PRATAP PHARMA PVT. LTD. AND ANR. ETC. ETC. versus UNION OF INDIA AND ORS.

Citation: [1997] 3 S.C.R. 492 · Decided: 01-04-1997 · Supreme Court of India · Bench: K. RAMASWAMY, D.P. WADHWA · Disposal: Disposed off

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Judgment (excerpt)

A 
PRATAP PHARMA PVT. LTD. AND ANR. ETC. ETC. 
B 
v. 
UNION OF INDIA AND ORS. 
APRIL 1, 1997 
[K. RAMASWAMY AND D.P. WADHWA, JJ.] 
D1Ugs and Cosmetics Act, 1940: Sections 3 (a), (b), 3(h) (As amended 
by Act 68 of 1982) and Section 33-C. 
C 
Sectio11 3(h)-'Patent and proprietary medicineL-Amendment of 
defi11iti011L-As a consequence any Aywvedic or Siddha or Unani d1ug which 
is administered by parental route and also giving a f onnula included in the 
auth01itative books specified in the Schedule attached thereto stood ex-
cluded-Held amendment was not ultra vires the Constitution-Held the 
D arbitrariness of a legislation violating A1ticle 14 cannot be adjudged to be 
arbitrary when the Parliament is of the view that it is to ensure safety of the 
life of human being; or animals-T71e regulation of manufacture of dmg and 
patenting it are necesswy and are in public interest as the evil is sought to be 
remedied by legislative measure--W71en d1Ugs are administered to human 
beings/animals, they are required to be regulated as adumbrated under the 
E Act-As a conseque11ce, though by implication the right to practice of 
medicine or manufacture of the d1Ugs has been guaranteed under Anicle 
19( 1) (g), it is a regulation within the meaning of Anic/e 19 (6) of the 
Constitution-As a consequence, it is a reasonable rest1iction on the right to 
cany on the trade or business of manufacture of the aywvedic dntgs by the 
F petitioners-17ie Act is intra vires the Constitution and does not violate the 
fundamental rights guaranteed under Anicles 14 and 19 ( 1) (g) of the 
Constitution. 
D1Ugs Manufactured for administration to the human beings or 
animals-Prohibiting manufacture of-Order of drug controller-Pennis-
G sibility of-Held there must be evidence on record before the authority to reach 
a conclusion that the drugs manufactured by the petitioners are prohibitable 
items under the Act--:An expen body should go into that question-Direction 
issued to Govemment of India to co11stitute an expen body-Govemment of 
India should take a decision 011 the basis of recommendation of expen 
H body-Dpponunity should be given to the persons concemed so that they Call 
492 
I
I 
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PAitTAP PHARMA(P) LID. v. U.O.I. 
493 
also place their mate1ial before the Committee. 
A 
Co11stitutio11 of 111dia, 1950: A1ticles 19 (1) (g) a11d 19 (6) 
Right to cany 011 trade a11d busi11ess-lmpositio11 of reasonable restric-
tio11--Held regulatio11 includes prohibition-Ma11ufacture of drugs for ad-
ministration to huma11 bei11gs/animals is regulated by the Act a11d therefore, B 
it attracts Arlicle 19 ( 6). 
ORIGINAL JURISDICTION: Writ Petition (C) No. 3530 or 1983 
Etc. 
Under Article 32 of the Constitution of India. 
M.N. Krishnamani, K.N. Shukla, P.K. Jain, Pankaj Kalra, (Akhilesh 
Kr. Pandey) for Surya Kant, Avatar Singh Rawat, Mrs. Sushila Shukla, Mrs. 
Anil Katiyar, (Irshad Ahmad) for R.B. Misra for the appearing parties. 
The following order of the Court was delivered : 
These three writ Petitions, filed under Article 32 of the Constitution 
of India, raise common question of law, challenging Section 3 (h) of the 
Drugs and Cosmetics Act, 1940, as amended by Act 68 of 1982 (for short, 
c 
D 
the "Act") with effect from February 1, 1983 as unconstitutional, being E 
arbitrary and violative of Article 14 and 19 (1) (g) of the Constitution. The 
grievance of the petitioners is that while the Act amends, the definition of 
"Patent and Proprietary Medicine" under Section 3 (h) of the Act, the 
definition 'drugs' under Section 3 (b) read with the definition of 'Ayurvedic 
drug' under Section 3 (a) has not been changed; as a consequence, there 
is no prohibition for patenting the A yurvedic drugs manufactured by the F 
petitioners whereas under the impugned order of the Drug Controller 
dated February 16, 1983 it is so construed and manufacture of those drugs 
is prohibited. Therefore, the Amendment Act 68 of 1983 and the order 
passed by the Drug Controller, Government of India, are ultra vires the 
legislative power. 
G 
Shri M.N. Krishnamani, learned senior counsel and Shri Pankaj 
Kalra, learned counsel appearing for the petitioners, seek to support their 
grievance, but we are unable to agree with the learned counsel. It is seen 
that patent and proprietary medicine was defined in the pre-Amendment 
Act under Section 3 (h) thus: 
H 
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494 
SUPREME COURT REPORTS 
[1997) 3 S.C.R. 
" 'Patent or Proprietary Medicine' means a drug w

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