Mint Explainer: All about the Dolo 650 case in the Supreme Court

The Federation of Medical and Sales Representatives Association of India (FMRAI) has filed a public interest litigation (PIL) in the Supreme Court seeking to fix accountability for freebies allegedly distributed to doctors in order to get them to prescribe Dolo 650, which was the most consumed anti-fever drug during the covid-19 pandemic.

What is the case?

The Supreme Court on Thursday asked the Centre to respond to a PIL filed by FMRAI which claims the makers of Dolo offered freebies worth ₹1,000 crore to doctors to promote the anti-fever drug. The court called it a “serious issue” and will take up the matter on 29 September.

What is Dolo?

Dolo 650, made by Bengaluru-based Micro Labs Ltd, became a household name during the covid-19 pandemic in 2020. Doctors had started prescribing Dolo as an over-the-counter anti-fever drug. Easy availability and doctors’ prescriptions fuelled sales.

What is FMRAI alleging?

FMRAI is a national trade union with units in 300 cities and towns. The body is seeking enforcement of the right to life under Article 21 of the Constitution, alleging mounting instances of unethical marketing practices by pharma companies in their dealings with healthcare professionals. This, it says, results in irrational and excessive prescriptions and a push for over-priced brands -- practices that directly affect citizens’ health.

What else does it say?

In the PIL, the petitioners have also prayed that a statutory code of ethical marketing, with penal consequences, be established for the pharma industry to curb such practices. Because the existing code is voluntary, unethical practices continue to proliferate, something that surfaced during the pandemic.

FMRAI counsel said the price of a tablet up to 500 mg is regulated by the government but that of a drug above 500 mg can be fixed by the drug maker.

What is the CBDT’s role here?

It was the Central Board of Direct Taxes that accused the makers of Dolo tablets of distributing freebies worth ₹1,000 crore. Earlier this month, the National Medical Commission (NMC) asked the Income Tax Department for details of doctors who allegedly received freebies from six pharma companies, including Micro Labs against which raids were conducted last month.

What are the relevant laws and regulations?

Indian Medical Council’s regulations prescribe a code of conduct for doctors in their relationship with pharma and allied health sector, and bar them from accepting gifts and entertainment, travel facilities, hospitality, cash etc. But the regulation does not apply to drug companies; so doctors’ licences are cancelled for misconduct which is actuated, encouraged, aided and abetted by pharma companies.

In a similar case, a bench of Justices U U Lalit and S Ravindra Bhat held that gifting freebies to health professionals is clearly “prohibited by law”, and not allowed to be claimed as a deduction.

What do pharma companies say?

Mint reached out to Micro Labs and the Indian Pharmaceutical Alliance (IPA) but there was no response till press time.

And the global scenario?

Many countries including the US, France, Germany, Hungary, Italy, UK, Venezuela, Argentina, Russia, China, Hong Kong, Singapore, Australia, South Korea, Philippines, Malaysia and Taiwan have stringent laws to check corruption in the pharmaceutical sector.