Essay · Section A19 September 2026

The question 'Is this drug safe?' cannot be answered by the state alone; it requires a coalition of the state, the market, and civil society.

A counterfeit drug enters the market when three systems fail simultaneously: the state fails to regulate, the market fails to self-police, and civil society fails to blow the whistle. Today's paper carries stories of drug enforcement tightening (CDCS vigilance), the regulatory split between central and state authorities (Drugs and Cosmetics Act), and the persistent success of spurious-drug networks in exploiting those gaps. Each story points to the same underlying problem: the state has tried to own the entire problem of drug safety, and in doing so, has diluted the incentives that would otherwise activate the market and civil society to solve it together.

The regulatory architecture is the culprit. The Drugs and Cosmetics Act vests manufacturing and import approval with the central authority (CDSCO, headed by the Drugs Controller General of India) but vests licensing for manufacture and sale with state drug controllers. This split made sense in 1940, when communications were slow and states needed local enforcement capacity. It makes no sense now. A fake drug is manufactured in one state, transported through a third, sold in a fourth, and consumed in a fifth — but no single authority owns the entire trail. The state drug controller in the manufacturing state has no incentive to prevent manufacture (it generates revenue and employment locally); the state drug controller in the selling state has no incentive to prevent sale (she does not bear the health consequence, the consuming state does). Responsibility is diffused, and diffusion breeds negligence.

The market, meanwhile, has no standing in this arrangement. A pharmaceutical company that invests in R&D and regulatory compliance cannot compete on quality against a counterfeiter who invests in none; instead, it competes on price, on kickbacks to doctors, on direct-to-consumer advertising that makes unverifiable claims. The incentive structure punishes legitimate entry and rewards regulatory arbitrage. A chain pharmacy that could police its suppliers is discouraged from doing so (it would raise costs and lose customers to cheaper competitors). The market mechanism that would ordinarily screen out the worst actors is disabled by the regulatory architecture.

Civil society — patients, doctors, pharmacists, social workers in rural areas — sees counterfeits but has no channel to report them that leads to action. A doctor who prescribes a drug and sees an adverse outcome has no systematic way to flag whether the drug was counterfeit or inherently unsafe. A patient who buys a drug at a small-town chemist has no simple recourse if it fails. These gaps are not incidental; they are structural. The state has assumed that it alone will guarantee drug safety, leaving civil society disempowered and dependent.

The solution is not to centralise everything (that is what we have now, and it is failing). The solution is to redistribute power: give states authority to revoke licenses immediately for counterfeiting (without waiting for a central hearing), create a public database of licensed chemists with real-time verification so patients can check before buying, mandate pharmacists to report adverse outcomes, reward chain pharmacies that exceed regulatory standards with tax breaks or preferential purchasing by government hospitals, and publish pharmacy inspection reports so consumers can compare. In each case, you are shifting from a model where 'the state guarantees safety' to a model where 'the state creates the conditions under which legitimate firms and aware consumers guarantee safety together.'

The hard political truth: states resist such redistribution because it means losing revenue (unlicensed chemists pay informal taxes) and losing employment (cracking down on counterfeiters will reduce local manufacturing jobs). The Centre is captured by the pharmaceutical lobby, which prefers weak states (whom it can negotiate with) to a strong, transparent licensing system (which would expose how many practising chemists have no qualification). The remedy is political will: the prime minister has to say, loudly and publicly, that drug counterfeiting is killing Indians, that the state's current role is inadequate, and that every stakeholder — states, firms, civil society — has to accept accountability. That is what the Antibiotic Stewardship Programme tried to do; what the Public Examinations Act tries to do now. Drug safety deserves the same sustained attention. It is not a technical fix; it is a political choice about who bears responsibility and who is empowered to act.