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New Pharma Code To Curb Unethical Marketing Push

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On March 12th, the Department of Pharmaceuticals announced a new regulation that forbids pharmaceutical corporations from providing travel and gift cards to medical practitioners or their relatives. The distribution of free samples to those who are not authorized to prescribe such a medicine is prohibited by the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) 2024. It is requested that all associations form an Ethics Committee for Pharmaceutical Marketing Practices (ECPMP), establish a UCPMP portal on their website, and take other appropriate actions to put this Code into effect.

General Points

  • Following the 'Ethical Criteria for Medicinal Drug Promotion,' which were endorsed by the World Health Assembly in 1988, "Promotion" refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase, and/or use of medical drugs.
  • The terms of a drug's marketing approval must be followed; a drug cannot be promoted before receiving its marketing approval from the appropriate authority, authorizing its sale or distribution.
  • Information about drugs must be impartial, current, verifiable, and free from direct or implicit misrepresentation.
  • Information about drugs must be balanced, current, verifiable, accurate, and free of substantiation; this information must be provided with the drug.

Ethics Committee For Pharma Marketing Practices

  • Every Indian Pharmaceutical Association will post the UCPMP on their website, along with a comprehensive complaint procedure that links to the Department of Pharmaceuticals' UCPMP portal. 
  • Each Association will establish an Ethics Committee for Pharma Marketing Practices (ECPMP), chaired by the Association's chief executive officer, to handle complaints. The Association Board will adopt the Committee's composition, which will be clearly displayed on its website, and it will consist of three to five members. 
  • When a complaint is received by one association and it doesn't pertain to its members, that association will enter the complaint's abstract and appropriately forward it to another association.
  • If a complaint received by one association does not pertain to its members, the receiving association will enter the complaint's abstract and properly forward it to another association in which the respondent company is a member. 
  • All pharma associations will post on their websites the specifics of complaints they receive, such as the type of complaint, the company the complaint is against, and the current status of the complaint. 
  • The Pharma Industry Association, to which the complainant has submitted the complaint, should normally handle complaints from businesses that are either not members of any associations at all or that belong to several associations. It will consult the Department of Pharmaceuticals for advice if needed. 

Handling Of Complaints

  • The "Ethics Committee for Pharma Marketing Practices (ECPMP)", "Chief Executive Officer", or "Name of Association" should receive all complaints pertaining to violations of the code.
  • To the greatest extent possible, all complaints regarding an alleged violation of the code have to be submitted at once. The complaint is to be filed within six months of the alleged Code violation, with an additional six months allowed for a legitimate delay that can be documented in writing. The Ethics Committee may combine related complaints into one group to accelerate processing and save time.
  • When an entity is found to have violated the Code, the Committee may suggest taking one of the following measures against the erring entity
  1. To banish or suspend the organisation from the Association
  2. To censure the organisation and make public all the specifics of such censure.
  3. To mandate that the entity release a corrective statement via the same (and other appropriate) media that was utilised to release textual or audio visual promotional material. The entity must submit details about the proposed content, mode, and timing of the corrective statement's dissemination to the Committee for approval in advance. 
  4. To request that the entity retrieve money or items that were given to individuals in contravention of the Code from them; the entity must provide the Committee with a written account of the steps it took in this respect. 
  5. The Committee may, through the Department of Pharmaceuticals, forward its recommendations to any government agency or body that, according to the statute, has the power to take disciplinary, criminal, or remedial action.
  • Ultimately, the company's chief executive officer bears the responsibility for adhering to this code. To that end, within two months of the end of each fiscal year, the executive head of the company must submit a self-declaration in the format provided in the annexure to the Association for uploading on their website. Alternatively, if he is not a member of any such body, he may submit it directly to the Department of Pharmaceuticals' UCPMP portal.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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