ALETTA GRACE BELL Vs. S TIRKEY

JUDGEMENT

(1.) The petitioner has moved this Court for quashing the letter sent by respondent No. 1 dated 19-9-1979 as contained in Annexure-2 directing the petitioner to obtain licence under Section 18 Sub-clause (c) of the Drugs and Cosmetics Act (hereinafter referred to as the Act). The sole point for consideration in this application is whether hospitals are exempted from taking out licence for the manufacture and distribution of drugs which they compound and dispense in the hospital.

(2.) Duncon hospital was established at Raxaul about half a century ago which is run by Emmenuel Hospital, which has hospitals also in Uttar Pradesh, Madhya Pradesh, Assam, Maharashtra besides Bihar and Petitioner is the Medical Sup-crintendent-cum-Senior Administrative Officer of the hospital at Raxaul. There are about two hundred beds in the hospital. Intravenous Injection (hereinafter to be referred as I. V. Solutions) which are prepared by compounding of glucose or sodium chloride compounded with distilled water are given to the patients in the hospital. These solutions are prepared under the guidance of competent person. On 2-5-1979, the Drug Inspector, Motihari, visited the hospital and sealed the Laboratory and took an understanding from the petitioner that I. V. Solutions will not be manufactured in the hospital. Thereafter, the petitioner learnt that a First Information Report has been lodged by the said Inspector on 6-5-1979, alleging offences under the Act a copy of the First Information Report has been filed and marked as Annexure-5, the main ground being that the petitioner manufacturing the aforesaid drug without licence and without there being proper facilities for the same. A number of officers of the Health Department had visited the hospital earlier but none of them complained about this and it was only Sri Anand Kumar Agrawal, Inspector of Drugs, when he visited the hospital and lodged this case in order to harass the petitioner. In this connection, a written complaint was also filed against the conduct of the aforesaid Inspector on 6-6-1979; a copy of the same has been filed and marked Annexure-1, Respondent No. 1, by letter dated 19-9-1979, directed the petitioner to take licence under Section 18 (c) of the Act; a copy of the letter has been filed as Annexure-2. On 8-10-1979 the petitioner sent a letter informing respondent No, I the circumstances under which the I. V. Solutions were compounded and administered to the patients and for that no licence was necessary and the hospital was exempted and it was also prayed in the aforesaid letter that the direction to obtain licence should be withdrawn; a copy of the letter has been filed and marked as An-nexure-3, But unfortunately the petitioner did not receive any reply. Again on 23-10-1979, reminder was sent to respondent No. 1 which was also not acknowledged; a copy of the letter has been filed and marked as Annexure-4. Being aggrieved by the letter as contained in Annexure-2 the petitioner has moved this Court under Articles 226 and 227 of the Constitution of India.

(3.) Learned Counsel appearing for the petitioner has contended that the petitioner's hospital is not a manufacturer as defined under Section 3 (f) of the Act and, therefore, it was not necessary to obtain licence. Secondly it has been contended that under Rule 123 of the Drugs and Cosmetics Rules framed under the Act certain establishments have been exempted from the operation of the Act and the petitioner also was entitled to that benefit. Learned Additional Advocate General, appearing on behalf of the State, has contended that there is no dispute that the hospital of the petitioner has been manufacturing drugs and it is necessary to obtain licence and such establishments are not entitled to any exemptions. Counter-affidavit has been filed on behalf of respondent No. 1, which has been sworn by Sri Anand Kumar Agrawal, Inspector of Drugs, who had reported the matter to the authorities, on which it has been ordered that the hospital has to obtain a licence under the Act. It has also been stated that a num- ber of complaints had been received that the I. V. solution, which was prepared by the petitioner's hospital, was of sub-standard quality. It has also been stated that On report that the solutions, which are manufactured were sub-standard, they were actually seized and sent for chemical analysis. It has also been stated that the hospital has been charging Rs. 7/- per bottle for the solution of five hundred milliliters and thus hospital has been making a profit out of it. Reply to the counter-affidavit has also been filed in which it has been stated on behalf of the hospital that the I. V. Solutions are supplied to the patients on payment of Rs. 7/- per bottle which is the actual cost and it is the service charge and no profit is made out of it though in market it is priced as Rs. 9.40, Paise per bottle.