NSQ and spurious drugs: what they mean and what to do

Last reviewed: 7 October 2026 · Pharma Mithra

The four terms, in plain English

Not of standard quality (NSQ)

Under section 16 of the Act, a drug is of "standard quality" when it complies with the standards set out in the Second Schedule to the Act. A sample that fails a test of those standards is declared not of standard quality. Reasons given in alerts include the amount of active ingredient (assay), dissolution, sterility or the product's description. An NSQ finding is about quality, not about who made the drug: by itself it does not mean the product is fake.

Spurious

Section 17B treats a drug as spurious if, among other things:

• it is made under a name that belongs to another drug;
• it imitates or substitutes for another drug, or resembles it in a way likely to deceive;
• the label names a manufacturer that is fictitious or does not exist;
• it has been substituted wholly or partly by another drug or substance; or
• it claims to be the product of a manufacturer whose product it is not.

In short, a spurious drug is a fake or counterfeit. The name on its label is often a real company that never made it.

Adulterated

Under section 17A a drug is adulterated if, for example, it contains filthy, putrid or decomposed matter; was prepared, packed or stored in insanitary conditions that may have contaminated it; is in a container made of a poisonous or harmful substance; contains a colour that is not permitted; contains a harmful or toxic substance; or has had something mixed in that reduces its quality or strength.

Misbranded

Under section 17 a drug is misbranded if it is coloured, coated, powdered or polished to hide damage or to look better than it is; if it is not labelled in the prescribed manner; or if its label, container or anything that comes with it makes a false or misleading claim.

Section 18 of the Act forbids anyone to sell, stock, exhibit or offer for sale, or distribute a drug that is not of standard quality, or is misbranded, adulterated or spurious. That applies to the pharmacy and the distributor as much as to the manufacturer.

How the monthly drug alerts work

Drug Inspectors have power under the Act to take samples of drugs being sold, stocked or distributed. The samples are tested by Government Analysts at central and state drug testing laboratories. Each month the Central Drugs Standard Control Organisation (CDSCO) publishes a drug alert listing the samples that those laboratories have reported as not of standard quality, spurious, adulterated or misbranded.

An entry in the alert typically gives:

• the product name;
• the batch number, with the manufacturing and expiry dates;
• the manufacturer as named on the label;
• the reason the sample failed, or that it was found to be spurious; and
• the laboratory that reported it.

An alert is about the batch that was tested. It does not by itself mean that other batches of the same product are bad. For a spurious entry, remember that the manufacturer shown is the one printed on the label, which may not be who actually made it. You can read this month's CDSCO drug alerts on Pharma Mithra.

What to do if you hold a listed batch

1. Match it exactly. Compare the product name, strength, batch number, manufacturer and dates on your pack with the alert. A similar product name with a different batch number is not a match. Check every location where you keep stock, including the godown and returns.
2. Stop sale and set it aside. Take the batch off the shelf, keep it apart from saleable stock in a box or area clearly marked "not for sale", and block the batch in your billing software so nobody sells it by mistake. Tell your staff.
3. Find where it came from. The Rules require purchase records that show the supplier, its licence number and the batch number. Use them to identify which supplier and which invoice the batch came on.
4. Distributors: find where it went. A wholesale invoice must show the buyer, its licence number and the batch number, so you can list every customer who received that batch. Tell them in writing.
5. Inform your supplier in writing. Give the batch, quantity and invoice reference, and ask how the stock is to be returned or collected.
6. Follow the regulator's and the manufacturer's instructions. Do not destroy the stock on your own. If a Drug Inspector orders you in writing not to dispose of it, you must not sell or otherwise dispose of it while that order stands.
7. Keep records. File a copy of the alert, your stock count, the letters you sent and received, and any return note or credit note. They show what you did and when.
8. Report a spurious find. If you find stock that matches a spurious entry, or packs you suspect are fake, inform the drugs control department of your state and keep the packs for their investigation.

Why buying from licensed suppliers protects you

Section 19(3) of the Act gives a defence to a person who is not the manufacturer or its agent. Such a person is not liable for a contravention of section 18 if it proves all three of these:

• it acquired the drug from a duly licensed manufacturer, distributor or dealer;
• it did not know, and could not with reasonable diligence have found out, that the drug contravened section 18; and
• the drug was properly stored while in its possession and stayed in the same state as when it was acquired.

The first point depends on your supplier's licence being genuine and in force when you bought, which is why a dated verification record matters. See how to verify a drug licence and how to spot a fake drug licence. The third point is why storage conditions on the label, such as temperature, matter too.

This guide is general information about Indian drug and tax law for businesses, not legal advice. Rules and procedures can differ by state; your state drug control department or GST office has the final word on any individual case.