UNION OF INDIA & ANR. ETC. versus BGP PRODUCTS OPERATIONS GMBH AND HAGENE IMMERMATT WEG. & ANR. ETC.

Citation: [2019] 11 S.C.R. 170 · Decided: 22-08-2019 · Supreme Court of India · Bench: ABHAY MANOHAR SAPRE · Disposal: Matter referred to larger bench

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Judgment (excerpt)

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SUPREME COURT REPORTS
[2019] 11 S.C.R.
UNION OF INDIA & ANR. ETC.
v.
BGP PRODUCTS OPERATIONS GMBH AND HAGENE
IMMERMATT WEG. & ANR. ETC.
(Civil Appeal Nos.6588-6591 of 2019)
AUGUST 22, 2019
[ABHAY MANOHAR SAPRE AND
INDU MALHOTRA, JJ.]
Drugs and Cosmetics Act, 1940: s.26-A – Notification dated
27.04.2018 issued under s.26A of the Act by the Ministry of Health
and Family Welfare – Validity of Notification challenged in these
appeals – Impugned Notification restricts the manufacture of
Oxytocin formulations for domestic use, only by public sector
undertakings or companies, to the complete exclusion of the private
sector companies while the manufacture of the drug for export
purposes is kept open to both public and private sector companies
– Held: These appeals raise serious issues having far reaching
implications – The substantial questions of law which arose for
consideration are:  Whether a drug included in the National List of
Essential Medicines published under Schedule 1 of the Drugs (Prices
Control) Order, 2013 notified under s.3 of the Essential Commodities
Act, 1955 would be subject to the provisions of s.26A of the Act;
Whether the impugned notification has resulted in creating a
monopoly in favour of public sector companies, to the complete
exclusion of private sector companies, and if so, whether it would
be protected by Art.19(6)(ii) r/w Art.14 of the Constitution; Whether
the classification made by the impugned notification between licensed
public sector and private sector companies, in the manufacture of
the drug Oxytocin for domestic use, would achieve the object and
purpose of preventing the unregulated and illegal use of the drug –
Whether it would be in public interest to restrict the manufacture of
a life-saving drug for domestic use, to a single public sector
undertaking, to the complete exclusion of the private sector
companies, particularly in view of the high maternal mortality rates
in the country; Whether there was relevant and objective material
before the Central Government to form the basis of satisfaction to
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   [2019] 11 S.C.R. 170
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exercise the power to prohibit the manufacture of the drug by the
private sector companies for domestic use, under s.26-A of the Act;
Whether the object of curbing the clandestine manufacture and
unregulated use of the drug Oxytocin, which is covered by s.18 of
the Act, can be achieved by taking recourse to s.26-A by imposing
a ban on the manufacture of licensed drugs by private sector
companies; Whether the exercise of power by the Central
Government under s.26-A of the Act is legislative or executive in
nature – Matter is referred to a larger Bench to consider these
questions of law.
Drugs and Cosmetics Act, 1940: s.26-A – Power of Central
Government under – Notification dated 27.04.2018 issued under
s.26-A by the Ministry of Health and Family Welfare – Legality of
Notification – Held: There is no decision so far on issue as to whether
the nature of powers exercised by the Central Government under
s.26-A of the Act is legislative or executive – If the exercise of power
under s.26-A is held as being legislative in nature, the parameters
to examine the legality of the impugned notification would be
different whereas if it is held to be executive in nature, the parameters
would be somewhat different than the former one – The decision
either way on any of these questions will have its far reaching effect
on the rights and health of public at large and especially on the
rights and health of the teenage girls, pregnant females and milching
animals – In effect, it will not be a judgment inter party but it will be
in rem laying down the law on the questions – Public Health
Administration. (Abhay Manohar Sapre, J.)
Referring the matter to larger Bench, the Court
HELD:
Per INDU MALHOTRA, J.
1. The present group of appeals raise serious issues having
far reaching implications. The twin issues which arise for
consideration are on the one hand, the unregulated and
clandestine manufacture of the drug Oxytocin, which is reportedly
misused in milch animals; and on the other hand, the continued
supply of an essential life-saving drug, which is used as the first
line drug for prevention and treatment of post-partum
haemorrhage at the time of childbirth. The following substantial
UNION OF INDIA v. BGP PRODUCTS OPERATIONS GMBH AND HAGENE
IMMERMATT WEG.
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172
SUPREME COURT REPORTS
[2019] 11 S.C.R.
questio

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