Pharmaceuticals
From plant to prescriber, the integrity programme a regulator expects to see.
The issues clients bring us.
- Data integrity at plants and labs
- UCPMP 2024 compliance
- HCP-payment reporting in US operations (Sunshine Act)
- Counterfeit medicines
- Distributor diversion and scheme leakage
- Export-market bribery risk
What we do about them.
- UCPMP Compliance and HCP Spend Assurance
- Sunshine Act and Open Payments assurance for US operations
- Data-integrity investigations
- Distributor and trade-scheme audits
- Anti-counterfeiting programmes
- Global head-of-investigations support
Keep the record with BDI's governance tools.
The numbers behind the risk.
The pharmacy of the world, now held to tighter manufacturing, marketing and data standards at home and abroad.
Regulatory and market updates
- Revised Schedule M enforcement
MSME units that applied for extension had until 31 December 2025; the DCGI has ordered state regulators to inspect units for compliance.Source: The Week (PTI)
- UCPMP 2024
The Uniform Code for Pharmaceutical Marketing Practices 2024 bans gifts to healthcare professionals, caps samples, bars CME events abroad and requires event spend to be published, with a self-declaration by the executive head within two months of each financial year.Source: Nishith Desai Associates
- UCMPMD 2024 for medical devices
A parallel Uniform Code for Marketing Practices in Medical Devices was notified in September 2024, extending similar rules on gifts, samples, hospitality and self-declarations to device companies.Source: Outlook Business
- Biopharma SHAKTI
₹10,000 crore over five years announced in the Union Budget 2026-27 to build biopharma capability.Source: IBEF
An import-dependent market building local manufacturing, with a regional role in distribution that brings exposure to diversion and counterfeits.
Regulatory and market updates
- Health insurance growth
Health premiums rose 16.3% to Dh30 billion in 2025, raising the stakes on provider and claims fraud.Source: Khaleej Times, citing the CBUAE annual statistical report
- AML reach into trade
The 2025 AML law expands obligations relevant to trade in high-value goods and regional distribution.Source: Hadef & Partners
- 03BiotechnologyProtecting the science, the data and the people behind it.
- 03Life SciencesMedical devices, diagnostics and CDMO services under global scrutiny.
- 03Hospitals & HealthcareClinical excellence depends on clean procurement, honest billing and protected patient data.
- 03Nutraceuticals & OTCFast-moving brands sold through every channel, and copied in every channel.
Platforms referenced: Whistle SentinelIP Octopus M2Pactinex
Sources
- IBEF, Pharmaceutical Industry in India, Updated Sep 2026.
- The Week, on the ASPA–CRISIL State of Counterfeiting in India 2025 report, 35% of Indians encountered fake products in one year; online platforms account for 53% of purchases, Mar 2026.
- The Week (PTI), DCGI orders inspections of pharma units to ensure compliance with revised Schedule M, Nov 2025.
- Nishith Desai Associates, Code for pharmaceutical marketing practices refurbished: no room for non-compliance, Mar 2024.
- Outlook Business, Government notifies uniform marketing code for medical devices sector, Sep 2024.
- The National, on an ADQ white paper, UAE pharma market to be valued at $4.7bn by 2025, Feb 2022.
- Khaleej Times, citing the CBUAE annual statistical report, UAE insurance premiums jump 15% to Dh74.8 billion, Aug 2026.
- Hadef & Partners, A new era for AML/CTF/PF in the UAE: Federal Decree-Law No. 10 of 2025, Oct 2025.
- Department of Pharmaceuticals, Government of India, Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, Mar 2024.
- KPMG in India, Navigating the new regulatory terrain: UCPMP 2024, Mar 2024.
- Centers for Medicare & Medicaid Services, Open Payments: covered recipient review and dispute, Accessed Oct 2026.
- Baker Donelson, Medicare spreads Sunshine Act coverage to new categories of payment recipients, 2019.
- Arnold & Porter, Manufacturers may face issues and concerns under the Physician Payments Sunshine Act, Jul 2014.