Explained: Dolo-650 controversy and Rs 1000 crore freebie accusation

Dolo-650 mg tablets were most commonly used in treatmentofCOVID-19 at the height of the coronavirus pandemic in India. When the drug became a meme, it attained its greatest level of popularity.

When the department accused the Dolo-650 manufacturer Bengaluru-based Micro Labs of tax cheating at the beginning of 2022, the lab was put under income tax scrutiny.

And now, in a hearing in the Supreme Court, the Federation of Medical & Sales Representatives Association of India (FMRAI) has accused the manufacturer of giving doctors gifts worth Rs 1000 crores to get them to prescribe Dolo-650 mg as the go-to medication.

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Even Chief Justice DY Chandrachud was upset by the accusation. He stated: "This is not music to my ears. I was also asked to have the same when I had Covid. This is a serious issue and matter."

What is Dolo-650 mg?

The trademark name for a fixed-dose combination medication with 650 mg of paracetamol is Dolo 650 mg. It is analgesic and antipyretic, which means it alleviates pain and brings down temperature.

It is a non-steroidal anti-inflammatory medication that is even sold without a prescription. The vast majority of OTC products include paracetamol with 500 mg of salt. Pain and fever were the main COVID-19 symptoms, hence the sale of all fever-relieving medications increased dramatically.

What's behind the popularity?

During the pandemic, sales of all paracetamol brands skyrocketed because it was thought to be safe to treat COVID-19-related fever and pain.

The income from paracetamol sales climbed by 138.42 per cent between the second quarters of 2020 and 2021, according to an Indian Express report citing market research firm AIOCD-AWACS. While companies like GlaxoSmithKline, the manufacturer of Crocin and Calpol, saw sales soar by 53% and 158.9%, respectively, during that time, Dolo-650 sales increased by a remarkable 289.6%.

According to pharmaceutical specialists, this is due to Micro Labs, the company that makes Dolo 650, overmarketing and decreased availability of rival paracetamol products. And now, allegations of corruption.

How did they find a way around price control?

Under the Necessary Commodities Act, some essential pharmaceuticals and their formulations are priced according to the Drugs Price Control Order (DPCO), and no business is allowed to sell drugs for more than that amount. The price of paracetamol was recently established by a National Pharmaceutical Pricing Authority order at Rs 2.88 per tablet.

The price of a 500 mg Paracetamol tablet is currently regulated, but not the price of a 650 mg tablet. This is why businesses like Micro Labs could charge more for their medicine. Of course, this is a huge issue, and estimates suggest that the DPCO does not cover about 80% of medications.

Can it cause harm?

According to the doctors we spoke to, an adult's daily intake of paracetamol can range up to 2 grammes. Therefore, consuming 2-3 Dolos every day during fever would not necessarily be harmful. However, excessive paracetamol use has been related to serious liver damage. Dolo-650 is not recommended for people with persistent alcoholism, liver disease, or kidney disease.

What is the Dolo-650 controversy about?

Even though the pharmaceutical company has described this practice as sales promotion, the plea against the company claimed that several "unethical" benefits, including gifts and entertainment, sponsored international travel, hospitality, and other benefits, are provided to doctors for promotingand prescribing the drug.

It was stated that unethical drug promotion can negatively affect doctors' attitudes toward prescribing medications and harm human health through overusing/over-prescribing medications, prescribing medications in higher doses than necessary, prescribing medications for longer periods of time than necessary, prescribing a higher number of medications than necessary, and prescribing an irrational combination of medications.

(with inputs from agencies)