Holding

Section 26A confers an additional power on the Central Government that can be exercised without prior DTAB consultation, provided the Government is satisfied on the basis of relevant material.

Summary

The Supreme Court examined whether the Central Government must obtain prior advice from the Drugs Technical Advisory Board (DTAB) before invoking the power under Section 26A of the Drugs and Cosmetics Act, 1940 to prohibit, restrict or regulate a drug or cosmetic in public interest. The Court held that Section 26A is an additional, standalone power that does not contain an express requirement for DTAB consultation, and Parliament’s omission of such a requirement was deliberate. The Government may be "satisfied" based on any relevant material, including but not limited to DTAB advice, and the power can be exercised without prior DTAB consultation. Consequently, the Delhi High Court’s judgment mandating mandatory consultation was set aside. The Court directed that the disputed Fixed Dose Combinations (FDCs) be referred to the DTAB or a sub‑committee for a fresh review, while maintaining the status quo on other cases until new notifications are issued.

Issues considered

Whether the Central Government is required to consult the Drugs Technical Advisory Board before exercising the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940.

Legislation cited

Drugs and Cosmetics Act, 1940s. 10(2), s. 12(1), s. 16(2), s. 18(2), s. 26A, s. 33, s. 33A, s. 33C, s. 33D, s. 33N, s. 5, s. 6(2), s. 7A, s. 8(2)
Drugs and Cosmetics Rules, 1945s. 122A, s. 122D, s. 122DA, s. 21, s. 68A

Subjects

Drugs and Cosmetics ActSection 26ADTABFixed Dose CombinationRegulatory powerPublic interestStatutory interpretationConsultation requirementCentral GovernmentPharmaceutical regulation

Judgment

[2017] 12 S.C.R. 179

UNION OF INDIA AND ANR. A
v.
PFIZER LIMITED AND ORS.
(Civil Appeal No. 22972 of2017)
DECEMBER 15, 2017 B
[R.F. NARIMAN AND SANJAY KISHAN KAUL, JJ.]
Drugs and Cosmetics Act, 1940 - s. 26A - Powers of Central
.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
G
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.
H
179
180 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 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
B
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.
c 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
D
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
E 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
F 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
G 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
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 181

Act, but this does not lead to the conclusion that if such advice is A
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
B
a so-called harmonious construction of the statute. It is clear that
the reason for Section 5(5) is completely different. Sub-
committees 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 c
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 sub-
D
committees, 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 E
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 F
but be said to be deliberate. [Para 21] [208-E-F]
1.5 As regards the submission that Section 7A 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 7A is again something very different
G
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. 7A, expressly provides that save as provided in this Drugs
H
182 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 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
B
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
c 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
D 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 non-
o 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
E 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
F 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
E
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, F
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]
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
H
184 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 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,
B
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)
c 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
D
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
E 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
F 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
G 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
H
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
B
orders already made) until the Central Government issues fresh
notifications in .this behalf. [Para 37-39][215-:F-H; 216-A-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 Para 10 F
(1994) Supp (1) SCC 160 referred to Para 10
[1978] 2 SCR 1 referred to Para 22
[1973] 1 SCR 822 referred to Para 22
[2016] 9 SCR 1 referred to Para 26 G

(2014) 5 Kant L.T 440 approved to Para 29
CIVIL APPELLATE JURISDICTION: Civil Appeal No. 22972
of2017.
H
186 SUPREME COURT REPORTS [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 Karanjaw 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 E
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 F
(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 G
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),
H
188 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 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
B
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
c 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,
D 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,
E 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.
F 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.
G 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
H Committees already constituted.
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 189
[R.F. NARIMAN, J.]

Composition of Expert Committee for examining the safety & A
efficacy of Fixed Dose Combinations (FDCs) is as under:
- -· -- -- - ---- - --· ···-· ----· ... .. ·-. . . ---
s.
-~-----

Name of' Name & Address of' Qualification Status in
No. Expt'rt ' Institutions the
Committee
'
I Prof. . V ce-Chancellor, M. Phann, Ph.D. Chairman B
Chandrakant KLE University,
Kokate Belgaum. Karnataka
& Ex-Pn~sident of
Pharmacy Council of
India.
2 Dr. C.L. Kaul Former Director. B. Pharn1, PhD. Member c
NIPER, 432,
' Mahatma Society,
Koth Road, Pw1e-38.
3 Prof. Sanjay Deptt. of M. Phann, Ph.D. Member
Singh ' Pharmaceutics, IIT.
BHU. Varanasi. D
4 Dr. C.D. Pmf.&HOD MD. Member
Tripathi (Phannacology), Pharama;ology
' Safdmjung Hospital,
New Delhi.
5 Dr. Bikash , Deptt. of MD, Member E
Medhi ' Pharmacology. Phmmaoology
PGIMER,
Chancligait1 .
.

6 Dr. Sanjeev ~ Pmf. (Medicine). MD, Medicine Member
Sinha AIIMS,New Delhi
;

7 Dr. RK. Khar · Former Dean & M. Ph.aim, Ph.D. , Co-opted
F
Head,Jamia Member
Hamdarcl,
403,L1lleshwa1i
Vati ka, GH-12,
Soctor-2 lD,
Faridabad-121001. G

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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190 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 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
B
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
c 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
D 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
E 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
F 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
H 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 A
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 B
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 C
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 D
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 E
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 F
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
H
192 SUPREME COURT REPORTS· [2017] 12 S.C.R.

A 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,
B
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
c 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.
D
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
E 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 7A 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
F so stated and that, therefore, the necessary inference would be that
Section 5 would apply in all situations other than those covered by Section
7A. 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.
G 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
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 193
[R.F. NARIMAN, J.]

the statute and, therefore, the High Courtj udgment is right in stating that A
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
B
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 c
which stated that conditional legislation, of which Section 26A is a clear
instance, would also require hearing the affected parties.
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 D
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
E
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.- F
(!) 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
to carry out the other functions assigned to it by this Act. G
(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;
H
194 SUPREME COURT REPORTS [2017] 12 S.C.R.

A (iii) the Director of the Central Drugs Laboratory, Calcutta, ex
officio;
(iv) the Director of the Central Research Institute, Kasauli, ex
officio;
(v) the Director of the Indian Veterinary Research Institute,
B 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,
C ex officio;
(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
D
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
E
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
F the Indian Council of Medical Research;
(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;
G
(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:
H
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 A
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 B
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 C
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 D
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 E
· 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 F
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. a
(2) the Central Government may, after consultation with the Board,
make rules prescribing-
(a) the functions of the Central Drugs Laboratory;

******** H
196 SUPREME COURT REPORTS [2017] 12 S.C.R.

A (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
B the said Laboratory to carry out its functions;
(f) the matters necessary to be prescribed for the purposes of the
proviso to sub-section (I).
7. The Drugs Consultative Committee.-
c (!) 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.
D (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
E to do so by the Central Government and shall have power to
regulate its own procedure.
7A. Sections 5 and 7 not to apply to Ayurvedic, Siddha or
Unani drugs.-
F Nothing contained in sections 5 and 7 shall apply to Ayurvedic,
Siddha or Unani drugs.

8. Standards of quality.-
(!) For the purposes of this Chapter, the expression "standard
quality" means-
G
(a) in relation to a drug, that the drug complies with the standard
set out in the Second Schedule, and

(b) in relation to a cosmetic, that the cosmetic compiles with such
standard as may be prescribed.
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 197
[R.F. NARIMAN, J.]

(2) The Central Government, after consultation with the Board A
and after giving by notification in the Official Gazette not less
than three months' notice of its intention so to do, may by a like
notification add to or otherwise amend the Second Schedule, for
the purposes of this Chapter, and thereupon the Second Schedule
shall be deemed to be amended accordingly.
B
10. Prohibition of import of certain drugs or cosmetics.-
From such date as may be fixed by the Central Government by
notification in the Official Gazette in this behalf, no person shall
import-
(a) any drug or cosmetic which is not of standard quality; c
(b) any misbranded drug or misbranded or spurious cosmetic;
(bb) ~n.~· adulterated or spurious drug;
(c) any drug or cosmetic for the import of which a licence is
prescribed, otherwise than under, and in accordance with, such D
licence;
(d) any patent or proprietary medicine, unless there is displayed in
the prescribed manner on the label or container thereof the true
formula or list of active ingredients contained in it together with
the quantities thereof; E
(e) any drug which by means of any statement, design or device
accompanying it or by any other means, purports or claims to
cure or mitigate any such disease or ailment, or to have any such
other effect, as may be prescribed;
(ee) any cosmetic containing any ingredient which may render it F
unsafe or harmful for use under the directions indicated or
recommended;
(f) any drug or cosmetic the import of which is prohibited by rule
made under this Chapter:
G
Provided that nothing in this section shall apply to the import, subject
to prescribed conditions, of small quantities of any drug for the
purpose of examination, test or analysis or for personal use:
Provided further that the Central Government may, after
consultation with the Board, by notification in the Official Gazette,
H
198 SUPREME COURT REPORTS [2017] 12 S.C.R.

A permit, subject to any conditions specified in the notification, the
import of any drug or class of drugs not being of standard quality.
12. Power of Central Government to make rules.-
( I) The Central Government may, after consultation with or on
the recommendation of the Board and after previous publication
B by notification in the Official Gazette, make rules for the purpose
of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with
if the Central Government is of opinion that circumstances have
arisen which render it necessary to make rules without suc.h
C consultation, but in such a case the Board shall be consulted within
six months of the making of the rules and the Central Government
shall take into consideration any suggestions which the Board may
make in relation to the amendment of the said rules.
(2) xxx xxx xxx
D 16. Standards of quality.-
( 1) For the purposes of this Chapter, the expression "standard
quality" means-
(a) in relation to a drug, that the drug complies with the standard
set out in the Second Schedule, and
E
(b) in relation to a cosmetic, that the cosmetic complies with such
standard as may be prescribed.
(2) The Central Government, after consultation with the Board
and after giving by notification in the Official Gazette not less
than three months' notice of its intention so to do, may by a like
F
notification add to or otherwise amend the Second Schedule for
the purposes of this Chapter, and thereupon the Second Schedule
shall be deemed to be amended accordingly.
18. Prohibition of manufacture and sale of certain drugs and
cosmetics.-
G
From such date as may be fixed by the State Government by
notification in the Official Gazette in this behalf, no person shall
himself or by any other person on his behalf-
(a) manufacture for sale or for distribution, or sell, or stock or
exhibit or offer for sale, or distribute-
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 199
[R.F. NARIMAN, J.]

(i) any drug which is not of a standard quality, or is misbranded, A
adulterated or spurious;
(ii) any cosmetic which is not of a standard quality or is misbranded,
adulterated or spurious;
(iii) any patent or proprietary medicine, unless there is displayed
in the prescribed manner on the label or container thereof the true B
formula or list of active ingredients contained in it together with
the quantities thereof;
(iv) any drug which by means of any statement, design or device
accompanying it or by any other means, purports or claims to
prevent, cure or mitigate any such disease or ailment, or to have c
any such other effect as may be prescribed;·
(v) any cosmetic containing any ingredient which may render it
unsafe or harmful for use under the directions indicated or
recommended; and
D
(vi) any drug or cosmetic in contravention of any of the provisions
of this Chapter or any rule made thereunder;
(b) sell, or stock or exhibit or offer for sale, or distribute any drug
or cosmetic which has been imported or manufactured in
contravention of any of the provisions of this Act or any rule made
E
thereunder;
(c) manufacture for sale or for distribution, or sell, or stock or
exhibit or offer for sale, or distribute any drug or cosmetic, except
under, and in accordance with the conditions of, a licence issued
for such purpose under this Chapter:
F
Provided that nothing in this section shall apply to the manufacture,
subject to prescribed conditions, of small quantities of any drug ·
for the purpose of examination, test or analysis:
Provided gurther that the Central Government may, after
consultation with the Board, by notification in the Official Gazette, G.
permit, subject to any conditions specified in the notification, the
manufacture for sale, or for distribution, sale, stocking or exhibiting
or offering for sale or distribution of any drug or class of drugs not
being of standard quality.

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200 SUPREME COlJRT REPORTS [2017] 12 S.C.R.

A 26A. Powers of Central Government to prohibit
manufacture, etc., of drug and cosmetic in public interest.-
Without prejudice to any other provision contained in this Chapter,
if the Central Government is satisfied, that the use of any drug or
cosmetic is likely to invqlve any risk to human beings or animals
B or that any drug does not have the therapeutic value claimed or
purported to be claimed for it or contains ingredients and in such
quantity for which there is no theraprntic justification and that in
the public interest it is necessary or e;;pedient so to do, then, that
Government may, by notification in the Official Gazette, regulate,
restrict or prohibit the manufacture, sale or distribution of such
c drug or cosmetic.
33. Power of Central Government to make rules.-
(1) The Central Government may after consultation with, or on
the recommendation of, the Board and after previous publication
D by notification in the Official Gazette, make rules for the purpose
of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with
if the Central Government is of opinion that circumstances have
arisen which render it necessary to make rules without such
E consultation, but in such a case the Board shall be consulted within
six months of the making of the rules and the Central Government
shall take into consideration any suggestions which the Board may
make in relation to the amendment of the said rules.
(2) Without prejudice to the generality of the foregoing power,
such rules may-
F
(a) provide for the establishment of laboratories for testing and
analysing drugs or cosmetics;
(b) prescribe the qualifications and duties of Government Analysts
and the qualifications oflnspectors;
G (c) prescribe the methods of test or analysis to be employed in
determining whether a drug or cosmetic is of standard quality;
(d) prescribe, in respect of biological and organometallic
compounds, the units or methods of standardisatioii;

H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 201
[R.F. NARIMAN, J.]

(dd) prescribe under clause (d) of section 17A the colour or colours A
which a drug may bear or contain for purposes of colouring;
(dda) prescribe under clause (d) of section l 7E the colour or
colours which a cosmetic may bear or contain for the purpose of
colouring;
(e) prescribe the forms of licences for the manufacture for sale B
or for distribution, for the sale and for the distribution of drugs or
any specified drug or class of drugs or of cosmetics or any specified
cosmetic or class of cosmetics, the form of application for such
licences, the conditions subject to which such licences may be
issued, the authority empowered to issue the same, the c
qualifications of such authority and the fees payable therefor; and
provide for the cancellation or suspension of such licences in any
case where any provision of this Chapter or the rules made
thereunder is contravened or any of the conditions subject to which
they are issued is not complied with;
D
(ee) prescribe the records, registers or other documents to be
kept and maintained under section I SB;
(eea) prescribe the fees for the inspection (for the purposes of
grant or renewal of licences) of premises, wherein any drug or
cosmetic is being or is proposed to be manufactured; E
(eeb) prescribe the manner in which copies are to be certified
under sub-section (2A) of section 22;
(f) specify the diseases or ailments which a drug may not purport
or claim to prevent, cure or mitigate and such other effects which
a drug may not purport or clairn to have; F
(g) prescribe the conditions subject to which small quantities of
drugs may be manufactured for the purpose of examination, test
or analysis;
(h) require the date of manufacture and the date of expiry of
potency to be clearly or truly stated on the label or container of G
any specified drug or class of drugs, and prohibit the sale, stocking
or exhibition for sale, or distribution of the said drug or class of
drugs after the expiry of a specified period from the date of
manufacture or after the expiry of the date of potency;
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202 SUPREME COURT REPORTS [2017] 12 S.C.R.

A (i) prescribe the conditions to be observed in the packing in bottles,
packages, and other containers of drugs or cosmetics, including
the use of packing material which comes into direct contact with
the drugs and prohibit the sale, stocking or exhibition for sale, or
distribution of drugs or cosmetics packed in contravention of such
conditions;
B
(j) regulate the mode of labelling packed drugs or cosmetics, and
prescribe the matters which shall or shall not be included in such
labels;
(k) prescribe the maximum proportion of any poisonous substance
c which may be added or contained in any drug, prohibit the
manufacture, sale or stocking or exhibition for sale, or distribution
of any drug in which that. proportion is exc~eded, antl specify
substances which shall be deemed to be poisonous for the purposes.
of this Chapter and the rules made thereunder;
D (I) require that the accepted scientific name of any specified drug
shall be displayed in the prescribed manner on the label or wrapper -
of any patent or proprietary medicine containing such drug;
[****]
(n)· prescribe the powers and duties of. Inspectors and the
E qualifications of the authority to which such Inspectors shalt be
subordinate and spcdfy the drugs or classes of drugs or cosmetics
or classes of cosmetics in relation to which and the conditions,
limitations or restrictions subject to which, such powers and duties
may be exercised or performed;
F (o) prescribe the forms of report to be given by Government
Analysts, and the manner of application for test or analysis under
section 26 and the fees payable therefor;
(p) specify the offences against this Chapter or any rule made
thereunder in relation to which an order of confiscation may be
G made under section 31;
(q) provide for the exemption, conditionally or otherwise, from all
or any of the provisions of this Chapter or the rules made
thereunder, of any specified drug or class of drugs or cosmetic or
class of cosmetics; and ·
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 203
[R.F. NARIMAN, J.]

(r) sum which may be specified by the Central Government under A
section 32-B.
33EED. Power of Central Government to prohibit
manufacture, etc., of Ayurvedic, Siddha or Unani drugs in
public interest.- •
Without prejudice to any other provision contained in this Chapter, B
if the Central Government is satisfied on the basis of any evidence
or other material available before it that the use of any Ayurvedic,
Siddha or Unani drug is likely to involve any risk to human beings
or animals or that any such drug does not have the th1:;rapeutic
value claimed or purported to be claimed for it and that in the c
public interest it is necessary or expedient so to do then, that
Government may, by notification in the Official Gazette, prohibit
the manufacture, sale or distribution of such drug.
33N. Power of Central Government to make rules.-
(1) The Central Government may, after consultation with, or on D
the recommendation of, the Board and after previous publication
by notification in the Official Gazette, make rules for the purpqse
of giving effect to the provisions of this Chapter:
Provided that consultation with the Board may be dispensed with
if the Central Government is of opinion that circumstances have E
arisen which render it necessary to make rules without such
consultation, but in such a case, the Board shall be consulted within
six months of the making of the rules and the Central Government
shall take into consideration any suggestions which the Board may
make in relation to the amendment of the said rules.
F
(2) Without prejudice to the generality of the foregoing power,
such rules may-
(a) provide for the establishment of laboratories for testing and
analysingAyurvedic, Siddha or Unani drugs;
(b) prescribe the qualification and duties of Government Analysts G
and the qualifications oflnspectors;
(c) prescribe the methods of test or analysis to be employed in
determining whether any Ayurvedic, Siddha or Unani drug is
labelled with the true list of the ingredients which it is purported to
contain;
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204 SUPREME COURT REPORTS [2017] 12 S.C.R.

A (d) specify any substance as a poisonous substance;
(e) prescribe the forms of licences for the manufacture for sale
of Ayurvedic, Siddha or Unani drugs, and for sale of processed
Ayurvedic, Siddha or Unani drugs, the form of application for
such licences, the conditions subject to which such licences may
B be issued, the authority empowered to issue the same and the
fees payable therefor; and provide for the cancellation or
suspension of such licences in any case where any provision of
this Chapter or rules made thereunder is contravened or any of
the conditions subject to which they are issued is not complied
with;
c
(f) prescribe the conditions to be observed in the packing of
Ayurvedic, Siddha and Unani drugs including the use of packing
material which comes into direct contact with the drugs, regulate
the mode oflabelling packed drugs.and prescribe the matters which
shall or shall not be included in such labels;
D
(g) prescribe the conditions subject to which small quantities of
Ayurvedic, Siddha or Unani drugs may be manufactured for the
purpose of examination, test or analysis;
(gg) prescribe under clause (d) of section 33EE the colour or
E colours which an Ayurvedic, Siddha or Unani drug may bear or
contain for purposes of colouring;
(gga) prescribe the standards for Ayurvedic, Siddha or Unani drugs
under section 33EEB;
(ggb) prescribe the records, registers or other documents to be
F kept and maintained under section 33 KB; and
(h) any other matter which is to be or may be prescribed under
this Chapter."
15. Having heard learned counsel for the parties, it is clear that
Section 26A has been introduced by an amendment in 1982. A bare
G reading of this provision 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, Section 26A is an
additional power which must be governed by its own terms. Under
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 205
[R.F. NARIMAN, J.]

Section 26A, the Central Government must be "satisfied" that any drug A
or cosmetic is likely to involve (i) any risk to human beings or families; or
(ii) that any drug does not have the therapeutic value claimed or purported
to be claimed for it; or (iii) 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 B
based upon its "satisfaction" as to the existence of any or all of these
factors. The power exercised under Section 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.
16. Undoubtedly, .Section 26A has to be read with the rest of the C
Drugs Act. So read, it is clear that unlike Section 6(2), Section 8(2),
second proviso to Section 10, proviso to Section 12(1), Section 16(2),
proviso to Section 18(2), Section 33 and Section 33N, there is no explicit
requirement to consult the DTAB set up under Section 5 of the Drugs
Act. The question is did the Parliament do so deliberately or is it something D
that the Court should read into the provision?
17. As has been stated hereinabove, 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 E
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 F
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 exertised under the said G
Section would be non est. Take the case of an FDC that is banned in 50
countries of the world owing to the fact that the said FDC involved
significant risk to human beings. Assuming that the Central Government
is satisfied based on this fact alone, which in turn is based on expert
committee reports in various nations which pointed out the deleterious
H
206 SUPREME COURT REPORTS [2017] 12 S.C.R.

A effects of the said drug, can it be said that without consulting the DTAB
set up under Section 5, the exercise of the power under Section 26A to
prohibit the manufacture or sale or distribution of a drug that is banned in
50 countries would be bad only because the DTAB has not been
consulted? The obvious answer is no inasmuch as the Central
Government's satisfaction is based upon relevant material, namely, the
B
fact that 50 nations have banned the aforesaid drug, which in turn is
based on expert committee reports taken in each of those nations. Take
another example. Suppose the Central Government were to ban an
FDC on the ground that, in tlli: recent past, it has been apprised of the
fact that the FDCs taken over a short period of time would lead to loss
c oflife, which has come to the notice of the Central Government through
reports from various district authorities, in let us say, a majority of districts
in which the said FDC has been consumed. Could not the Central
Government then base its ban order on material collected from district
authorities which state that this particular drug leads to human mortality
and ought, therefore, to be prohibited? The obvious answer again is yes
D
for the reason that the Central Government has been satisfied on relevant
material that it is necessary in public interest to ban such drug. Examples
of this nature can be multiplied to show that the width of the power
granted under Section 26A cannot be cut down by artificially cutting
down the language of Section 26A.
E 18. We were referred to a judgment of this Court in Systopic
Laboratories (supra) at 169. Paragraph 19 of the said judgment reads
as follows:-
"19. Having considered the submissions made by the learned
counsel for the petitioners and the learned Additional Solicitor
F General in this regard, we must express our inability to make an
assessment about the relative merits of the various studies and
reports which have been placed before us. Such an evaluation is
required to be done by the Central Government while exercising
its powers under Section 26-A of the Act on the basis of expert
G advice and the Act makes provision for obtaining such advice
through the Board and the DCC."
19. It is clear that a stray sentence in a judgment without a focused
argument cannot be considered as the ratio of such a judgment. Also,
on a careful reading of the second sentence in paragraph 19, it is clear
H that all that is stated by this Court is that, while exercising its power
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS~ 207
[R.F. NARIMAN, J.]

under Section 26A of the Drugs Act, the basis of the Central A
Government's decision must be "expert advice". The sentence then
goes on to add that the Drugs Act makes provision for obtaining such
advice through the Board and the DCC. According to us, there was no
focused argument on whether such advice is or is not mandatory before
powers under Section 26A of the Drugs Act can be exercised, and merely
B
reading a stray sentence in this judgment does not lead to such a
conclusion. Equally, the single Judge's reliance upon a Division Bench
judgment contained in E. Merck (supra), where, in holding Section 26A
to be constitutional, the Court stated:
"Before the Government records its satisfaction to prohibit the
manufacture, sale, distribution etc. of a particular drug, opinion of
c
the DTAB and/or Drugs Consultative Committee is obtained."
This is an equally stray sentence and what has been stated with
respect to Systopic Laboratories (supra), applies equally to this
sentence.
D
20. We have now to consider certain other arguments made on
behalf of the respondents. 0Hc argument was that Section 5 is in two
parts and that the first part necessarily applies to all technical matters
that arise out of the administration of the Drugs Act, and that, therefore,
the Central Government is bound to take the advice of the DTAB in all
such matters. We must first advert to the fact that the DTAB is only an E
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 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, F
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. Another argument made is that Section 5 makes it clear
that the DTAB alone can constitute sub-committees which may have
persons who are not members of the Board on them. We are afraid that G
this again does not lead us very far. It is clear that the reason for Section
5(5) is completely different. Sub-committees 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 H
208 SUPREME COURT REPORTS [2017] 12 S.C.R.

A matters and make reports which the DTAB may then utilize. This is a
power of the DTAB which can be exercised when the DTAB 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 sub-committees, the Central Government may not, under
Section 26A, refer to any persons other than those who are board
B
members. This argument, therefore, is also rejected.
21. Yet another argument has been made that since Section l OA
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
c under Section 5. We have already pointed out how 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 I OA and 26A cannot but be said to be
deliberate. This argument also need not detain us further.
D 22. A negative argument was made stating that Section 7A 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 7A is again something very different from what
has been argued. It must first be pointed out that under Chapter IVA,
E which is a separate Chapter introduced by Act 13 of 1964, Ayurvedic,
Siddha and Unani drugs are completely separately dealt with. Indeed,
Section 33A, which must be read with Section 7A, expressly provides
that save as provided in this Drugs Act, nothing contained in this Chapter,
i.e. Chapter IV, shall apply toAyurvedic, Siddha or Unani drugs. Chapter
IVA consists of a separate and distinct drill to be followed in the case of
F 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
(see Section 33D). When Section 7A says that nothing in section 5 shall
apply to Ayurvedic, Siddha or Unani drugs, all that it affirms is that the
G DTAB set up under Section 5 will apply to all drugs exceptAyurvedic,
Siddha or Unani medicines. The Latin maxim "expressio uni us est exclusio
alterius" cannot apply, as has been held in State of Karnataka v Union
of India & Ors., (1977) 4 SCC 608 at 662, making it clear that 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". This
H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 209
[R.F. NARIMAN, J.]

has also been held in Assistant Collector of Central Excise, Calcutta A
Division v. National Tobacco Co. of India Ltd., (1972) 2 SCC 560
at 575 as follows:
"The High Court's view was based on an application of the rule
of construction that where a mode of performing a duty is laid
down by law it must be performed in that mode or not at all. This B
rule flows from the maxim: "Expressio unius ast exclusio
alterius". But, as was pointed out by Wills, J., in Colguoboun v.
Bmoks [(1888) 21QBD52, 62] this maxim "is often a valuable
servant, but a dangerous master .... ". The rule is subservient to
the basic principle that Courts must endeavour to ascertain the
legislative intent and purpose, and then adopt a rule of construction
c
which effectuates rather than one that may defeat these. "
This argument, therefore, also need not detain us.
23. It was also argued that Section 26A had no non obstantc clause
to keep Section 5 out of harm's way. On our construction of Section D
26A, it is clear that no such non obstantc 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. As has been stated by us
hcreinabove, 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. E

24. An argument was made that unless the provisions of Section
5 requiring consultation with the DTAB arc read into Section 26A, the
said Section would be arbitrary. In our opinion, there are sufficient
indicators in the Section to eschew any ground of arbitrariness. The
power can only be exercised based on satisfaction of material that is F
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 manufacture, sale or
distribution of the said drug in public interest. Indeed, this is made explicit
in Section 33 EED of the Drugs Act, wherein a similar power is given to G
the Central Government qua Ayurvedic, Siddha or Unani drugs, where
the Section states:
" ... the Central Government is satisfied on the basis of any
evidence or other material available before it that ... "
H
210 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 25. 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 struck down on this ground. Further, it is argued
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.
B
26. In Cellular Operators Association of India and others v.
Telecom Regulatory Authority of India and others, (2016) 7 SCC
703 at 740-741, this Court held as under:
"50. But it was said that the aforesaid Regulation should be read
c down to mean that it would apply only when the fault is that of the
service provider. We are afraid that such a course is not open to
us in law, for it is well settled that the doctrine of reading down
would apply only when general words used in a statute or regulation
can be confined in a particular manner so as not to infringe a
constitutional right. This was best exemplifiecf in one of the earliest
D judgments dealing with the doctrine of reading down, namely, the
judgment of the Federal Court in Hindu Womens Rights to
Property Act, 1937, Jn re [Hindu Womens Rights to Property
Act, 1937, In re, AIR 1941 FC 72]. In that judgment, the word
"property" in Section 3 of the Hindu Women's Rights to Property
E Act was read down so as not to include agricultural land, which
would be outside the Central Legislature's powers under the
Government oflndiaAct, 1935. This is done because it is presumed
that the legislature did not intend to transgress constitutional
limitations. While so reading down the word "property", the Federal
Court held:
F
" ... If the restriction of the general words to purposes within
the power of the legislature would be to leave an Act with
nothing or next to nothing in it, or an Act different in kind,
and not merely in degree, from an Act in which the general
words were given the wider meaning, then it is plain that the
G Act as a whole must be held invalid, because in such
circumstances it is impossible to assert with any confidence
that the legislature intended the general words which it has
used to be construed only in the narrower sense: Owners of
SS Kalibia v. Wilson [(1910) II CLR 689 (Aust)], Vacuum
H Oil Co. Pty. Ltd. v. Queensland [(1934) 51 CLR 677 (Aust)],
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 211
[R.F. NARIMAN, J.]

R. v. Commonwealth Court of Conciliation and Arbitration, A
exp Whybrow & Co. [(1910) 11 CLR 1 (Aust)] and British
Imperial Oil Co. Ltd. v. Federal Commr. of Taxation [(1925)
35 CLR 422 (Aust)]."
51. This judgment was followed by a Constitution Bench of this
Court in DTC v. Mazdoor Congress [1991 Supp (1) SCC 600: B
1991 SCC (L&S) 1213]. In that case, a question arose as to
whether a particular regulation which conferred power on an
authority to terminate the services of a permanent and confirmed
employee by issuing a notice terminating his services, or by making
payment in lieu of such notice without assigning any reasons and
without any opportunity of hearing to the employee, could be said c
to be violative of the appellants' fundamental rights. Four of the
learned Judges who heard the case, the Chief Justice alone
dissenting on this aspect, decided that the regulation cannot be
read down, and must, therefore, be held to be unconstitutiunal. In
the lead judgment on this aspect by Sa want, J., this Cu mt stated: D
(SCC pp. 728-29, para 255)
"255. It is thus clear that the doctrine of reading down or of
recasting the statute can be applied in limited situations. It is
essentially used, firstly, for saving a statute from being struck
down on account of its unconstitutionality. It is an extension of E
the principle that when two interpretations are possible - one
rendering it constitutional and the other making it
unconstitutional, the former should be preferred. The
unconstitutionality may spring from either the incompetence
of the legislature to enact the statute or from its violation of
any of the provisions of the Constitution. The second situation F
which summons its aid is where the provisions of the statute
are vague and ambiguous and it is possible to gather the
intentions of the legislature from the object of the statute, the
context in which the provision occurs and the purpose for which
it is made. However, when the provision is cast in a definite 0
and unambiguous language and its intention is clear, it is
not permissible either to mend or bend it even if such
recasting is in accord with good reason and conscience.
In such circumstances, it is not possible for the court to remake
the statute. Its only duty is to strike it down and leave it to the
H
212 SUPREME COURT REPORTS [2017] 12 S.C.R.

A legislature if it so desires, to amend it. What is further, if the
remaking of the statute by the courts is to lead to its distortion
that course is to be scrupulously avoided. One of the situations
further where the doctrine can never be called into play is
where the statute requires extensive additions and deletions.
Not only it is no part of the court's duty to undertake such
B
exercise, but it is beyond its jurisdiction to do so."
(emphasis supplied)
52. Applying the aforesaid test to the impugned Regulation, it is
clear that the language of the Regulation is definite and
c unambiguous - every service provider has to credit the account
of the calling consumer by one rupee for every single call drop
which occurs within its network. The Explanatory Memorandum
to the aforesaid Regulation further makes it clear, in Para 19
thereof, that the Authority has come to the conclusion that call
drops are instances of deficiency in service delivery on the part
D of the service provider. It is thus unambiguously clear that the
impugned Regulation is based on the fact that the service provider
is alone at fault and must pay for that fault. In these circumstances,
to read a proviso into the Regulation that it will not apply to
consumers who are at fault themselves is not to restrict general
E words to a particular meaning, but to add something to the provision
which does not exist, which would be nothing short of the court
itself legislating. For this reason, it is not possible to accept the
learned Attorney General's contention that the impugned
Regulation be read down in the manner suggested by him."

F 27. Also, as a matter of statutory interpretation, words can only
be added if the literal interpretation of the Section leads to an absurd
result. As has been stated by us, the construction of Section 26A on a
literal reading thereof does not lead to any such result. Dr. Singhvi's
argument to read in words to save Section 26A must, therefore, be
rejected.
G
28. We may also mention that the Madras High Court in its
judgment in Macleods Pharmaceuticals Limited v. Union of India
& Ors., Writ Petition Nos.21933 and 25442 of2011, specifically held as
under:

H
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 213
[R.F. NARIMAN, J.]

"38. Thus, the Act gives in every Chapter, an indication of the A
functions to be exercised by the DTAB. In other words, the
territory within which the DTAB is to operate and exercise its
functions, is clearly demarcated in various provisions of the Act
such as 5(1), 6(2), 7(1), 8(2), second proviso to Section 10, 12(1)
and 33(1). But Section 26-A is completely silent about any
B
consultation with DTAB. It is so even with Section 26-B.
39. While the advisory role of DTAB is indicated in broad and
general terms in Section 5( 1), it is indicated in specific terms in
Sections 6(2), 7(1 ), 8(2), second proviso to Section 10, 12(1) and
33( 1). Therefore, the absence of any reference to such
requirement of consultation in Section 26-A assumes great C
significance. It is a well settled principle of interpretation of statutes
that the Cuurts are not expected to supply the omission. The
Parliament hi.d consciously incorporated the expressions "after
consultation with the Board" or "on the recommendation of the
Board", in certain provisions of the Act such as Sections 5(1), D
6(2), 7(1), 8(2), second proviso to Section 10, 12(1) and 33(1).
But it has deliberately omitted to include any of those expressions
while inserting Sections 26-A and 26-B. It is a case of casus
omisus. Therefore, the argument that the Central Government
ought to have taken the consultation of the DTAB before issuing
the ban order, can hold good only ifl can supply into Section 26- E
A, what was deliberately left out by the Parliament. This cannot
be done by me and hence the first contention has to be rejected."
29. To similar effect is the judgment of a single Judge of the
KarnatakaHigh Court in Lundbeck India Pvt. Ltd. v Union of India,
(2014) 5 Kant LJ 440. F

30. We approve of these two judgments as having laid down the
correct law on the construction of Section 26A of the Drugs Act.
31. Though arguments have been made as to whether Section
26A is legislative in nature and therefore excludes natural justice, we do G
not propose to go into the same inasmuch as since the learned single
Judge's judgment is being set aside on one point and one point alone. In
this view of the matter, we are of the opinion that the impugned judgment
dated 1.12.2016 deserves to be set aside.

H
214 SUPREME COURT REPORTS [2017] 12 S.C.R.

A 32. On the facts of these cases, a suggested course of action was
stated by learned counsel appearing on behalf of the petitioners/appellants.
This course is that instead of now remitting the matter back to the Delhi
High Court for an adjudication on the other points raised in the writ
petitions, the case of 344 FDCs that have been banned, plus another 5
FDCs that have been banned, which comes to 349 FDCs, (barring 15
B
FDCs that are pre 1988 and 17 FDCs which have DCG(I) approval)
pursuant to the Kokate Committee report, by notifications of the Central
Government under Section 26A of the Drugs Act, should be sent to the
DTAB, constituted under Section 5 of the Drugs Act, so that it can
examine each of these cases and ultimately send a report to the Central
c Government. We reiterate that only on the peculiar facts of these cases,
we think that such a course commends itself to us, which would obviate
further litigation and finally set at rest all other contentions raised by the
petitioners. We say so becau;;e we find that the Kokate Committee did
deliberate on the 344 FDCs plus 5 FDCs and did come to a conclusion
that the aforesaid FDCs be banned, but we are not clear as to what
D
exactly the reasons for such conclusions are, and whether it was
necessary in the public interest to take the extreme step of prohibiting
such FDCs, instead of restricting or regulating their manufacture and
supply. In order that an analysis be made in greater depth, we, therefore,
feel that these cases should go to the DTAB and/or a Sub-Committee
E 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 will not only hear the petitioners/appellants before us, but
that they also hear submissions from the All India Drugs Action Network.
The DTAB/Sub-Committee set up for this purpose will deliberate on the
parameters set out in Section 26A of the Drugs Act, as follows.
F
33. First and foremost 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
aforesaid three things:
G (a) that they are likely to involve any risk 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
H which there is no therapeutic justification.
UNION OF INDIA AND ANR. v. PFIZER LIMITED AND ORS. 215
[R.F. NARIMAN, J.]

34. The DTAB/Sub-Committee must also apply its mind as to A
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. In short, the DTAB/Sub-Committee must clearly indicate in its
report:
(1) as to why, according to it, any one of the three factors indicated B
above is attracted;
(2) post such satisfaction, 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.
35. The DTAB/Sub-Committee must also indicate in its report as c
to why, in case it prohibits a particular FDC, restriction or regulation is
not sufficient to control the manufacture and use of the FDC. We request
the DTAB/.'.;ub-Committee to be set up for this purpose to afford the
necessary hearmg to all concerned, and thereafter submit a consolidated
r~port, insofar as these FDCs are concerned, to the Central Government D
within a period of six months from the date on which this judgment is
received by the DTAB. We may also indicate that the Central
Government, thereafter, must have due regard to the report of the DTAB
and td'any other relevant information, and u1timately apply its mind to
the parameters contained in Section 26A of the Drugs Act and,
accordingly, either maintain the notifications already issued, or modify/ E
substitute them or withdraw them.
36. With these directions given on the peculiar facts and
circumstances of these cases, the appeals are disposed of.
37. Insofar as the drugs that have been banned and which were F
manufactured pre 2 I" September, I 988, a list of I 5 such drugs has been
given to us by Mr. Kapil Sibal, learned senior counsel for the respondents.
We set aside the Central Government notifications banning them as these
cases were never meant to be referred to the Kokate Committee. It
will be open, however, for the Central Government, if it so chooses, de
novo, to carry out an inquiry as to whether such drugs should be the G
subject matter of a notification under Section 26A of the Drugs Act.
38. Insofar as the list of 17 cases handed over by Shri Sibal, in
which DCG(I) approvals have allegedly been granted, we are of the
view that since the Parliamentary Standing Committee itself refers to
H
216 SUPREME COURT REPORTS [2017] 12 S.C.R.

A DCG(I) approvals and the manner in which they were granted, we do
not accede to Mr. Sibal's request that these 17 cases be kt:pt outside the
purview of the fresh look that has to be given by the DTAB/Sub-
Committee in these cases.
39. Insofar as the status quo, obtaining as on today, is concerned,
B that will 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.
MADRAS CASES <TRANSFERRED CASES)
T.C.<C)Nos. 308-317 of 2017 @ T.P.<C)Nos.2108-2117 of 2017
c
40. Mr. Gopal Subramanium; learned senior counsel appearing on
behalf of the original petitioners in these cases, stated that these cases
have been transferred to this Court from the Madras High Court. A
Section 33 ban, which was imposed on 294 FDCs in these cases, has
been stayed by the Madras High Court, and the very exercise that we
D have proposed in the Delhi cases has apparently been carried out in this
group of cases. A report of the expert committee of the DTAB to
review the rationality and safety of 294 FDCs is taken on record. The
report indicates that 42 FDCs reportedly were repeated or duplicate; 44
were already prohibited for manufacture in the country; 83 were
E considered rational; 56 were considered not rational; 49 required further
generation of data; 17 were considered inadequate so far as rationality,
safety and efficacy is concerned; and 3 other cases were sent for further
examination by an expert committee constituted by the Ministry of Health
and Family Welfare. The DTAB after review of the report and
deliberations recommended that the FDC Ofloxacin and Prednisolone
F at serial number 75 under the category of GI in Annexure C does not
appear to be rational and should be re-examined. The list of the drugs
mentioned in Annexure Dare 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, we accept the
G report, and accordingly dispose of these petitions in accordance therewith.

Nidhi Jain Appeals and TCs disposed of.