Random checks finds paracetamol, other drugs ‘not of standard quality’: What should you do?

CDSCO and NSQ

Every month, the regulator, Central Drugs Standard Control Organisation (CDSCO), releases a list of drugs that are found to be “not of standard quality” (NSQ) during checks. Central and state regulators periodically collect samples of various medicines from the market at random and put them through tests.

A list of medicines that fail the test, along with the parameters on which they have fallen short, is published every month.

Why this is done

The monthly lists are released to inform the general public, government health departments, industry, and the state drug regulators of the drugs available in the market that may not be of the desired quality.

As the samples are tested at random and the results are made public, it is also a way to tell drug manufacturing companies that their products are under constant watch.

Why drugs fail tests

Drugs that fail quality checks broadly fall into three categories.

SPURIOUS DRUGS: These are essentially fakes — products that pretend to be popular brands of medicines, which mislead people into buying them. These fakes may or may not contain the active ingredient, and are not manufactured by the company that makes the drug of that brand name.

For example, samples of telmisartan (used for the treatment of hypertension) and pantoprazole were found to have been not manufactured by the companies whose branding they carried, Glenmark and Sun Pharma respectively.

POOR QUALITY: Drugs that may contain a faulty description, or may not dissolve in the proper way, or may have a lesser quantity of active ingredient, etc. are considered to be not of standard quality, or NSQ. These medicines may not actively harm the person who consumes them, but the patient may suffer because the drug fails to do what it is meant to.

Metformin, which is on the recently released list for August, failed the dissolution test, which means that the medicine, once consumed, would not dissolve properly and work in the way it is supposed to.

ADULTERATED DRUGS: These contain contaminants or adulterants that can cause direct harm to the person who consumes them. The entire batches of these drugs are usually recalled by the regulator; the company too, could initiate a recall on its own.

What you should do

The drug regulator’s alerts are not intended to cause alarm or panic. They are mainly in the nature of flags to companies to self-correct, or to regulators to take necessary action.

That some randomly picked samples of a drug have been found to be NSQ does not mean every pill or capsule of that drug available in the market is fake or dangerous. You can continue to consume these medicines if they have been prescribed to you.

However, the fact that a sample was found to be NSQ in theory also means that there could be other, undetected fakes in the market.