A meeting of the Drug Advisory Committee held on March 25 decided to grant permission to register 650mg paracetamol in Nepal in a move that would open the door for Nepali pharma companies, which currently produce the most commonly used anti-fever and pain relief drug in 500mg tablets, to start producing 650mg tablets.
The decision, however, ran into controversy, with claims that the move to permit a higher dose of the drug is aimed at benefiting “certain groups.” The Ministry of Health and Population as well as the Drug Advisory Committee have refuted such claims. Some consumer rights groups have said the decision to increase the dose strength from 500mg per tablet to 650mg is also aimed at increasing the price of the drug. According to them, a higher dose of paracetamol could lead to some liver diseases and kidney problems, hence certain interest groups that are trying to establish liver treatment hospitals are pushing for increasing the dose strength.
Here’s what you need to know about the controversy surrounding paracetamol.
What is paracetamol?
Paracetamol, or acetaminophen, is a common drug used worldwide mainly for relieving pain and reducing fever.
It is used to treat many conditions—headache, muscle aches, arthritis, backache, toothache, sore throat, menstruals pain, musculoskeletal pain, colds and fevers.
The drug may also be used for other purposes if deemed necessary by the physician.
Nepal has listed paracetamol as an essential drug and provides it free of cost from state-run health facilities throughout the country. Paracetamol is available in the market under different brand names, with Cetamol, manufactured by the state-owned Nepal Drug Limited, being the most common one.
What is the new decision regarding paracetamol in Nepal?
A meeting of the Drug Advisory Committee on March 25 decided to allow the Department of Drug Administration to register 650mg paracetamol. Until now, Nepali pharmaceuticals companies can produce only 500mg paracetamol tablets and importers can import the drug of the 500mg dose strength. The Drug Advisory Committee decision allows pharmaceutical companies to manufacture 650mg paracetamol.
Who takes part in the meeting of the drug advisory committee?
The secretary at the Ministry of Health and Population, the expert advisor to the health minister, director general of the Department of Drug Administration, director general of the Department of Health Services, director of the Nepal Standard Fixation Committee, chief of Drug Research Laboratory, a representative of the Law Ministry, chairman of Nepal Medical Council, president of Nepal Medical Association, a representative of Nepal Pharmaceutical Association, and a representative of Chemists and Druggists Association are on the committee.
Why did the committee decide to permit the drug authority to register 650mg paracetamol?
Officials at the Ministry of Health and Population said that the decision was taken as per the recommendation of the majority of committee members.
Doctors say the dosage of paracetamol is prescribed as per the body weight. According to them, 650mg paracetamol is used throughout the world and it is also necessary for the treatment of some patients in Nepal, especially those whose weight is more than the average. During the Covid-19 pandemic, physicians recommended up to two tablets of regular strength paracetamol (1,000mg) for patients with severe bodyache.
“We recommended two tablets of 500mg paracetamol at once to the patients infected with the coronavirus,” said Dr Lochan Karki, president of Nepal Medical Association, an umbrella association of medical doctors. “The 500mg tablet of paracetamol does not work properly to relieve pain in some patients, especially those whose weight is above 50kg.”
Doctors recommend the 650mg paracetamol be taken every four hours and 1gram (1,000mg) paracetamol every six hours to patients, whose weight is over 50kg.
If a patient weighs less than 50kg and if paracetamol has to be given every four hours, 12.5 mg per kg body weight should be given, according to Karki.
He said that if the medicine has to be given every six hours, it should be 15mg per kg body weight.
Surgeons have been using 1gram paracetamol for a long time in Nepal to those who weigh more than 50kg.
Does granting permission to register 650mg paracetamol mean the 500mg paracetamol won’t be manufactured anymore?
No. Multiple officials, who took part in the Drug Advisory Committee meeting, said that registration of 650mg paracetamol doesn't mean that it is an alternative to the 500mg tablet or the 500mg tablets will be displaced from the market.
“The dose of paracetamol or any other drugs is determined as per the need,” said Dr Roshan Pokhrel, secretary at the Ministry of Health and Population. “Pharmaceutical companies will manufacture 500mg tablets as well besides manufacturing 650mg tablets. After all, patients will be taking the drug as per the doctors’ prescription.”
Have authorities carried out a clinical trial for the 650mg paracetamol?
No. But doctors said that it is already being used in many countries throughout the world.
“None of the drugs—those manufactured in Nepal or imported from other countries—have undergone clinical trials in Nepal,” said Biplab Adhikari, general secretary of the Association of Pharmaceutical Producers of Nepal. “The medicines including paracetamol which we produce or the country imports are generic drugs, which undergo clinical trials in many countries. So there is no need for chemical trials in Nepal.”
How much difference will there be in the prices between paracetamol of different strengths?
A 500mg paracetamol tablet costs Re1. As the 650mg paracetamol is not manufactured or imported in the country, the price has yet to be determined.
Paracetamol is among 118 medicines, whose prices are determined by the Department of the Drug Administration. Paracetamol is one of the 96 medicines whose prices were determined by the department some 14 years ago. The department later in 2016 determined the prices of 22 medicines.
“The price of the 650mg paracetamol will be less than that in the international market,” said Pokhrel, secretary for the Ministry of Health.
Is paracetamol an essential drug?
Yes. It is included in the list of essential drugs and the government provides it free of cost from all state-run health facilities throughout the country. The drug can be purchased over-the counter [without prescription] from dispensaries.
Are there health hazards of the 650mg paracetamol?
Doctors say firstly there has to be a clear understanding of the difference between “dose” and “dosage”. Drug doses are expressed in metric units—mg or milligram.
Dosage, on the other hand, is the dose along with additional information like when and how often to take it. For example, a physician may prescribe the dosage like this: 500mg every four to six hours, or 500mg four times a day. Physicians say one should not take more than 10 paracetamol tablets in 24 hours, regardless of the dose strength of the drug.
The risk, however, is since paracetamol is a common drug which is sold over-the- counter, people could take the extra strength tablet, which could be hazardous.
In India, paracetamol tablets are available with different dose strengths.
In the United States, paracetamol is called acetaminophen, and the commonly used brand name is Tylonel, which is available in 325mg, 500mg and 650mg tablets.
As far as health hazards are concerned, say doctors, not just paracetamol but any other drug could lead to complications.
“There is nothing wrong in giving permission to register 650mg paracetamol in the country, which is necessary to many patients,” said Karki, president of the Nepal Medical Association. “As there are concerns about health hazards and pricing, the medicine should be taken only as prescribed by a doctor and it is the responsibility of the authorities concerned to determine the price.”
