A hasty prescription for doctors

Less than 0.1 per cent of the drugs manufactured in India are tested for quality. This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are non-negotiable. Rather than taking the NMC route, the government should take the pharma route and ban all branded drugs. The government allows several categories like branded, branded generic and generic, and permits pharma companies to sell the same product at different prices. Such loopholes in the law should be plugged.

Unfortunately, in recent years, both the art and science of medicine have been eroded by commercial interests and politics. The NMC move, which has been on the cards for quite some time, seems to have gained momentum due to political expediency. In 2017, while inaugurating a hospital in Surat, Prime Minister Narendra Modi announced that his government was planning to mandate that doctors prescribe generic drugs only. Following this up, the prime minister made a statement in London in 2018 that doctors prescribed branded medicines because of their nexus with pharmaceutical companies.

The IMA, in a strongly worded letter to the prime minister’s office expressed anguish: ‘Indian doctors are known and respected for their proficiency not only in India but across the world, where countries like the UK and the US have acknowledged it time and again. Maligning the medical fraternity in a foreign land in a language which is derogatory to the core is not expected from the prime minister.’ The IMA was concerned that such statements from the prime minister would harm doctor– patient relationships too.

Modern medicine is a strong weapon, which has equal potential to harm and to heal if not used carefully. There should be a proper blend of the art and the science of medicine. Unfortunately, with regulations rolled out in unholy haste due to political expediencies and commercial interests, without sound science, we are killing the art and putting the health of the people at risk.

Decoding the Debate

The current issue in India is the disparity between two kinds of generics—branded generics vs unbranded generics. The critics of the NMC decision are basically demanding that the regulators do their job and ensure that all drugs in the market are of assured quality.

• Globally, companies marketing a generic drug do not have to conduct trials on the drug’s efficacy (which the company with the patented drug had to undertake to get a licence). But the manufacturers of generics do have to provide evidence that their drug is similar to the patented one in all characteristics. The FDA and European regulators insist on bioequivalence studies to make sure that a generic drug works as well as the patented one.

• However, in India, companies making/ selling generic drugs are not asked by regulators to conduct bioequivalence studies before getting the licence to sell the drug. Thus, quality is not assured.

Moreover, the statement from the prime minister and the recent NMC guidelines make the chemists the scapegoats, using the assumption that they will pick the lowest-priced brand.

The IMA’s concerns both on the PM’s statements earlier and the recent NMC guidelines are legitimate. These have nothing to do with kickbacks to doctors from pharma but with the sorry state of India’s drug regulatory framework as well as the judgment and intuition based on personal experience of doctors practising the art of medicine.

These doctors through trial and error recommend those brands of generics which have shown efficacy in their practice. This is also reflected in price differences between different brands of medicine based on the patterns driven by the experience of practising doctors. Science unfortunately has not kept pace with the expanding pharmaceutical industry in the country.

Thakre and Patil in the medical journal Indian Pediatrics narrate their personal experience and rue the poor drug regulations in the country. When they prescribed generic drugs, there was difficulty in getting the medicine because of the ignorance of the pharmacist or the drug being unavailable, a substitute being offered, a branded drug given, or patients being told by the pharmacist not to buy because of doubtful potency and safety.

The patients were left totally confused and were at a loss about how, where and whether to buy this ‘new’ medicine. Such experiences made the authors wonder whether prescribing generics really is a smart initiative.

Our regulations are lax and have not kept pace with drug development. Studies showing equivalence of generics to branded products originate from countries with stringent regulations and cannot be extrapolated to our country as the regulatory environment prevailing in India is not robust, raising questions on whether the generics are as effective as branded drugs.

The drug regulatory system in the country suffers from inadequate human resources and infrastructure. We have ill-equipped drug testing laboratories, with inadequate documentation, pharmacovigilance and databases.

With serious shortcomings in the center–state coordination in the implementation of the Drugs and Cosmetics Act and Rules, there is an urgent need for transparency and accountability. Though some steps have been implemented, they are far from satisfactory.

Guidelines drafted in unholy haste for doctors to prescribe generic drugs go against both the art and science of medicine.

Policymakers should ensure the availability of quality generic drugs before regulating doctors, who seem to have become the bête noire of all and sundry. They should first set in place stringent quality control at all levels of the manufacturing chain, including for stability under Indian climatic conditions. Without these in place, thoughtless implementation of policy is like putting the cart before the horse and to add insult to injury, flogging the latter.

The Truth Pill by Dinesh Thakur and Prashant Reddy has devoted a whole chapter to the shortcomings in quality control of generic drugs in India. It is essential reading for all stakeholders, including the citizens of India, lest they get swayed by demagogy, endangering their health.

When doctors lose autonomy due to overregulation, they lose the art. With the sabotage of science, the vacuum is filled with politics and commercial interests—but it is human lives that are at stake.

Source: National Herald, NMC,

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