V K MITTAL Vs. UOI

JUDGEMENT

(1.) In this writ petition, filed by way of public interest, the Petitioner is challenging the recruitment rules for the post of Drug Controller of India. It may be mentioned at the outset that the main grievance of the Petitioner is that the aforesaid post of the Drug Controller, as per the relevant recruitment rules, is to be filled up by deputation only and submission is that having regard to the sensitive nature of the post and the importance of the functions which the drug controller is required to discharge as per the provisions of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Act"), it is not in public interest that such a post is filled up 100% by deputation including short term contract. The Petitioner perceives so many dangers in filling up of the post in the said manner. Learned counsel for the Petitioner referred to Sections 5, 17, 17A, 17B of the Act to highlight the sensitive nature of the post of Drug Controller. Referring to these provisions, it was argued that the post of Drug Controller is highly technical in nature as it is his duty to regulate the launch of new drugs, monitor the clinical trials and to supervise the import of drugs in the country and their related standards. In terms of the aforesaid provisions, the Drug Controller is both the licensing as well as the controlling authority and is empowered to issue, suspend or cancel licence with respect to manufacture of drugs and cosmetics, apart from the role of regulator. He acts as a key member of the Consultative Committee and Drug Technical Advisory Board, which are statutory in nature. It is, thus, argued that the Drug Controller has very important functions to discharge, which include laying down standard of drugs, cosmetics, diagnostics and devices. He also acts as a regulator by making amendments to the Acts and Rules and also regulates market and authorization of new drugs. The argument is that for such a post preference should be given to long tenure and appointment to this post, should be made on regular basis. It is argued that by bringing the person as Drug Controller by means of deputation, the period whereof may not be certain, the very purpose of the post for which aforesaid important functions are to be discharged by the Drug Controller, is defeated.

(2.) At this stage, we would like to refer to the relevant recruitment rules for appointment to the post of Drug Controller of India. It is pertinent to state that the recruitment rules are made by the President in exercise of the powers conferred by the proviso to Article 309 of the Constitution which prescribe the method of recruitment to the post of Drug Controller (India). The Rules were made vide notification dated 14.6.2011 and are known as Central Drugs Standard Control Organization [Drugs Controller (India)] Recruitment Rules, 2011 in the Directorate General of Health Services. Rule 4 thereof mentions the "disqualification" and list out the persons who cannot be appointed as the Drug Controller. There is one post of Drug Controller (India) as per the schedule attached to these Rules. Method of recruitment is stated in column 11. As per column 11, the post is to be filled with 100% deputation including short-term contract. The qualifications are stated therein are to the following effect:

(3.) The Rules also provide consultation with Union Public Service Commission. As per the Rules, it would be necessary to consult with Union Public Service Commission on each occasion when the appointment is to be made to the aforesaid post. A reading of the column relating to qualifications would reveal that there are essential qualifications which cannot be relaxed and then there are desirable qualifications which a candidate is required to possess. These qualifications are inconsonance with Rules 49A and 50A of the Drugs and Cosmetics Rules, 1945. It is also necessary to point out here that a person with the aforesaid qualifications though appointed on deputation, the deputation period is five years. When we keep in mind the essential and desirable qualifications which are stipulated for this post and the tenure of five years fixed for a person who is appointed through deputation, almost all apprehensions of the Petitioner expressed in this petition are taken care of. The essential qualifications disclose that a candidate who is to be considered for this post is required to be holding analogous posts on regular basis in the present cadre/department. This would mean that a person who is already holding almost equivalent/similar posts on regular basis in the parent cadre/department is considered for appointment to this post on deputation. The prescription of minimum pay scale which is almost equivalent to that of Drug Controller, further fortifies this. Educational qualifications and experience mandate that such a candidate should have a graduate degree in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical, Pharmacology or Microbiology from a recognized University established in India. He should also have a postgraduate degree in Pharmacy in the aforesaid disciplines from a recognized University or equivalent. Not only this, the eligibility condition further prescribes 15 years experience in manufacture or testing of drugs in a concern of repute or enforcement of the provisions of the Act and Rules contained therein. When we look into the desirable qualifications contained in these Rules, a candidate is expected not only to have two years experience in dealing with problems connected with drugs standardization and control but also the import and export of drugs and/or administration of the Act and Rules. A candidate with Ph.D. in Pharmaceutical Sciences is to be given preference. Thus, a person who possesses these essential and desirable qualifications would necessarily not only have requisite educational qualifications but experience in this very field for which he would take charge as Drug Controller. As mentioned above, the 15 years experience in manufacture or testing of drugs in a concern of repute or enforcement of the provisions of the Act and Rules as well as administration of the Act and Rules is also prescribed.