Unhealthy prescription

Promoting generics is the wrong way to address a problem

The National Medical Commission’s (NMC’s) regulation stipulating that doctors prescribe only generic drugs, failing which they would be liable to be penalised, represents a flawed diagnosis of a chronic problem. The stricture on generic prescriptions has been in place since 2002; having been observed mostly in the breach, the NMC has sought to give teeth to the rule by adding penal provisions that could include suspension of the licence. The NMC has posited this as a pro-patient move, arguing that generic drugs — those that have the same ingredient as an equivalent brand-name drug and offer the same effect — are 30 to 80 per cent cheaper than branded drugs and are likely to lower healthcare costs. It has observed that out-of-pocket medication accounts for a major proportion of public health spending. These concerns are valid but the NMC’s regulation, which came into effect on August 2 and is being protested by the medical fraternity, could cause fresh problems.

There is no doubt that the generics-only rule will play its part in weakening the notorious nexus between doctors and pharmaceutical companies that perpetuates corruption and is hard to track or control. The new rule, however, shifts the balance of power to chemists and pharmacies rather than the patient. Currently, there is no restriction on them to stock generics, but they prefer not to because of low profit margins. Even under the new rules, it would be easy for pharmacists to offer a relatively expensive branded version of the drug prescribed. That would defeat the intended purpose of the regulation. It could also have the unintended consequence of strengthening the nexus between pharma companies and chemists’ networks, which already exist thanks to the lax practice of allowing patients to buy drugs without valid prescriptions.

Although India’s pharma industry has historically developed robust capabilities of reverse-engineering expensive drugs that go off-patent and manufacture them at a fraction of the cost — cancer and AIDS drugs being two honourable examples — poor monitoring standards have contributed to the proliferation of sub-standard or outright fake medicines. The Indian Medical Association (IMA), a medical practitioners’ body, avers that only 0.1 per cent of medicines undergo quality checks. While manufacturers counter that it is not possible for inspectors to check every batch, the recent scandal involving the supply of contaminated children’s cough syrups to Africa is an example of good manufacturing practices observed more in the breach. Pharma sector experts admit that there are generics in the market that did not undergo bioequivalence studies to gauge their efficacy.

Given this reality, doctors fear that the uncertain quality of generic medicines will compromise the efficacy of their treatment. A loss of reputation is one consequence, and a serious one in a profession that relies substantially on references. In hospitals and clinics, the threats could multiply if sub-standard generics produce suboptimal results. Here, doctors routinely face the prospect of physical harm inflicted by irate relatives of patients (a predicament enhanced by the near-impossibility of filing malpractice lawsuits). If the NMC regulation has one virtue, it is to insist that prescriptions be written legibly, an important rule given that medical practitioners are reputed for their poor handwriting. In its other details, the new rule is likely to create another kind of generic problem in health care.