked in this post up to January 1982. During this period, the third respondent has stated that as a Demonstrator, he worked in the Pharmacology Department for analysing and testing various drugs and he learnt testing, processing and dispensing of drugs. This experience as a Demonstrator was independent of his postgraduation studies because it was only in January 1980 that he registered for the postgraduate course and he obtained his postgraduation in Pharmacology in December 1982. Therefore, his experience from September 1978 to January 1982 can be considered as experience in the testing of drugs. However, his subsequent experience is of a different kind. Respondent 3 has strongly relied upon his work as a Chemical Examiner of the Government of Punjab from 27-5-1988 to 4-6-1992. The notification appointing him as a Chemical Examiner states that he has been so appointed for the purpose of analysing the samples of excise and medico-legal cases and reporting thereon. The chemical analysis, therefore, which the third respondent was required to undertake in this post was in the context of excise and medico-legal cases. In the latter category, he may, for example, have to analyse samples of viscera and other samples taken from a dead body for the purpose of ascertaining the cause of death. Undoubtedly, it is possible that in the case of a suspected death due to overdose of drugs or poisonous drugs, what the third respondent may have to analyse, may contain traces of drugs. But the whole exercise cannot be described as testing of drugs, which is the prescribed experience. The same would be the case with analysis of samples for the purposes of an excise case. In the context of the Drugs and Cosmetics Act, 1940, the experience must be an experience relevant to the implementation of the provisions of the Act.

8. The term "drugs" in Rule 50-A(ii) has to be understood as defined in this Act because Rule 50-A of the Drugs and Cosmetics Rules, 1945 is a rule framed under the Drugs and Cosmetics Act, 1940. Section 3(b) of the Drugs and Cosmetics Act, 1940 defines a "drug". It gives an extensive definition of "drug" as including, inter alia, all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals. It also includes preparations applied on the human body for the purpose of repelling insects and such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals. We need not examine the entire definition. What is clear, however, is that the drugs in the context of this Act, refer to medicinal or other preparations for internal or external use of human beings or animals etc. Therefore, the relevant experience must be the experience of testing these preparations as such, and not incidentally isolating such preparations in the course of analysis for other purposes.

9. Moreover, under Sections 8 and 16 of the said Act, there is a provision for prescribing the standard quality of a drug; and a responsibility is cast under the Act on the appropriate authority under the Act to ensure that a drug complies with the standard set out in the Act. The IInd Schedule to the Act sets out the standards to be complied with by drugs locally manufactured or sold and by imported drugs. Therefore, any experience of testing drugs to ensure that they comply with the requisite standards would also be a relevant experience. In this context also, in our view, Respondent 3's experience as a Chemical Examiner cannot be considered as relevant experience since his work did not directly deal with the kind of testing which is contemplated under the Drugs and Cosmetics Act, 1940.

10. Respondent 3 has also relied upon his experience as a Bacteriologist to the Government for a period of 11 months while working in the laboratory where water samples were tested. Once again, this experience cannot be considered as the experience of testing any drugs. He has also relied upon his appointment as a Technical Expert in the Office of the Chemical Examiner w.e.f. 13-7-1994 to 21-3-1995. This was in the same department where he was earlier the Chemical Examiner. Looking to the nature of the duties of this Department, his experience as a Technical Expert also cannot be termed as his experience in the testing of drugs.

11. Learned counsel for Respondent 3 has emphasised that while Respondent 3 was Medical Officer in charge of Block Level Primary Health Centre from 1972 to 1976 he was also an ex officio Drugs Inspector and, therefore, he should be treated as having the experience in the enforcement of the provisions of the Drugs and Cosmetics Act, 1940. Unfortunately, we do not have any particulars of what Respondent 3 had done in his capacity as ex officio Drugs Inspector. Unless we have the details of his requisite experience in that capacity, it is not possible to say that he had the requisite experience in the enforcement of the provisions of the Drugs and Cosmetics Act, 1940. Merely being appointed as ex officio Drugs Inspector per se cannot be treated as giving him the requisite experience unless he had., in fact, discharged any functions as such officer during the said period. The High Court has also discarded his experience in the said capacity for the purposes of his appointment as the Controlling Authority.

12. In this view of the matter, it is difficult for us to accept the finding of the High Court that Respondent 3 had the requisite 5 years' experience in either testing of drugs or in the enforcement of the Drugs and Cosmetics Act, 1940.

13. In the premises, the appeals are allowed and the impugned judgment and order of the High Court is set aside. The appointment of Respondent 3 as the Controlling Authority is also set aside. We, however, make it clear that if Respondent 3 has acted as the Controlling Authority so far or has received any salary or emoluments for that post, the same will not be recovered from him and our judgment will operate prospectively. We also make it clear that the present judgment will not affect any action taken by Respondent 3 in discharge of his duties as the Controlling Authority.