Nicknamed “COVID-pandemic’s favourite snack” and the source of multiple social media memes, Dolo-650 mg, which registered a sales of over ₹500 crores during the COVID pandemic since March 2020, is back in the news following the public interest litigation in Supreme Court by the Federation of Medical and Sales Representatives Association of India (FMRAI), a national trade union, that sought enforcement of Right to Life under Article 21 of the Constitution.
In its petition, FMRAI has alleged mounting instances of unethical marketing practices by pharma companies in their dealings with healthcare professionals, which in turn has a negative effect on the health of those who are already unwell.
“The existing code is voluntary and unethical practices will continue to proliferate. The ultimate sufferer is the ailing patient for whom we are fighting. We demand that all essential medicines be brought under price control and be made tax free. This will ensure that patients are directly benefited. No one should die for want of medicines,’’ said Santanu Chatterjee of FMRAI.
“This current case is certainly not about Dolo-650 alone. It is just one of the examples cited. Paracetamol is one of the examples that we have referred to in the petition that was filed some years ago. We are working for bringing in regulations that would stop malpractice in the pharma industry,’’ said Aparna Bhat, advocate for FMRAI.
The advocate explained that government price control is applicable till 500 mg of the paracetamol salt. “The idea of Dolo-650 and freebie caught on because it is so widely used especially during COVID. Also it was in the news in July,’’ she added.
As per data available with IQVIA, a healthcare research firm, Dolo-650 mg registered sales of ₹28.9 crore in December 2021, up 61.45% from the same month the previous year. Its highest sales figures are from April and May 2021, when it witnessed sales of ₹48.9 crore and ₹44.2 crore, respectively. The growth was when the country was witnessing the second wave of COVID.
Dolo-650 is one brand of paracetamol, also known as acetaminophen, and used to treat fever and mild to moderate pain. It is manufactured by Micro Labs Ltd. and is no different from other brands like Crocin, Calpol, Pacimol etc. However, unlike Dolo-650 mg, most other brands sell their paracetamol brand with 500 mg salt. Data from IQVIA also show that Dolo-650 and Calpol (manufactured by GSK Pharmaceuticals) are the key brands driving the paracetamol segment.
In all, there are over 30 brands of paracetamol that are top-sellers in different regions of India.
While the Supreme Court is now scheduled to take up the matter on September 29, earlier this month the National Medical Commission (NMC) sought details from the Income Tax Department of doctors who allegedly received freebies from six pharma companies, including Dolo-650 maker Micro Labs against whom raids were conducted last month.
The Central Board of Direct Taxes (CBDT), the administrative body for the I-T department, in July had accused the makers of the widely-used Dolo-650 tablet of indulging in “unethical practices” and distributing freebies of about ₹1,000 crore to doctors and medical professionals in exchange for promoting its products.
The Income Tax department had on July 6 raided 36 premises of Bengaluru-based Micro Labs Ltd. across nine states.
‘Still safe to use’
A recent study by Future Market Insights (FMI) notes that the global acetaminophen market is expected to grow to over US$ 14.1 billion by 2031 from the US$ 9.4 billion in 2021. In such a market, Dolo-650’s popularity comes with the fact that it is one of three-four familiar brands that contain the drug paracetamol, what with Dolo having been around for almost three decades, said Dr. Rajeev Jayadevan, co-chairman national, Indian Medical Association COVID task force.
“A specific advantage of Dolo 650 is that if a single tablet is taken up to three times a day, it comes well under the safe limit of 4 g per 24 hours. (More number of pills might be needed if the 500 mg strength tablet is used). So it is convenient for adults of average build and weight. I understand other leading brands also released ads about their own 650 mg versions, apparently after seeing the popularity of this particular dose during the pandemic,’’ he explained.
Meanwhile, paracetamol is considered a safe drug to use within the recommended dosage. “However, in some cases, you may experience side effects such as nausea, vomiting, indigestion, diarrhoea, stomach pain, etc. Consult your doctor if these symptoms stay for a long time or if they become severe,’’ noted experts.