UNION OF INDIA AND ANR. versus PFIZER LIMITED AND ORS.

Citation: [2017] 12 S.C.R. 179 · Decided: 15-12-2017 · Supreme Court of India · Bench: R.F. NARIMAN · Disposal: Disposed off

Cited by 2 judgment(s) · cites 3 · see the full citation network in Lexace

Judgment (excerpt)

[2017] 12 S.C.R. 179 
UNION OF INDIA AND ANR. 
v. 
PFIZER LIMITED AND ORS. 
(Civil Appeal No. 22972 of2017) 
DECEMBER 15, 2017 
[R.F. NARIMAN AND SANJAY KISHAN KAUL, JJ.] 
Drugs and Cosmetics Act, 1940 -
s. 26A - Powers of Central 
A 
B 
. Government to prohibit manufacture, etc., of drug and cosmetic in 
public interest - Exercise of - Prior consultation with Drugs 
Technical Advisory Board (DTAB) set up u/s. 5 - Mandatory or not c 
- Held: s. 26A is an additional power which must be governed by 
its own terms - Section 26A has to be read with the rest of the Drugs 
Act - Unlike s. 6(2), s. 8(2), second proviso to s. JO, proviso to s. 
12( I), s. 16(2), proviso to s. 18(2), s. 33 ands. 33N, there is no 
explicit requirement to consult the DTAB set up u/s. 5 - Section 26A 
was brought in by an amendment in 1982, which specifically made 
D 
changes in ss. 33 and 33N wherein the words "on the 
recommendation of the Board" were added - It is clear that the 
additional power that is given to the Central Government u/.s. 26A 
does not refer to and, therefore, mandate any previous consultation 
with the DTAB - On the contrary, the Central Government may be 
E 
"satisfied" on any relevant material that a drug is likely to involve 
any risk to human beings etc. as a result of which it is necessat)' in 
public interest to regulate, restrict or prohibit 111u11ufacture, sale or 
distribution thereof- So long as the Central Gnn'm111ent's 
satisfaction can be said to be based 011 relevant 11w1erial, it is not 
possible to say that not having consulted the DIAB, the power F 
exercised under the said Section wauld ·be non est. 
s. 26A - Scope of - Explained. 
Disposing of the appeals arid the transferred cases, the 
Court 
HELD: 1.1 A bare reading of s. 26A of the Drugs and 
Cosmetics Act, 1940 would show, firstly, that it is without prejudice 
to any other provision contained in this Chapter (meaning thereby 
Chapter IV). This expression only means that apart from the 
Central Government's other powers contained in Chapter IV, s. 
179 
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180 
A 
B 
c 
D 
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F 
G 
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SUPREME COURT REPORTS 
[2017] 12 S.C.R. 
26A is an additional power which must be governed by its own 
terms. Under s. 26A, the Central Government must be "satisfied" 
that any drug or cosmetic is likely to involve any risk to human 
beings or families; or that any drug does not have the therapeutic 
value claimed or purported to be claimed for it; or contains 
ingredients in such quantity for which there is no therapeutic 
justification. Obviously, the Central Government has to apply its 
mind to any or all of these three factors which has to be based 
upon its "satisfaction" as to the existence of any or all of these 
factors. The power exercised u/s 26A must further be exercised 
only if it is found necessary or expedient to do so in public interest. 
When the power is so exercised, it may regulate, restrict or 
prohibit manufacture, sale or distribution of any drug or cosmetic. 
Section 26A has to be read with the rest of the Act. So read, it is 
clear that unlike s. 6(2), s. 8(2), second proviso to s. 10, proviso 
to s. 12(1), s. 16(2), proviso to s. 18(2), s. 33 and s. 33N, there is 
no explicit requirement to consult the DTAB set up u/s. 5 of the 
Drugs Act. [Para 15-16] [204-G-H; 205-A-C] 
1.2 Section 26A was brought in by an amendment in 1982. 
The amendment specifically made changes in Sections 33 and 
33N in which it added the words "on the recommendation of the 
Board". From this, it is clear that Parliament in the very 
Amendment Act which introduced Section 26A made certain 
changes which involved the DTAB under Section 5 of the said 
Act. It is clear that the additional power that is given to the Central 
Government under Section 26A does not refer to and, therefore, 
mandate any previous consultation with the DTAB. On the 
contrary, the Central Government may be "satisfied" on any 
relevant material that a drug is likely to involve any risk to human 
beings etc. as a result of which it is necessary in public interest 
to regulate, restrict or prohibit manufacture, sale or distribution 
thereof. So long as the Central Government's satisfaction can be 
said to be based on relevant material, it is not possible to say 
that not having consulted the DTAB, the power exercised under 
the said Section would be non est. [Para 17] [205-E-G] 
1.3 The DTAB is only an advisory body. No doubt, it would 
be desirable for the Central Government to take its advice o

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