# UNION OF INDIA AND ANR v. PFIZER LIMITED AND ORS

- **Citation:** [2017] 12 S.C.R. 179
- **Court:** Supreme Court of India
- **Decided:** 2017-12-15
- **Case number:** Civil Appeal No. 22972 of2017
- **Bench:** R.F. Nariman, Sanjay Kishan Kaul
- **Source:** https://unisonlegal.in/judgment/supreme-court-of-india/union-of-india-and-anr-v-pfizer-limited-and-ors-31520
- **Pages:** 38

## Headnote

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.
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[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 possib

## Text

_Characters 0–39,898 of 86,194. This is a partial read: ask again with offset=39898 for what follows._

[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.
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[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 on
technical matters arising out of the administration of· the Drugs
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
Act, but this does not lead to the conclusion that if such advice is
not taken power under Section 26A cannot be exercised. Indeed,
the Central Government's satisfaction may be based on a number
of factors, one of which may be advice tendered to it by the DTAB
under Section 5. There is no warrant to read Section 26A to
constrict the wide powers granted to the Central Government by
a so-called harmonious construction of the statute. It is clear that
the reason for Section 5(5) is completely different. Subcommittees may be appointed for such periods not exceeding
three years or temporarily for the consideration of particular
matters. Such sub-committees may be set up in the wisdom of
the DTAB for short periods of time or temporarily to consider
certain matters and make reports which the DTAB may then
utilize. This is a r-ower of the DTAB which can be exercised when
the DT,'.I; deems it desirable. From this power, it cannot be
inferred, as a matter of logic, that since Section 5(5) permits
persons who are not members of the board to sit on subcommittees, the Central Government may not, under Section 26A,
refer to any persons other than those who are board members.
[Para 20] [207-E-H; 208-A-B]
1.4 As regards the submission that since Section lOA and
26A were brought in together by an Amendment Act in 1982, it
must, therefore, somehow be assumed that the Amendment Act
necessarily included a mandatory consultation with the DTAB
set up under Section 5, it is pointed out about the very amendment
Act of 1982 also amended Sections 33 and 33N by referring to
the DTAB and that, therefore, it is obvious that the omission of
any reference to the DTAB under Sections lOA and 26A cannot
but be said to be deliberate. [Para 21] [208-E-F]
1.5 As regards the submission that Section 7 A of the Drugs
Act makes it clear that Section 5 will not apply to Ayurvedic,
Siddha or Unani drugs and that, therefore, it will apply to all other
drugs, the reason for Section 7 A is again something very different
from what has been argued. It must first be pointed out that under
Chapter IVA, which is a separate Chapter introduced by Act 13
of 1964, Ayurvedic, Siddha and Unani drugs are completely
separately dealt with. Indeed, s. 33A, which must be read with
s. 7 A, expressly provides that save as provided in this Drugs
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[2017] 12 S.C.R.
Act, nothing contained in this Chapter, i.e. Chapter IV, shall apply
to Ayurvedic, Siddha or Unani drugs. Chapter IVA consists of a
separate and distinct drill to be followed in the case of Ayurvedic,
Siddha and Unani drugs. Under Section 33C, there is a separate
technical advisory board for Ayurvedic and Unani drugs and a
separate consultative committee for Ayurvedic, Siddha and Unani
drugs (Section 33D). When Section 7A says that nothing in section
S shall apply to Ayurvedic, Siddha or Unani drugs, all that it affirms
is that the DTAB set up u/s. S will ~pply to all drugs except
Ayurvedic, Siddha or Unani medicines. Th:; Latin maxim
"expression unius est exclusion alterius"' cannot apply. The said
maxim should be very carefully applied and when misapplied
would turn out to be a "dangerous master" as opposed to a
"useful servant". [Para 22] [208-E-H]
State of Karnataka v. Union (~f India & Ors. (1977) 4
SCC 608 : [1978] 2 SCR 1; Assistant Collector of
Central E'Ccise, Calcutta Division v. National Tobacco
Co. of India Ltd. (1972) 2 SCC 560 : [1973] 1 SCR
822 '- referred to.
1.6 As regards the submission that Section 26A had no nono bstan te clause to keep Section 5 out of harm's way, on
construction of Section 26A, it is clear that no such non-obstante
clause was necessary in that the width of the expression "is
satisfied" contained in Section 26A cannot be cut down by
reference to Section 5. The expression "without prejudice"
makes it clear that Section 26A is an additional power given to
the Central Government which must be exercised on its own
terms. [Para 23] [209-D-E]
1.7 As regards the submission that unless the provisions
of Section 5 requiring consultation with thl! DTAB are read into
Section 26A, the said Section would be arbitrary, there are
sufficient indicators in the Section to eschew any ground of
G arbitrariness. The power can only be exercised based on
satisfaction of material that is relevant to form an opinion that
the drug in question falls within any of the three categories outlined
by the Section and that, further, it is necessary or expedient to
either regulate, restrict or prohibit manufactur~, sale or
distribution of the said drug in public interest. Indeed, this is
H-..,.
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
183
.
made explicit in Section 33 EED of the Drugs Act, wherein a
A
similar power is given to the Central Government qua Ayurvedic,
Siddha or Unani drugs. If the power under Section 26A is
exercised on the basis of irrelevant material or on the basis of no
material, the satisfaction itself that is contemplated by Section
26A would not be there and the exercise of the power would be
B
struck down on this ground. Further, it was submitted that the
provision may be read down to make it constitutionally valid, but
in so doing, words cannot be added as a matter of constitutional
doctrine. Also, as a matter of statutory interpretation, words can
only be added if the literal interpretation of the Section leads to
an absurd result. The construction of Section 26A on a literal . C
reading thereof does not lead to any such result. The submission
to read in words to save Section 26A must, be rejected. [Paras
24, 25 antl ,;,7] [209-F-H; 210 A-B; 212-F-G]
Macleods Phannaceuticals Umited v. Union of India .&
Ors. Writ Petition Nos.21933 and 25442 of 2011
D
Madras High Court; Lundbeck India Pvt. Ltd. v Unio11
of lnllia (2014) 5 Kant L.T 440 - approved.
1.8 The Kokate Committee did deliberate on the 344 FDCs
plus 5 FDCs and did come to a conclusion that the said FDCs be
banned, but it is not clear as to what exactly the reasons.for such
conclusions are, and whether it was necessary in the public
interest to take the extreme step of prohibiting such FD Cs, instead
of restricting or regulating their manufacture and supply. In order
that an analysis be made in greater depth, these cases should go
to the DTAB and/or a Sub-Committee formed by the DTAB for
the purpose of having a relook into these cases. It is important,
however, that the DTAB/Sub-Committee _appointed for this
purpose would not only hear the petitioners/appellants, but that
they also hear -submissions from the All India Drugs Action
Network. [Para 32] [214-D-F]
E
F
1.9 The DTAB/Sub-Committee set up for this purpose G
would deliberate on the parameters set out in Section 26A of the
Drugs Act, as follows. In each case, the DTAB/Sub-Committee
appointed by it must satisfy itself that the use of the Fixed Dose
Combinations (FDC) in question is likely to involve any one of
the said three things: (a) that they are likely to involve any risk
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SUPREME COURT REPORTS
[2017] 12 S.C.R.
to human beings or animals; or (b) that the said FDCs do not
have the therapeutic value claimed or purported to be claimed
for them; or (c) that such FDCs contain ingredients and in such
quantity for which there is no therapeutic justification. The DTAB/
Sub-Committee must also apply its mind as to whether it is then
necessary or expedient, in the larger public interest, to regulate,
restrict or prohibit the manufacture, sale or distribution of such
FDCs. The DTAB/Sub-Committee f'lust clearly indicate in its
report: (1) as to why, according to it, any one of the three factors
indicated above is attracted; (2) post such salisfaction, that in
the larger public interest, it is necessary or expedient to (i)
regulate, (ii) restrict, or (iii) prohibit the manufacture, sale or
distribution of such FDCs. The DTAB/Sub-Committee must also
indicate in its report as to why, in case it prohibits a particular
FDC, restriction or regulation is not sufficient to control the
manufacture and use of the FDC. It is requested that the DTAB/
Sub-Committee be set up for this purpose to afford the necessary
hearing to all concerned, and thereafter, submit a consolidated
report, insofar as these FDCs are concerned, to the Central
Government within the stipulated period. The Central
Government, thereafter, must have due regard to the report of
the DTAB and to any other relevant information, and ultimately
apply its mind to the parameters contained in Section 26A of the
Drugs Act and, accordingly, either maintain the notifications
already issued, or modify/substitute them or withdraw them. [Para
33-35] [214-G-H; 215-A-E]
1.10 Insofar as the drugs that have been banned and which
were manufactured pre 21'' September, 1988, a list of 15 such
drugs has been given by the counsel for the respondents, the
Central Government notifications banning them are set aside as
these cases were never meant to be referred to the Kokate
Committee. It would be open, however, for the Central
Government, if it so chooses, de nova, to carry out an inquiry as
to whether such drugs should be the subject matter of a notification
under Section 26A of the Drugs Act. Insofar as the list of 17 cases,
in which DCG(I) approvals have allegedly been granted, since
the Parliamentary Standing Committee itself refers to DCG(I)
approvals and the manner in which they were granted, request of
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
185
the respondent's counsel that these 17 cases be kept outside A
the purview of the fresh look that has to be given by the DTAB/
Sub-Committee in these cases, cannot be acceded to. Insofar as
the status quo, obtaining as on the date the judgment is
pronounced is concerned, that would continue in all cases
(including the 5 FDCs which are not the subject matter of stay
orders already made) until the Central Government issues fresh
notifications in .this behalf. [Para 37-39][215-:F-H; 216-A-B]
B
1.11 A report of the expert committee of the DTAB to
review the rationality and safety of 294 FDCs is taken on record.
The DTAB after review of the report and deliberations
recommended that the FDC Ofloxacin and Prednisolone at serial
C
number 75 under the category of GI does not appear to be rational
and should be re-examined. The list of the drugs mentioned in
Annexure D are required to be prohibited/withdrawn from the
market as these are not rational. Considering that an expert body
has already deliberated upon and decided these cases, the report o
is accepted. lPara 40][216-D-G]
E. Merck (India) Ltd. and another v. Union <4' India
and another (2001) 90 DLT 60 ; Systopic Laboratories
(Pvt) Ltd. v. Dr. Prem Gupta & Ors. 1994 Supp (1)
SCC 160 ; Cellular Operators Associatio11 of India and
E
others v. Telecom Regulatory Authority of India a11d
others (2016) 7 SCC 703 : [2016] 9 SCR 1 - referred
to.
Case Law Reference
(2001) 90 DLT 60
referred to
(1994) Supp (1) SCC 160 referred to
[1978] 2 SCR 1
referred to
[1973] 1 SCR 822
[2016] 9 SCR 1
(2014) 5 Kant L.T 440
referred to
referred to
approved to
Para 10
Para 10
Para 22
Para 22
Para 26
Para 29
CIVIL APPELLATE JURISDICTION: Civil Appeal No. 22972
of2017.
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[2017] 12 S.C.R.
A
From the Judgment and Order dated 01.12.2016ofthe High Court
of Delhi at New Delhi in Writ Petition (C) No. 2212 of 2016
WITH
Civil Appeal Nos. 22793-22981, 22982-23404, 23405-23472 of
2017, Transferred Case (C) Nos. 29, 30, 31, 32, 33, 34, 35, 36, 38, 39, 40,
B 41, 42, 43, 44, 45, 258,259, 260, 261, 262, 263, 264, 265, 266, 308-317 of
2017 and Transfer Petiuc:i Nos. 1176-1182 of 2017.
Kapil Sibal, Gopal Subramanium, Ajit Kumar Sinha, A.K. Panda,
Colin Gonsalves, K. V. Viswanathan, P. Chidambaram, Mukul Rohtagi,
P. P. Tripathi, Abhinav Vashisth, Shyam Divan, Abhinav Vashisht, C. S.
C Vaidyanathan, Sr. Advs, Ashish Prasad, Ms. Mukta Dutta, Avinash
Tripathi, Rohit Sharma, Ashutosh Jha, M. P. Devanath, Sanjay Kumar
Pathak, Mrs. Vimla Sinha, S. Wasim A. Qadri, Mo. Sadhna Sharma,
Amo! Chandra, ZaidA!i, Saeed Qadri, Rishi Singh, Kirtiman Singh, Mouris
Khan, Mrs. Saudamini Sharma, Anmol Chauhan, G. S. Makker,
Ms. Tanya Agarwal, Satya Mitra, Raghavendra S. Srivatsa, Venkita
D Subramoniam T. R., Amit P., Sagar Chandra, Ms. Aastha Bhasin,
Bibhunanda Mishra, Mishra Saurabh, Ms. Richa Kapoor, Ash ish N egi,
Shyam D. Nandan, Siddharth B., Ms. Snigdha Singh, R. Jawahar Lal,
· Siddharth Bawa, Shyamal Anand, Ashwani Kumar, Arunabh Chowdhury,
Ms. Diksha Rai, Ms. Kanika Saran, Ms. Shivangi Saran Singh, Abhay
E
Jadeja, Ms. Archana Sahadeva, Nikhil Lal, Vivek Ranjan, Mrs. Neelima
. Tripathi, K. V. Mvl1:::n. Ms. Gunjan Singh, Shivam Singh, Aditya Raina,
Gopal Singh, Mrs. Vanita Bhargava, Ajay Bhargava, Arvind Kumar Ray,
Karan Gupta (For Mis. Khaitan & Co.), Ms. Sani.an Ahsan, Akshay
Mahajan, Abhay Anand Jha, Ranjit B. Raut, Ms. Surbhi Kapoor,
Ms. Bina Gupta, Rajeev K. Panday, Rajeev Mahe~hwaranand Roy,
· F
P. Srinivasan, R,ahul Dwarkadas, Mahesh Agarwal, RishiAgrawala, Joran
Diwan, Ms. Devika Mohan, Ms. Niyati Kohli, E. C. Agrawala, Ashwin
Sapra, Kapil Arora, Biplab Lenin, Madhav Khosla, Ms. Shraddha
Kulshrestha, Mis. Cyril Amarchand Mangaldas, Debmalya Banerjee,
Samarjit Pattnaik, Arjun Mahajan, Puneet Relhan, Rahul Tyagi, Mridul
Yadav, Mrs. Manik Karanjawala, Mis Karan jaw ala & Co., Ajay Kumar
G Arora, Ms. Tatini Basu, Kuna! Mimani, Kuna! Chaturvedi, Manish Jha,
Mohit Bakshi, Dheeraj Nair, Anupam Lal Das, Abhay Jadeja,
Ms. Ranje.etaRohatgi, Vaibhav Tomar, Ms. Shruti Choudhry, Ms. Pragya
Baghel, Karma Dorjee, Rohit Rathi, Deoul Pathak, Apoorv Kump,
Harikrishna Pramod, Ms. Liz Mathew, Ms. Herinder Kaur Brar, Sarvesh
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
187
[R.F. NARIMAN, J.]
Singh, Sachin Gupta, Dhruv Pall, Smarhar Singh, Binay Kumar, Amit
A
Sharma, Balaji Srinivasan, Advs for the appearing parties.
The Judgment of the Court was delivered by
R. F. NARIMAN, J. 1. Leave granted.
2. The present appeals and transfer petitions relate to the
interpretation of Section 26A of the Drugs and Cosmetics Act, 1940
B
(hereinafter referred to as "the Drugs Act"). By the impugned judgment
of the learned single Judge of the Delhi High Court dated 1.12.2016, the
learned single Judge has held that the mandatory condition precedent
for the exercise of the power by the Central Government under Section
26A of the Drugs Act is the prior consultation of the Drugs Technical
C
Advisory Board (DTAB) set up under Section 5 of the said Act. It must
be stated that the learned single Judge differed from judgments of the
Karnataka and Madras High Courts in this regard, wherein two other
learned single Judges of two other High Courts have held that such
consultation with the DTAB is not mandatory before exercise of such
power under Section 26A. Since we are concerned only with this narrow
D
question that has been decided by the learned single Judge of the Delhi
High Court, we are not going into any other contentions that have been
raised by learned counsel for the parties.
3. The issue regarding the prevalence of many Fixed Dose
Combinations (hereinafter referred to "FDCs") that were flooding the
Indian market and had not been tested for efficacy or safety was
considered by the Parliamentary Standing Committee on Health and
Family Welfare in its 591h Report in May, 2012. The Standing Committee
observed that some of the State Licensing Authorities have issued
manufacturing licenses for a very large number of FDCs without prior
clearance from the Central Drugs Standard Control Organization
(CDSCO). Such FDCs can pose significant risks to persons and need
to be withdrawn immediately in that human lives can be at risk. The
Committee recommended that a clear and transparent policy may be
framed for approving FDCs based on scientific principles, and that, at
present, Section 26A of the Drugs Act is adequate to deal with the
problem ofFDCs not cleared by the CDSCO. Pursuant to the aforesaid
report, the Ministry of Health in October, 2012 issued directions to States
and Union Territories under Section 33P of the Drugs Act not to grant
licenses to FDCs falling under the definition of "new drugs" and not
approved by the Drug Controller General oflndia (DCG(I) ). The DCG(I),
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[2017] 12 S.C.R.
in turn, had requested all States/Union Territories Drug Controllers to
ask concerned manufacturers in their respective States/Union Territories
to prove the safety and efficacy of such FDC licenses issued prior to
1.10.2012, without due approval of the DCG(l), within a period of 18
months, failing which such FDCs would be considered for being
prohibited, both qua manufacture and marketing in the country. On
5.7.2013, the DCG(I) vide its communication to the State Drug Controllers
asked manufacturers to make applications as per the procedure
prescribed within this 18 month period. We have been informed that a
large number of applications were received from the manufacturers
within the .18 month period for 291 l products, which had to be subj~cted
to examination.
4. With the approval of the Ministry of Health and Family Welfare,
the CDS CO constituted 10 different Committees for examination of the
said applications which were received on 3.2.2014. As the said
Committees could examine only about 295 applications, on 16.9.2014,
the Ministry of Health and Family Welfare constituted a Committee under
the Chairmanship of Professor C.K. Kokate, Vice Chancellor of KLE
University, Belgaum, Kamataka for examining the safety and efficacy
as per the following terms of reference:
a. Those FDCs which are considered grossly irrational/unsafe
b;:sed on pharmacokinetic and pharmacodynamic interaction,
dosage c0mpatibilities ofFDCs vis-a-vis that of single ingredients
present in the FDC and available literature/evidence.
b. Those FDCs which the Committee may consider necessary
for further deliberation with any of the 10 Expert Committees
already constituted.
c. Those FDCs which are considered as s;1fe and effective based
on pharmacokinetic and pharmacodynamic interaction, dosage
compatibilities ofFDCS vis-<1-vis that of single ingredients present
in the FDC, available literature/evidence, clinical experience and
other data available.
d. Those FDCs which may be considered as rational, based on
present data and knowledge available. However, data in post
market scenario is required to be generated within a period of 1 to
2 years to confirm the same.
e. All the FDCs falling, under category "b" above would be
referred to the respective Expert Committee out of 10 Expert
Committees already constituted.
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
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[R.F. NARIMAN, J.]
Composition of Expert Committee for examining the safety &
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efficacy of Fixed Dose Combinations (FDCs) is as under:
-- --
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···-· ----· ...
..
·-. . .
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Name of'
Name & Address of'
Qualification
Status in
'
Expt'rt
Institutions
the
Committee
'
Prof.
. V ce-Chancellor,
M. Phann, Ph.D. Chairman
Chandrakant
KLE University,
Kokate
Belgaum. Karnataka
& Ex-Pn~sident of
Pharmacy Council of
India.
Dr. C.L. Kaul
Former Director.
B. Pharn1, PhD.
Member
NIPER, 432,
' Mahatma Society,
Koth Road, Pw1e-38.
Prof. San jay
Deptt. of
M. Phann, Ph.D. Member
Singh
' Pharmaceutics, IIT.
BHU. Varanasi.
Dr. C.D.
Pmf.&HOD
MD.
Member
Tripathi
(Phannacology),
Pharama;ology
' Safdmjung Hospital,
New Delhi.
Dr. Bikash
, Deptt. of
MD,
Member
Medhi
' Pharmacology.
Phmmaoology
PGIMER,
Chancligait1 .
.
Dr. Sanjeev
~ Pmf. (Medicine).
MD, Medicine
Member
Sinha
AIIMS,New Delhi
;
Dr. RK. Khar · Former Dean &
M. Ph.aim, Ph.D. , Co-opted
Head,Jamia
Member
Hamdarcl,
403,L1lleshwa1i
V ati ka, GH-12,
Soctor-2 lD,
Faridabad-121001.
A series of meetings were conducted by the Committee (6
meetings corresponding to 11 days) as well as by a sub-group of
the Committee (2 meetings) for examination of these approx. 6320
applications.
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5. The first assessment report of the aforesaid Committee was
submitted to the Ministry of Health and Family Welfare on 19.1.2015
and was presented before the Ministry on 4.3.2015, wherein the
Committee was requested to mention detailed reasons against each FDC
considered as "irrational" by the Committee. The Committee did not
discuss FDCs already approved by the DCG(I) and FDCs which were
licensed pre 21.9 .1988 i.e. before the introduction of Schedule Y to the
Drugs Act. The Committee stated, "in case the Committee made any
comment with respect to the above inadvertently, it shall be treated as
not discussed."
6. On 16.4.2015, a detailed report in this regard was submitted by
the Kokate Committee to the Ministry stating the reasons for declaring
FDCs as irrational. We have been informed that for the FDCs which
were considered as irrational by the Committee, the Committee wrote
to various manufacturers/associations calling upon them to submit material
to establish the therapeutic justification/rationality of the FDCs. Replies
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received from such associations were examined by the Expert Committee
and final recommendations therein were given only on 10.2.2016. In
category A, following the final recommendations of the Expert Committee,
the Central Government has banned 344 FDCs. In category B, 944 FDCs
needed to be considered/deliberated upon further, which meant that they
would be referred to the respective Expert Committees out of the 10
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Expert Committees already constituted for further examination. In
category C, 1493 FDCs have been declared "rational" and we are
informed that approvals have since been issued by the DCG(I) in respect
·of these FDCs. In category D, 126 FDCs have to be considered for
further generation of data by the prospective applicants. It is only after
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carrying out of this exercise, that by notifications dated 10.3.2016 issued
under Section 26A, the Central Government banned manufacture and
sale of 344 FDCs.
7. In March 2016, a large number of writ petitions were filed in
the Delhi High Court against the aforesaid notifications. The impugned
G judgment then followed on l.12.2016disposingof454petitions, followed
by an order dated 21.12.2016, in which the Delhi High Court disposed of
51 further writ petitions in terms of the judgment dated 1.12.2016.
8. Letters Patent Appeals were filed before the Delhi High Court.
Meanwhile, the Union oflndia filed transfer petitions in this_Court. This
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js how these matters have been heard by us in civil appeals arising out of
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
191
[R.F. NARIMAN, J.]
SLPs against the judgment of the single Judge dated 1.12.2016 and in
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transfer cases in which the LPAs pending before the Delhi High Court
have been transferred to us.
9. Ms. Pinky Anand, learned Additional Solicitor General, took us
through vari~us provisions of the Drugs Act, and emphasized that Section
26A does not expressly refer to the DTAB. According to her, a large
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number of provisions of the Drugs Act expressly refer to the DTAB in
various contexts and, therefore, it is not permissible for the Court to read
a mandatory requirement of consultation with the DTAB into Section
26A, when such mandatory consultation is present in other provisions,
but is conspicuous by its absence in Section 26A. She further went on
to state that the provisions of Section 26A are legislative in nature, and
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ultimately, once the Central Government arrives at a satisfaction based
on relevant materials, judicial review of the Central Government decision
taken on the basis of Expert Committee reports is extremely limited.
She launched an all out attack against the single Judge's judgment and
stated that the Madras and Karnataka view, with which the Delhi High
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Court differed, is the correct view in law. Shri Colin Gonsalves, learned
senior counsel, supportec.i ii.::r arguments, and appeared in civil appeal
arising out of SLP(C) Nos.10170-10178 of 2017.
10. By way ofreply, Shri C.S. Vaidyanathan, learned senior counsel,
argued that the impugned singleJudgejudgment was based on an earlier
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Division Bench judgment in E. Merck (India) Ltd. and another v.
Union of India and another, (2001) 90 DLT 60, which upheld the
constitutional validity of Section 26A on the ground that since the DTAB
had to be consulted before passing an order under Section 26A, the said
Section would pass constitutional muster. He also referred us to this
Court's judgment in Systopic Laboratories (Pvt) Ltd. v. Dr. Prem
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Gupta & Ors., 1994 Supp (I) SCC 160 in furtherance of the same
proposition. According to learned counsel, it is clear on a reading of
Section 5 of the Drugs Act, that it will apply to both the Central
Government and the State Governments on all technical matters that
arise out of the administration of the Drugs Act. Since Section 26A . G
deals only with such technical matters, it is obvious that the DTAB's
advice has to be taken in every such case as otherwise, if it were open
to the Central Government to pick and choose in which case they would
take such advice and which case they would not take such advice, the
provision itself would become arbitrary and unreasonable. According to
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the learned senior counsel, Section 5(5) of the Drugs Act is very important
in that it is the DTAB alone who may constitute sub-committees
consisting of persons who are not members of the DTAB, who may
consider particular matters, thereby making it clear that the DTAB alone
can induct experts who are outside Section 5 and not the Central
Government. He further referred to the Drugs and Cosmetics Rules,
1945 (hereinafter referred to as the "Drugs Rules"), in particular Rules
21,68A, 122A, 122D and 122DA, to buttress his submission that a detailed
filtration process has to be gone through before a drug can be
manufactured and put on the market and that the Central Government
cannot ban such drug without consulting the technical expert under the
Drugs Act namely, the DTAB, that is set up under Section 5. He also
argued that Sections JOA and 26A were introduced by way of an
amendment in 1982 and this being so, it is clear that it is assumed by
Parliament that Section 5 of the Drugs Act will be read along with both
of them so as to make the DTAB a mandatory consultee before action
is taken under Section 26A.
11. Shri Vashisht, learned senior counsel appearing for some of
the respondents, adverted to Section 5 and stated that it was in two
parts, the first being advice to the Central Government on all technical
matters arising out of the administration of the Drugs Act and the second
(and distinct part) being to carry out other functions assigned to it by the
Drugs Act. It is clear, therefore, that in all matters which fall within the
first part, the advice of the Board would be mandatory before the Central
Government were to take action under Section 26A. He also referred
us to Section 7 A of the Drugs Act and argued that when the said Drugs
Act expressly states that nothing in Section 5 is to apply, it is expressly
so stated and that, therefore, the necessary inference would be that
Section 5 would apply in all situations other than those covered by Section
7 A. He further argued that Section 26A does not have a non obstante
clause which puts out of harm's way Section 5, but only a "without
prejudice" clause and that too restricted only to Chapter IV, making it
clear that Section 26A would have to be read along with Section 5.
According to him, therefore, there is no reason to interfere with the
judgment of the Delhi High Court.
12. Dr. A.M. Singhvi, learned senior counsel, argued that on a
cursory look at the persons who constitute the DTAB under Section 5, it
is an extremely high ranking body which is the technical expert set up by
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
[R.F. NARIMAN, J.]
the statute and, therefore, the High Courtj udgment is right in stating that
in all cases arising under Section 26A prior consultation with the DTAB
is a must. He argued, in the alternative, that on a purposive and harmonious
construction of the Drugs Act as a whole, a middle approach could be
that the Central Government may, in emergent situations, not consult the
DTAB, but in all other situations should give reasons why the DTAB
was not consulted, otherwise the exercise under Section 26A would be
found to be constitutionally infirm. According to the learned senior
counsel, hearing is mandatory under the said Section and the High Court's
reading in the requirement of hearing into the said Section was absolutely
correct. He also referred us to judgments dealing with not only how
hearing must be added when it is absent, but to a judgment of this Court
which stated that conditional legislation, of which Section 26A is a clear
instance, would also require hearing the affected parties.
193
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13. In answer to these submissions, the learned Additional Solicitor
General, in rejoinder, went through the 1982 amendment, which introduced
Section 26A, and stated that Sections 29 and 35 thereof make it clear
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that amendments were made in certain Sections with reference to the
DTAB under Section 5 and that, therefore, the omission of any reference
to the DTAB in Section 26A is deliberate. She also went on to state that
Rule 66 of the Drugs Rules, which deals with cancellation of individual
licenses and which requires compliance with natural justice, should be
contrasted with Section 26A of the Drugs Act which, according to her, is
a legislative power as opposed to an administrative power.
14. Having heard learned counsel for the parties, it is first important
to set out some of the provisions of the Drugs Act.
"S. The Drugs Technical Advisory Board.-
(!) The Central Government shall, as soon as may be, constitute
a Board (to be called the Drugs Technical Advisory Board) to
advise the Central Government and the State Governments on
technical matters arising out of the administration of this Act and
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to carry out the other functions assigned to it by this Act.
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(2) The Board shall consist of the following members, namely:-
(i) the Director General of Health Services, ex officio, who shall
be Chairman;
(ii) the Drugs Controller, India, ex officio;
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(iii) the Director of the Central Drugs Laboratory, Calcutta, ex
officio;
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(iv) the Director of the Central Research Institute, Kasauli, ex
officio;
(v) the Director of the Indian Veterinary Research Institute,
Izatnagar, ex officio;
(vi) the President of the Medical Council of India, ex officio;
(vii) the President of the Pharmacy Council of India, ex officio;
(viii) the Director of the Central Drug Research Institute, Lucknow,
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ex officio;
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(ix) two persons to be nominated by the Central Government from
among persons who are in charge of drugs control in the States;
(x) one person, to be elected by the Executive Committee of the
Pharmacy Council oflndia, from among teachers in pharmacy or
pharmaceutical chemistry or pharmacology on the staff of an
Indian university or a college affiliated thereto;
(xi) one person, to be elected by the Executive Committee of the
Medical Council of India, from among teachers in medicine or
therapeutics on the staff of an Indian university or a college
affiliated thereto;
(xii) one person to be nominated by the Central Government fre:n
the pharmaceutical industry;
(xiii) one pharmacologist to be elected by the Governing Body of
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the Indian Council of Medical Research;
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(xiv) one person to be elected by the Central Council of the Indian
Medical Association;
(xv) one person to be elected by the Council of the Indian
Pharmaceutical Association;
(xvi) two persons holding the appointment of Government Analyst
under this Act, to be nominated by the Central Government.
(3) The nominated and elected members of the Board shall hold
office for three years, but shall be eligible for re-nomination and
re-election:
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS.
195
[R.F. NARIMAN, J.]
Provided that the person nominated or elected, as the case may
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be, under clause (ix) or clause (x) or clause (xi) or clause (xvi) of
sub-section (2) shall hold office for so long as he holds the
appointment of the office by virtue of which he was nominated or
elected to the Board.
(4) The Board may, subject to the previous approval of the Central
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Government, make bye-laws fixing a quorum and regulating its
own procedure and the conduct of all business to be transacted
by it.
(5) The Board may constitute sub-committees and may appoint
to such sub-committees for such periods, not exceeding three
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years, as it may decide, or temporarily for the consideration of
particular matters, persons who are not members of the Board.
(6) The functions of the Board may be exercised notwithstanding
any vacancy therein.
(7) The Central Government shall appoint a person to be Secretary
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of the Board and shall provide the Board with such clerical and
other staff as the Central Government considers necessary.
6. The Central Drugs Laboratory.-
( I) The Central Government shall, as soon as may be, establish a
Central Drugs Laboratory under the control of a Director to be
· appointed by the Central Government, to carry out the functions
entrusted to it by this Act or any rules made under this Chapter:
Provided that, if the Central Government so prescribes, the
functions of the Central Drugs Laboratory in respect of any drug
or class of drugs or cosmetic or class of cosmetics shall be carried
out at the Central Research Institute, Kasauli, or at any other
prescribed Laboratory and the functions of the Director of the
Central Drugs Laboratory in respect of such drug or class of
drugs or such cosmetic or class of.cosmetics shall be exercised
by the Director of that Institute or of that other Laboratory, as the
case may be.
(2) the Central Government may, after consultation with the Board,
make rules prescribing-
( a) the functions of the Central Drugs Laboratory;
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(d) the procedure for the submission of the said Laboratory under
Chapter IV or Chapter IVA of samples of drugs or cosmetics for
analysis or test, the forms of Laboratory's reports thereon and
the fees payable in respect of such reports;
( e) such other matters as may be necessary or expedient to enable
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the said Laboratory to carry out its functions;
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(f) the matters necessary to be prescribed for the purposes of the
proviso to sub-section (I).
7. The Drugs Consultative Committee.-
(!) The Central Government may constitute an advisory committee
to be called "the Drugs Consultative Committee" to advise the
Central Government, the State Governments and the Drugs
Technical Advisory Board on any matter tending to secu!"e
uniformity throughout India in the administration of this Act.
(2) The Drugs Consultative Committee shall consist of two
representatives of the Central Government to be nominated by
that Government and one representative of each State Government
to be nominated by the State Government concerned.
(3) The Drugs Consultative Committee shall meet when required
to do so by the Central Government and shall have power to
regulate its own procedure.
7 A.