DR. (MISS) ALETTA GRACE BELL v. DR. (MISS) S. TIRKEY AND ANR.

The following Order of the Court was delivered :

G This is an appeal against the judgment and order of a Division Bench of the Patna High Court passed in Civil Writ Jurisdiction Case No. 3326 of 1979, on 17-7-1980.

The appellant - Dr. (Miss) Alette Grace Bell, as Medical Superin- tendent-cum-Administrative Officer of the Duncan Hospital at Raxaul in H the State of Bihar, was served with a letter from the Drug Controller Bihar

ALETIA GRACE BELL v. S. TIRKEY 845

..- to the effect that the hospital being in the manufacture and distribution of A a drug referred to as LV. Solution, was required to take a licence under the provisions of the Drugs and Cosmetics Act, 1940, for the default of which it had to suffer prosecution. Challenging the same before the Patna High Court, the appellant contended that since its product was a prepara- tim, by compounding of glucose or sodium with distilled water and ad- B ministered to patients in the hospital, this solution was manufactured not for sale but for distribution, and the act of manufacture for distribution required no licence. The High Court on examining the various provisions ' of the Act, came to hold that the appellant's hospital"was required to obtain licence under clause ( c) of Section 18 of the Drugs and Cosmetics Act,

1940. This view of the High Court has led to this appeal. C \Vhen leave was granted, intcrin1 order of stay was vacated. We are therefore not aware whether any prosecution of the appellant followed or not. Be that as it may, we must state the legal position. The offence was committed on 2.5.1979 when the Drugs Inspector on his usual visit, dis- covered the appellant engaged in the manufacture of l.V. Solution for administration to patients in the hospital. The provision requiring licence, being Section 18(c) of the Act then read as follows :

"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 manufacture for sale, or sell, or stock or exhibit 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."

With effect from J.2.1983, the provision reads : F 11 ••••••• n1anufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute any drug or cosn1etic,except under, and in accordance with the conditions of, a licence issued for such purpose under this Chapter." G As is evident, prior to the amcndn1cnt, n1anufacturc for sale of any drug or cosmetic, as a con1posite activity required a separate licence. Likewise, distribution of any drug or co~metic required a separate licence. The significant change effected by the atnendmcnt is that ''manufacture for -A" sale or for distribution'' is now one composite activily and \VOuld require·~ H

846 SUPREME COURT REPORTS f1995] SUPP. 4 S.C.R.

A licence. If distribution of any drug or cosmetic is a separate activity unconnected wilh .n1anufactun.\ then as of before, it requires a separate licence. In all situations licence n1ust be ohtaincJ to carry out activity on the conditions given under Chapter IV of the said Act of which Section 33 is a part, en1powering the Central Ciovi.;rn1nent to n1ake rules. Section 33 is laid in the usual format. Clause (e) of Section 33(2) says that Rules to B be framed by the Government may prescribe the forms of licences for the manufaclurcfor sale or for distribution (the relevant words added after the amendment) and inter alia for the distribution of drugs etc. as also the form of application for such licences, and the condition subject to which such licences may be issued, and the authority empowered lo issue the same etc. c etc. Significantly, no form of licence for manufacture for distribution of drugs or cosmetics has been provided. No conditions has been laid subject to which such licence may be issued. Only two forms stood prescribed prior lo the amendment. Those were for obtaining licence (i) for the manufac- ture for sale and (ii) for sale of drugs and cosmetics. Now after the amendment the form is for the manufacture for sale or for distribution of drugs or cosmetics. In the absence of the requisite form of licence being part of the rules as per requirements of Section 18(c), it is difficult lo conceive as to how the appellant was obligated lo apply for obtaining the requisite licence, and before which authority and in which form and subject f lo which conditions. It thus appears clear to us that the requirement in that regard leaves a vacuum which for reasons best known lo the Executive has remain unfilled. The obligation of the appellant and her sequel prosecution being founded on the supposed requirement of Section 18(c) of the Act, not only the provision, but the rules which carry out its purpose have to be viewed strictly. When there is a vacuum, as spelled out before, its benefit must go to the appellant. She thus has been able lo successfully plead and prove that in the absence of the requisites laid down in Sections lS(c) and 33 of the Act, she and hence the hospital could not be required to obtain a licence for manufacture and distribution of the drug on the date when the offence was allegedly committed. !

G Thus, for the aforesaid reasons~ we differ from the view taken by the High Court, an<l upset its judgtn~nt and order granted the \Vrit to the appellant, as prayed. There shall be no orders as lo costs.

R.P. Appeal allowed.