Paracetamol usages regulation: A need of the hour

Dear Editor

This letter is written to show concern regarding the excessive use of paracetamol among the Indian population. The most widely used analgesic and antipyretic medicine globally is paracetamol, which is available both over-the-counter (OTC) and on prescription. It is a medication that the World Health Organization has approved for use in patients of all ages, with adult dosages ranging from 1000 mg in a single dose to 4000 mg per day. Despite being largely regarded as the safest OTC medication, paracetamol has a significant hepatic injury rate, making it exceedingly misleading [1]. According to studies, a sizable portion of the population is ignorant of paracetamol toxicity [2]. The distinct salt of paracetamol is so well-liked since it is so easily accessible and readily available. These medications saw a fourfold increase in demand during the COVID-19 pandemic. According to the latest market research statistics, there will be a significant 5.22% CAGR global market expansion [3]. The cause for this dramatic increase is the spike in demand for this particular medication, which prompted local authorities to prohibit the export of necessary medications while retaining adequate stocks domestically. Additionally, it is essential to mention that a recommendation from the Centers for Disease Control and Prevention (CDC) explicitly advises patients with COVID-19 to use acetaminophen [4]. “Get rest and take over the counter medicines, such as acetaminophen, to help you feel better.” Another reason for its steep increase is that it is regarded as a safe drug during pregnancy and breastfeeding; however, it is also used to treat other common ailments such as headache, toothache, backache, menstrual pain, and so on, making it more popular among all. Because the medicine is offered over the counter, there is a lack of regulation, leading to the drug's uncontrolled use. Many studies have proved that long-term use of paracetamol may cause cardiovascular disease, respiratory diseases etc. [5].

This medication has recently gained attention in India. Dolo-650 tablet, a commonly used medicine among Indian households, dominated social media trends and was dubbed "India's favorite snack," selling 350 crore tablets during the pandemic period [6]. However, a recent trend has been observed in which PCM doses have been increased from 500mg to 650mg. There could be various explanations for this dose shift:

• 1.The Drug Price Control Order (DPCO) 2013 controlled the price of PCM 500mg pills but not 650mg tablets, making the 500mg tablets less viable, resulting in fewer manufacturing and consumption of PCM500 tablets. Furthermore, market figures suggest that PCM 500mg tablet sales have dropped by around 50% since March 2007 [7]. It is a concerning situation because, in other nations, the strength of PCM generally used is 325mg. Additional strength containing 500mg, and 650mg are only used for moderate arthritis patients.
• 2.One of the primary reasons is unethical behavior by pharma behemoths. A well-known PCM maker was recently charged in a "Serious Allegation" of doling out Rs. 1000 crore in freebies to doctors. This brought into serious doubt pharmaceutical corporations' marketing methods.

Therefore, it is high time to limit and regulate the availability and use of paracetamol. Although OTC medications, particularly PCM, anti-cold medications, and anti-allergy medications, were restricted and monitored during the COVID-19 era, these limitations became lifted once the pandemic subsided. Now is the time to control and oversee the sale of PCM by requiring a doctor's prescription; however, all medical professionals must adhere to appropriate and stringent PCM usage guidelines. Additionally, to prevent any illicit incidents, a stringent price restriction policy should be followed in India, as well as a strict vigilance system applied to the marketing techniques of pharmaceutical businesses. Nevertheless, it is important to raise awareness among the general public about the negative effects of long-term and excessive PCM usage.

Ethical approval

Not applicable.

Source of funding

No funding received.

Author contribution

All authors contributed equally, read and approve for the final manuscript.

Trail registry number

N/A.

Garantor

Bijaya K Padhi.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.