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Dr. Aletta Grace Bell (Ms) v. Dr. S. Tirkey (Ms) And Another
Factual and Procedural Background
The appellant, Dr. (Miss) Aletta Grace Bell, was the Medical Superintendent-cum-Administrative Officer of Duncan Hospital, Raxaul, Bihar. On 2 May 1979, a Drugs Inspector discovered that the hospital was manufacturing an intravenous (I.V.) solution composed of glucose or sodium in distilled water for administration to its own patients. The Drug Controller, Bihar, issued a notice stating that this activity required a licence under the Drugs and Cosmetics Act, 1940, and threatened prosecution for non-compliance.
Challenging the notice, the appellant filed Civil Writ Jurisdiction Case No. 3326 of 1979 before the Patna High Court. A Division Bench held on 17 July 1980 that a licence was indeed necessary under Section 18(c) of the Act. The present appeal was filed against that decision. During the pendency of the appeal, an interim stay was vacated, and the Court was uncertain whether prosecution had proceeded.
Legal Issues Presented
- Whether, on 2 May 1979, the manufacture of an I.V. solution by a hospital solely for distribution to its own patients required a licence under Section 18(c) of the Drugs and Cosmetics Act, 1940, as it then stood.
- Whether the absence of prescribed licence forms and conditions in the Rules framed under Section 33 of the Act created a legal vacuum that relieved the appellant of any obligation to obtain such a licence.
Arguments of the Parties
Appellant's Arguments
- The I.V. solution was manufactured exclusively for distribution to in-patients and not for sale; therefore, no licence was required under the unamended Section 18(c).
- Even if a licence were theoretically necessary, the relevant Rules did not prescribe any form, conditions, or authority for obtaining a licence for “manufacture for distribution,” creating a statutory vacuum that could not be used to impose criminal liability.
Respondent’s Position
- The Drug Controller’s notice asserted that any manufacture and distribution of a drug—regardless of sale—required a licence under Section 18(c).
Table of Precedents Cited
No precedents were cited in the provided opinion.
Court's Reasoning and Analysis
The Court examined the text of Section 18(c) both before and after its 1983 amendment. Prior to amendment, “manufacture for sale” and “distribution” were treated as separate activities, each requiring its own licence. After amendment, “manufacture for sale or for distribution” became a single composite activity requiring a licence.
Turning to the Rules authorised by Section 33(2)(e), the Court noted:
- No form of licence for “manufacture for distribution” existed when the alleged offence occurred.
- Only two forms were prescribed: one for “manufacture for sale” and another for “sale” of drugs and cosmetics. Post-amendment, there was still no distinct form addressing “manufacture for distribution.”
This absence of prescribed forms, conditions, and licensing authority constituted a legislative vacuum. Because criminal liability under Section 18(c) must be strictly construed, the Court held that the appellant could not be compelled to obtain an unspecified licence, nor prosecuted for failing to do so.
Accordingly, the Court disagreed with the Patna High Court’s interpretation and found that, on the date of the alleged offence, the statutory framework did not impose the asserted licensing obligation on the appellant.
Holding and Implications
APPEAL ALLOWED – The judgment and order of the Patna High Court are set aside, and the writ is granted in favour of the appellant.
Implications: The immediate effect is that neither Dr. Bell nor Duncan Hospital can be prosecuted for failing to obtain a licence for the manufacture and in-house distribution of the I.V. solution as of 2 May 1979. The decision turns on a perceived regulatory gap rather than any broader doctrinal shift; it does not create new precedent beyond underscoring that criminal liability under Section 18(c) depends on the existence of properly framed licensing rules.
Order
1. 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.
2. The appellant Dr (Miss) Aletta Grace Bell, as Medical Superintendent-cum-Administrative Officer of the Duncan Hospital at Raxaul in the State of Bihar, was served with a letter from the Drug Controller, Bihar to the effect that the hospital being in the manufacture and distribution of a drug referred to as I.V 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 preparation by compounding of glucose or sodium with distilled water and administered 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.
3. When leave was granted, interim 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, discovered the appellant engaged in the manufacture of I.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—
(c) 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 1-2-1983, the provision reads:
“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.”
4. As is evident, prior to the amendment, manufacture for sale of any drug or cosmetic, as a composite activity required a separate licence. Likewise, distribution of any drug or cosmetic required a separate licence. The significant change effected by the amendment is that “manufacture for sale or for distribution” is now one composite activity and would require a licence. If distribution of any drug or cosmetic is a separate activity unconnected with manufacture, then as of before, it requires a separate licence. In all situations licence must be obtained to carry out activity on the conditions given under Chapter IV of the said Act of which Section 33 is a part, empowering the Central Government to make rules. Section 33 is laid in the usual format. Clause (e) of Section 33(2) says that Rules to be framed by the Government may prescribe the forms of licences for the manufacture for 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 conditions subject to which such licences may be issued, and the authority empowered to issue the same etc. etc. Significantly, no form of licence for manufacture or for distribution of drugs or cosmetics has been provided. No conditions have been laid subject to which such licence may be issued. Only two forms stood prescribed prior to the amendment. Those were for obtaining licence (i) for the manufacture 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 to conceive as to how the appellant was obligated to apply for obtaining the requisite licence, and before which authority and in which form and subject to which conditions. It thus appears clear to us that the requirement in that regard leaves a vacuum which for reasons best known to the Executive has remained 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 to successfully plead and prove that in the absence of the requisites laid down in Sections 18(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.
5. Thus, for the aforesaid reasons, we differ from the view taken by the High Court and upset its judgment and order granting the writ to the appellant, as prayed. There shall be no orders as to costs.
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