Context

• The article discusses the relationship between the medical profession and pharmaceutical industry that has provoked intense scrutiny and attempted regulation in India.
• The Central Board of Direct Taxes (CBDT) has accused the makers of a popular medicine tablet, Dolo-650 of indulging in “unethical practices" and giving away freebies of around Rs 1,000 crore to medical professionals and doctors in order to get them to promote the products made by the pharmaceutical group.

Background

• In 2018 when speaking in London about the high cost of drugs, PM Modi hinted to pharma-sponsored trips by doctors to foreign countries as an obstacle to them prescribing cheaper generic medicines.
• Though this remark by PM drew the ire of doctors but Civil society activists in India have for long fought a battle to bring this area under a legal framework and accountability.

The Dolo scandal that refuses to die

• Dolo scam: Dolo-650 manufacturer Micro Labs Ltd came under the income tax scanner for suspected tax evasion as the company saw a rise in sales of Dolo-650 during Covid-19 pandemic.
• Evidence: The raids on Micro Labs for tax evasion reportedly led to uncovering evidence of large sums of money being used for freebies to doctors to prescribe Dolo.
• Statistics: The revenue generated by Dolo-650 increased by 6% between the second quarter of 2020 and the second quarter of 2021.
  • In the same time, revenue generated by two popular brands of paracetamol by GlaxoSmithKline, Crocin and Calpol increased by 53% and 158.9%, respectively.
• Company claims: Though news items mentioned the amount as Rs 1,000 crore, the company’s executive VP in an interview stated that this amount would be around Rs 5-6 crore.
  • He also mentioned that apart from normal samples, pens, writing pads, small printed books, hand sanitisers and masks, no major so-called freebies or big gifts were given to doctors for the anti- fever drug.
• Plea in Apex court: The Federation of Medical and Sales Representatives Association of India (FMRAI) whose members are directly involved in drug promotion to doctors, moved the Supreme Court with the following claims:
  • Since the market price of paracetamol up to 500 mg was regulated, the company moved to higher doses.
  • And in a bid to increase sales, freebies were given to doctors to incentivise them to prescribe Dolo 650 mg, the higher dose.
• The PIL by FMRAI has also alleged the unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals.
  • As per the trade union body, Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations of 2002, prescribes a code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry, and prohibit acceptance of freebies by medical practitioners from pharma companies.
  • But it is enforceable against doctors only and does not apply to drug companies.
  • This leads to anomalous situations where doctor’s licenses are cancelled for misconduct and the pharma companies go scotfree.

Failure of Voluntary ethics codes

• Fine distinction: Pharma companies need to inform and update doctors about their products. But the rather thin dividing line between legitimate promotional activities and illegitimate incentivisation has been a much contested one.
• India code: In an attempt to draw this line, many countries have developed codes of conduct including India.
  • The previous Medical Council of India (MCI) code and the upcoming ethics code of the National Medical Commission label gifting and hospitality as unethical conduct.
• Internal codes: MNC pharma companies are supposed to be bound by internal codes, but they are ignored with impunity and regularity, owing to vested mutual interests of both pharma companies and medical professionals.
  • For pharma it is a way to push new products including irrational combinations.
  • For the medical profession it is a bonanza of individual gifts and trips and for medical associations to earn money through conferences.
• Moral collapse: The pharma-doctor relationship is thus fertile territory for unreasonable incentivisation.
  • Though many doctors believe they can stay neutral after accepting freebies, evidence clearly points otherwise. Appealing to the good sense of both parties through the lens of moral ethics has largely failed.

Pandemic-inspired opportunity for reform

• Aware citizenry: Covid has created a sense of urgency for collective action on healthcare and has made ordinary citizens acutely aware of the dangers of unregulated healthcare.
• Induced Scepticism: Drug prescriptions and costs are arousing suspicions. For instance, the bizarre prescriptions of antiviral drugs in Covid. It has led to demand for an actionable code for defining relationship between pharma and doctors in clear terms.
• Stronger UCPMP: FMRAI is asking SC for early implementation of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) which is currently a voluntary code on paper.
  • The apex court is also examining their plea seeking direction to the Centre to give teeth to UCPMP by making it law, thus ensuring an effective monitoring mechanism and transparency as well as punishments for violations.