Express Pharma

Will FMRAI’s PIL finally prod govt to make UCPMP mandatory?

As COVID-19 continues to extract its price, will a more aware patient pool build up public opinion and turn the tide?

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The Federation of Medical and Sales Representatives Association of India (FMRAI) had filed a PIL in the Supreme Court in March, asking the government to make the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) a statutory code.

As per reports, the PIL shows that the top seven pharma companies together had spent Rs 34,187 crore in marketing over eight years. The data cited in the PIL shows that these costs make up 20 per cent of the cost of drugs and include direct and indirect benefits to doctors such as gifts, entertainment, trips, and hospitality.

The PIL, therefore, seeks to make pharma companies criminally liable for bribing doctors through freebies, as in this situation, the customer pays for branded medicines that are “over-prescribed” or “irrationally prescribed” by doctors, as per the PIL.

The PIL’s rationale that a statutory basis to UCPMP will provide transparency and accountability in the process is a given. However, the UCPMP has remained a voluntary code for over a decade. Each time previous such PILs prodded the government to make it mandatory, industry associations gave assurances that the code was the best self-regulation strategy.

However, this time, as COVID-19 continues to extract its price, will a more aware patient pool build up public opinion and turn the tide?

The FMRAI’s PIL got a fresh lease of life when Micro Labs, makers of one of the most visible brands of the COVID times, Dolo-650, was hauled up in early August by the Central Board for Direct Taxes (CBDT) for tax evasion. The CBDT accused the company of distributing freebies worth Rs 1,000 crore to push prescriptions of Dolo-650.

In media reports, Jayaraj Govindaraju, Executive Vice President of Marketing and Communication for Micro Labs has rubbished these allegations, reasoning that it was unfeasible to spend that sum on marketing when his company’s turnover during the COVID year was Rs 350 crores. While allowing that the sum would be in the range of around Rs 5-6 crores, he disclosed this would have been used to supply items like “normal samples, pens, writing pads, small printed books, hand sanitisers and masks,” specifying that “no major so-called freebies or big gifts were given to doctors” to prescribe Dolo-650. He also refuted the PIL’s allegation that the company chose an irrational grammage of paracetamol to avoid price control and overcharge the patient, pointing out that Dolo650 was part of the COVID kit prescribed by government hospitals for patients who tested positive.

Micro Labs is not the only company to have increased sales during the pandemic. Bar and Benchreported that FMRAI’s lawyer cited similar increased sales of the anti-viral Remdesivir during the COVID-19 pandemic.

Nevertheless, the larger point is that while margins might be small for paracetamol, this logic does not hold for all medicines. Especially lifesaving medicines for cancer, rare diseases, etc. COPD patients on inhalers and diabetics who need life-long insulin injections are just a few examples of patients depending on the ethical diagnosis and prescription of doctors to live healthy lives.

Industry associations like IPA, IDMA and OPPI have always claimed that their member companies adhere to the UCPMP and do not incentivise doctors. There are now promises to review the allegations and make more efforts to sensitise their member companies to the requirements of the Code.

Will the problem reduce if the government could ensure that doctors prescribe generics and not selected brands? However, should we trust chemists more than doctors? After all, they too stand accused of being part of the same unholy nexus!

While we can hope that the next hearing of FMRAI’s PIL scheduled on September 29 will lead the way to a lasting solution, a pragmatic reality is that there are too many vested interests at play.

Pharma freebies are not an India-specific phenomenon. It took the US government years to acknowledge that overprescription of painkillers had led to the opioid crisis. Maybe we can adapt some learnings from other countries as they define the fine line between legitimate expenses on disease awareness campaigns and brand recall versus expensive freebies.

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