Only 40 Inspectors for 10,000+ Drug Stores: A Recipe for Disaster
Swapnil R Mishra
The Maharashtra Food and Drugs Authority is gearing up for surprise inspections across medical stores in the state to ensure compliance with regulations. However, a shortage of drug inspectors threatens to hinder this effort, potentially compromising the effectiveness of these inspections.
However, the Maharashtra Drug Inspection Unit is facing a severe manpower crisis, operating at only 40% capacity due to inadequate staffing. To exacerbate matters, nearly half of the available inspectors have been temporarily reassigned to election duties, leaving fewer than 40 inspectors to oversee the entire state.
Meanwhile, the FDA has launched surprise inspections of medical stores across the state. This move comes after 53 essential drugs failed quality tests conducted by the Central Drugs Standard Control Organization. To ensure compliance, each drug inspector will inspect 10 medical stores monthly.
According to data, 80 out of 200 drug inspectors sanctioned posts are currently filled, while over 50% of the remaining inspectors have been reassigned to election-related duties, further depleting the state’s capacity for effective drug regulation.
“There is a drastic shortage of drug inspectors in Maharashtra is alarming, with only 35 to 40 inspectors overseeing the quality of medicines across the state, including over 10,000 licensed medical stores in Mumbai alone. This inadequate staffing level compromises the enforcement of drug quality standards, detection of substandard medications and protection of public health,” said a senior official.
“The FDA’s responsibilities are divided into two key parameters: Drugs and Foods, requiring frequent testing to guarantee safety. However, the skeletal staff has made it challenging to achieve this goal,” he added.
State drug inspectors are vital in ensuring the quality and safety of medications, primarily responsible for collecting samples for testing. However, persistent manpower shortages severely impede their ability to fulfil this duty.
A staggering disparity exists between the required and actual drug sample testing in Maharashtra. Officers reveal that while a minimum of 10,000 samples should be tested annually, only 3,000 are currently being evaluated. The significant gap between the required and actual drug sample testing in Maharashtra raises serious concerns regarding the reliability of drug quality assessment and public safety.
“Maharashtra faces a severe pharmaceutical crisis, compromising public health and safety. Inspections have plummeted, and only a fraction of required samples are tested, paving the way for substandard medications to flood the market.,” said Abhay Pandey, president of the All Food and Drug Licence Holders Foundation.
Recent actions underscore these concerns. The FDA recently cracked down on a bogus medicine racket, seizing 21,600 Ciprofloxacin 500mg tablets from medicine stores under the Nagpur Civil Surgeon at Indira Gandhi Government Medical College and Hospital (IGGMCH). These tablets were found to be substandard and fake, posing serious health risks to patients.
However, this comes after the sample taken by the FDA for testing revealed antibiotics lacking essential components. Following this Police submitted a comprehensive 1,200-page chargesheet.
Concerns extend to common medications for fever, cold, cough, stomach pain, and headaches, which are rarely tested, with only 1.5% to 2% of samples found to be sub-standard.
Staff shortages within regulatory bodies hinder timely inspections of substandard medications, despite receiving intelligence on suspicious activities. With additional manpower, regulatory bodies could uncover more incidents of substandard medications, such as the case at Nagpur hospital, protecting public health and upholding pharmaceutical standards,” said a drug inspector.
Delays in obtaining test results from government labs are severely hindering the FDA’s ability to ensure medication quality. An FDA officer revealed that samples collected from Nagpur Hospital in February 2023 took nine months to yield results, received only in November.
The Mumbai lab’s severe staffing shortage, with over 50% of positions unfilled, has led to reliance on interns for assistance. This hinders effective testing, particularly for perishable goods like milk, bread and prepared foods. Officials stress the need to prioritize testing for these items, as delays can compromise consumer safety.
