Breaking Down India’s Transparency Codes for Pharmaceutical and MedTech Marketing

The codes lay out strict requirements for how companies engage with healthcare professionals (HCPs), covering everything from brand reminders and sample distribution to limitations and in some cases, outright bans—on gifts, travel, hospitality, and monetary support.

This push for accountability comes in the wake of high-profile incidents that raised public and regulatory concern. For instance, Micro Labs was accused of distributing over ₹1,000 crore in freebies to promote its popular paracetamol brand Dolo 650 during the COVID-19 pandemic. Similarly, AbbVie was reportedly involved in sponsoring expensive overseas trips for doctors. These cases have intensified calls for a tighter regulatory framework and stricter monitoring of life science-HCP relationships.

Who the Code Applies To

These codes apply to all pharmaceutical and medical device companies operating in India, including foreign entities involved in local sales or distribution.

The Executive Head (CEO or equivalent) is responsible for affirming compliance, which means ensuring the company has met all restrictions, such as the INR 1,000 per-item cap on brand reminders and the 2% limit on free/evaluation samples (based on domestic sales).

Deadline

The deadline for submitting detailed marketing expenditure disclosures for the financial year 2024–25, initially set for 31 May, has been extended to 31 July 2025. This extension was announced by the Department of Pharmaceuticals (DoP) and Medical Devices Associations in India in May 2025 to allow companies additional time for preparation.

What Needs to Be Reported

Both the codes mandate pharmaceutical and medical device companies operating in India to submit two key documents:

1. Self-Declaration: A self-declaration in the format provided in the annexure of the UCPMP and UCMPMD codes shall be submitted by the executive head of the company within two months of the end of every financial year to the Association to be uploaded on their website. In case the executive head is not a member of such a body, or is a member of more than one body, they can submit the self-declaration directly on the UCPMP portal of the Department of Pharmaceuticals.
2. Marketing Expenditure Disclosure: A detailed breakdown of promotional spend is required to be submitted using the form provided at the end of the both the codes, including:
   • Distribution of free evaluation samples.
   • Sponsorship or organization of CME/CPD activities.
   • Conference, seminar, training, and workshop details (including third-party involvement).

Required data includes corporate identifiers (CIN/FCRN, PAN, address, etc.), event-specific details (dates, locations, organisers), and spend per category. All marketing expenditure disclosures must be uploaded directly on the DoP’s UCPMP Portal.

Enforcement and Penalties

Enforcement primarily rests with industry associations, which are tasked with forming Ethics Committees to review any violations. These committees can:

• Issue formal reprimands and publish the details.
• Recommend recovery of any items or funds provided in violation.
• Escalate severe breaches to government authorities.

Failure to submit disclosures on time, or submitting false/incomplete data, can attract penalties under Section 405 of the Companies Act, 2013, including fines up to INR 3,00,000 for the company and responsible officers. There may also be implications under the Income Tax Act if marketing expenditures are not properly disclosed or are deemed non-deductible.

How to Prepare and Ensure Compliance

With the July 31, 2025 deadline rapidly approaching, companies should act now if they haven’t already. Key steps include:

• Maintaining year-round documentation of all marketing-related activities.
• Verifying compliance with monetary caps and restrictions set in the codes.
• Reviewing all CME/CPD and event-related spend, especially third-party engagements.
• Ensuring the Executive Head is fully briefed and confident in making the self-declaration.

If there’s uncertainty about any provision or disclosure format, companies should consult legal or regulatory experts without delay.

Looking Ahead

As UCPMP and UCMPMD 2024 usher in a major shift toward ethical marketing, pharma and medtech firms must firmly embed transparency, internal controls, and interdepartmental coordination into their strategic DNA. Relying on consistent valuation of samples, meticulous documentation of all HCP engagements—especially indirect benefits—and proactive disclosures will be non-negotiable to mitigate regulatory, tax, and reputational risks. With the Ethics Committees actively monitoring compliance and empowered to enforce penalties, a tech-enabled audit infrastructure becomes essential.

CEOs and executive heads must champion this initiative, ensuring alignment across sales, finance, legal, and medical affairs, underpinned by clear legal frameworks and training programs. In light of the strengthened mandates, adopting this forward-looking, integrated compliance posture isn’t just prudent—it’s imperative for sustaining trust, managing costs, and preserving your licence to operate.

For prompt and thorough evaluation of your existing compliance framework, book a discovery session with us today.

An FAQ-based resource for more details on the code:

• arogyalegal.com
• www.pib.gov.in