Dolo 650 freebies case: Why is SC asking Centre to act?
PremiumDolo 650 became a household name during the Covid-19 pandemic and doctors had started prescribing it as an over the counter anti-fever drug
The Federation of Medical and Sales Representatives Association of India (FMRAI) has filed a public interest litigation (PIL) in the Supreme Court seeking to hold pharma companies accountable for distributing freebies to doctors in order to get them to prescribe Dolo 650 mg, which was the most consumed anti-fever drug during the Covid-19 pandemic.
What is the pharma freebies case?
The Supreme Court on Thursday asked the Centre to reply on the PIL filed by FMRAI which claimed that the Dolo maker offered freebies worth ₹1,000 crore to doctors to promote its anti-fever drug. The top court has called it a “serious issue". The matter will be taken up on 29 September.
What is Dolo and who is its manufacturer?
The case assumes significance since Dolo 650 became a household name during the Covid-19 pandemic in 2020. Its manufacturer is Bengaluru-based Micro Labs Ltd. Doctors had started prescribing Dolo as an over the counter anti-fever drug . Easy availability and doctor’s prescription fuelled the sales of the drug.
Who is FMRAI and what are they alleging?
FMRAI is a national level trade union with local units in 300 cities and towns of the country, registered in 1963 under the Trade Unions Act, 1926. The body is seeking enforcement of Right to Life under Article 21 of the Constitution of India in view of the ever-increasing instances of unethical marketing practices by pharmaceutical companies in their dealings with healthcare professionals resulting in prescription of excessive and/or irrational drugs and a push for high-cost and/or over-priced brands, which are practices that directly affect citizens’ health, violating their rights under Article 21 of Constitution.
What is FMRAI alleging on Code of Ethical marketing ?
In the PIL, the petitioners have also prayed that a statutory code of ethical marketing for the pharmaceutical industry, with penal consequences, be established to curb such practices for the enforcement of the fundamental Right to Health of the people of India. Due to voluntary nature of the existing code, unethical practices continue to increase and have also surfaced during the Covid-19 pandemic.
The concerns around such practice
FMRAI’s counsels Sanjay Parikh and advocate Aparna Bhat said that the market price of any tablet up to 500 mg is regulated under price control mechanism of the government but the price of the drug above 500 mg can be fixed by the pharma company concerned.
Parikh alleged that to ensure a higher profit margin, the company manufacturing Dolo tablets distributed freebies to doctors to prescribe the 650 mg drug. The advocate also said he would like to bring more such facts to the knowledge of the court after a response is filed by the Centre.
The CBDT’s role
Essentially, it was the Central Board of Direct Taxes that had accused the makers of Dolo tablets of distributing freebies worth ₹1,000 crore to the doctors for prescribing their 650 mg anti-inflammatory, fever-reducing drug.
Earlier this month, the National Medical Commission (NMC) had asked the Income Tax Department for details of doctors who allegedly received freebies from six pharma companies, including Dolo 650 maker Micro Labs against whom raids were conducted last month.
On July 6, the Income Tax officials searched 36 locations across nine states belonging to Micro Labs. NMC wrote to CBDT chairperson Nitin Gupta on August 3 requesting that he “provide the names along with registration number and addresses of doctors implicated so that those records may be forwarded to state medical councils concerned for information and required action."
What are the current laws & regulations for giving such freebies?
The Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations of 2002 prescribe a code of conduct for doctors in their relationship with pharmaceutical and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from pharmaceutical companies. This Code is enforceable against doctors, but does not apply to drug companies, leading to anomalous situations where doctors’ licences are cancelled for misconduct which is actuated, encouraged, aided and abetted by pharma companies. The pharma companies go scot-free, according to the PIL.
In a similar case, a bench of Justices U U Lalit and S Ravindra Bhat held that pharmaceutical companies’ gifting freebies to doctors, etc., is clearly “prohibited by law", and not allowed to be claimed as a deduction. The top court said it is a matter of great public importance when it is demonstrated that a doctor’s prescription can be manipulated, and driven by the motive to avail the freebies offered to them by pharmaceutical companies.
These freebies are technically not ‘free’ – the cost of supplying such freebies is usually factored into the drug, driving prices up, thus creating a perpetual publicly injurious cycle. “The threat of prescribing medication that is significantly marked up, over effective generic counterparts in lieu of such a quid pro quo exchange was taken cognizance of by the Parliamentary Standing Committee on Health and Family Welfare,“ the bench pointed out.
Global scenario
Numerous countries across the world, including the United States, France, Germany, Hungary, Italy, UK, Venezuela, Argentine, Russia, China, Hong Kong, Singapore, Australia, South Korea, Philippines, Malaysia and Taiwan, have enacted stringent laws to curb corruption in the pharmaceutical sector, in one or both of the two ways, viz., by enacting: general laws to prevent and control bribery in the private sector, and/or special laws/provisions to prevent and control pharma corruption.
These laws have been effectively enforced in several countries around the world where stringent criminal sanctions and hefty fines have been levied against pharma companies that were found to have paid kickbacks or other advantages to healthcare professionals to promote sales of their products.
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