Firm Measures Announced for Controlling Non-Prescription Drug Sales: Tamil Nadu’s New Drug Controller

M Sridhar, the incoming director of the Tamil Nadu Drug Control Administration (DCA), has announced plans to severely restrict the sale of habit-forming drugs and abortion pills without a prescription. Offenders will face stringent consequences.

District-level awareness campaigns, headed by Assistant Drug Controllers (ADCs), will focus on enlightening communities, particularly the youth, about the dangers associated with narcotics and psychotropic substances. Additionally, a workshop addressing antimicrobial resistance (AMR) is on the agenda.

Retail chemist outlets will undergo rigorous surveillance for the distribution of these and Schedule X medications. Furthermore, action will be taken against pharmacies operating without registered pharmacists. Legal proceedings will target any record-keeping discrepancies.

In a conversation with Pharmabiz, Sridhar outlined his objectives for the upcoming three months, noting that processing pending applications for various certificates required for tenders will be prioritized, with ADCs tasked to expedite this process. The pharmaceutical industry can directly communicate their concerns to him, and they will be swiftly resolved.

The implementation of the Revised Schedule M is slated to commence on January 4 of the coming year. Regulatory inspections aligned with the new GMP guidelines are underway. In September, initial inspections across 46 companies showed only four fully adhering to the updated regulations of the D&C Act. Following this, a second phase targeting 64 companies is scheduled for December 16 and 17, with a commitment to inspect all firms by year-end.

A scarcity of manpower in the department has been a bottleneck for prompt inspections, Sridhar noted. To alleviate this, the government intends to recruit 15 drug inspectors by February or March, streamlining enforcement activities.

Regarding licensing for the forthcoming Muthalvar Marundhakam, government-backed generic pharmacies, Sridhar mentioned a sparse number of applications have been received, though 83 licenses have already been issued. Another 20 applications are under review in ADC offices. As these stores receive medicines from cooperative societies, applicants must also obtain a license from the society registrar.