Enforceable Marketing Code for Pharma and Medical Device Companies

In a significant stride towards promoting responsible and ethical practices to be adhered by the pharmaceutical and medical device companies, the Department of Pharmaceuticals (DoP) notified the Uniform Code for Pharmaceuticals Marketing Practices, 2024 (UCPMP) on March 12, 2024.

UCPMP builds upon its predecessor, the Uniform Code for Pharmaceuticals Marketing Practices (2015 Code), which came into effect on January 1, 2015. There was an anticipation for a considerable time that the 2015 Code would be enforced as a codified law, but it remained as a set of guidelines that could be voluntarily followed by pharmaceutical companies with respect to marketing practices.

Until the UCPMP was notified as law, there was no law to regulate the marketing practices of pharmaceutical or medical device companies in India. As lawyers advising healthcare companies on issues related to marketing practices over the years, the legal advice was primarily based on the good practices set out in the voluntary 2015 Code, and the code of pharmaceutical practices issued by the Organization of Pharmaceutical Producers of India (OPPI Code). Wherever any such practice required interaction between healthcare companies and medical doctors, the healthcare companies were advised to align their marketing practices with the provisions of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (MCI Regulations) which prescribe the code of conduct and ethics to be adhered to by medical doctors.  

To a good extent, the UCPMP imbibes the elements of its predecessor, the voluntary 2015 Code, the OPPI Code and the MCI Regulations. But unlike the 2015 Code and the OPPI Code, the UCPMP is not limited to a prescription of good marketing practices for healthcare companies but provides legal force to the code of conduct to be adhered to by both pharmaceutical and medical device companies.

a) Drug Promotion

The promotion of a drug must be consistent with the terms of its marketing approval and be promoted only after receipt of marketing approval from the competent authority. The information about drugs must be balanced, up-to-date, verifiable and not misleading.

Any comparisons made between drugs must be factual, fair, and capable of substantiation, safeguarding against any misleading claims or undue emphasis.

Emphasis has been on accurate and fair claims used for the promotion of a drug. The word “safe" must not be used without qualification and categorical assertions about a medicine having no side effects, toxic hazards, or risk of addiction are prohibited. The word "new" must not be used to describe any drug that has been generally available, or any therapeutic intervention that is generally promoted in India for more than a year.

b) Promotion Material

The UCPMP prescribes conditions for promotional material that is circulated to healthcare professionals or is otherwise generally made available through mails, journals and audio-visual mediums. Among these conditions, UCPMP prohibits the use of names or photographs of healthcare professionals in promotional materials and mandates adherence to principles of professionalism and integrity.

c) Medical Representatives

Medical representatives (which has been defined to include sale representatives, including those retained by way of contract with third parties) are required to maintain a high standard of ethical conduct in the discharge of their duties, refraining from employing any inducements or subterfuge to gain access to healthcare professionals.

Healthcare companies will be responsible and accountable for the activities of the medical representative and therefore, such companies are to ensure compliance with UCPMP by their respective medical representatives. The UCPMP categorically mentions that third parties working for and on behalf of pharmaceutical companies who are authorised to undertake any activity regulated by the UCPMP should also have sound working knowledge of the requirements of the UCPMP.

d) Brand Reminders

The UCPMP establishes regulations regarding brand reminders distributed by pharmaceutical companies to healthcare professionals. Permissible items include informational and educational materials such as books, calendars, diaries, journals (including e-journals), dummy device models, and clinical treatment guidelines. These items are allowed as long as their individual value does not exceed ₹1,000. The distribution of free samples is permissible under stringent conditions, including on the quantity.

e) Continuing Medical Education

The UCPMP provides that continuing medical education (CME), continuing professional development (CPD), and events such as conferences, seminars and workshops should only be allowed through a well-defined, transparent and verifiable set of guidelines based on which the pharmaceutical industry may undertake such expenditures.

The UCPMP stands clear that such events are not to be conducted in foreign locations; details of the events including expenditure incurred by the companies are to be shared on the company’s website and organizers are required to disclose the procedure followed to select the participants and speakers. To serve the purpose of transparency, the UCPMP contemplates that such event-related information may be subject to a random audit.

f) Studies and Research

Pharmaceutical companies and healthcare professionals can collaborate to drive research and innovation, provided such study and research is authorized by a competent authority in India and the engagement of the healthcare professional is in consultant-advisory capacity under a consultancy agreement.

g) Gifts, Travel, Hospitality and Monetary Grants - Relationship with Healthcare Professionals

The UCPMP establishes strict guidelines regarding the relationship between pharmaceutical companies and healthcare professionals. It prohibits the offering of gifts, hospitality, or monetary grants for personal benefit in alignment with the MCI Regulations. The travel and hospitality facilities are only permitted if the person is a speaker for a CME or a CPD programme.

h) Enforceability Mechanism

The responsibility of enforcing the UCPMP is primarily of the Indian pharmaceutical associations, which is to be discharged through an internally constituted ethics committee. The central and pivotal role is of the DoP, being (a) the authority that oversees the complaint redressal procedure; and (b) the authority that is vested with the power to issue standing orders in furtherance of UCPMP.

• Ethics Committee for Pharma Marketing Practices (ECPMP)

  The UCPMP requires each pharmaceutical association to establish of a three to five-member ECPMP chaired by its chief executive officer. The member composition is to be approved by the association's board and made public on its website. This committee is to address complaints related to violations of the UCPMP.

• Complaint Redressal

  The complaint redressal procedure codified under the UCPMP follows an approach which facilitates the DoP to oversee the entire process. The complaint lodging process and all relevant details of the complaint are to be uploaded on the association’s website and also be linked/ uploaded on the UCPMP portal of the DoP.

  The complaints regarding any breach of the UCPMP are to be lodged with the respective association’s ECPMP within six months of the alleged breach. Each complaint is to be in writing, accompanied by evidence, and a nominal non-refundable fee. Media reports suggesting any breach of the UCPMP may be treated as complaints and the ECPMP may request the concerned publication for further information.

  Following the submission of a complaint, the ECPMP promptly initiates an inquiry process. ECPMP decisions are reached by majority consensus.

• Penalties

  In case of a breach of UCPMP being established, the ECPMP has the authority to take appropriate action, including suspension or expulsion from associations, reprimands, requisition for corrective measures or requisition for the company to recover money or items wrongfully advanced in violation of UCPMP. Additionally, if the disciplinary or remedial actions fall under the government's jurisdiction, ECPMP can submit its recommendations to the appropriate authorities through the DoP.

  Those unsatisfied with the order of ECPMP have the option to appeal to a committee for pharma marketing practices headed by the Secretary of the DoP (referred to as the “Apex Committee for Pharma Marketing Practices”).

• Fixation of Responsibility

  The UCPMP contemplates the managing director or chief executive officer of the healthcare companies to be responsible for adherence to the UCPMP. Accordingly, upon receipt of a complaint by a pharmaceutical association, the managing director or chief executive offer is required to provide a complete response to the information submitted to the association in relation to the complaint. Furthermore, the executive head of the company is required to submit a self-declaration confirming adherence to the UCPMP in a prescribed form within two months of the end of every financial year to the association.

The UCPMP does not refer to medical device companies while explaining the regulations but clearly provides that it is applicable to medical device companies. Therefore, the constituents and conditions of the UCPMP have to be read and construed accordingly.

The standards for ethical marketing practices and related accountability measures prescribed under the UCPMP may not be new to the industry. However, the industry is not acquainted with the consequences that can follow an established breach of the UCPMP, which are of a serious nature. This is a good time for healthcare companies to revisit their existing contracts and policies on marketing and engagement of third parties for the performance of promotional activities.

There are certain aspects that may require clarity from the DoP as healthcare companies make their way to implement the UCPMP. This includes clarity on the authority which will formulate the guidelines for CME, CPD and educational events and if any power for audit will be vested with the associations.

It will be interesting to see in future if the consequences for a breach of the UCPMP could trigger a connected violation of provisions of other regulations applicable to the pharmaceutical and medical device companies.

About the authors: Ritika Ganju is the Managing Partner of Rise Legal. Yash Gangwani is an Associate at the Firm.