With just 8 drug inspectors, dubious meds go undetected in Karnataka

Bengaluru: Karnataka has only eight drug inspectors against the sanctioned strength of 112, which is hobbling the state government's efforts at cracking down on sub-standard drugs and creating "some kind of fear of law" among manufacturers.

Data shows that nearly 97 per cent of over 1,000 drug samples were declared ‘not-of-standard quality’ (NSQ) over the past three years in Karnataka came from manufacturers based out of the state. But a lack of inspectors is coming in the way of taking action against such callous manufacturers, especially in the case of ‘grossly substandard’ drugs. 

According to the Central Drugs Standard Control Organisation (CDSCO), non-standard drugs include drugs that are spurious and adulterated, have minor defects, or are grossly substandard drugs having low or nil active ingredient content, fail assay, pyrogen, sterility, toxicity or dissolution tests to name a few.

Drugs inspectors perform critical functions such as monitoring drug manufacturing and conducting random inspections. But only eight of the sanctioned 112 posts in Karnataka have been filled, revealing a poor state of affairs.

Recruitment process that began in 2018 got mired in legal proceedings, with the case still in the Supreme Court. A hearing is scheduled later this month.

A well-placed source in the department detailed the problems that arise when there are not enough inspectors. 

“Each officer has a specific target of random samples to collect and test every month," said the source. "However, because we have only eight drug inspectors, the 55 assistant drugs controllers (ADCs) have to shoulder their targets and establish the distribution chain for each batch that is found NSQ, which is an added burden on top of several ongoing cases, committee meetings and other inspections.” 

Manufacturers have 28 days to challenge the NSQ reports. If found ‘grossly substandard’, then a lengthy prosecution process ensues. According to a senior official, at least one in every 20 NSQ cases in a year fall in the ‘grossly substandard’ category.

“In the case of grossly substandard quality drugs, drugs inspectors, with the cooperation of concerned states’ drugs control officers, conduct an investigation at the manufacturing unit and collect necessary documents of people responsible for manufacturing such drugs,” said Dr Jagashetty B R, former state drugs controller, Karnataka, and former National Advisor (Drugs Control) to the Ministry of Health and Family Welfare.

“They file a criminal case against them, including the manufacturing unit as per the Drugs and Cosmetics Act, 1940, in the competent jurisdictional court of the state where the drug in question is declared as not-of-standard quality,” he added.

Having more drug inspectors will lead to more random inspections, which department officials believe is necessary to “create some kind of fear of law” among manufacturers to strictly maintain quality standards.

“Currently, we are unable to draw required samples and do more routine testing; it is a little difficult to look after all operations in the state,” said another senior official.

Spurious scare

Between January 1, 2022 and January 18, 2025, 1,007 batches of various drugs were declared NSQ, according to data from the state drugs control department (now known as the Food Safety and Drugs Administration).

This included 96 batches of widely consumed paracetamol, 53 batches of domperidone, 52 batches of folic acid and several gastro-resistant tablets, besides 86 batches of compound sodium lactate (ringer's lactate) IV solution samples.

Barring 30 batches of drugs, which were manufactured by 16 companies based in Karnataka, the rest are from outside the state.

Once found NSQ, drugs under these batch numbers are recalled from the market. Officers will write to respective state drug controllers to take administrative action against manufacturers, which can include a temporary suspension of said drug’s manufacturing and sales.

Importance of drug inspectors

Drugs inspectors are responsible for monitoring drug manufacturing and conducting random inspections Each officer has a specific target of random samples to collect and test every month But if there is a shortage, assistant drugs controllers have to shoulder  responsibilities on top of their other work More drug inspectors will lead to more random inspections, which is necessary to maintain quality standards

Quote - In the case of grossly substandard quality drugs drugs inspectors with the cooperation of concerned states’ drugs control officers conduct an investigation at the manufacturing unit and collect necessary documents of people responsible for manufacturing such drugs - Dr Jagashetty B R former state drugs controller Karnataka