A meeting of the Drugs Advisory Committee held on March 25 decided to grant permission to register 650mg of paracetamol in Nepal, which would open the door to Nepalese pharmaceutical companies, which currently produce the anti-fever and analgesic drug. most commonly used in 500 mg. tablets, to start producing 650mg tablets.
The decision, however, has sparked controversy, with claims that the decision to allow a higher dose of the drug is intended to benefit “certain groups”. The Ministry of Health and Population as well as the Advisory Committee on Medicines have refuted these claims. Some consumer rights groups have said the decision to increase the dose from 500mg per tablet to 650mg was also intended to increase the price of the drug. According to them, a higher dose of paracetamol could lead to certain liver diseases and kidney problems. This is why some interest groups trying to establish liver treatment hospitals are pushing to increase the dose.
Here’s what you need to know about the controversy surrounding paracetamol.
What is paracetamol?
Paracetamol, or acetaminophen, is a commonly used medication around the world primarily for pain relief and fever reduction.
It is used to treat many conditions: headaches, muscle pain, arthritis, back pain, toothache, sore throat, menstrual pain, musculoskeletal pain, colds and fevers.
The medicine can also be used for other purposes if deemed necessary by the doctor.
Nepal has listed paracetamol on the essential medicine list and provides it free of charge at state-run health facilities across 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.
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 650 mg of paracetamol. Until now, Nepalese pharmaceutical companies could only produce 500mg paracetamol tablets and importers could import the drug in the 500mg dose. The decision of the drug advisory committee authorizes pharmaceutical companies to manufacture 650 mg of paracetamol.
Who attends the Drug Advisory Committee meeting?
The Secretary in the Ministry of Health and Population, the Consultant to the Minister of Health, the Director General of the Department of Drug Administration, the Director General of the Department of Health Services, the Director of Nepal Standard Fixation Committee, the head of the Drug Research Laboratory, a representative of the Ministry of Justice, the chairman of the Nepal Medical Council, the president of the Nepal Medical Association, a representative of the Nepal Pharmaceutical Association and a representative of the Association of Chemists and Pharmacists are part of the committee.
Why did the committee decide to authorize the pharmaceutical authority to register 650 mg of paracetamol?
Officials from the Ministry of Health and Population said the decision was made on the recommendation of the majority of committee members.
Doctors say that the dosage of paracetamol is prescribed based on body weight. According to them, 650mg of paracetamol is used worldwide and it is also needed for the treatment of some patients in Nepal, especially those who are above average weight. During the Covid-19 pandemic, doctors have recommended up to two regular strength paracetamol tablets (1000mg) for patients with severe body ailments.
“We have recommended two 500mg tablets of paracetamol at a time for patients infected with coronavirus,” said Dr Lochan Karki, president of the Nepal Medical Association, an umbrella association of doctors. “The 500mg paracetamol tablet does not work well for pain relief in some patients, especially those weighing more than 50kg.”
Doctors recommend taking 650 mg of paracetamol every four hours and 1 gram (1000 mg) of paracetamol every six hours for patients weighing more than 50 kg.
If a patient weighs less than 50 kg and paracetamol needs to be given every four hours, 12.5 mg per kg of body weight should be given, according to Karki.
He said if the drug was to be given every six hours it should be 15mg per kg of body weight.
Surgeons have long used 1 gram of paracetamol in Nepal for those weighing over 50 kg.
Does the authorization to register 650 mg of paracetamol mean that paracetamol 500 mg will no longer be manufactured?
No. Several officials, who participated in the meeting of the drug advisory committee, said that the registration of paracetamol 650 mg does not mean that it is an alternative to the 500 mg tablet or that the tablets 500mg will be moved from the market.
“The dose of paracetamol or any other medicine is determined according to need,” said Dr Roshan Pokhrel, secretary at the Ministry of Health and Population. “The pharmaceutical companies will also manufacture 500mg tablets in addition to manufacturing 650mg tablets. After all, patients will take the drug as prescribed by doctors.
Have the authorities conducted a clinical trial for paracetamol 650mg?
No. But doctors said it was already being used in many countries around the world.
“None of the drugs – those manufactured in Nepal or imported from other countries – have been clinically tested in Nepal,” said Biplab Adhikari, secretary general of the Pharmaceutical Producers Association of Nepal. “The drugs including paracetamol that we produce or that the country imports are generic drugs, which are undergoing clinical trials in many countries. So there is no need for chemical testing in Nepal.
What difference will there be in prices between paracetamol of different strengths?
A 500mg paracetamol tablet costs Re1. As Paracetamol 650mg is neither manufactured nor imported into the country, the price has not yet been determined.
Paracetamol is one of 118 drugs whose prices are determined by the Department of the Drug Administration. Paracetamol is one of 96 drugs whose prices were set by the department 14 years ago. Later in 2016, the department determined the prices of 22 drugs.
“The price of paracetamol 650mg will be lower than the international market,” said Pokhrel, secretary of the Ministry of Health.
Is paracetamol an essential drug?
Yes. It is included in the list of essential medicines and the government provides it free of charge in all public health facilities in the country. The drug can be purchased over the counter [without prescription] dispensaries.
Are there any health risks of Paracetamol 650mg?
Doctors say first of all that there must 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 doctor may prescribe the following dosage: 500 mg every four to six hours or 500 mg four times a day. Doctors say that you should not take more than 10 tablets of paracetamol in 24 hours, regardless of the dose of the drug.
The risk, however, is that since paracetamol is a common over-the-counter drug, people could take the stronger tablet, which could be dangerous.
In India, paracetamol tablets are available with different strengths.
In the United States, paracetamol is called acetaminophen and the commonly used brand name is Tylonel, available in 325mg, 500mg and 650mg tablets.
When it comes to health risks, doctors say, not only paracetamol but any other drug could lead to complications.
“There is nothing wrong with giving permission to register 650mg paracetamol in the country, which is needed for many patients,” said Karki, president of the Nepal Medical Association. “As there are concerns about health risks and price, the drug should only be taken as prescribed by a doctor and it is up to the relevant authorities to determine the price.”