Can Expired Or Poorly Stored Medicines Reach Patients? Here's How India's Drug Safety System Works

The Maharashtra Food and Drug Administration's recent enforcement drive under Commissioner Tukaram Mundhe has brought the spotlight back on India's pharmaceutical supply chain. As authorities crack down on adulterated food, illegal drugs and regulatory violations, many patients are wondering how medicines reach hospitals and pharmacies—and whether expired or improperly stored medicines can slip through the system.

How government hospitals procure medicines

In India, the manufacture, distribution and sale of medicines are regulated under the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. According to the Central Drugs Standard Control Organisation (CDSCO), medicines supplied to government hospitals are typically procured through state medical services corporations or government-approved tender systems. Suppliers must hold valid licences and comply with prescribed quality standards before medicines are accepted into the public healthcare system.

However this is a tiered model which allows decentralised local purchases.

For specific day-to-day requirements or emergency items not covered by bulk tenders, hospitals utilize the centralized Government e-Marketplace (GeM) portal. This digital platform ensures standardized pricing and transparency for hospital consumables and certain medicines.

The CDSCO's Good Distribution Practices (GDP) Guidelines state that medicines should be stored, transported and distributed under conditions that preserve their quality. Government warehouses and hospitals are expected to maintain proper inventory records, rotate stock so older batches are used first, and regularly monitor storage conditions to reduce the risk of expired medicines reaching patients.

What happens when cold-chain systems fail

Not every medicine can be stored at room temperature.

Vaccines, insulin, blood products, biologics and several injectable medicines require continuous temperature-controlled storage from the manufacturer to the patient. This is known as the cold chain.

According to the CDSCO's Good Distribution Practices Guidelines, every participant in the pharmaceutical supply chain—including manufacturers, distributors, transporters, warehouses and hospitals—is responsible for maintaining the recommended storage temperatures and documenting them throughout distribution.

If the cold chain is broken because of power failures, transport delays or faulty refrigeration, medicines may lose their potency even though they continue to look perfectly normal. In such cases, patients often have no way of detecting that the medicine's effectiveness has been compromised, making proper storage one of the most critical safeguards in the healthcare system.

Can patients check expiry dates themselves?

Every medicine legally sold in India must display important information on its packaging, including the manufacturing date, expiry date, batch number and manufacturer's details. For several medicines, QR codes or barcodes are also being introduced to help regulators—and in many cases consumers—verify a medicine's authenticity and trace its batch information.

Patients should always check the expiry date before purchasing or consuming medicines and avoid products with damaged or tampered packaging.

However, does an expiry date automatically mean a medicine becomes dangerous the next day?

According to a report by Harvard Health Publishing, most medicines do not suddenly become toxic immediately after their expiry date. Instead, many gradually lose their effectiveness over time. While some drugs may retain much of their potency beyond the labelled expiry date, Harvard Health advises consumers not to rely on expired medicines because reduced effectiveness can be risky, especially for medicines used to treat serious illnesses, infections or life-threatening conditions.

Who is responsible for medicine storage?

Responsibility for medicine quality does not rest with a single organisation.

Manufacturers are responsible for producing medicines that meet quality standards. Distributors and transporters must ensure medicines remain within prescribed storage conditions during transit. Hospitals, pharmacies and wholesalers are responsible for storing medicines correctly, monitoring expiry dates and dispensing only products that remain fit for use.

Regulatory oversight is shared between the Central Drugs Standard Control Organisation (CDSCO) and State Food and Drug Administrations, which conduct inspections, collect samples, investigate complaints and take action against manufacturers or sellers found violating drug safety norms.

The recent directions issued by the Maharashtra FDA—including reminding hospitals that patients cannot be compelled to buy medicines only from hospital-linked pharmacies—form part of this broader regulatory framework.

What citizens should do if they suspect a problem

If patients suspect that a medicine is expired, counterfeit, improperly stored or ineffective, they should stop using it and preserve the packaging, bill and batch details and report the case.

These details can help the State Food and Drug Administration or the CDSCO trace the medicine through the supply chain and determine whether a particular batch needs to be investigated or recalled.

Expired medicines should also be disposed of safely.

According to the CDSCO's Guidance Document on Disposal of Expired/Unused Drugs, expired, damaged or recalled medicines should not be casually mixed with household waste or disposed of in ways that may contaminate the environment. Improper disposal can expose people to unsafe medicines, contribute to antimicrobial resistance and pollute water and soil.

The guidance recommends keeping medicines in their original packaging until disposal wherever possible and following authorised disposal or biomedical waste management systems.

For consumers, the simplest precautions remain the most effective: buy medicines only from licensed pharmacies, check the expiry date before use, inspect the packaging for signs of tampering, and report any suspected counterfeit or poor-quality medicines to the authorities. With regulators stepping up inspections across the country, public vigilance remains an important part of keeping unsafe medicines out of the supply chain.