A Central Drugs Standard Control Organisation (CDSCO) investigation has found 240 drug samples across the country to be substandard, including 82 medicines manufactured in Himachal Pradesh. The samples included medicines used for heart, blood pressure and other diseases.
Drug samples are tested against prescribed quality standards. A sample is classified as Not of Standard Quality (NSQ) when it fails to meet specified requirements related to the quantity of active ingredients, quality, purity or other prescribed parameters. An NSQ classification does not mean that the medicine is counterfeit; it means the tested sample did not meet the prescribed quality standards.
CDSCO and the relevant state drug control departments periodically collect drug samples from the market for testing. The process is intended to ensure that medicines reaching patients comply with prescribed quality and safety standards. When deficiencies are found, the manufacturer and the relevant batch are subject to further examination.
Himachal Pradesh is among the country's pharmaceutical production centres, with a large number of drug companies operating in its industrial areas. Medicines manufactured in the state are supplied to different parts of the country.
When a medicine fails quality testing, monitoring of the relevant batch and action to remove it from the market become part of the regulatory process. The samples identified in the report include medicines used for different medical requirements, including heart and blood pressure-related conditions and other diseases.
Regulatory authorities may direct companies to take necessary action when deficiencies are identified. If a relevant batch is available in the market, a recall process may also be initiated. Other measures can include inspection of the manufacturing facility, examination of records and legal action where required.
A failed sample does not establish that every medicine manufactured by the same company or sold under the same brand is substandard. Testing is generally based on a specific sample or batch, and regulatory action is determined on the basis of the relevant batch, manufacturer and investigation report.
A substandard medicine and a counterfeit medicine are not the same. CDSCO classifies samples that fail to meet prescribed standards as NSQ and takes regulatory action according to the findings. Declaring a medicine counterfeit involves a separate legal and investigative process.
The CDSCO testing system forms part of the country's mechanism for monitoring drug quality. Central and state agencies collect samples from different locations and send them for laboratory testing. Where prescribed standards are not met, action is taken against the relevant manufacturer and, where required, against products available in the market.
The quality of production processes, raw materials, machinery, storage and testing of finished products is subject to prescribed standards for drug manufacturing units. Following the finding that 240 drug samples across the country were substandard, attention remains focused on the quality monitoring of medicines, including those used for heart, blood pressure and other diseases.
Patients should not discontinue regular medicines solely on the basis of a news report. If an official regulatory warning or recall applies to a particular medicine or batch, patients should contact a doctor or pharmacist for further advice.
