Executive Summary:
The Ministry of Chemicals and Fertilizers addresses unethical marketing practices in the pharmaceutical industry, specifically concerning gifts and incentives offered to medical professionals. The response refers to the Drugs and Magic Remedies Objectionable Advertisements Act, 1954, the Indian Medical Council (IMC) Regulations, 2002, the Income-tax Act, 1961, and the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024. The UCPMP 2024 replaced UCPMP 2015 following a review and recommendations by a High-Level Committee.
Key Points / Main Content:
Legal Framework Against Unethical Practices:
* Advertising of drugs for diseases listed in the Drugs and Magic Remedies Objectionable Advertisements Act, 1954, is prohibited.
* The IMC Regulations, 2002, prohibit doctors from receiving gifts, cash, monetary grants, travel facilities, or hospitality from pharmaceutical companies. Penalties for violations include censure and removal from medical registers.
* Section 37 of the Income-tax Act, 1961, disallows income tax deductions for pharmaceutical companies' expenditures on gifts and incentives to doctors violating the IMC Regulations, 2002.
* UCPMP, 2024, prohibits gifts and incentives to doctors and their families, with penalties including recovery of money/items, reprimands, and publication of details.
UCPMP Implementation and Enforcement:
* The UCPMP 2024 replaced the earlier UCPMP 2015, based on recommendations from a High-Level Committee and stakeholder consultations.
* Seven complaints were received under UCPMP 2015 and UCPMP 2024 in the last five years, with one company reprimanded for offering incentives.
Disclosure and Transparency:
* UCPMP 2024 requires pharmaceutical companies to disclose expenditures on continuing medical education/professional development events and the value of free samples given to doctors.
* IMC Regulations, 2002, mandate doctors to disclose funding sources from the pharmaceutical sector for research/study and affiliations with pharmaceutical industries.
Public Health and Prescription Integrity:
* The government promotes rational drug prescription and curbs unethical marketing via the IMC Regulations, 2002, the Income-tax Act, 1961, and UCPMP, 2024.
* Rule 65(11A) of the Drug Rules, 1945, prevents pharmacists from substituting prescribed drugs in Schedules H, H1, or X.
Impact Analysis:
Pharmaceutical Companies:
Impact: Cannot offer gifts or incentives to doctors and must disclose expenditures on medical education events and free samples. Cannot claim income tax deductions for expenses violating IMC Regulations, 2002.
Action Required: Comply with UCPMP 2024 guidelines, disclose required expenditures, and cease unethical marketing practices.
Medical Professionals:
Impact: Prohibited from accepting gifts or incentives from pharmaceutical companies. Must disclose funding sources for research and affiliations with the pharmaceutical industry.
Action Required: Adhere to IMC Regulations, 2002, disclose financial relationships, and avoid accepting prohibited benefits.
Pharmacists:
Impact: Cannot substitute prescribed drugs with other preparations for drugs listed in Schedules H, H1, or X.
Action Required: Ensure compliance with Drug Rules, 1945, specifically Rule 65(11A), to maintain prescription integrity.
Public:
Impact: Aims to protect public health, ensure prescription integrity, and restore trust in the healthcare system by curbing unethical marketing practices.
Action Required: No direct action required; benefits from increased transparency and ethical practices in the pharmaceutical and healthcare sectors.
Key Entities Referenced
Uniform Code of Pharmaceutical Marketing Practices: A voluntary code issued by the Department of Pharmaceuticals to regulate the marketing practices of pharmaceutical companies. It aims to prevent unethical marketing and ensure responsible promotion of pharmaceutical products.
UCPMP, 2015: The initial version of the Uniform Code of Pharmaceutical Marketing Practices, effective from January 1, 2015.
UCPMP, 2024: The revised version of the Uniform Code of Pharmaceutical Marketing Practices that replaced the earlier UCPMP, 2015.
Drugs and Magic Remedies Objectionable Advertisements Act, 1954: An Indian law that restricts advertising of drugs for diagnosis, cure, mitigation, treatment, or prevention of certain diseases and conditions.
Indian Medical Council Professional Conduct, Etiquette and Ethics Regulations, 2002: Regulations established under the Indian Medical Council Act, 1956, that govern the professional conduct, etiquette, and ethics of medical practitioners, including restrictions on receiving gifts and incentives from pharmaceutical companies.
Indian Medical Council Act, 1956: An act of the Parliament of India to provide for the reconstitution of the Medical Council of India, and the maintenance of the Indian Medical Register and for matters connected therewith.
Incometax Act, 1961: An Indian law related to income tax, where Section 37 disallows income tax deductions for pharmaceutical companies offering gifts and incentives to doctors in contravention of the IMC Regulations, 2002.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India, responsible for policy and regulation related to the pharmaceutical industry.
GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
DEPARTMENT OF PHARMACEUTICALS
LOK SABHA
UNSTARRED QUESTION No. 3322
TO BE ANSWERED ON THE 08TH AUGUST 2025
Regularisation of Pharmaceutical Companies
3322. Shri Bapi Haldar:
Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:
(a) whether the Government is aware of the fact that pharmaceutical companies are
continuing to offer gifts and incentives to medical professionals to promote their products;
(b) if so, whether such practices are in violation of the Uniform Code of Pharmaceutical
Marketing Practices (UCPMP), if so, the number of complaints/violations reported during
the last five years and the action taken therein;
(c) whether the Government plans to conduct a review of the efficacy of UCPMP, if so, the
details thereof;
(d) whether there is any proposal to make the code legally binding with enforcement
provisions, if so, the details thereof;
(e) whether there is any regulatory mechanism put in place to ensure full disclosure and
transparency in doctor–pharma financial relationships, including through mandatory
reporting of such transactions, if so, the details thereof; and
(f) the steps being taken by the Government to protect public health interests, ensure
prescription integrity and restore trust in the healthcare system by curbing unethical
marketing practices?
ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND
FERTILIZERS
(SMT. ANUPRIYA PATEL)
(a) to (d): Under the provisions of the Drugs and Magic Remedies (Objectionable
Advertisements) Act, 1954, advertising of any drug for diagnosis, cure, mitigation,
treatment or prevention of any disease, disorder or condition specified in the Schedule to
the said Act is barred. The said Schedule covers most of the prevalent diseases, disorders
and conditions and, therefore, pharmaceutical companies are required to rely on doctors to
promote their products.
The legal regime to counter, control and disincentivise unethical marketing
practices of pharmaceutical companies that offer gifts and incentives to doctors includes
the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
(“IMC Regulations, 2002”) made under the Indian Medical Council Act, 1956 and section
37 of the Income-tax Act, 1961. Under the IMC Regulations, 2002, a doctor is prohibited
from receiving any gift or cash or monetary grants from any pharmaceutical or allied health
care industry. Further, a doctor and his/her family member are prohibited from accepting
incentives in form of travel facilities and hospitality from pharmaceutical or allied
healthcare industry. Penalties under the said regulations include censure, removal from the
Indian Medical Register or the State Medical Register of a doctor for a period of threemonths, six months, one year or more than a year, depending on the value of cash, gift,
travel or hospitality received in contravention of these regulations.
Under section 37 of the Income-tax Act, 1961, any expenditure to provide benefits
to a doctor that contravenes the IMC Regulations, 2002 is not an allowable expenditure.
Consequently, pharmaceutical companies cannot claim an income tax deduction for gifts
and incentives to doctors.
Further, with the aim of preventing unethical marketing and ensuring responsible
promotion of pharmaceutical products by regulating interactions between doctors and
representatives of pharmaceutical companies, the Department of Pharmaceuticals initially
issued the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), 2015,
effective from 1.1.2015.
Following review and examination of pharmaceutical marketing practices and
alignment of interventions for effective implementation among healthcare providers and
industry by a High-Level Committee constituted by the Government, and detailed
consultations with stakeholders and analysis of domestic and international practices, based
on the committee’s recommendations, the Government has recently replaced the earlier
UCPMP with UCPMP, 2024. The said committee, while examining the matter, also
observed that UCPMP may not be made statutory, as there already exists a statutory
framework, namely, IMC Regulations, 2002.
UCPMP, 2024 explicitly prohibits the offering of gifts and incentives such as
monetary grants, travel facilities and hospitality to doctors or their family members. The
prohibitions are backed by penalties, which may include recovery of money or items from
the persons concerned, reprimand for the pharmaceutical entity and the publication of full
details thereof.
During the last five years, a total of seven complaints were received under UCPMP,
2015 and UCPMP, 2024, which were disposed of in accordance with the provisions of
UCPMP. In these cases, a company was reprimanded in one case for offering incentives
like travel and hospitality to doctors and details were published on the website of the
Department of Pharmaceuticals.
(e): UCPMP, 2024, requires pharmaceutical companies to disclose their expenditures on
continuing medical education / continuing professional development events and the value
of free samples given to doctors. Under the IMC Regulations, 2002, doctors are required
to disclose the source and amount of funding they receive from the pharmaceutical and
allied health sector for research and study. Doctors are also required to disclose their
affiliations with pharmaceutical and allied healthcare industries, if they work in any
professional capacity, such as an advisor, a consultant, a researcher or a treating doctor.
(f): The Government is promoting rational prescription of drugs and curbing unethical
marketing practices through the framework of the IMC Regulations, 2002, the Income-tax
Act, 1961 and UCPMP, 2024. These are intended to protect public health interests, ensure
prescription integrity and restore trust in the healthcare system. Further, prescription
integrity of drugs is also ensured through sub-rule (11A) of rule 65 of the Drug Rules, 1945,
which provides that a pharmacist or any other person dispensing a prescription containing
drugs specified in Schedule H and H1 or Schedule X of the said rules cannot substitute the
prescribed drug with any other preparation.
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