CDSCO Tightens Drug Quality Surveillance With Revised Sampling Guidelines

Amid a sharp rise in the number of medicines being flagged as Not of Standard Quality (NSQ), India's top drug regulatory has revised its guidelines for the sampling and reporting of drugs, cosmetics and medical devices.

The Central Drugs Standard Control Organisation (CDSCO) move aims to strengthen quality surveillance and improve transparency, traceability and enforcement across the pharmaceutical supply chain.

The revised guidelines, issued by the Enforcement Division of CDSCO a few days ago, update procedures that have been in force since 2024 and introduce more detailed reporting formats for NSQ products and spurious drugs.

Regulatory officials said the changes are aimed at improving data collection, enabling faster investigations and enhancing public awareness about substandard and counterfeit medicines circulating in the market.

The new framework requires drug inspectors from both Central and State drug regulatory authorities to provide substantially more information while reporting NSQ products. Besides the product name, batch number and manufacturing details, inspectors will now have to specify the product category, brand name, dosage form, route of administration, manufacturing State, reporting source, reporting period and other key identifiers.

The enhanced reporting structure is expected to help regulators better track patterns of quality failures, identify manufacturing trends and undertake targeted enforcement action where necessary.

Under the revised system, reports received from State and Central drug testing laboratories must be submitted in a standardised digital format, accompanied by test reports, preferably before the 10th of every month.

The information will subsequently be uploaded on the CDSCO portal as part of public alerts related to substandard drugs, medical devices and cosmetics, said an official from the CDSCO.

The latest revision also brings changes to the reporting mechanism for spurious drugs — products that are falsely represented, deceptively labelled or deliberately manufactured to resemble genuine medicines.

The updated format aligns reporting procedures with the system currently followed by the national regulator. Significantly, the reporting template now includes fields for the reason behind the failure, the authority that collected the sample, responses received from concerned firms and regulatory remarks, he said.

These additions are expected to strengthen investigations and provide a clearer picture of the circumstances surrounding the detection of counterfeit products.

At the same time, some reporting requirements have been streamlined. Earlier formats contained provisions to disclose details of sales outlets involved in distributing spurious medicines, including addresses and pharmacist registration details. These elements have now been omitted from the standard reporting format.

The revised guidelines also provide greater clarity on what constitutes a spurious drug under the law. A medicine may be classified as spurious if it is manufactured under the name of another drug, imitates or substitutes another product in a deceptive manner, falsely claims association with a legitimate manufacturer, or contains wholly or partly substituted ingredients.

Similarly, products bearing the name of a fictitious manufacturer or falsely purporting to originate from a genuine pharmaceutical company can also be categorised as spurious. Such definitions are particularly important in an era when counterfeit medicines pose a growing threat to patient safety worldwide.

Drug quality surveillance has emerged as a major regulatory priority in recent years. As part of routine monitoring, samples are regularly collected from pharmacies, distributors and other points in the supply chain and tested in government laboratories. Medicines that fail prescribed quality standards are publicly listed by CDSCO every month to alert healthcare professionals, manufacturers, distributors and consumers.

The revised guidelines emphasise that cases involving suspected spurious medicines arising from distribution-chain breaches or complaints from manufacturers must be accompanied by detailed investigation reports. Regulators have also sought information from manufacturers on how genuine products can be distinguished from counterfeit versions, enabling stakeholders to identify suspect batches more effectively.

The changes assume greater significance against the backdrop of a substantial increase in NSQ reports across the country. Data released by CDSCO show that 1,879 drug samples were declared Not of Standard Quality during 2025, more than double the 877 samples reported in 2024.

The increase, however, is not necessarily indicative of a worsening quality situation, clarified the regulatory officials. They attributed this rise to enhanced surveillance and improved participation by State and Union Territory drug regulators, who have become more active in sample collection and reporting since the launch of the strengthened monitoring framework in 2024.

Of the 1,879 NSQ samples reported during 2025, as many as 1,163 originated from State regulatory authorities, accounting for nearly 62% of all reports. In comparison, States contributed only 339 NSQ reports in 2024, representing around 39% of the total.