Lok Sabha Question No. 3449 (UNSTARRED), answered on 2022-08-05
Subject: Uniform Code of Pharmaceutical Marketing Practices
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Nalin Kumar Kateel, D.K. Suresh, Hasmukhbhai Somabhai Patel

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

LOK SABHA UNSTARRED QUESTION No. 3449 TO BE ANSWERED ON THE 5 th  AUGUST, 2022

## Uniform Code of Pharmaceutical Marketing Practices

## 3449.   SHRI NALIN KUMAR KATEEL:

SHRI D.K. SURESH:

SHRI PATEL HASMUKHBHAI SOMABHAI:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a)  whether  it  is  a  fact  that  the  Government  has  proposed  a  voluntary  Uniform  Code  of Pharmaceutical Marketing Practices (UCPMP) for marketing of drugs, if so, the details thereof; (b) whether it is a fact that there are several instances of violation of the voluntary UCPMP by pharma companies in the country;
- (c) if so the details thereof;
- (d) whether the pharmaceutical companies are indulging in unfair and unethical practices to promote their medicines by sponsoring trips and offering gifts to doctors;
- (e) if so, the details thereof and the steps taken by the Government to check such unfair and unethical practices;
- (f) whether the Government has received representations from civil societies and patients group to make the UCPMP mandatory; and
- (g) if so, the details thereof and the action taken by the Government in this regard?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI BHAGWANTH KHUBA)

(a) to (c):   The Government has put in place a Uniform Code for Pharmaceutical Marketing Practices (UCPMP) for Pharmaceutical companies, which is in operation since 01.01.2015, to prevent unethical practices by the pharmaceutical companies. This code governs the conduct of pharmaceutical companies in their marketing practices, duly covering the various aspects such as medical representatives, textual and audio-visual promotional materials, samples, gifts, etc.  Further,  the  code  establishes  relationship  with  healthcare  professionals,  wherein  the provisions related to travel facilities, hospitality and cash or monetary grants to physicians or their families have been elaborated.

The  code  also  details  the  mode  of  operation  of  the  code,  responsibilities  of  the Pharmaceutical  Associations  in constituting the  Ethics  Committee  for  Pharmaceutical Marketing Practices (ECPMP) for handling the complaints and Apex Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) for review, procedure of lodging a complaint, procedure of handling of complaints by the Pharmaceutical Associations and various penalty provisions.

The  code  has  been  adopted  by  the  all  the  major  associations  of  pharmaceutical companies and the Department on various instances has reviewed implementation of the code by the Pharmaceuticals associations.

The complaints of violation of the voluntary UCPMP by pharma companies which are perceived by the Department are forwarded to the concerned associations for taking necessary action.

(d)  and  (e):  The  Indian  Medical  Council  (Professional  Conduct,  Etiquette  and  Ethics) Regulations, 2002 formed under Indian Medical Council Act, 1956 (102 of 1956), provides for conduct  for  doctors  and  professional  association  of  doctors  in  their  relationship  with pharmaceutical  and  allied  health  sector  industry. Under  this,  any  complaint  of  professional misconduct of a medical practitioner or professional is to be addressed by the respective State Medical Councils.

Besides UCPMP, there exists sufficient and enforceable legal regime to counter, control and  dis-incentivize  the  unethical  marketing  practices  such  as  'Indian Medical Council Professional  Conduct,  Etiquette  and  Ethics)  Regulations,  2002'  under  the  Indian  Medical Council Act, 1956, provisions available under the Income Tax Act, Drugs and Cosmetics Act, Prevention of Corruption Act, etc.

(f) & (g):  The Department has not received any representations in the recent past from civil societies and patents group to make the UCPMP code mandatory. Further, in the writ petition (Civil)  No.  (s).323/2021  filled  by  federation  of  the  Medical  and  Sales  Representatives Associations  of  India  &  others  against  Union  of  India  and  others,  the  matter  is  under consideration of Hon'ble Supreme Court of India.

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