REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL APPELLATE JURISDICTION

CIVIL APPEAL NO. 22972 OF 2017

(ARISING OUT OF SLP (C) NO.7061 OF 2017

UNION OF INDIA AND ANR. …APPELLANTS

VERSUS

PFIZER LIMITED AND ORS. ...RESPONDENTS

WITH

CIVIL APPEAL NOS. 22973-22981 OF 2017

(ARISING OUT OF SLP (C) NO.10170-10178 OF 2017)

CIVIL APPEAL NOS. 22982-23404 OF 2017

(ARISING OUT OF SLP (C) NO.28960-29382 OF 2017)

TRANSFERRED CASE (C) NO.29 OF 2017

TRANSFERRED CASE (C) NO.30 OF 2017

TRANSFERRED CASE (C) NO.31 OF 2017

TRANSFERRED CASE (C) NO.32 OF 2017

TRANSFERRED CASE (C) NO.33 OF 2017

TRANSFERRED CASE (C) NO.34 OF 2017

TRANSFERRED CASE (C) NO.35 OF 2017

TRANSFERRED CASE (C) NO.36 OF 2017

1

TRANSFERRED CASE (C) NO.38 OF 2017

TRANSFERRED CASE (C) NO.39 OF 2017

TRANSFERRED CASE (C) NO.40 OF 2017

TRANSFERRED CASE (C) NO.41 OF 2017

TRANSFERRED CASE (C) NO.42 OF 2017

TRANSFERRED CASE (C) NO.43 OF 2017

TRANSFERRED CASE (C) NO.44 OF 2017

TRANSFERRED CASE (C) NO.45 OF 2017

TRANSFER PETITION (C) NOS.1176-1182 OF 2017

TRANSFERRED CASE (C) NO.258 OF 2017

TRANSFERRED CASE (C) NO.259 OF 2017

TRANSFERRED CASE (C) NO.260 OF 2017

TRANSFERRED CASE (C) NO.261 OF 2017

TRANSFERRED CASE (C) NO.262 OF 2017

TRANSFERRED CASE (C) NO.263 OF 2017

TRANSFERRED CASE (C) NO.264 OF 2017

TRANSFERRED CASE (C) NO.265 OF 2017

TRANSFERRED CASE (C) NO.266 OF 2017

CIVIL APPEAL NOS. 23405-23472 OF 2017

(ARISING OUT OF SLP (C) NOS. 36044-36111 OF 2017

Diary No.28274 of 2017

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TRANSFERRED CASE (C) NOS. 308-317 OF 2017

(ARISING OUT OF T.P. (C) NOS.2108-2117 OF 2017)

J U D G M E N T

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 (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

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

3

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 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 59

th

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,

4

Section 26A of the Drugs Act is adequate to deal with the

problem of FDCs 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 of India (DCG(I)). The DCG(I), 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(I),

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 2911 products,

which had to be subjected to examination.

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4.With the approval of the Ministry of Health and Family

Welfare, the CDSCO 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, Karnataka for examining the safety and

efficacy as per the following terms of reference:

a.Those FDCs which are considered grossly

irrational/unsafe based on pharmacokinetic and

pharmacodynamic interaction, dosage

compatibilities of FDCs 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 safe

and effective based on pharmacokinetic and

pharmacodynamic interaction, dosage

compatibilities of FDCS vis-a-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

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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.

Composition of Expert Committee for examining the

safety & efficacy of Fixed Dose Combinations

(FDCs) is as under:

S.No.Name of

Expert

Name &

Address of

Institutions

Qualificati

on

Status in the

Committee

1 Prof.

Chandrakant

Kokate

Vice-Chancellor,

KLE University,

Belgaum,

Karnataka &

Ex-President of

Pharmacy

Council of India.

M. Pharm,

Ph.D.

Chairman

2 Dr. C.L. KaulFormer Director,

NIPER, 432,

Mahatma

Society, Koth

Road, Pune-38.

B. Pharm,

Ph.D.

Member

3 Prof. Sanjay

Singh

Deptt. of

Pharmaceutics,

IIT, BHU,

Varanasi.

M. Pharm,

Ph.D.

Member

4 Dr. C.D.

Tripathi

Prof. & HOD

(Pharmacology),

Safdarjung

Hospital, New

MD,

Pharamacol

ogy

Member

7

Delhi.

5 Dr. Bikash

Medhi

Deptt. of

Pharmacology,

PGIMER,

Chandigarh.

MD,

Pharmacolo

gy

Member

6 Dr. Sanjeev

Sinha

Prof. (Medicine),

AIIMS,New Delhi

MD,

Medicine

Member

7 Dr. R.K. KharFormer Dean &

Head, Jamia

Hamdard,

403,Lalleshwari

Vatika, GH-12,

Sector-21D,

Faridabad-1210

01.

M. Pharm,

Ph.D.

Co-opted

Member

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.

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

8

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 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 Expert Committees already

constituted for further examination. In category C, 1493 FDCs

9

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 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 judgment then followed on 1.12.2016 disposing of

454 petitions, 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 of India filed transfer petitions in

this Court. This is how these matters have been heard by us in

civil appeals arising out of SLPs against the judgment of the

single Judge dated 1.12.2016 and in transfer cases in which the

10

LPAs pending before the Delhi High Court have been

transferred to us.

9.Ms. Pinky Anand, learned Additional Solicitor General,

took us through various provisions of the Drugs Act, and

emphasized that Section 26A does not expressly refer to the

DTAB. According to her, a large 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 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 Court differed, is the correct

view in law. Shri Colin Gonsalves, learned senior counsel,

11

supported her arguments, and appeared in civil appeal arising

out of SLP(C) Nos.10170-10178 of 2017.

10.By way of reply, Shri C.S. Vaidyanathan, learned senior

counsel, argued that the impugned single Judge judgment was

based on an earlier 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 Gupta & Ors., 1994 Supp (1) 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 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

12

they would take such advice and which case they would not

take such advice, the provision itself would become arbitrary

and unreasonable. According to 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 10A 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

13

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 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 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

14

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 the statute and, therefore, the High

Court judgment 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

15

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.

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 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.

“5. The Drugs Technical Advisory Board.—

(1) The Central Government shall, as soon as may

be, constitute a Board (to be called the Drugs

Technical Advisory Board) to advise the Central

16

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.

(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;

(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, 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, 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 of India, 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

17

staff of an Indian university or a college affiliated

thereto;

(xii) one person to be nominated by the Central

Government from the pharmaceutical industry;

(xiii) one pharmacologist to be elected by the

Governing Body of 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;

(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:

Provided that the person nominated or elected, as

the case may 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 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 years, as it may

decide, or temporarily for the consideration of

particular matters, persons who are not members of

the Board.

18

(6) The functions of the Board may be exercised

notwithstanding any vacancy therein.

(7) The Central Government shall appoint a person

to be Secretary 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.—

(1) 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;

********

(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;

19

(e) such other matters as may be necessary or

expedient to enable the said Laboratory to carry out

its functions;

(f) the matters necessary to be prescribed for the

purposes of the proviso to sub-section (1).

7. The Drugs Consultative Committee.—

(1) 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

secure 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.

7A. Sections 5 and 7 not to apply to Ayurvedic,

Siddha or Unani drugs.—

Nothing contained in sections 5 and 7 shall apply to

Ayurvedic, Siddha or Unani drugs.

8. 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

(b) in relation to a cosmetic, that the cosmetic

compiles with such standard as may be prescribed.

20

(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 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.

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;

(b) any misbranded drug or misbranded or spurious

cosmetic;

(bb) any 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 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) 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 unsafe or harmful for use under the

directions indicated or recommended;

21

(f) any drug or cosmetic the import of which is

prohibited by rule made under this Chapter:

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, 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.

—

(1) The Central Government may, after consultation

with or on the recommendation of the Board and

after previous publication 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

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)xxxxxxxxx

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

22

(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 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.—

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—

(i) any drug which is not of a standard quality, or is

misbranded, 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 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 any

such other effect as may be prescribed;

23

(v) any cosmetic containing any ingredient which

may render it unsafe or harmful for use under the

directions indicated or recommended; and

(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

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:

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 further that the Central Government may,

after consultation with the Board, by notification in

the Official Gazette, 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.

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 involve any risk to human beings or animals

24

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 therapeutic justification and that in the public

interest it is necessary or expedient so to do, then,

that Government may, by notification in the Official

Gazette, regulate, restrict or prohibit the

manufacture, sale or distribution of such 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 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

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—

(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 of

Inspectors;

(c) prescribe the methods of test or analysis to be

employed in determining whether a drug or

cosmetic is of standard quality;

25

(d) prescribe, in respect of biological and

organometallic compounds, the units or methods of

standardisation;

(dd) prescribe under clause (d) of section 17A the

colour or colours which a drug may bear or contain

for purposes of colouring;

(dda) prescribe under clause (d) of section 17E 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 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 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;

(ee) prescribe the records, registers or other

documents to be kept and maintained under section

18B;

(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;

(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

26

and such other effects which a drug may not purport

or claim to have;

(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 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;

(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;

(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 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 exceeded,

and specify substances which shall be deemed to

be poisonous for the purposes of this Chapter and

the rules made thereunder;

(l) 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;

27

[****]

(n) prescribe the powers and duties of Inspectors

and the qualifications of the authority to which such

Inspectors shall be subordinate and specify 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;

(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 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

(r) sum which may be specified by the Central

Government under 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, 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 therapeutic value

claimed or purported to be claimed for it and that in

the public interest it is necessary or expedient so to

do then, that Government may, by notification in the

28

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 the recommendation of, the Board and

after previous publication 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

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—

(a) provide for the establishment of laboratories for

testing and analysing Ayurvedic, Siddha or Unani

drugs;

(b) prescribe the qualification and duties of

Government Analysts and the qualifications of

Inspectors;

(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;

(d) specify any substance as a poisonous

substance;

(e) prescribe the forms of licences for the

manufacture for sale of Ayurvedic, Siddha or Unani

29

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 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;

(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

of labelling packed drugs and prescribe the matters

which shall or shall not be included in such labels;

(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 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 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

30

1982. A bare 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 Section 26A,

the Central Government must be “satisfied” that any drug 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 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.

31

16.Undoubtedly, Section 26A has to be read with the rest of

the 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 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 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

32

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. 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 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 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.

33

Suppose the Central Government were to ban an FDC on the

ground that, in the recent past, it has been apprised of the fact

that the FDCs taken over a short period of time would lead to

loss of life, 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 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.

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:-

34

“19. Having considered the submissions made by

the learned counsel for the petitioners and the

learned Additional Solicitor 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

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 that all that is stated by this Court is

that, while exercising its power under Section 26A of the Drugs

Act, the basis of the Central 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 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),

35

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 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.

20.We have now to consider certain other arguments made

on behalf of the respondents. One 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 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

36

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. 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

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 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

37

other than those who are board members. This argument,

therefore, is also rejected.

21.Yet another argument has been made that since Section

10A 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. 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 10A and 26A cannot but be said to

be deliberate. This argument also need not detain us further.

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, which is a separate

Chapter introduced by Act 13 of 1964, Ayurvedic, Siddha and

38

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 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 (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 DTAB set up under

Section 5 will apply to all drugs except Ayurvedic, Siddha or

Unani medicines. The Latin maxim “ expressio unius 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 has also been

held in Assistant Collector of Central Excise, Calcutta

39

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 rule flows

from the maxim: “Expressio unius ast exclusio

alterius”. But, as was pointed out by Wills, J.,

in Colguoboun v. Brooks [(1888) 21 QBD 52, 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 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 obstante

clause to keep Section 5 out of harm’s way. On our

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. As has been stated by us

hereinabove, 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.

40

24.An argument was made that unless the provisions of

Section 5 requiring consultation with the DTAB are 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 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 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 …”

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

41

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.

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 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 exemplified in one

of the earliest judgments dealing with the doctrine of

reading down, namely, the judgment of the Federal

Court in Hindu Women’s Rights to Property Act,

1937, In re [Hindu Women’s 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 Act was read down so as not to

include agricultural land, which would be outside the

Central Legislature’s powers under the Government

of India Act, 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:

42

“… 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 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) 11 CLR 689 (Aust)],

Vacuum Oil Co. Pty. Ltd. v. Queensland

[(1934) 51 CLR 677 (Aust)], R. v.

Commonwealth Court of Conciliation

and Arbitration, ex p 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 : 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 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 unconstitutional. In the lead

43

judgment on this aspect by Sawant, J., this Court

stated: (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 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

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

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 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

44

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 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 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 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 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.”

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

45

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.

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 of 2011,

specifically held as under:

“38. Thus, the Act gives in every Chapter, an

indication of the 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 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 significance. It is a well settled

principle of interpretation of statutes that the Courts

are not expected to supply the omission. The

Parliament had 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), 6(2),

7(1), 8(2), second proviso to Section 10, 12(1) and

33(1). But it has deliberately omitted to include any

46

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 if I can

supply into Section 26-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

Karnataka High Court in Lundbeck India Pvt. Ltd. v Union of

India, (2014) 5 Kant LJ 440.

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 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.

47

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

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 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 because 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 exactly the

48

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 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.

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:

(a) that they are likely to involve any risk to human beings or

animals; or

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(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.

34.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. 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 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 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/Sub-Committee to be set up

for this purpose to afford the necessary hearing to all

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concerned, and thereafter submit a consolidated report, insofar

as these FDCs are concerned, to the Central Government

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 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.

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 manufactured pre 21

st

September, 1988, a list of 15 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

51

novo, 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.

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 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 kept 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, 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

52

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 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 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 at serial number 75 under the

category of GI in Annexure C does not appear to be rational

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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,

we accept the report, and accordingly dispose of these petitions

in accordance therewith.

……………………….J.

(R.F. Nariman)

……………………….J.

(Sanjay Kishan Kaul)

New Delhi;

December 15, 2017.

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