MCI circular on generic medicine impractical

The Medical Council of India (MCI), a statutory body that registers and regulates the medical doctors in order to protect and promote the health and safety of the public, issued a circular dated April 21 that all doctors should prescribe medicines in generic only as far as possible and if a doctor violates the same, then suitable disciplinary action would be undertaken by the MCI.

It is to be noted that MCI itself is embroiled in huge corruption and controversial charges. Hence, this circular really did not attract much attention. Subsequently, the news did create a flutter when the prime minister issued a statement just few days prior to the MCI circular at a public event in Surat that the government may bring in legal framework so that doctors prescribe in generics only.

This triggered a series of actions wherein the associations of allopathic doctors, drug manufacturers and chemists ganged-up stating that the circular was impractical because “we cannot assure quality of a drug if prescribed in generics”.

The medical profession is also of the strong view that the judgement to choose a drug vests exclusively with the doctor and this is their right. This means that for ‘quality drugs’ there should be brand names but alas, this has no scientific basis at all. On the contrary, there are studies that have proved beyond doubt that brand names have nothing to do with the quality of the medicines.

A recent study titled “National Drug Survey 2014-2016” by the National Institute of Biologicals, under Ministry of Health and Family Welfare, Government of India, has proved it. The report is based on the results of a survey in which 47,954 samples of drugs were tested across the country revealing that only 13 samples (that is 0.024%) were spurious and as many as 1,850 samples (that is 3.16%) were not of quality.

Interestingly, this report is on their website and makes it clear that even internationally renowned drug manufacturers can produce drugs that are not of quality. For example, the report highlights that Pfizer’s 56.52% were Not of Standard Quality (NSQ).

This multinational drug company is the world’s biggest company with its headquarters in New York with revenue of $53 billion. Similarly, Cipla, an Indian generic company revealed that 3.51% of their drugs were of NSQ.

This company has revenue of $1.6 billion and is one among the top in India. The report also presents that 10% of drugs are substandard in government pharmacies, whereas 3% in retail outlets. Thus, the biggest global and the big one in India are all involved in manufacturing medicines which are questionable in nature.

The only real solution for getting rid of such medicines from the market is that they should be periodically tested by reputed drug laboratories. Such of those manufacturers found to be manufacturing spurious or drugs not of quality should be heavily penalised. All this is part of good governance and no doctor can ever say anything about a drug's quality.

This highlights that the practising physician is not able to identify if a drug is of good quality or not. It needs a good and reputed ‘drug testing laboratory’ that can pinpoint if a drug is of quality or not. Most doctors would shun this and insist that “in my last several years of experience, I find that only this particular brand has effective action”. Unfortunately, such a statement has no scientific validity.

But what the medical and other bodies failed to notice was that none of the drug companies in India manufacture drugs in generic name. So even if a doctor takes initiative and prescribes medicines in generic name, the chemist will have no choice but to say ‘no’. So, the circular by the MCI for all its purpose is impractical.

The core issue is that medicines have to be made available at affordable cost to the consumer. This undoubtedly needs that medicines should be made available in generics. But that is just one important step and should include among its fold a comprehensive list of essential drugs that is updated regularly.

Also, removing from the market irrational and unscientific medicines that constitute at least around 65% of the market as per government’s own assessment and strengthening of the public sector.

Also, irrational and unscientific medicines that constitute at least around 65% of the market as per government’s own assessment should be removed from the market while strengthening the public sector. And above all, there needs to be in place an effective drug price regulation mechanism that is cost-based rather than on the average.

Affordable healthcare

It is unquestionably the priority of the government to make healthcare affordable. More so because the National Health Policy 2017 mentions that 63 million people in India are pushed into poverty due to out-of-pocket expenditure and shockingly the cost of the medicines is a major contributing factor.

The current circular by the MCI puts the entire onus on the prescribing doctors instead of looking at the issue holistically. It is this piecemeal approach by the government that often does more harm to issues that are beyond doubt useful tools for public health.

Let us not forget that in India, the 1975 Hathi Committee had recommended that all brand names in the market should be removed in a phased manner and only generic drugs should be manufactured. The World Health Organisation (WHO) advocates the use of generic medicines as a part of strategy for access to universal healthcare.

India exports generic medicines to around 200 countries including the USA and European countries. Medical students are taught about medicines in generic name only all over the world.

People definitely need healthcare at affordable cost and generic medicines are undoubtedly an important component, however much it may be opposed by the profit-making industries and other lobbies. Is the government listening?

(The writer is president, Drug Action Forum — Karnataka)