47 Drug Inspectors for 2.5 Lakh Batches: Kerala Faces Oversight Strain
Thiruvananthapuram: Despite having an annual pharmaceutical market valued at nearly Rs15,000 crore, Kerala currently has only 47 drug inspectors responsible for monitoring the quality, sale and distribution of medicines and cosmetic products across the state, raising serious concerns about regulatory oversight and public safety.
Every year, around 2.5 lakh batches of medicines from various manufacturers enter the Kerala market. Of these, almost 98% are sourced from outside the state, significantly increasing the workload on the already stretched drug control machinery. Due to manpower shortages, authorities are able to collect only about 1,000 samples per month for quality testing, a number considered grossly inadequate when compared to the volume of medicines in circulation.
The situation has remained unchanged for decades, as no new drug inspector posts have been created since 1998. A government report submitted as early as 2013 had recommended the creation of at least 15 additional drug inspector posts, but the proposal was never implemented. Later, the Administrative Reforms Department also suggested appointing 10 more drug inspectors and two regional inspectors, but this recommendation continues to remain pending.
Under the provisions of the Drugs and Cosmetics Act, every licensed medical establishment is required to be inspected at least once a year by a drug inspector. However, with the existing workforce, fulfilling this statutory requirement has become increasingly difficult. In many cases, one inspector is responsible for overseeing up to three taluks, while some inspectors are forced to share vehicles to conduct inspections and attend official duties.
In addition to inspections, drug inspectors are tasked with issuing and renewing licences, conducting follow-up inspections of allopathic and homoeopathic medical stores, supervising cosmetic manufacturing units, handling registration of medical device units, licensing blood banks and storage facilities, and attending court proceedings, further stretching their capacity.
Substandard and fake products are reported to be most commonly detected among antibiotics, painkillers, cough syrups, sexual enhancement drugs and cosmetic items, highlighting the risks posed by limited regulatory oversight.
According to a recent media report published by Kerala Kaumudi Online, Kerala has drug testing laboratories located in Thiruvananthapuram, Ernakulam, Thrissur and Konni, but with only 57 analyst posts available statewide, timely testing and reporting of samples remains a major operational challenge.
Health officials and regulatory experts have repeatedly warned that without urgent strengthening of the drug control workforce and laboratory infrastructure, ensuring medicine quality in a market of this size will remain a significant challenge for the state.
