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

Citation: [1995] SUPP. 4 S.C.R. 843 · Decided: 08-11-1995 · Supreme Court of India · Bench: M.M. PUNCHHI, SUJATA V. MANOHAR · Disposal: Appeal(s) allowed

Judgment (excerpt)

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DR. (MISS) ALETTA GRACE BELL 
v. 
DR. (MISS) S. TIRKEY AND ANR. 
NOVEMBER 8, 1995 
[MADAN MOHAN PUNCHHI AND SUJATA V. MANOHAR, JJ.] 
Dntgs and Cosmetics Act, 1940 : 
Ss. IB(C) and 33(2)-Dmgs-'Manufacture for distribution'-Prohibi-
tion on-Requirement of application for licence-fonns to be prescribed--Ac-
tually no forms prescribed nor any conditions laid dowlt-Hospital 
manufactwing d1ug for distlibution to its patients~Held, in absence of any 
fonns prescribed and conditions laid down, the requirement leaves a vacuum 
and its benefit must go to hospital which could not be required to obtain a 
licence on the date of alleged offence. 
TI1e appellant was Medical Superintendent-cum- Administrative Of-
ficer of a Hospital in the State of Bihar. On 2.5.1979, the Drug Inspector 
noticed that the hospital was engaged in the manufacture of a drug, 
referred to as J.V. Solution, for administration to patients in the hospital. 
A 
B 
c 
D 
The Drug Controller, Bihar served on the appellant a letter stating that E 
for manufacture and distribntion of I.V. Solution the hospital was required 
to obtain a licence under the provisions of the Drugs and Cosmetics Act, 
1940, and for default it had to suffer prosecution. The appellant filed a 
writ petition before the High Court contending that the product was 
manufactured not for sale, but for distribution in the hospital and the Act 
of manufacture for distribution required no licence. The High Court 
dismissed the writ petition holding that the hospital was required to obtain 
licence under S.18(c) of the Act. Aggrieved, the appellant filed the present 
appeal by special leave. 
F 
Allowing the appeal and setting aside the judgment of the High G 
Court, this Court 
HELD: I.I. The scheme of chapter N of the Drugs and Cosmetics Act, 
1940 and particularly the provisions of S.18(c) and S. 33(2) indicate that 
Government is required to frame rules and prescribed from of licence for 
"manufacture for sale or for distribution" of drugs as also the form of ap-
H 
843 
844 
SUPREME COURT REPORTS [1995] SUPP. 4 S.C.R. 
A 
plication for such licence, the conditions subject to which such licence may 
be issued, and the authority empowered to issue the same. [845-C, 846-B) 
1.2. Prior to amendment of S.18(c) of the Act with effect from 
l.2.1983 only two forms of licence namely (i) for the manufacture for sale 
and (ii) for sale, of drugs and cosmetics. were prescribed as the two 
B activities were distinct, and separate licences were required for the respec-
tive activities. 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. Significantly, no form of licence for 'manufac-
ture for distribution' of drugs or cosmetics has been provided. Nor any 
C condition has been laid subject to which such licence may be issued. The 
requirement in that regard leaves a vacuum which for reasons best known 
to the Executive has remained unfilled and its benefits must go to the 
appellant. (845-H, 846-C-F] 
1.3. The appellant has been able to successfully plead and prove that 
D 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. [846-F] 
E 
F 
CIVIL APPELLATE JURISDICTION 
Civil Appeal No. 85 of 
1981. 
From the Judgment and Order dated 17.7.80 of the Patna High Court 
in C.W.J.C. No. 3326 of 1979. 
K.D. Prasad and (Mr. R.P. Singh) (NP) for the Appellant. 
D. Goburdhan for the Respondents. 
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 
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ALETI A GRACE BELL v. S. TIRKEY 
845 
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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 tha

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