Think seriously about state capacity

Notes on prescribing generic drugs

Medical Council of India (MCI) regulations require all doctors to prescribe drugs using pharmacological names (like Paracetamol) instead of brand names (like Dolo). The regulation is directed at doctors who get kickbacks from pharmaceutical companies to prescribe their drugs.

Over the last few months, the case of Kishan Chand Jain v Ethics and Medical Registration Board has been listed before the Chief Justice’s bench in the Supreme Court. The petition wants the regulation enforced strictly and coercively: conduct surprise raids, track prescriptions, take disciplinary measures.

But this won’t solve the problem. The MCI has already issued circulars warning strict disciplinary action if doctors irrationally prescribe brand names. Before we demand court orders, we must grapple with the structural reasons why the regulation has been ineffective.

The regulation against prescribing brand names failed because the knowledge and the capacity to enforce it didn’t exist and still does not exist. The monitoring of lakhs of prescriptions and the conduct of raids in tens of thousands of hospitals is a difficult task. There is significant discretion in the hands of frontline officials. The stakes are high – a mistake means punishing an innocent doctor.

Who is to carry out this task? Under Indian law, it is the state medical councils (SMCs) or, if an SMC does not exist, the Ethics and Medical Registration Board (EMRB). SMCs are not capable of implementing the regulation consistently and fairly. Few medical councils have a public complaints procedure or publish their proceedings or penalties issued. And that is if a functioning state medical council exists in your state at all. A study by the Vidhi Centre for Legal Policy has found that state medical council laws have not been implemented in many states.

Theoretically, in these cases, the Ethics and Medical Registration Board (EMRB) is supposed to step in. But it has been three years since the National Medical Commission Act 2019 came into force, and the five-member EMRB has three vacant seats, including that of its president. The EMRB, therefore, is not a promising backstop.

Some will argue that a lack of capacity should not prevent the government or the medical councils from making regulations. Perhaps an order from the Supreme Court or a push from the Ministry for more stringent enforcement might have positive effects. This is a common pattern in Indian regulation. Often, there is a sudden push from the ministry or a court to strictly enforce a law or a regulation.

We must be wary of the tendency to authorise enforcement first and build capacity later. There is little reason to welcome enforcement actions by an organisation with low capacity. Some officers will go to hospital after hospital, pharmacy after pharmacy, and evaluate prescriptions en masse. They will be compelled to meet unrealistic targets by making an arbitrary number of enforcement actions. In the haste to show results, and in the absence of procedural safeguards, enforcement has a tendency to become unjust and coercive.

Instead, thoughtful and effective regulation involves a more comprehensive analysis. It involves thinking carefully about the problem, assessing the jurisdiction and powers of the regulator, evaluating the costs and the benefits of the regulation, and drafting it precisely so that it obtains the intended outcome. It involves thinking about technical feasibility and procedural safeguards before authorising a single enforcement action. It means acquiring a more sophisticated regulatory toolkit.

In contrast, MCI Regulations contain vague drafting and moralistic exhortations to doctors. They should be revised top to bottom. Societies may have many preferences about how doctors should act. These preferences should only be regulations if the government has the capacity to enforce them. The alternative is a regulator with wide powers and low capacity — a combination which almost uniformly produces poor results.

There are other ways to promote the use of generic drugs. We can work on making doctors more sensitive to price, and making both patients and doctors more aware of generic alternatives. Union and State governments can improve pharmaceutical regulation, make it easier to trust generic drugs in the market, and regulate the marketing activities of pharmaceutical companies. While these measures are difficult, they are more practical than nation-wide enforcement actions that seek to assess the legality of each prescription.