In a move aimed at strengthening drug quality surveillance and tackling the circulation of substandard and spurious products, the Central Drugs Standard Control Organisation (CDSCO) recently issued revised regulatory guidelines for the sampling of drugs, cosmetics and medical devices.
The updated framework introduces a uniform sampling methodology for Drugs Inspectors operating under central and state drug regulatory authorities and places a stronger focus on inspections in rural, tribal and remote areas, where regulatory surveillance has often been limited.
According to the guidance document, earlier sampling practices lacked a defined methodology for selecting products and locations, with sampled drugs often collected from big brands located in urban or suburban locations.
“The interior locations or rural distributions are not covered and thereby quality of drugs at distant user/ last user is not being assessed,” the document stated.
Key Highlights of the Revised Guidelines
Under the revised guidelines, each Drugs Inspector will now be required to prepare monthly and annual sampling plans, ensuring coverage of their entire jurisdiction area.
“Sampling plan should include rural/ tribal agency areas and drugs used in areas endemic for certain diseases, drugs for seasonal diseases,” the guidelines noted.
The guidelines also mandate that every Drugs Inspector collect at least 10 samples per month under Sections 22 and 23 of the Drugs and Cosmetics Act, 1940. These samples should include:
- Nine samples of drugs, including APIs, excipients and formulations
- One sample of either a cosmetic product or a medical device
Inspectors have also been directed to collect samples from different therapeutic categories, formulations and manufacturers from sales outlets based on identified risk factors, which include drugs sold at huge discounts, products with tampered label, drugs with poor quality primary packing, and products distributed outside authorised supply chains.
The guidelines emphasise the need to avoid delays in testing and obtaining laboratory reports so that the use of identified Not of Standard Quality (NSQ) products can be halted at the earliest through drug alerts and product recall notices.
To ensure timely action, Drugs Inspectors have been directed to plan sampling activities in a manner that enables samples to be forwarded to laboratories on the same day of collection. In cases where delays occur due to transit from rural or remote locations, the samples must be sent to the laboratory the following day and no later.
Additionally, the guidelines direct Drugs Inspectors to submit NSQ reports received from state and central laboratories before the 10th of every month for publication on the CDSCO website.
Similarly, products identified as spurious due to distribution chain breakage or confirmed by manufacturers as counterfeit must be reported monthly.
“Not of standard Quality (NSQ) and Spurious drugs can cause treatment failure and adverse reactions, increase morbidity and mortality, and contribute to the development of drug resistance,” CDSCO said.
In addition to operational changes, the revised norms also provide detailed specifications regarding the quantity of samples required for laboratory analysis of drugs, vaccines, cosmetics and medical devices.
“It is important that sufficient quantity of samples are collected & forwarded to laboratory so that all the parameters are tested and re-testing, if any required by laboratory before issuing of NSQ test report,” it stated.
