M/S. Unitabulas Pvt.... v. The Director, Drug C...

(1) Sri bhagiratha rao, learned counsel for the petitioner has contended that before prohibiting the manufacture of the listed drugs, escort under section 18 of the drugs and cosmetics act, 1950, for short, "the act", publication of notication in the official gazette is mandatory. In this case, the respondents have not issued any gazzette notification. As a result, the direction issued by the respondents withdrawing the permission for manufacture of the drug by name 'escort' is invalid in law.

(2) Section 26 - a of the act reads thus:

"without prejudice to any other provision contained in this chapter, if the central government is satisfied, that use of any drug or entireties is likely to involve any risk to human - beings or animals or unit any drug does not have the rapeutic value claimed or purported to be claimed for it or contains ingredients and in such quality for which there is no therapeutic justification and that in the public interest it is expedient so to do, then, that government, by notification in the official gazette prohibit the manufacture, sale, or distribution of such drug or cosmetic."

(3) Section 18 reads thus :

"18. Prohibition of manufacture and sale of certain drugs and cosmetics : from such date as may be fixed by the state government by notification in the official gazette in this behalf, no person shall himself or by any other person on his behalf (a) manufacture for sale or for distribution or sell or stock or exhibit or offer for sale (i) any drug which is not of a standard quality or is misbranded, adultered or spurious. (ii) any cosmetic which is not of a standard quality or is misbranded or spurious; (iii) any patent or proprietory medicine, unless there is displayed in the prescribed manner on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof. (iv) any drug which by means of any statement, design or device. Accompanying it or by any other means, purports or claims to prevent, cure or mitigate any such disease or ailment, or to have any such other effect as may be prescribed; (v) any cosmetic containing any ingredient which may render it unsafe or harmful for use under the directions indicated or recommended ; (vi) any drug or cosmetic in contravention of any of the provisions of this chapter or any rule made thereunder. (b) sell or stock or exhibit or offer for sale, or distribute any drug (or cosmetics) which has been imported or manufactured in contravention of any of the provisions of this act or any rule made thereunder ; (c) manufacture for sale or for distribution, or sell, or stock or exhibit, or offer for sale or distribute any drug (or cosmetic) except under and in accordance with the conditions of, a licence issued for such purpose under this chapter. Provided that nothing in this section shall apply to the manufacture, subject to prescribed condition or small quantities of any drug for the purpose of examination, test for analysis; provided further that the (central government) may, after consultation with the board, by notification in the official gazette permit subject to any conditions specified in the notification, manufacture for sale or for distribution, sale, stocking or exhibiting or offering for sale or for distribution of any drug or class of drugs not being of standard quality. The gazette notifications required under this clauses are (a) for the date from which the drugs and cosmetics act and rules come into force in the state of andhra pradesh ; (b) for the permission and condition to manufacture for sale or sale of any drug or class of drugs not being of standard quality."

(4) A combined reading of the above provisions expressly indicates that if the central government is satisfied that the use of the drug or a cosmetic is likely to involve any risk to human beings or animals or that the drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest if it is found necessary and expedient so to do, the government may by notification in the official gazette prohibit the manufacture or sale or distribution of the drugs or cosmetics. The publication as required under section 18 is a pre - condition. In the counter - affidavit filed by the deputy drugs controller (india) , central drugs standard control organisation, madras - 6, dr. Prem k. Gupta has stated that the central government have issued the notification in gsr 578 (e) dated july 23, 1983 and item 14 of the said notification "fixed dose combination of steroids with other drugs for asthma" are prohibited for manufacture and sale. The gazette notification was issued after obtaining opinion of the experts in medical field in this country. As such the petitioner has obtained the licence to manufacture escort, the combination of antihistamine and corticostcroid by misrepresenting to the state government that the drug is for the purpose of treating bronchial asthma only. On clarification by the second - respondent to first respondent that the combination of antihistamine and corticosteriod has no justification in management of bronchial asthma, the authorisation given to the petitioner to manufacture escort was withdrawn, it is seen that the drug controller is given onerous powers for the protection of the health and well being of the patients who use the drugs. The control of the manufacture of the drugsessential life - saving ones, are absolutely necessary and the authority is the best person to take a decision whether it is expedient or necessary in the public interest, viz. , the health hazards of the patients, whether such a particular drug should be permitted to be manufactured or whether it is manufactured in conformity with the standards prescribed or not. In the counter - affidavit it is stated that they have consulted the experts in the field and thereafter the decision was taken to prohibit the manufacture of escort which does not conform to the standards prescribed. This is an objective satisfaction based on the study and expert opinion and the decision taken was published in the gazette dated july 23, 1983. Accordingly, the action taken by the respondents in prohibiting the manufacture of the drug 'escort' is clearly within their power and does not vitiate by any manifest error apparant on the face of the record warranting interference. The writ petition is accordingly dismissed. No costs. Advocate's fee : rs. 350/ -.