Friends, for the last few days you must be reading in newspapers or hearing from news channels about the controversy related to DOLO 650 medicine.
Dolo 650 has become a household name when it comes to fever or common flu medication. The company reached its high point during the Covid 19 pandemic, when doctors started prescribing and recommending this tablet as the medication for any mild symptoms, even in case of a person contacting Covid this was recommended for patients with other medicines. Dolo 650 became popular because it contained 650 mg of paracetamol as compared to 500mg of paracetamol in other similar drugs like Crocin, Metacin, etc.
The company that manufactured Dolo 650 tablets Micro Labs Bangaluru, had its profits soaring during the peak of the coronavirus outbreak, so much that the medicine became a meme on social media due to its frequent use in Indian households.
When the department caused accused the Dolo manufacturer of tax cheating at the beginning of 2022, the lab was put under income tax scrutiny. Now, the company Micro Labs which manufactures Dolo 650 has found itself in the middle of controversy after the Federation of Medical & Sales Representatives Association of India (FMRAI) has alleged that the company distributed freebies worth Rs 1000 Cr to doctors to push the drug.
FMRAI has approached the Supreme Court (SC) in this matter and the case is being heard in the SC. As per FMRAI, the company Micro Labs was giving freebies that amounted up to over Rs 1000 Cr total to prescribe Dolo 650 as the go-to drug to all patients with flu symptoms including Covid 19 which is described as some form of flu.
The case is being heard by a bench of justices DY Chandrachud and AS Bopanna. The bench was briefed by the advocates of FMRAI “that the market price of any tablet up to 500 mg is regulated under price control mechanism but the price of the drug over 500 mg can be fixed by manufacturer Pharma Company. So to ensure a higher profit margin, the company distributed freebies to doctors to prescribe Dolo 650, as the price of the same is being fixed by the manufacturer. The Dolo 650 prescription for most of the patients was an irrational dose combination”. After this even justice, Chandrachud remarked that the drug was exactly the same as what he was given when he was suffering from Covid 19.
The FMRAI plea stated that the company has said that even though they have termed this as sales promotion, several unethical benefits are offered to doctors to push the drug as gifts and entertainment, sponsored foreign trips, hospitality, and other benefits. It is said that 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, and prescription of an irrational combination of drugs.
Though Dolo-650 is usually considered a safe drug as it contains paracetamol, its excessive dosage can be linked to liver damage. People suffering from liver conditions, kidney diseases, and alcoholism are urged to refrain from using this drug.
Yesterday the SC bench asked the Additional Solicitor General to file his response to the plea in 10 days, and gave one week time thereafter to FMRAI to file its rejoinder. The matter is going to be heard now on 29th September 2022. The SC allowed the permission sought by the counsel of the Pharma company, to file an intervention on behalf of the company.
In this plea, FMRAI has also requested that ‘ till an effective law is enacted as prayed, the SC may lay down the guidelines to control and regulate unethical marketing practices by pharma companies or in the alternative make the existing Code binding with proper and reasonable modifications/additions, which should be followed’.
There is an existing code of conduct by the Indian Medical Association, for doctors in their relationship with the pharma and allied health industry, and it prohibits acceptance of gifts and entertainment, travel facilities, hospitality, cash or monetary grants. But in reality, this code of conduct is only on paper, and it is hardly followed by the medical fraternity. Secondly, this code does not apply to drug companies leading to situations where doctors’ licenses can be canceled for misconduct, which is actuated, encouraged, aided, and abetted by pharma companies. In reality, though termed as ‘sales promotion’, direct or indirect advantages are offered to doctors in exchange for an increase in drug sales.
What has happened in India during the Covid pandemic is that the medicine which provided relief from the fever and throat pain of Covid for millions, and the safest and cheapest drug for this purpose is paracetamol. Whatever the reason, the medicine once synonymous with ‘Crocin’ has slowly become known as ‘Dolo’.
In the market, the MRP of Dolo 650 is almost 70% to 80% more than Crocin
It is not certain what will be the fate of the Dolo saga in the highest court.
The pharma companies offering freebies to doctors is going on for ages, and this menace is prevailing in every country of the world, and to date, no solution has come out which will be foolproof. In fact, in a country like the USA, pharma companies contribute to the funding of both the Democratic and Republican parties in a big way. It is often said in the political circles of the USA that pharma and arms manufacturing companies control the federal government, whether it is ruled by Democrats or Republicans.
Waiting for your views on this blog.
Anil Malik
Mumbai, India
24th August 2022