80 of the 200 drug inspector vacancies vacant, rampant corruption is killing us: Ex FDA Commissioner

In India, the pharma industry is worth around Rs 1.72 lakh crore

Are you aware that Adverse Drug Reaction (ADR) claims about 100,000 lives annually in the US? Or that India, as a whole, has no comprehensive precautions in place to prevent ADR? Do you ensure that a pharmacist is present at your local chemist shop? Do you insist on a bill after buying medicine?

These are some basic questions rooted in various laws enacted in India to safeguard consumers. However, few bother to follow them, says Mahesh Zagade, former commissioner of the Food and Drug Administration (FDA) in Maharashtra and a retired IAS officer. He was reacting to the recent exposé by Nagpur rural police regarding a spurious drug case, which, according to him, is just the tip of the iceberg. "Unless the public becomes more vigilant in enforcing laws, the situation will not improve," he warned, while speaking to mid-day in its last of a three-part series on spurious drugs.

Former Food and Drug Administration Commissioner Mahesh Zagade. Pic/Ashish Raje

Zagade explained, "The spurious drug issue has been documented as far back as 1937 when Elixir Sulfanilamide caused over 100 deaths in 15 US states. The drug had not been tested for toxicity, as safety studies were not mandated at the time. One of the drug's ingredients, diethylene glycol - commonly used as antifreeze - proved to be a deadly poison."

He added, "In 2023, 66 children under the age of five in Gambia died after ingesting a contaminated cough syrup. The common symptom among them was an inability to urinate due to kidney damage. The culprits were four products manufactured by Maiden Pharmaceuticals, a company in Haryana. To date, the company has not provided assurances about their safety."

FDA's limited scope

"Why is the state FDA laboratory restricting itself to Active Pharmaceutical Ingredient (API) testing only," Zagade asked, "When it could easily go beyond API checks to identify other harmful chemicals used in spurious drugs? The state has three state-of-the-art laboratories capable of uncovering the root of such rackets. Their refusal to conduct more comprehensive tests reflects a lack of seriousness."

Asked about the size and growth of the pharmaceutical industry, he said, "Globally, the pharma industry is growing faster than many economies. I estimate it has surpassed $1.48 trillion (approximately Rs 12.66 lakh crore). In India, the industry is worth around R1.72 lakh crore. While India is the third-largest producer of medicines by volume due to our dominance in generic drugs, we rank 13th or 14th by value since generics are priced lower than branded drugs."

The Drug and Cosmetics Act of 1940 was meant to safeguard public health, but its poor enforcement has allowed antibiotic misuse and counterfeit drugs to flourish, warns Zagade. "Antibiotics are sold like candy," he said, adding that over-the-counter sales without prescriptions are rampant.

Dirty nexus and corruption

Zagade exposes a "systemic plan" to keep drug inspector posts vacant - just 80 of 200 sanctioned positions were filled. "Drug inspectors divided chemist outlets alphabetically, not geographically. This allowed cozy arrangements with chemists for monthly bribes while ignoring violations," he said. During his tenure (2011-2014), Zagade cancelled 6,000 pharmacy licences for operating without qualified pharmacists. "For chemists, bribing inspectors was easier than hiring full-time professionals," he recalled.

Zagade highlights cases of regulatory failure, including action against an MNC using ethylene oxide to sterilise baby powder, exposing newborns to cancer risks. "The company didn't even follow FDA procedures. I ensured an FIR was filed. Similarly, faulty implants were sold in India while recalled globally. They treated India as a third-rate market, ignoring our regulations," he added.

Way forward

Zagade called for strict enforcement of the Drug and Cosmetics Act, enhanced surveillance, and public awareness campaigns to combat antimicrobial resistance (AMR) and counterfeit drugs. "Leadership with integrity is essential. The stakes couldn't be higher, and the time to act is now," he said.