Lok Sabha Question No. 3322 (UNSTARRED), answered on 2025-08-08
Subject: Regularisation  of Pharmaceutical Companies
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Bapi Haldar

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA UNSTARRED QUESTION No. 3322 TO BE ANSWERED ON THE 08 TH  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 three months, 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.