CDSCO Plans Tighter Monitoring Of Narcotic Drugs In Medicines

Mumbai: The Central Drugs Standard Control Organisation (CDSCO) is planning a stronger regulatory mechanism to track pharmaceutical preparations containing narcotic drugs and psychotropic substances, aiming to prevent their illegal diversion and improve monitoring of their manufacture, sale and stocking across the country.

It will also introduce a standard format for states and Union Territories to submit monthly data, aiming to plug regulatory gaps and prevent illegal diversion of these drugs.

The initiative assumes significance following instances of medicines containing opioid substances allegedly being sold without valid drug licences. In June 2026, the Maharashtra Food and Drug Administration (FDA) and Anti-Narcotics Cell-1 seized 10,492 capsules of SPAS-TRASCEN PLUS in Pune. The medicine contains Tramadol Hydrochloride, Dicyclomine Hydrochloride and Acetaminophen. Authorities recovered 424.06 grams of Tramadol, classified as a commercial quantity under the Narcotic Drugs and Psychotropic Substances (NDPS) Act.

Tramadol is an opioid painkiller that requires medical supervision. Although it can be effective when prescribed appropriately, misuse or consumption without medical guidance can lead to dependence and addiction.

The proposed regulatory measures form part of the Vision Document on Drug Control 2026–2029, and CDSCO has been tasked with examining gaps in the existing regulatory framework and preparing measures to prevent and detect illegal diversion by March 2027.

Under the proposed mechanism, CDSCO will circulate a standard format for monthly data submission by states and Union Territories. The information will include the number and categories of licences issued, quantities of drugs handled, inspections and audits conducted, and enforcement actions taken. The format may be finalised in consultation with state drug regulators.

The committee also recommended developing a common digital platform to facilitate data submission and analysis, enabling authorities to identify regulatory gaps and improve coordination between central and state agencies.

Additionally, the DCC suggested exploring whether the online portal developed by the Central Bureau of Narcotics could be adapted for pharmaceutical regulation. Such a system could support end-to-end tracking of these drugs across the supply chain.

The proposed measures are expected to strengthen oversight of medicines containing controlled substances and help authorities detect irregularities in their distribution before they reach unauthorised channels.

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