New Delhi, May 26 (PTI) The Central Drugs Standard Control Organisation (CDSCO) has issued revised regulatory guidelines for sampling of drugs, cosmetics and medical devices, mandating wider surveillance across rural and tribal areas, and stricter monitoring of spurious and substandard products in the market.
The guidelines, issued by the CDSCO, the apex drug regulatory body under the Union Health Ministry, seek to bring uniformity in sampling practices followed by drug inspectors of central and state regulatory authorities.
The document uploaded on the CDSCO portal on Tuesday noted that there was no defined methodology for the selection of samples and locations earlier, with inspections often limited to urban areas and established brands.
“Interior locations or rural distributions are not covered and thereby the quality of drugs at distant user/last user is not being assessed,” the guidelines said.
The revised framework directs drug inspectors to prepare monthly and annual sampling plans covering the entire jurisdiction, including rural and tribal regions, endemic disease areas and medicines used for seasonal illnesses.
The guidelines emphasised that poor-quality and spurious medicines can lead to treatment failure, adverse reactions, higher mortality and growing drug resistance, especially among vulnerable patients.
Under the new guidelines, each drug inspector will have to collect at least 10 samples every month, including nine drug samples and one cosmetic or medical device sample.
Inspectors have also been advised to prioritise high-risk products and suspicious supply chains while selecting samples.
The criteria include medicines sold at unusually high discounts, drugs with tampered labels, products with poor packaging, medicines from unauthorised supply chains and brands resembling established products.
The guidelines also called for increased scrutiny of outlets linked to repeated cases of Not of Standard Quality (NSQ) or spurious drugs, border-area pharmacies and stores operating during odd hours.
To ensure quicker action, inspectors have been directed to send samples to laboratories on the same day of collection or by the next day in case of remote locations.
The CDSCO has also mandated monthly reporting of NSQ and spurious drug alerts for publication on its website to improve public awareness and prevent further circulation of such products.
The guidelines further require drug control offices to maintain a centralised database of wholesalers and retailers linked to spurious products or broken supply chains, which would be shared publicly to alert consumers.
The revised norms additionally provide detailed specifications for sample quantities required for laboratory analysis of drugs, vaccines, cosmetics and medical devices. PTI PLB KSS KSS
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