MAC LABORATORIES (P) LTD. versus COLLECTOR OF CENTRAL EXCISE, BOMBAY

Citation: [1994] SUPP. 5 S.C.R. 621 · Decided: 22-11-1994 · Supreme Court of India · Bench: R.M. SAHAI · Disposal: Appeal(s) allowed

Judgment (excerpt)

MAC LABO RA TORIES (P) LTD. 
A 
v. 
COLLECTOR OF CENTRAL EXCISE, BOMBAY 
NOVEMBER 22, 1994 
[R.M. SAHAI AND N.P. SINGH, JJ.] 
B 
Central Excise Rules, 1944-Rule 8 (1)-Notification No. l 16169-CE 
dated 3.5.1969 as amended by Notification No. 106180-CE dated 
19.6.1980-Word 
'Parenteral 
use'-Meaning and scope-Whether 
Kemicetine Vaginal Suppositories, a patent and proprietary medicine which C 
contained antiniotic Chloramphenicol was 'Chloramphenicol and its esters 
for oral and parenteral use',-Held, Yes, therefore, entitled for total. 
exemption. 
The appellant is a manufacturer of Kemicetine Vaginal Sup-
positories, a patent and proprietary medicine which contained the D 
antiniotic chloramphenicol. These suppositories are introduced in the 
vagina 
by hand. 
Its wax-like material containing antiniotic 
chloramphenicol melts at the temperature of the vagina and the melted 
medicine then gets absorbed into the system through the epitheliums or 
mucous preparation lining the vagina. The administration of this 
medicine is not against any topical or local infection but is directed at E 
the internal infection of vagina resulting from the oral functional 
system. By absorption into the system its effect is to remove the vaginal 
infection. It is primarily used to cure vaginal discharge resulting from 
oral functioning of the system. It acts as oral antibiotic. 
The appellant was being granted exemption on the suppositories F 
till notices were issued raising demand. The basis for the notices for 
short levy of excise duty was that the medicine produced ·by the 
appellant was neither for oral nor pa~enteral use. It was claimed that 
'Kemicetine Vaginal Suppositories' were treated by the Drug Control 
Authorities as life saving drug. And the produce was classified by the G 
department for concessional rate of duty at 2-1/l % ad-valorem since it 
was specified at serial No. 14 of the Schedule. But after the drug 
became wholly exempt from duty the department erroneously bas 
taken the view that the medicine which was in tablet form and was 
meant for parenteral use was not entitled to exemption since it was not 
administered through oral route. It was administered through oral H 
621 
A 
B 
c 
D 
E 
F 
G 
H 
622 
SUPREME COURT REPORTS 
[1994] SUPP. 5 S.C.R 
route. It was claimed that the word 'parenteral' was very wide and it 
could not be confined to use of injections only. 
The Assistant Collector confirmed all five notices and the order 
was maintained by the appellate authority. In further appeal, the 
Customs, Excise and Gold (Control) Appellate Tribunal also held 
against the appellant, not agreeing with the claims of the appellant that 
any medicine which is not administered through mouth would be 
parenteral. The Tribunal found that 'parenteral' refers to introduction 
of a medicine by route other than alimentary canal. It also held that 
parenteral administration of medicine refers to method that involved 
absorption into the body Iluids and system of the drug by active 
therapeutic effect. It further held that even though the Drug Control 
Authority had classified the medicine other than parenteral it was 
covered in the notification. However, it rejected the claim of the appel-
lant. 
This appeal has been filed against tht order of the Tribunal. The 
question 
for 
consideration 
is, 
whether 
Kemicetine 
Vaginal 
Suppositories which contained the antiniotic chloramphenicol was 
'chloramphenicol and its esters for oral and parenteral use within the 
meaning of the Notification No. 116/69-CE dated 3.5.1969 as amended 
by the Notification No. 106/80-CE dated 19.6.1980 issued in exercise of 
powers conferred by sub-rule (1) of rule 8 of Ce~tral Excise Rules, 
1944. 
Allowing the appeal, this Court 
HELD 1.1 The ambit of the word 'parenteral' is very wide. Its use 
in the Notification No. 116/69-CE as amended by the Notification No. 
106/80-CE dated 19.6.1980 issued in exercise of powers conferred by 
sub-rule (1) of rule 8 of Central Excise Rules, 1944, has been in still 
under sense. The use of the word 'oral' for 'enteral' and 'parenteral' 
for injections in the Notification is not without purpose. Enteral 
administration of medicine may be sublingual, that is, 'absorption of 
drugs by oral mucous membrane producing systemic effects' or oral, 
one of the most popular routes of administering drugs in the form of 
tablets, capsules, mixtures, powder, pills, emulsion or rectal of local or 
topical, that is, the ad

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