Dolo makers ‘distributed freebies’ worth Rs 1,000 crore to doctors to prescribe 650-mg drug, SC says ‘serious issue’

The Supreme Court (SC) yesterday described as a “serious issue” the matter raised by an NGO relating to the CBDT’s allegation against the makers of Dolo tablets that they had distributed freebies worth about Rs 1,000 crore to doctors for prescribing their 650 mg anti-inflammatory, fever-reducer drug.

A bench of Justices DY Chandrachud and AS Bopanna was told by senior advocate Sanjay Parikh and advocate Aparna Bhat, appearing for petitioner ‘Federation of Medical and Sales Representatives Association of India,’ 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. “What you are saying is music to my ears. This is exactly the drug that I had when I had COVID recently. This is a serious issue and we will look into it,” Justice Chandrachud said.

The bench then asked additional solicitor general KM Nataraj to file his response to the plea by the petitioner in 10 days and gave one week time, thereafter, to the latter to file his rejoinder. It listed the matter for further hearing on 29th September.

The Central Board of Direct Taxes (CBDT) had, on 13th July, accused the makers of the Dolo-650 tablet of indulging in “unethical practices” and distributing freebies worth about Rs 1,000 crore to doctors and medical professionals in exchange for promoting products made by the pharma group. The claims were made after the Income Tax department had on 6th July raided 36 premises of the Bengaluru-based Micro Labs across nine states.

A counsel sought permission from the court to file an intervention on behalf of the pharma companies, which the court allowed saying it would like to hear them also on the issue. On 11th March, the top court agreed to examine a plea seeking direction to the Centre for formulating a Uniform Code of Pharmaceutical Marketing Practices (UCPMP) to curb alleged unethical practices of pharma companies and ensure an effective monitoring mechanism, transparency, accountability as well as consequences for violations.

The top court had said it wants to know what the government has to say on this issue. Parikh had said this is an important issue in the public interest.

He submitted that pharma companies are claiming that they are not liable for punishment as the bribe-takers are the doctors. Parikh said the government should look into this aspect and the code should be made statutory in nature as “we all know what happened with Remdesivir injections and other drugs of those combinations.”

The top court had then asked the petitioner why can’t a representation be made to the government to which Parikh had said they have already done it. He had said they have been pursuing the issue with the government since 2009 and till the time the government comes out with the code to regulate, this court may lay down some guidelines.

The petition said the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations of 2002 prescribe a code of conduct for doctors in their relationship with the pharma and allied health sector industry, and prohibit acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants by medical practitioners from pharma companies.

“This code is enforceable against doctors. However, it does not apply to drug companies, leading to anomalous situations where doctors’ licenses are cancelled for misconduct which is actuated, encouraged, aided, and abetted by pharma companies. The pharma companies go scot-free,” it added.

The petition claimed that though termed as sales promotion, in fact, direct or indirect advantages are offered to doctors (as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits) in exchange for an increase in drug sales. It said unethical drug promotion can adversely influence doctors’ prescription attitudes and harm human health by overuse/over-prescription of drugs, prescription of higher doses of drugs than necessary, prescription of drugs for a longer period than necessary, prescription of a higher number of drugs than necessary and prescription of an irrational combination of drugs.

Edits by EP News Bureau