Dr.
(Miss) Aletta Grace Bell Vs. Dr. (Miss) S. Tirkey & Anr [1995] INSC 638 (8 November 1995)
Punchhi,
M.M. Punchhi, M.M. Manohar Sujata V. (J)
CITATION:
1996 AIR 538 1996 SCC (1) 285 JT 1995 (8) 203 1995 SCALE (6)445
ACT:
HEAD NOTE:
O R D
E R
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
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 affect that the hospital being in the manufacture and distribution of a
drug referred to a 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
has 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 had led to this
appeal.
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 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." 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 nay 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 objection which such lliecneesmayabd
authority empowered to issue the same etc. 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 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 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 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.
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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