Pune FDA Crackdown: 102 Chemist Licences Cancelled, 286 Suspended Over Drug Law Violations

According to official data, during the period from April 2025 to March 2026, the FDA cancelled licences of 102 chemists and suspended licences of 286 others. The action was implemented across multiple districts under the Pune division, including Pune, Satara, Sangli, Kolhapur, and Solapur, with Pune district accounting for a significant share of the violations.

The enforcement measures covered both wholesale and retail sectors. Among those penalised, licence cancellations were imposed in serious cases involving major non-compliance, while suspensions were issued where corrective action was deemed possible. In addition to these actions, several chemists received notices instructing them to rectify irregularities within a specified time frame.

The FDA also extended its regulatory action to the manufacturing sector. Licences of eight drug manufacturing units were cancelled due to serious violations, while several other units, including both allopathic and ayurvedic manufacturers, faced suspension. Furthermore, multiple firms were served show-cause notices for failing to meet regulatory requirements.

Officials stated that inspections were conducted through a combination of routine checks and surprise visits to ensure compliance with legal and quality standards. Although inspections are mandated periodically, authorities have intensified monitoring efforts by conducting them more frequently to strengthen enforcement and ensure public safety.

During these inspections, several common violations were identified. These included dispensing medicines without valid prescriptions, inadequate maintenance of records, absence of registered pharmacists at medical stores, and unauthorised sale of restricted or habit-forming drugs. In certain instances, adulteration issues were also observed, particularly where ayurvedic products were found to contain allopathic drug ingredients.

FDA authorities clarified that strict penalties such as licence cancellation were reserved for cases posing serious risks to public health, while suspension was applied in situations where compliance could be restored. They also emphasised that due legal procedure was followed in all cases, with concerned parties being given an opportunity to present their explanation before action was finalised.

According to a recent media report in the Pune Mirror, officials have made it clear that such enforcement drives will continue in the future. Chemists, manufacturers, and all stakeholders involved in the pharmaceutical supply chain have been urged to strictly comply with regulatory standards to ensure safe, legal, and ethical distribution of medicines.