Stories
India's Food and Drug Crackdown: Why Strict Rules Aren't Enough for Product Safety
- •India possesses detailed food and drug regulations, but enforcement has historically been inconsistent, leading to a recent push for stricter implementation across various sectors.
- •The effectiveness of regulations is hampered by insufficient enforcement capacity, including infrequent inspections, overburdened laboratories, and delayed penalties, making compliance a calculated business risk for many companies.
- •India's regulatory ambitions have outpaced its enforcement infrastructure, with challenges like staffing shortages, limited resources, and varying compliance standards across states, particularly affecting smaller manufacturers.
- •A key challenge is the lack of a strong compliance culture, where many businesses view regulations as a box-ticking exercise rather than a commitment to quality, often only strengthening controls after external scrutiny.
- •Fragmented accountability among multiple agencies and a lack of transparency in outcomes undermine public confidence; sustainable safety requires continuous monitoring, better infrastructure, and predictable enforcement, not just episodic crackdowns.
Key Questions Answered
India operates on a dual model where the FSSAI acts as the apex national regulator responsible for setting standards and framing policies, while state governments handle the actual implementation, licensing, inspections, and enforcement. Nearly 98 percent of Food Business Operators fall under state licensing regimes.
Since late 2022, regulators have conducted over 960 risk-based inspections and audits, taking enforcement action against about 90 percent of inspected high-risk pharmaceutical facilities. These actions ranged from stop-production orders and licence suspensions to complete cancellations.
In FY 2025-26, the FSSAI conducted 3,97,009 inspections across food establishments and analysed 1,65,747 samples, of which 17.16 percent were non-conforming. This led to 23,580 adjudication cases, 1,756 criminal convictions, Rs 154.87 crore in financial penalties, and 945 food recalls.
