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Paracetamol, metformin fail quality check: Why drug regulator’s random tests can track spurious drugs

Metformin failed the dissolution test, meaning once consumed, the fake medicine would not dissolve properly and work in the way it is supposed to

spurious drugsThe country’s apex drug regulator releases a list of drugs that are found to be not of standard quality (NSQ) every month. (Representational Image)

Around 50 medicines — including common ones like paracetamol, which is used for fever, metformin, which is the first line of treatment for diabetes, and pantoprazole, whch is used for acidity — were found to be spurious or not of standard quality (NSQ) by the country’s apex drug regulator. This was part of a routine testing exercise by the Central Drugs Standard Control Organisation (CDSCO), which does random sample checks.

What is the alert raised by the CDSCO all about?

The country’s apex drug regulator releases a list of drugs that are found to be not of standard quality (NSQ) every month. The Central, as well as the state drug regulators, routinely collect samples of various medicines from the market at random and test them. The monthly list puts out the names of the medicines that fail the tests and on what parameters.

Take for example, the metformin that has been named in the recently released list for the month of August. The drug has failed the dissolution test, meaning once consumed, the medicine would not dissolve properly and work in the way it is supposed to.

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Why is this done?

The monthly lists are released to inform the people, government health departments, industry, and more importantly, the state drug regulators of drugs available in the market that may not be of best quality. As the drugs are tested at random — and the results made public — it is also a way to ensure that companies make quality products.

What are NSQ or spurious medicines?

When it comes to quality checks by the drug regulators, the drugs that fail broadly fall in three categories:

Spurious drugs:  These are products that imitate others, mostly popular brands of medicines, to trick people into buying them. They may or may not contain the active ingredient. For example, Glenmark’s Telmisartan (used for the treatment of hypertension) and Sunpharma’s pantoprazole were found to not have been manufactured by the original company at all.

NSQ drugs: These fail on parameters such as faulty description, the medicine not dissolving properly, or less quantity of active ingredients. While these medicines may not directly harm a person consuming them, they can affect them by not actually doing what they are meant to. In the process, the health condition remains unattended and could get worse.

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Adulterated drugs: These are drugs in which contaminants or adulterants are present and can cause direct harm to people consuming them. The drug regulator usually recalls drugs that are found to be adulterated.

What should you do?

These alerts raised by the drug regulator are not meant to cause alarm. They are issued for the companies to self-correct or regulators to take necessary action, like pulling out entire batches for which an alert is issued via a public notification. You can continue to consume any medicines that you may have been prescribed.

Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More

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