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  • Writer's picturePalak Jawa and Shriyanka Dash

Are you aware of the laws against expired medicines?

Updated: Oct 12, 2020


Expiration is a date after which medicine might not be safe to use. This date is supposed to be printed on the packaging of the medicine. Medicines are nothing but a composition of chemicals, and just like your food, even medicines have an expiry date. The expired medicine becomes less effective or at times even becomes risky to use because of the change in their chemical composition. Sometimes, the expired medicines might also lead to side effects and more serious illness instead of curing the problem.


There have been recent events where it was seen that many shops were selling expired medicines to the customers. If something like this happens to you, this article will help you to determine your rights in this respect.


1. The expired medicines should be cleared out from the pharmacy within 15 days of their

date of expiry. There is no law which makes it obligatory upon a pharmacist to

dest roy or throw away the stock as soon as it crosses the date of expiry. But

if the medicines are not removed within a reasonable time needed for such disposal, the drug inspectors can cancel the licences of such shops.

2. Manufacturers of medicines have a duty to destroy the expired medicines, keeping in mind the state pollution norms.

3. Pharmacies have a duty to issue a proper bill to the customers mentioning the following –

a. Name of the drug

b. Quantity of the drug purchased

c. Cost of the drug

d. Batch number

e. Date of expiry.

4. Medicines need to be stored at a clean, ventilated and cool storage facility, since some drugs, in particular, the vaccines need to be stored in a low-temperature freezing zone.

6. 5. Substances specified in Schedule ‘H’ or Schedule ‘X’ (like sedatives, or medicines of high power) of the Drugs and Cosmetic Act, 1940 should not be sold by retail except in accordance with the prescription of a registered medical practitioner.

7. If the pharmacist has distinguished the expired medicines for withdrawal, reimbursement or disposal such drugs may be stocked after the date of expiration, but separately from the trade stocks. And all such drugs are to be kept in packages or cartons, the top of which must display prominently, the words ‘not for sale'.

Even though it is the responsibility of the chemist to remove expired drugs from his shelve, you as a customer/consumer also have some rights too.

Customer’s duties while purchasing drugs/medicines:

1. Always check the expiry date of the medicine on the packaging as well as on the bill.

2. Never purchase medicine without a proper bill by the pharmacist.

3. Always consult a doctor before purchasing and consuming any medicine. The pharmacies are only supposed to sell prescribed medicines and not otherwise.

4. There are a lot of medicines with similar names. Always consult the doctor in case of any confusion.

5. In case you feel any side-effects of the medicine on your body, immediately visit the doctor.

6. Remember, you as a customer/consumer have the right to ask for the licence from the pharmacy to sell, stock, exhibit or offer for sale or distribute] drugs and he shall be bound to show you one. Make sure, in such a situation he pResents the renewed one before you granted by the competent authority under Drugs and Cosmetic Act, 1940.

Laws under which medicines and drugs are dealt with –

1. License for manufacture sale and distribution of drugs is dealt with by – State Licencing


2. Drugs and Cosmetics Act, 1940.

3. Drugs and Cosmetics Rules( Sections 17,

4. Indian Penal Code, 1860 (Sections 269, 270, 274 and 275)

5. The Prescription Drug Marketing Act of 1987.

In case a pharmacy sells you expired medicines, the following can be done –

1. Approach the drug control office available in every state.

2. Approach the State Licencing Authorities who are empowered to take strict actions

against violations. One of the most important conditions of licence – not to sell expired


3. The customers can also approach the consumer court since getting expired goods is also a matter of violation of consumer rights. Remedies under the Consumer Protection Act is in addition to all the other remedies.

4. Selling of expired goods is also a criminal offence under the Indian Penal Code as well as the Drugs and Cosmetics Act, 1940.

Example –

In 2014, a resident of Mumbai was awarded a sum of Rs. 30,000/- because the shopkeeper sold him an expired strip of tablets. The consumer felt uneasy and vomited twice after taking the medicine. On checking the tablet, it was found that the date of expiry on medicine strip was different from that printed on the bill. He then complained to the medical store owner, then the Food and Drugs Administration (FDA) and finally approached the Consumer Forum. He was awarded this sum by the District Consumer Forum on the basis of mental harassment and litigation costs.

Disposal of expired medicines: Not only the pharmacies but also you at your personal level are responsible for the proper disposal of medicines from your possession. Unused or expired medicines can sometimes prove to be a source of danger for others at home. A child, elderly person or even a normal adult can sometimes mistake the medicine for another and consume it, resulting in numerous side effects, sometimes fatal. Also, if someone at home as a suicidal tendency he/she may reach out for a handful of such medicines in order to attempt suicide. the are several safe methods for disposal such as flushing it down the sink or toilet, returning to the manufacturer, landfill, and waste immobilization.

Remember your remedies under the law when you face an issue like this the next time.

Do not be the next victim. Be aware!

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