The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024

What’s in Today’s Article?

• Why in News?
• Need for the UCPMP 2024
• Highlights of the UCPMP 2024 on Ethical Practices of Pharma Companies
• Highlights of the UCPMP 2024 on Drugs
• Implementation of the UCPMP 2024

Why in News?

The Department of Pharmaceuticals issued the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.

Need for the UCPMP 2024

• The UCPMP 2015 for Pharmaceutical as well as Medical Device Industry is being implemented (w.e.f. 1.1.2015) to prevent unethical practices by the pharmaceutical companies.
• Much of the criticism that this version of the code attracted was related to its voluntary nature. There was no legal backing to its provisions and it therefore remained toothless.
• There has been a long-pending demand of various health activists to make it mandatory. Even the 2017-18 annual report of the Department of Pharmaceuticals insisted on making it mandatory.
• While the government has now removed the word ‘voluntary’ from the code, which was there in the previous version, it has stopped short of making it mandatory.
• It has now merely ‘requested’ the pharmaceutical companies’ associations to see to it that the code is ‘implemented’.

Highlights of the UCPMP 2024 on Ethical Practices of Pharma Companies

• Engagement of the pharmaceutical industry with healthcare professionals for Continuing Medical Education (CME) should only be allowed -
  • Through a well-defined, transparent, and verifiable set of guidelines, and
  • Conduct of such events in foreign locations is prohibited by the uniform code.
• Medical representatives must not use any incentive and must not pay for access to a healthcare practitioner.
• Companies or their representatives should not pay cash or monetary grants to any healthcare professional or their family members (both immediate and extended) under any pretext.
  • Gifting is prohibited by any pharmaceutical company or its agent (distributors, wholesalers, retailers, etc).
• Additionally, no pecuniary advantage or benefit in kind may be offered, supplied or promised to any person qualified to prescribe or supply drugs by any pharmaceutical company or its agent.
• Paid travel, hotel stays should not be extended to healthcare professionals or their family members by pharmaceutical companies or their representatives, unless the person is a speaker for a CME, etc.
• The Union government has allowed firms to provide research grants for healthcare professionals, provided these are done in a transparent manner.
• The guidelines allow the industry to support research for studies authorised by bodies such as the Indian Council for Medical Research or the Drug Controller General of India.

Highlights of the UCPMP 2024 on Drugs

• On drugs, the UCPMP states that promotion of a drug must be consistent with the terms of its marketing approval.
• Claims for the usefulness of a drug must be based on up-to-date evaluation of all available evidence.
• The word ‘safe’ must not be used without qualification, and it must not be stated categorically that a medicine has no side effects, toxic hazards, or risk of addiction.
• The word ‘new’ must not be used to describe any drug which has been generally available or any therapeutic intervention which has been generally promoted in India for more than a year.

Implementation of the UCPMP 2024

• The UCPMP is to be circulated for strict compliance, and all associations have been requested -
  • To constitute an Ethics Committee for Pharmaceutical Marketing Practices,
  • Set up a dedicated UCPMP portal on their website, and
  • Take further necessary steps for the code’s implementation.
• All Indian pharmaceutical associations are to upload the UCPMP on their website along with the detailed procedure for lodging of complaints.
  • This will be linked to the UCPMP portal of the Department of Pharmaceuticals.

Q1) What is the Drug Controller General of India (DCGI)?

DCGI is the head of department of the Central Drugs Standard Control Organisation of the Government of India responsible for approval of licences of specified categories of drugs in India.

Q2) What is the Indian Council for Medical Research (ICMR)?

The ICMR is the apex body in India for the formulation, coordination and promotion of biomedical research and is one of the oldest (formed in 1911) and largest medical research bodies in the world.

Source: Govt releases guidelines to curb unethical pharma sector practices | TH | The Wire