The Pharma Integrity Dossier 2026: from plant to prescriber
Six areas where fraud and misconduct surface in pharmaceutical companies, the rules they are tested against, and the response a regulator expects to see.
1. The market
India's domestic pharmaceutical market reached about US$60 billion in FY26 and is projected to reach US$130 billion by 2030. Exports were about US$31 billion. India is the third-largest producer by volume and supplies around a fifth of global generics.
2. Six areas of risk
- Sourcing, plants and capital projects: kickbacks and bid rigging on API, KSM and packaging; inflated capex; scrap and solvent leakage.
- Quality and data integrity: altered batch, laboratory or stability records and backdated GMP documents.
- Contract manufacturing and IP: leakage of formulations and tech-transfer data; undisclosed conflicts; billing disputes.
- Channel and distribution: trade-scheme leakage, diversion and counterfeits at chemists and online.
- Sales, marketing and HCP engagement: inducements through CMEs, camps, sponsorships or fees; inflated events and field claims.
- Global and hospital markets: rebate and tender manipulation; agents in higher-risk export markets.
3. The rulebook
- UCPMP 2024
- Prevention of Corruption Act, 1988
- Drugs and Cosmetics Act, Schedule M
- USFDA 21 CFR Part 11
- US FCPA
- UK Bribery Act
- Companies Act s.177
- SEBI LODR
- DPDP Act, 2023
- Income-tax Act s.37
4. Schedule M is now enforced
Revised Schedule M was notified in December 2023. MSME units that applied for an extension had until 31 December 2025 to upgrade, and the DCGI has directed state regulators to inspect units for compliance, with action up to suspension or cancellation of licences.
5. Counterfeits reach patients
In the 2025 ASPA–CRISIL survey, a third of consumers had encountered a counterfeit healthcare product in the past year, and only about half check whether a product is genuine before buying.
6. The response
Each risk needs a matched response with a named owner: procure-to-pay and capex forensic reviews; data-integrity investigations on lab systems and audit trails; IP-leakage investigations with device forensics; distributor audits and market surveys; UCPMP review of camps, CMEs, samples and fees; and FCPA and UK Bribery Act risk assessment of agents. A single risk register across all six areas, reported quarterly to the audit committee, turns them into one programme.
Sources
- IBEF, Pharmaceutical Industry in India, Updated Sep 2026.
- BW Healthcare World, Government extends Schedule M deadline for MSME pharma units, Feb 2025.
- The Week (PTI), DCGI orders inspections of pharma units to ensure compliance with revised Schedule M, Nov 2025.
- 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.
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