India needs a law to check drug marketing malpractices

The entire pharmaceuticals industry as well as the medical community has become embroiled recently in a controversy involving ethical issues with consumers looking on as concerned bystanders. The issue has been taken right up to the Supreme Court by the Federation of Medical and Sales Representatives Associations. The public interest litigation filed by the organisation alleges that the makers of a particular paracetamol brand have been giving freebies valued at over Rs 1000 crores to doctors to prescribe their product. The question that arises, however, is whether this is just an isolated case or whether such incentives are rampant in the pharma sector. It is quite possible that during the course of this case, many skeletons in the cupboard of the industry may come tumbling out.

It is clear that while examining the issue, paramount importance needs to be given to consumers interests since prescribing the correct medicine is critical in the health sector. In the case of paracetamol, it is widely accepted that it is the drug of choice for dealing with fever and inflammation in respect to many diseases. As far as Covid is concerned, medical experts have been advising that patients should avoid other formulations for controlling fever and focus only on the generic drug, paracetamol. This suggestion has metamorphosed into doctors prescribing a particular brand, Dolo 650, though the same strength of paracetamol is available from other manufacturers.

My own personal experience during the recent bout of Covid indicated the widespread use of this particular brand. A friend asked whether I was having Dolo 650 during my Covid infection recently. She was concerned that my doctor was not giving the correct advice as 'everyone' is now recommending this drug. My own doctor, on the other hand, merely enquired whether the 500 mg dose was working for me. And on my saying yes, she advised me to continue taking it. She also informed that the 650 dose was available from other manufacturers. Whether such options have been given to most patients is not yet known.

The PIL filed by the federation has also put the spotlight on regulations to ensure that best practices are followed by the medical community. It turns out that there is a code of ethics, known as the uniform code for pharmaceutical marketing practices (UCPMP). It governs the conduct of pharma companies in their marketing practices. The snag is that it is a voluntary code and therefore not legally binding on the industry. The federation has urged the court to ensure that this code is given statutory status and thereby allow companies to face penal action.

Health sector activists, on the other hand, have argued that marketing malpractices need to be brought under the ambit of the new draft Drugs, Medical Devices and Cosmetics bill. This will ensure that these come under the Health Ministry rather than the Department of Pharmaceuticals. This will put the focus on consumers' interests, they maintain, rather than those of industry while considering ethics of marketing practices.

The medical practices issue needs to be viewed in the backdrop of the present status of the Indian pharma industry. The size of the industry is estimated at 42 billion dollars currently and is expected to rise to 65 billion dollars by 2024, according to the Economic Survey. India is the world's largest supplier of generic medicines accounting for 20 per cent of the worldwide supply by volume and provides about 60 per cent of the global vaccination demand. Exports are estimated at about 24.35 billion dollars in 2020-21 and growth is expected to be of the order of 18 per cent annually.

The indigenous pharma industry is the third largest in the world in volume terms and the 14th in terms of value. It is thus not only one of the country's largest economic segments but also a major player on the global stage.

Given the fact that the domestic pharma sector plays a significant role not just within the country but abroad, it is imperative to ensure that it follows ethical rules while carrying out marketing practices. Consumers need to be reassured that medical practitioners are providing the best possible service to them without being influenced by monetary or other incentives given by pharma companies. The experiences of other countries in this regard need to be taken into account while formulating policies. For instance, there has been a huge crisis of opioid addiction in the US in the past with medical practitioners routinely prescribing pain medication without advising about the potential of addiction to such drugs. Now, however, strict regulations have been introduced to govern the relationship between the pharma industry and the medical community.

In fact, it would be advisable for the government to seek out models of such regulations in other countries where these have worked successfully to protect consumers interests. The first step should be to ensure that the voluntary code is converted into a statutory one. It should also be revised to take into account the new technology that is transforming the healthcare sector.

It would not be advisable to view the PIL being considered by the apex court as a matter revolving around only one company. Instead it should be taken up as an industry-wide malaise. It is not possible that only one company has been offering incentives to doctors as it is an open secret that wooing of the medical community is a regular marketing feature of the pharma industry.

In fact, it would be better if the government were to resolve this issue by strengthening regulatory mechanisms rather than leaving it to the courts. The present litigation has only put the spotlight on a malady in the healthcare and pharmaceutical industry. It is for the executive to cure the disease by taking firm action that will reassure consumers that their health is in the right hands.