The Maharashtra Food and Drug Administration (FDA) has launched a robust crackdown on illicit drug trade to strengthen pharmaceutical compliance and uphold impeccable drug quality standards. Commissioner Abhimanyu Kale sheds light on these initiatives in an exclusive interview, outlining measures to tackle challenges and augment blood safety.
Enhancing compliance:
The state drug regulator is prioritizing advancements in lab testing and the method of analysis (MoA) to bolster compliance. High-end testing tools such as HPLC, IR, UV, and Mass Spectroscopy are deployed for effective testing of medicinal products. A new drug testing lab in Pune is being upgraded, and the FDA is enhancing manpower, with 82 active staff members and a total of 200 sanctioned posts.
Actions against illicit drug trade:
The FDA has taken decisive steps against illicit drug trade following 6,779 inspections across the value chain. These inspections exposed non-compliance issues, leading to the suspension of 892 retail licenses and 1,033 wholesale licenses. Targeted raids, totaling 53, resulted in the confiscation of pharmaceuticals worth Rs. 2.85 crore. The FDA filed 28 FIRs addressing violations related to spurious drugs and unauthorized sale of prescription medications.
Outcome of crackdown:
The regulatory crackdown led to more than 30 arrests and initiated 3,102 prosecutions against individuals involved in the illicit trade of spurious drugs. Quality control measures were intensified, with around 120 samples declared as not meeting standard quality out of the 3,200 samples scrutinized by state drug controllers (SDCs).
Challenges and future plans:
Recognizing the need for reinforced compliance measures, the FDA is actively augmenting its workforce, particularly in regions facing a pronounced shortage. The regulatory body faces a shortage of Assistant Commissioners (ACs), with 38 out of 66 sanctioned posts vacant. Measures to ensure blood safety include granting licenses to 23 more blood banks, bringing the total to 366 within three years.
Blood safety measures:
The Maharashtra FDA has granted licenses to 23 additional blood banks, totaling 366 within the past three years. This aligns with the Union health ministry’s mandate of fostering voluntary blood donation. The diverse landscape of blood banks in Maharashtra now comprises 279 trust-operated, 77 civic-run, and 10 private establishments.
