2026 INSC 1097 1

REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL ORIGINAL JURISDICTION

WRIT PETITION (C) NO(S).323 OF 2021

FEDERATION OF MEDICAL

& SALES REPRESENTATIVES

ASSOCIATION OF

INDIA & ORS. ….PETITIONER(S)

VERSUS

UNION OF INDIA & ORS. ….RESPONDENT(S)

O R D E R

Mehta, J.

1. The present writ petition under Article 32 of the

Constitution of India has been instituted by the

petitioners seeking enforcement of the fundamental

right to health, which forms an integral part of the

right to life guaranteed under Article 21 of the

Constitution of India. Petitioner No.1, Federation of

Medical & Sales Representatives Association of India,

is a Trade Union registered under the Trade Unions

Act, 1926 and is stated to be the only national

organisation representing field workers, having local

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WRIT PETITION (C) NO(S).323/2021

units in about 300 cities and towns across the

country. Petitioner No.2 is the Secretary of petitioner

No.1, whereas petitioner No.3 is the National

Coordinator of Jan Swasthya Abhiyan , an

organisation engaged in health-related issues and

stated to have been working as a watchdog in relation

to the pharmaceutical industry for several decades.

The petitioners have been raising, since 2005,

concerns regarding unethical marketing practices in

the pharmaceutical industry and have been engaging

with the Government seeking an effective regulatory

framework. The issues raised in the present petition,

concerning the regulation of pharmaceutical

marketing practices, the integrity of medical

prescriptions, affordability of medicines and,

ultimately, the protection of the health and lives of

citizens, undoubtedly assume immense public

importance.

2. The principal grievance of the petitioners is with

regard to the alleged prevalence of unethical

marketing and promotional practices adopted by

pharmaceutical companies in their dealings with

healthcare professionals. The petitioners have set up

a case that such practices include, inter alia, direct

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or indirect monetary benefits, gifts, hospitality,

sponsored travel, entertainment and other

inducements extended to medical practitioners with

a view to influencing their drug prescribing practices.

According to the petitioners, such practices have the

potential to result in over-prescription or irrational

prescription of medicines, prescription of drugs in

excess of therapeutic requirements, prescription of

irrational combinations of medicines and a

preference for high-valued or over-priced branded

medicines.

3. The petitioners contend that the consequences

are not confined to an increase in the cost burden

upon patients but extend to serious implications for

public health, including adverse drug reactions,

irrational consumption of medicines and the

emergence of antimicrobial/antibiotic resistance.

They further contend that while the medical

profession is subject to statutory ethical restrictions

governing its relationship with pharmaceutical

companies, including restrictions against acceptance

of gifts, hospitality, travel facilities and monetary

benefits, there is no corresponding enforceable

regulatory regime under which pharmaceutical

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WRIT PETITION (C) NO(S).323/2021

companies can be proceeded against for inducing or

facilitating such conduct.

4. The petitioners contend that the aforesaid

regulatory gap has persisted notwithstanding

repeated governmental recognition of the need to

curb unethical pharmaceutical marketing practices.

It is their case that the Department of

Pharmaceuticals formulated the Uniform Code for

Pharmaceutical Marketing Practices, 2015

1, initially

to be voluntarily adopted by pharmaceutical

companies, but that the voluntary nature of the

UCPMP, 2015 has rendered it ineffective, there being

no adequate statutory mechanism for monitoring,

transparency, accountability or enforceable

consequences for its violation. The petitioners rely

upon the subsequent deliberations and

communications of the Government wherein the need

for statutory backing and mandatory implementation

of the UCPMP, 2015 was acknowledged, as also upon

India’s obligations under the International Covenant

on Economic, Social and Cultural Rights and the

United Nations Convention against Corruption. On

1

For short, “UCPMP, 2015”.

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WRIT PETITION (C) NO(S).323/2021

this basis, the petitioners assert that the absence of

an enforceable legal framework regulating unethical

marketing practices by pharmaceutical companies

has a direct bearing upon the right to health under

Article 21 of the Constitution of India and warrants

appropriate legislative measures and, in the

interregnum, judicial intervention. They accordingly

seek either the conferment of statutory force to the

UCPMP, 2015 or the laying down of appropriate

guidelines by this Court, in exercise of its jurisdiction

under Articles 32, 141, 142 and 144 of the

Constitution of India, until suitable legislation is

enacted.

5. Based on the aforesaid averments, the following

reliefs have been sought by the petitioners: -

“1. To direct the Respondents to give the Uniform

Code of Pharmaceutical Marketing Practices

statutory basis and make it effective by providing a

monitoring mechanism, transparency,

accountability as well as consequences of violations;

2. To direct that till an effective law is enacted as

prayed above, this Hon’ble Court may lay down the

guidelines to control and regulate unethical

marketing practices by pharmaceutical companies

or in the alternative make the existing Code binding

with such modifications/additions as this Hon’ble

Court may find proper and reasonable, which

should be followed by all the authorities/courts

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WRIT PETITION (C) NO(S).323/2021

under Articles 32, 141, 142 and 144 of the

Constitution.

3. For such other order(s) as this Hon’ble Court may

deem fit and proper in the facts and circumstances

of the present case.”

6. This Court issued notice in the present petition

on 11

th March, 2022. Thereafter, the matter was

adjourned from time to time awaiting the responses

of the parties. Vide order dated 18

th November, 2025,

this Court granted Mr. Sanjay Parikh, learned senior

counsel, three days’ time to furnish a brief note

setting out his suggestions and directed that a copy

thereof be shared with Mr. K.M. Nataraj, learned

Additional Solicitor General as well as with Mr. Kapil

Sibal, Mr. Kavin Gulati, and Mr. Gaurav Sharma,

learned senior counsel appearing for the

parties/intervenors. The Court further granted Mr.

Nataraj three weeks to obtain instructions on behalf

of the Union of India and permitted the other

respondents to file their responses. Mr. Kaleeswaram

Raj, learned counsel, was also permitted to forward

his suggestions to the learned Additional Solicitor

General and other counsel appearing for the

respondents.

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7. When the matter was taken up on 16

th

December, 2025, this Court noted that, pursuant to

the order dated 18

th November, 2025, Mr. Sanjay

Parikh, learned senior counsel, and Mr. Kaleeswaram

Raj, learned counsel, had furnished their respective

suggestions to Mr. K.M. Nataraj, learned Additional

Solicitor General, and the other learned counsel

appearing in the matter. Mr. Tushar Mehta, learned

Solicitor General appearing for the Union of India

sought time to deliberate upon the issues with the

concerned officers and place the outcome before the

Court. Thereafter, the matter was taken up on several

occasions, during which the Court was apprised that

deliberations between the concerned authorities were

ongoing and that efforts were being made to arrive at

a concrete solution. The suggestions furnished by the

learned counsel for the petitioners and the

intervenors were also directed to be placed before the

competent authority for consideration. On 28

th July,

2026, noting that sufficient time had already been

granted and that no concrete outcome of the

deliberations had been placed before the Court, this

Court, by way of a last opportunity, deferred the

matter and directed that the decision, if any, taken

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WRIT PETITION (C) NO(S).323/2021

pursuant to the ongoing deliberations be placed

before the Court.

8. When the matter was taken up on 8

th

September, 2026, Mr. Tushar Mehta, learned

Solicitor General, apprised the Court that an affidavit

had been filed on behalf of Respondent No. 1

(Ministry of Chemicals and Fertilizers, Department of

Pharmaceuticals) and Respondent No. 3 (Ministry of

Health and Family Welfare). The affidavit sets out the

deliberations undertaken amongst the concerned

Departments pursuant to the directions of this Court,

with a view to strengthening the regulatory

framework governing pharmaceutical marketing

practices. A meeting was held on 7

th August, 2026

between the Secretaries of the Department of

Pharmaceuticals and the Department of Health and

Family Welfare, wherein the existing framework was

discussed with particular focus on the need for

greater transparency, independent scrutiny and

improved compliance monitoring. Thereafter, a

further meeting was held on 10

th August, 2026 with

representatives of the Indian Drug Manufacturers’

Association (IDMA), Indian Pharmaceutical Alliance

(IPA) and Organisation of Pharmaceutical Producers

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WRIT PETITION (C) NO(S).323/2021

of India (OPPI) wherein the industry associations

apprised the Departments of the existing compliance,

self-declaration, disclosure and complaint-handling

mechanisms and suggested measures for graded

enforcement and greater clarity.

9. So far as medical professionals are concerned,

the affidavit places reliance upon the existing

statutory and regulatory framework governing

professional misconduct, particularly the Indian

Medical Council (Professional Conduct, Etiquette and

Ethics) Regulations, 2002. Regulation 6.8.1 places

restrictions on the acceptance of gifts, travel facilities,

hospitality and cash or monetary grants by medical

practitioners from the pharmaceutical and allied

healthcare industry, while permitting bona fide

medical research subject to the prescribed

safeguards. The said framework further regulates the

professional affiliations of medical practitioners with

the pharmaceutical industry and prohibits them from

endorsing drugs or products of the industry, subject

to the requirements prescribed therein. Violation of

these provisions attracts disciplinary action,

including censure and, in appropriate cases, removal

of the name of the medical practitioner from the

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Indian Medical Register or State Medical Register for

the period prescribed under the Regulations.

10. As regards the pharmaceutical industry, the

affidavit records that the Government proposes to

constitute a three-member Committee to examine the

issues arising in the present proceedings and to make

recommendations as to the appropriate statutory and

regulatory framework for regulating the conduct of

pharmaceutical companies, particularly to ensure

that such companies do not indulge in unethical

practices in their dealings with medical practitioners.

The Committee is intended to consider the existing

regulatory mechanisms, the need for greater

transparency and accountability, and the measures

required to strengthen enforcement, and to place its

recommendations before the Government for

appropriate action. In the meantime, and until the

recommendations of the Committee are considered

and acted upon by the Government, the existing

Uniform Code for Pharmaceutical Marketing

Practices, 2024 (UCPMP, 2024) shall continue to

govern pharmaceutical marketing practices.

11. Mr. Sanjay Parikh, learned senior counsel,

submitted that the present proposal is not the first

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WRIT PETITION (C) NO(S).323/2021

occasion on which the Union of India has constituted

a Committee to examine the issue. He referred to the

counter affidavit dated 28

th September, 2022 filed on

behalf of the Union of India, which records that, on

12

th September, 2022, a High-Level Committee under

the Chairmanship of the Member (Health), NITI

Aayog, with representation from the Department of

Health and Family Welfare, Department of

Pharmaceuticals and the Central Board of Direct

Taxes, was constituted to examine the provisions

governing pharmaceutical marketing practices, align

the interventions of the concerned Departments for

their effective implementation, and consider the

requirement of a legally enforceable mechanism for

regulating such practices, including by studying

practices followed across the globe. The Committee

was expected to submit its recommendations within

90 days. Learned senior counsel submitted that,

despite the constitution of the said Committee, no

concrete outcome has emerged therefrom, and the

issue continues to remain unresolved.

12. However, learned senior counsel in all fairness

submitted that he has no objection to the

constitution of the newly proposed Committee and

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the petitioners do not seek to come in the way of the

process proposed by the Union of India. He fairly

acknowledged that the issues arising for

consideration involve matters of policy, and that the

formulation of an appropriate regulatory framework

must ultimately emerge from a considered decision of

the Union of India. He, however, submitted that such

decision-making ought to be preceded by a

meaningful and effective consultative process,

particularly having regard to the nature and wider

ramifications of the issues inv olved. It was

accordingly urged that the proposed Committee may

take into consideration the suggestions already

furnished by the petitioners and afford the concerned

stakeholders the opportunity to place their views

before it before finalising its recommendations, so

that the ultimate policy decision is informed by a

comprehensive consideration of the competing

concerns and perspectives.

13. The learned counsel appearing for the

intervenors, in substance, adopted the submissions

advanced by learned senior counsel appearing for the

petitioners. They also expressed their desire to place

their respective views and suggestions before the

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WRIT PETITION (C) NO(S).323/2021

Committee to be constituted by the Union of India

and requested that an opportunity for making such

representation be afforded to them.

14. Responding to the aforesaid submission, Mr.

Tushar Mehta, learned Solicitor General,

controverted the submission advanced by learned

senior counsel for the petitioners with regard to the

earlier High-Level Committee, submitting that the

same was not borne out by the record. He submitted

that the issue of strengthening the regulatory

framework governing pharmaceutical marketing

practices had been under consideration of the Union

of India for several years. Various options for

according legal enforceability to the UCPMP, 2015,

including mechanisms under the Essential

Commodities Act, 1955 and the Drugs and Cosmetics

Act, 1940, had been examined. He further submitted

that the High-Level Committee constituted in

September, 2022 under the chairmanship of Dr. V.K.

Paul had specifically examined the requirement of a

legally enforceable mechanism and international

practices and, upon such consideration, had

recommended strengthening the existing framework

rather than making the UCPMP, 2015 statutory at

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that stage. According to the learned Solicitor General,

the recommendations of the said Committee acted as

a catalyst in formation of the UCPMP, 2024, which

has introduced enhanced disclosure and oversight

mechanisms, CEO self -declarations, stricter

provisions relating to gifts, brand reminders,

physician samples and CME activities, defined

timelines for complaints, audit and referral

mechanisms, and the Apex Com mittee for Pharma

Marketing Practices (ACPMP) under the

Chairmanship of the Secretary, Department of

Pharmaceuticals. He thus submitted that the

assertion that the earlier exercise had yielded no

concrete outcome was contrary to the record.

15. We have heard the learned counsel appearing

for the parties at considerable length and have given

our anxious and thoughtful consideration to the

submissions advanced. We have also carefully

examined the pleadings, documents and other

material placed on record.

16. At the outset, this Court considers it

appropriate to observe that the issues arising in the

present proceedings are of considerable public

importance. The matter concerns the adequacy of the

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existing statutory and regulatory framework

governing pharmaceutical marketing practices and

the mechanisms for their implementation,

monitoring and enforcement. This Court is, therefore,

called upon to examine whether the existing

framework adequately add resses the concerns

relating to ethical practices, transparency and

accountability in the pharmaceutical sector, while

keeping in view the larger public interest in

accessible and affordable healthcare.

17. The material placed before us, including the

submissions and material furnished by the

petitioners and the intervenors, indicates that the

existing framework has not proved entirely effective

in preventing and curbing unethical practices in the

pharmaceutical sector. The concerns brought to our

notice are of considerable significance. In a sector

which has a direct bearing upon the health and well-

being of citizens, the efficacy of the regulatory

framework cannot be assessed merely by the

existence of prescribed norms; it must also be judged

by their efficacy, implementation and enforcement.

The material on record, therefore, warrants a careful

examination of the measures required to strengthen

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the existing regulatory mechanism, so as to ensure

that such practices are effectively checked and do not

gain further ground, while safeguarding the larger

public interest in ensuring the availability of ethical,

accessible and affordable healthcare services.

18. This aspect also finds reflection in the stand

taken by the Union of India itself. The material placed

on record demonstrates that the concerns arising in

these proceedings have been engaging the attention

of the involved Departments and have been the

subject of deliberations at the highest level.

Significantly, the Union of India has now proposed to

constitute a Committee to comprehensively examine

the issues arising in the present proceedings and to

make recommendations regarding the appropriate

statutory and regulatory framework for regulating the

conduct of pharmaceutical companies, particularly

with a view to ensuring that pharmaceutical

companies do not indulge in unethical practices in

their dealings with medical practitioners. The

constitution of such a Committee itself reflects the

need for a closer examination of the existing

framework and the measures required to strengthen

it.

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WRIT PETITION (C) NO(S).323/2021

19. The proposed exercise assumes significance as

the efficacy of any regulatory framework depends not

merely upon the standards and obligations

prescribed therein, but equally upon the existence of

effective mechanisms for implementation,

monitoring, transparency and accountability. It is

necessary to ensure that the safeguards incorporated

in the regulatory framework are capable of being

meaningfully enforced in practice, and that

appropriate measures are available to identify,

address and prevent violations. Such a framework

must, ultimately, ensure that the legitimate interests

of the pharmaceutical industry are balanced with the

paramount consideration of protecting patients and

safeguarding the larger public interest in ethical,

accessible and affordable healthcare.

20. At this juncture, it is necessary to bear in mind

the constitutional and institutional contours within

which the present issue falls for consideration. The

regulation of pharmaceutical marketing practices

entails questions of legislative and executive policy,

including the choice of the appropriate statutory

framework, the nature and extent of regulatory

oversight, the permissible contours of industry

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WRIT PETITION (C) NO(S).323/2021

practices, and the mechanisms for monitoring and

enforcement. These matters fall primarily within the

domain of the Union of India and its authorities, who

are better equipped, by virtue of their institutional

expertise and access to relevant material, to assess

the competing considerations and formulate an

appropriate regulatory policy. This Court, while

exercising its constitutional jurisdiction, must

therefore remain mindful of the doctrine of separation

of powers and cannot substitute its own policy

determination for that of the executive. At the same

time, the Court is required to ensure that the

regulatory framework ultimately adopted is

consistent with the constitutional guarantees and the

larger public interest.

21. At the same time, judicial restraint cannot be

understood as requiring this Court to remain

indifferent where the material before it discloses

concerns having a direct bearing upon public health

and the right to health. The present proceedings have

already resulted in a consultative exercise being

undertaken by the Union of India, culminating in the

proposal to constitute a Committee to examine the

issues arising herein and to recommend an

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WRIT PETITION (C) NO(S).323/2021

appropriate statutory and regulatory framework. At

this stage, therefore, the role of this Court is not to

enter into the domain of policy formulation, but to

facilitate a meaningful and effective consultative

process, ensuring that the concerns raised and the

suggestions placed before the Court receive due and

objective consideration. Such an approach would

preserve the institutional boundaries between the

judicial and executive domains while ensuring that

the exercise undertaken by the competent authorities

is comprehensive, informed and capable of

translating into an effective regulatory framework in

the larger public interest.

22. In view of the aforesaid discussion, and having

regard to the constitutional obligation to protect the

right to health as well as the continuing need for an

effective and enforceable framework to regulate

pharmaceutical marketing practices, we consider it

appropriate to exercise our jurisdiction under Articles

32 and 142 of the Constitution of India. The

directions which follow are intended to secure

effective implementation of the existing framework

and to facilitate the ongoing exercise of the Union of

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India towards evolving an appropriate regulatory

mechanism.

23. In exercise of the powers under Articles 32 and

142 of the Constitution of India, and in furtherance

of the constitutional mandate under Article 21, this

Court hereby issues the following directions: -

A. The Union of India shall, if not already constituted,

constitute the Committee proposed by it within a

period of two weeks from the date of this order.

B. The Committee so constituted shall undertake a

holistic and comprehensive examination of all

issues relating to unethical pharmaceutical

marketing practices, including the adequacy of the

existing statutory and regulatory framework, the

efficacy of the mechanisms presently in place for

monitoring, oversight and enforcement, and the

measures required to ensure greater transparency,

accountability and effective compliance, with a

view to strengthening the regulatory framework

and safeguarding the larger public interest.

C. The Committee shall take into consideration the

material already placed on record before this Court

by the petitioners and the intervenors, and shall

also afford them a reasonable opportunity to place

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before it their respective views, suggestions and

concerns. The Committee shall also provide an

appropriate opportunity to other stakeholders

concerned with the subject matter to place their

representations, so as to enable a comprehensive

and informed consideration of all aspects of the

issues under examination.

D. The Committee shall duly consider the

suggestions, representations and concerns placed

before it by the petitioners, the intervenors and

other stakeholders, and shall, upon an objective

and comprehensive consideration thereof, make

its recommendations to t he Union of India

regarding the appropriate regulatory and /or

statutory framework for effectively regulating

pharmaceutical marketing practices, keeping in

view the need for transparency, accountability and

effective enforcement.

E. For the purposes of undertaking an informed,

comprehensive and objective examination of the

issues, the Committee shall be at liberty to seek

the assistance of such technical, professional and

domain experts, institutions or bodies as it may

consider necessary, and may obtain such expert

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inputs as may be required for a proper

appreciation of the regulatory, medical,

pharmaceutical and other relevant aspects arising

for its consideration.

F. The Committee shall endeavour to complete the

entire exercise in a time-bound manner and

submit its recommendations to the Union of India

within a period of two months from the date of its

first meeting, after duly undertaking the

consultative process and considering the material

and suggestions placed before it.

G. The Union of India shall, upon receipt of the

recommendations of the Committee, duly consider

the same and take an appropriate and reasoned

decision at the earliest, having regard to the

constitutional mandate under Article 21 of the

Constitution of India and the larger public interest

involved in ensuring ethical, transparent and

accountable pharmaceutical marketing practices.

24. The Union of India shall file a compliance

affidavit before this Court, setting out the steps taken

pursuant to the aforesaid directions, including the

constitution of the Committee, the date of its first

meeting, the manner in which the consultative

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process has been undertaken, and the progress made

towards completion of the exercise. The affidavit shall

also place on record the recommendations of the

Committee and the decision taken thereon by the

Union of India, together with the further measures

proposed to be undertaken for strengthening the

regulatory framework governing pharmaceutical

marketing practices. The compliance affidavit shall

be filed within two weeks of the expiry of the period

prescribed for completion of the exercise by the

Committee.

25. List on 29

th January, 2027, as Part-Heard, for

consideration of the compliance affidavit to be filed

by the Union of India.

….……………………J.

(VIKRAM NATH )

...…………………….J.

(SANDEEP MEHTA)

NEW DELHI;

OCTOBER 08, 2026 .