Marketing Code For Pharmaceutical Companies Gets Tougher: A Comparison Of The 2024 And 2014 Codes – Healthcare

The Department of Pharmaceuticals has introduced the new Uniform
Code for Pharmaceuticals Marketing Practices (UCPMP), 2024,
significantly tightening the regulatory framework surrounding
pharmaceutical marketing practices. The Department has notified the
new Uniform Code for Pharmaceuticals Marketing Practices (UCPMP),
2024 (2024 Code) in place of the previous
voluntary Code, Uniform Code for Pharmaceuticals Marketing
Practices (UCPMP) (2014 Code). Notably, the 2024
Code introduces significant changes in how breaches of the Code by
pharmaceutical companies are handled, with a significant shift
towards greater accountability for pharmaceutical companies. The
key differences between the 2024 and 2014 Codes and implications
for industry are discussed in our alert.

• The 2014 Code required the information about drugs to be up-to
  date, verifiable and accurately reflect current knowledge or
  responsible opinion. The New Code has added one more criterion to
  be fulfilled and requires the information to be also
  “balanced“, while maintaining the above
  criteria.




• The ambit of comparison of drugs and the care to be taken by
  pharmaceutical companies were wide in the 2014 Code. While the 2014
  Code mentioned that the care must be taken in the manner mentioned
  therein, or “any other way“, the 2024
  Code states that care must be taken by the pharmaceutical companies
  in the manner prescribed there in or in any other
  “similar” way.




• The 2024 Code has introduced the term “Brand
  Reminders” to the Code, which includes in its purview
  (i) informational and education items and (ii) free samples
  provided by the companies to medical professionals. The 2014 Code
  however only mentions free samples. More guidelines on Brand
  Reminders given below:




• • Under the 2024 Code, informational and educational items refers
    to books, calendars, diaries, journals (including e-journals),
    dummy device models and clinical treatment guidelines for
    professionals used in healthcare settings. The value these items
    should not exceed Rs. 100 per item. The 2024 Code permits Brand
    Reminders for the above items, as long as they do not have an
    independent commercial value for healthcare professionals.

  
  

  • With respect to free samples, the 2024 Code has made the
    following changes that shall be observed while providing
    samples:

  
  

  • • The companies should note the name and address of the
      healthcare practitioner to whom samples of products are
      distributed.

    
    

    • Samples are provided only for the purpose of creating awareness
      about treatment options and for acquiring experience in dealing
      with the product.

    
    

    • Sample packs should be limited to prescribed dosage for not
      more than three patients for the required course of treatment.

    
    

    • A company is permitted to offer not more than twelve sample
      packs per year per drug to any healthcare practitioner.

    
    

    • The earlier requirement of procuring a signed and dated request
      for supply of sample packs has been done away with.

    
    

    • The monetary value of samples distributed should not exceed two
      percent of the domestic sales of the company per year.




• The 2024 Code clarifies that as long as receipt of Brand
  Reminders by healthcare practitioners does not amount to
  recommendation or issuance of a statement by a healthcare
  professional with respect to use of the brand, it will not be
  construed as endorsement activity.




• The 2024 Code also requires the supplier and the receiver of
  the Brand Reminders to comply with the relevant provisions of the
  Income Tax Act, 1961 with respect to deductions and reporting of
  income.




• An entire section on Continuing Medical Education (CME) has
  been added to the 2024 Code. Pharmaceutical companies are permitted
  to engage with healthcare professionals and incur expenditure for
  CME, Continuing Professional Development (CPD) or otherwise for
  conferences, seminars, workshops, etc., only through a
  well-defined, transparent, and verifiable set of guidelines. The
  following framework has been developed in order to achieve the
  above:




• • Conducting of events in foreign locations is prohibited.

  
  

  • CME/CPD meetings are permitted to be conducted only by:

  
  

  • • Medical Colleges/Teaching
      Institutions/Universities/Hospitals

    
    

    • Professional Associations of Doctors/Specialists

    
    

    • NIPERs, Laboratories of ICMR, DBT, CSIR etc., Pharma
      Colleges/other academic and research institutions

    
    

    • Pharmaceutical companies, including their trusts/associations,
      either alone or in collaboration with professional bodies,
      institutions as stated in a, b & c above.

  
  

  • Pharmaceutical companies conducting such events are required to
    share on their website, details of the events conducted, including
    the expenditure incurred which may be subject to independent,
    random and risk-based audit for this purpose.

  
  

  • The 2024 Code also requires companies to publish the procedure
    followed in the selection of participants and speakers, display a
    statement of their funding sources and expenditures on their
    website, which may be subject to special audit for this
    purpose.

  
  

  • The companies organizing such events and incurring expenditure
    must be compliant with the provisions under the Income Tax Act,
    1961.




• In order to encourage research and innovation, the 2024 Code
  permits interaction between pharmaceutical companies and healthcare
  professionals with certain restrictions:




• • The said study or research should be one that has the requisite
    approval from the competent authority such as ICMR, DGCI, Ethics
    Committee, etc. It also requires compliance with the instructions
    by relevant bodies such as the National Medical Council;

  
  

  • Engagement of healthcare professionals in a consultant-advisory
    capacity shall be for bona-fide research services, under a
    consultancy agreement involving a consultancy fee or an
    honorarium-based payment (in compliance with the Income Tax Act,
    1961).

  
  

  • The engagement of healthcare professionals mentioned above must
    also ensure that patients interest is not compromised and integrity
    of the healthcare professional is maintained as per the NMC
    regulations.

  
  

  • The expenditure by pharmaceutical companies on research
    activities through healthcare professionals has been permitted,
    subject to compliance with the provisions of the Income Tax Act,
    1961.




• The 2014 Code prohibited pharmaceutical companies from
  providing travel facilities for vacations or professional events
  like conferences, seminars, workshops, or Continuing Medical
  Education (CME) programs to healthcare professionals and their
  families, necessitating that these individuals bear their travel
  expenses. However, the updated 2024 Code introduces a significant
  modification by allowing pharmaceutical companies to offer travel
  facilities to healthcare professionals, but exclusively when they
  are serving as speakers for CME or Continuing Professional
  Development (CPD) programs. In keeping with this, similar
  restrictions are also imposed for extending hospitality services,
  unless the person is a speaker for a CME or a CPD programme.




• As against the 2014 Code, the 2024 Code requires a committee
  named as “Ethics Committee for Pharma marketing Practices
  (ECPMP)” to be constituted by all the
  Pharmaceutical Associations in India with the following roles and
  responsibilities:




• • The Committee to consist of 3 to 5 members (as against the 2014
    Code which required a 3 member committee) and chaired by its Chief
    Executive Officer (the 2014 Code required the committee to be
    represented by the Executive Head and not below the rank of a
    Director). The composition of the committee will be approved by the
    Board of the Association and prominently placed on its
    website.

  
  

  • In case a complaint is filed with an association not concerning
    its members, the same is to be transferred to the relevant
    association.

  
  

  • If a company is a member of multiple Associations, or is not a
    member of any association, complaints are to be dealt with by the
    Pharma Industry Associations.

  
  

  • The Pharmaceutical Associations are required to share on their
    website, the details of complaints received, including the nature
    of complaint, the company against whom the complaint has been made,
    the status of the complaint and any action taken by ECPMP.

  
  

  • The duration for maintaining the above details on the website
    of the association has been increased from 3 days to 5 days. It
    also requires that the above should be uploaded on the UCPMP portal
    of the Department of Pharmaceuticals.




• The 2024 Code has also made certain changes to the procedure
  for lodging complaints:




• • Where the complaints used to be earlier addressed to the
    Secretary General/ Chairman/President, now, under the 2024 Code,
    the complaints are to be addressed to the Chief Executive Officer
    of the Association.

  
  

  • The 2014 Code required a complaint to be registered within 3
    months of the breach. Whereas, the 2024 Code has relaxed this
    requirement and provides a time of 6 months with an additional 6
    months (for reasonable delay to be explained in writing).

  
  

  • The 2024 Code has clarified that no pseudonymous or anonymous
    complaints or any complaints made without the prescribed fee will
    be entertained.




• In the provisions of how the complaint is to be handled, the
  2014 Code provided that even if a complaint is withdrawn, the
  process of enquiry must be completed. Although such explicit
  terminology is not found in the 2024 Code, it requires that the
  process of enquiry be taken up and completed.




• The time period for the Company to respond to a complaint has
  been increased from 10 days to 30 days in the 2024 Code. Similarly,
  the time period for the committee to render a decision has also
  been increased from 30 days to 90 days.




• Under the 2024 Code, in case the Committee decides that there
  is a breach of the Code, the Committee is required to advise on
  remedial measures that need to be taken. In the 2014 Code, the
  Committee was merely required to provide reasons for its
  decision.




• The 2014 Code provided for the following penalties if the
  Company is found to be in breach of the Code. These penalties are
  also reflectedin the new 2024 Code. These include




• • suspending the company from the Association it is a member
    of;

  
  

  • to reprimand the company and publishing full details of such
    reprimand on their websites;

  
  

  • to require the company to issue a corrective statement (textual
    or audio-visual) in the same media which was used to promote the
    material;

  
  

  • to ask the entity to recover the money or items given in
    violation of the Code.

The 2024 Code enhances the authority of the overseeing
Committee, empowering it to forward its recommendations to relevant
agencies or authorities via the Department of Pharmaceuticals. This
means that companies found violating the Code could be scrutinized
by statutory bodies and held accountable under pertinent
legislation, such as the Drugs and Cosmetics Act, 1940, and its
associated rules and regulations. Consequently, regulatory bodies
like the Drugs Controller General of India (DGCI) or the Central
Drugs Standard Control Organization (CDSCO) may recognize these
breaches and enforce the recommended penalties or actions under
their regulations. The Appeals Committee of the Pharmaceutical
Marketing Practices (ACPMP) is also vested with similar enforcement
powers.

• By terming it as “Appeal” and not “Review”
  as mentioned in the 2014 Code, the Apex Committee for Pharma
  Marketing Practices (ACPMP) under the 2024 Code, has made the
  following changes:




• • A period of 15 days has been provided for filing the Appeal,
    with an additional 15 days (by providing reasons for the delay in
    writing),. The 2014 Code provided for a period of merely 5 days for
    filing this Appeal.

  
  

  • As against the 2014 Code, which provided a period of 10 days
    for filing of response to the review, the new Code merely states
    that the ACPMP shall give notice to both the parties. A reasonable
    opportunity of being heard will be given the final decision must be
    provided within a period of six months.

The 2024 Code has eliminated the previous requirement from the
2014 Code that mandated pharmaceutical companies to comply with
decisions made by the erstwhile AECPMP. Specifically, the
obligation for companies to submit an undertaking within five days,
affirming the cessation of any promotional activities or the
retrieval of items distributed in violation of the 2014 Code, has
been removed.

• The 2024 Code also does not require the final decision of the
  Appeal and the corrective measures/actions taken by the Company to
  be uploaded on the website of the Association, as was provided
  under the 2014 Code.

Next Steps for Pharma / Medical Devices Companies

• The Chief Executive Office of companies will have to
  provide a self-declaration in the format given, within two months
  of the end of every financial year to the Association for uploading
  on their website, or directly on the UCPMP portal of the Department
  of Pharmaceuticals in case he is not a member of such a body, or a
  member of more than one such bodies.




• Companies shall have to issue and/ or modify the terms
  of appointment of medical representatives to bring it line with the
  Code.




• Companies shall have to monitor and record the size,
  packaging, and distribution of the free samples of its
  products.




• Promotional and advertising material including audio
  visual media, has to now confirm strictly to the restrictions
  placed in the 2024 Code, including but not limited to comparisons
  and healthcare professionals endorsements.

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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