RANBAXY LABORATORIES LIMITED Vs. UNION OF INDIA THROUGH THE MINISTRY OF HEALTH & FAMILY WELFARE, NIRMAN BHAWAN, NEW DELHI

JUDGEMENT

(1.) THE five writ petitions raise a common question and, as such, have been taken up for final disposal at this stage itself with consent of parties.

(2.) THE question raised is whether the products, as manufactured, stored and marketed by them, are drugs within the meaning of Drugs and Cosmetics Act, 1940, (hereinafter "Drugs Act") thus, requiring statutory compliance of the said Act and the Rules framed thereunder or they are food within the meaning of the Prevention of Food Adulteration Act, 1954 (hereinafter referred to as "Food Act") or they fall under both the Acts. The proceedings emanated from, so far as the first writ application is concerned (Ranbaxy Laboratories Limited), an inspection report dated 30.11.2005 conducted at their godown at Bahadurpur, Kankarbagh Road, Patna wherein the petitioner was directed not to sell some products without licences under the Drugs Act. During pendency of the writ petitions, the Parliament enacted on 23rd August, 2006 the Food Safety and Standards Act, 2006 (Central Act 34 of 2006), thus, the provisions and the applicability of this Act also became a matter to be considered. In various writ applications, different commodities are in question which will be indicated later at an appropriate stage. The Bihar State Drug Controller, in substance, was of the view that notwithstanding these commodities having been accepted as "food" within the meaning of Prevention of Food Adulteration Act, in other States where they were manufactured were "drugs" covered by the Drugs Act and could not be marketed withogt statutory compliance under the Drugs Act and the Rules framed thereunder. Effectively, the storage for same and marketing of those commodities without drug licence came to be prohibited in this State. When this matter came up before this Court, this Court, on 28.4.2008, inter alia, recorded: - "The core issues in all these writ applications are whether the articles manufactured and sold by various petitioners, are Drugs covered under the provisions of the Drugs and Cosmetics Act, 1940 or food covered by the Prevention of Food Adulteration Act. The question is of some importance as the authorities in most of the cases outside the State of Bihar have held those articles to be food articles covered by Prevention of Food Adulteration Act whereas the Respondent -Bihar State Drug Controller has held them to be drug as contemplated under the Drugs and Cosmetics Act, 1940. In my view, the question whether it is a drug as defined by Section 3 of the Drugs and Cosmetics Act or is an item of food or it is covered by both is a matter which should first receive the attention of a technical person who is competent to decide this question at the first instance. Mr. Rajiv Nayyar learned senior counsel appearing in the case of Ranbaxy Laboratories Pvt. Ltd. submits that the articles sold by his company Ranbaxy Laboratories Pvt. Ltd. are food articles and duly licensed by authority under the PFA Act. The State Drug Controller has erroneously assumed jurisdiction in the matter. Referring to various clarifications and recommendations in their favour and other document that the article is not drug and pointed out that in terms of Section 5 of the Drugs and Cosmetics Act, 1940, a statutory body is there which is chaired by the Director General of Health Services, Government of India, ex -officio. He points out that under the provisions of the PFA Act there is a Central Committee in terms of Section 3 thereof in which again the Director General, Health Services, Government of India is the Chairman ex -officio. To my mind, this brings about an easy solution wherein the same expert chairs both the committees under both the Acts. Recently there has been a third Act i.e. Food Safety and Standards Act 2006. In the opinion of this Court it is better if first Director General, Health Services, Government of India as noted above who is the ex -officio Chairman of both the expert committees should decide whether the articles produced and sold by the petitioner would fall under which of the Acts and what was the obligation of the petitioners because if it is held to be a drug then different standards and considerations are to be applied. Keeping in view public health, if it is a food item then different standards are to be applied if it is covered by the third new Act then again different standards are to be applied. The public must also know what they are consuming and what the precautions etc. are." 3. In this connection, one may refer to Section 3(1) and Section 3(2)(a) of the Food Act and Section 5(1) and Section 5(2)(i) of the Drugs Act which are quoted hereunder respectively: - 3. The Central Committee for Food Standards. - (1) The Central Government shall, as soon as may be after the commencement of this Act, constitute a Committee called the Central Committee for Food Standards to advise the Central Government and the State Governments on matters arising out of the administration of this Act and to carry out the other functions assigned to it under this Act. (2) The Committee shall consist of the following members, namely: - (a) The Director General, Health Services, ex -officio, who shall be the Chairman; ......... 5. The Drugs Technical Advisory Board. - The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act, (2) The Board shall consist of the following members, namely: - (i) the Director General of Health Services, ex -officio, who shall be the Chairman; .........

(3.) THIS Court found a common expert under the two subjects whom even the legislature, the Parliament, found competent to be Chairman both under the Food Act and under the Drugs Act and it is because of this expertise legislatively recognized, the Court designated him to take a decision in the matter. Further, the Director General of Health Services, Government of India is the delegate of Central Government who has to ensure implementation of the two Central Acts, the Food Act and the Drugs Act throughout the territory of India, would surely be the right person to decide such a matter which would have an all India repercussions and the Bihar State Drug Controller can only be a subordinate delegate being merely a State functionary within the territorial jurisdiction of a State within the territory of India. The Court must admit that these are highly technical matters having serious repercussions and are better left to experts rather than non -expert Judge. The stand of this Court is inspired by observation of the Apex Court in the case of Tata Cellular V/s. Union of India since reported in (1994)6 Supreme Court Cases 651 wherein at page 681. of the reports, the following passage is to be found: - "It is not the function of a Judge to act as a superboard, or with the zeal of a pedantic school master substituting its judgment for that of the administrator. The result is a theory of review that limits the extent to which the discretion of the expert may be scrutinized by the non -expert Judge. The alternative is for the court to overrule the agency on technical matters where all the advantages of expertise lie with the agencies. If a court were to review fully the decision of a body such as State board of therapeutics or boggling at the mysteries of the pharmacopoeia '. Such a situation as a State court expressed it many years ago 'is not a case of the blind leading the blind but of one who has always been deaf and blind insisting that he can see and hear better than one who has always had his eye -sight and hearing and has always used them to the utmost advantage in ascertaining the truth in regard to the matter in question '."