Safety first: on Indian pharma products and drug safety

Reports of drugs manufactured in India causing severe harm and dozens of patient deaths from across the world continue to trickle in, the latest being the deaths of two patients in Sri Lanka who were administered Indian-made anaesthetic drugs. Just last month, eye drops manufactured in India had caused eye infection in about 30 patients and blindness in 10 in Sri Lanka. While anaesthetic drugs made in India causing deaths are a first in the recent past, eye drops causing infections, blindness and even deaths were reported a few months ago in the United States, with the Atlanta- based Centers for Disease Control and Prevention (CDC) finding a highly drug-resistant bacteria in them. The series of adverse reports against drugs produced in India began last year when the World Health Organization (WHO) linked the deaths of at least 70 children in Gambia from acute kidney injury, to cough syrups. The culprit ingredient in the syrups was diethylene glycol and ethylene glycol — deadly chemicals used as a cheaper substitute for propylene glycol — that should never have been found in any medicine. Soon after the deaths in Gambia, cough syrups made in India and containing the two deadly chemicals killed 18 children in Uzbekistan in December 2022. In end-April this year, Indian-made cough syrup was again in the news when WHO flagged the contaminated drugs found in the Marshall Islands and Micronesia; the contamination was identified by the Australian regulator. Diethylene glycol-contaminated drugs have led to at least five incidents of poisoning in Chennai, Mumbai, Bihar, Gurugram and Jammu between 1972 and 2020.

The conduct of the Indian drug regulator ever since WHO first raised a red flag in October last year has been on predictable lines. Even after serious violations, it gave a clean chit to the company that had supplied the drugs to Gambia and then went on the offensive to fault the global health body. While WHO held its ground, the drug regulator’s stand was exposed — test results from Switzerland and Ghana confirmed the presence of toxic chemicals in the cough syrup sample from Gambia. Also, a detailed causality assessment by Gambia and independent investigations by the Gambian Parliamentary Committee and CDC Atlanta found a link between the deaths and the toxic chemicals. Except for some customary inspections, the Indian drug regulator has so far failed to institute measures to make sure drugs produced in India for export and domestic use are safe. India can continue to be the pharmacy of the global south only if the regulator begins to behave like a watchdog to ensure drug safety, and not as a facilitator for the pharma industry.

Summary of the Editorial

1. Recent reports indicate Indian-made drugs causing severe harm and patient deaths globally, with the latest cases reported in Sri Lanka.

2. Last month, Indian-made eye drops caused eye infections in 30 patients and blindness in 10 in Sri Lanka.

3. Similar issues with eye drops were reported in the U.S. months ago, with the CDC finding a highly drug-resistant bacteria in the medication.

4. Last year, WHO linked the deaths of 70 children in Gambia to Indian-made cough syrups containing deadly chemicals diethylene glycol and ethylene glycol.

5. The same chemicals in cough syrups resulted in the death of 18 children in Uzbekistan in December 2022.

6. In April this year, contaminated Indian-made cough syrup was flagged in the Marshall Islands and Micronesia, identified by the Australian regulator.

7. Incidents of poisoning from diethylene glycol-contaminated drugs have been recorded in various Indian cities between 1972 and 2020.

8. The Indian drug regulator's response to these issues has been criticized, even giving a clean chit to the company supplying drugs to Gambia.

9. The regulator's stance was debunked when tests from Switzerland and Ghana confirmed toxic chemicals in the Gambian cough syrup sample.

10. Independent investigations by the Gambian Parliamentary Committee and CDC Atlanta linked the deaths to these toxic chemicals.

11. The Indian drug regulator's efforts so far have largely been limited to inspections, with no substantial measures implemented to ensure drug safety.

12. To maintain its position as the global south's pharmacy, the Indian drug regulator needs to step up its role in ensuring the safety of drugs produced for both export and domestic use.

13. The ongoing concerns surrounding drug safety highlight the need for more rigorous testing and regulatory scrutiny of pharmaceuticals in India.

14. Quality and safety of drugs manufactured in India must be the prime focus for Indian regulators, instead of facilitating the pharmaceutical industry.

15. The continued occurrence of these incidents calls for an overhaul of the regulatory framework, putting patient safety at the forefront.