The Supreme Court on 18 August 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. Senior advocate Sanjay Parikh and advocate Aparna Bhat, appearing for petitioner Federation of Medical and Sales Representatives Association of India, told a bench of Justices DY Chandrachud and AS Bopanna that the market price of any tablet up to 500 mg was regulated under a price-control mechanism of the government but the pharmaceutical company making the drug above 500 mg could fix the price.
Parikh alleged that to ensure a higher profit margin, the company manufacturing Dolo tablets had distributed freebies to doctors to prescribe the 650 mg drug. The advocate said he would like to bring more such facts to the knowledge of the court after a response is filed by the union government. "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 ten days and gave one week time thereafter to the latter to file his rejoinder. It listed the matter for further hearing on 29 September.
The Central Board of Direct Taxes (CBDT) had on 13 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 pharmaceutical group. The claims surfaced after the CBDT had on 6 July raided 36 premises of the Bengaluru-based Micro Labs Ltd. 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 on the issue.
On 11 March, the highest court agreed to examine a plea seeking direction to the union government for formulating a Uniform Code of Pharmaceutical Marketing Practices to curb alleged unethical practices of Pharma companies and ensure an effective monitoring mechanism, transparency and accountability as well as consequences for violations.
The Supreme Court had said that it wanted to know what the government has to say on this issue.
Parikh had said that this is an important issue in the public interest. He submitted that Pharmaceutical 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 apex 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 that 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, 2002, prescribed a code of conduct for doctors in their relationship with the 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. 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 over-use/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.