The Hindu’s editorial dated June, 20th on safety issues relating to produced in India..u’s editorial dated June 20
India’s regulators must ensure quality and safety of drugs
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.
Paraphrased and simplified version of the same…
Indian pharma industry must not lower its guards on quality- Stringent checks needed to dispel customers’ safety concerns
Disquieting reports of complications and even deaths of patients given Indian-origin drugs have come in from Sri Lanka. Not long ago, similar reports about apparently unsafe Indian cough syrups had emerged from countries like Gambia forcing the WHO to step in and investigate. The Gambian debacle cast a long shadow on the safety standards followed in India by its drug manufacturers. In Sri Lanka, it was the anesthetic drugs supplied by a Gujarat-based firm that caused a few deaths and severe eye infection among 30 patients who used them. Quite understandably, the Sri Lankan doctors raised an alarm and stopped using such suspect medicines.
In the Gambian case, WHO investigations revealed that the cough syrups contained two unsafe ingredients–Diethylene glycol and Ethylene glycol. These two ingredients were used to substitute Propylene glycol which is costlier than the former two components. Quite clearly, the drug makers in India went for profits at the expense of safety. To make matters worse, in December, 2022, Uzbekistan reported 18 deaths of children who were given the same cough syrups that had caused the death of 70 children in Gambia. As if this was not enough, Australian drug regulators red-flagged Indian cough syrups used in the Marshall Islands and Micronesia.
It defies logic to understand why the cough syrups containing the deadly Diethylene glycol were allowed to be used inside the country despite the fact that the syrup had caused scores of deaths in Chennai, Mumbai, Bihar, Gurugram and Jammu between 1972 and 2020. The country’s drug regulators apparently slept over the matter treating the country’s young children as dispensable.
Such reports emerging from different parts of the world on Indian drugs cast a dark shadow on our quality enforcement. Consequently, the bad press received internationally puts India’s flourishing drug export sector under the lens. The development is very damaging for our pharma industry. The malady, in order to be cured, warrants urgent and stringent remedial measures by the drug regulators.
Quite strangely, the company that produced and exported such dangerous cough syrups managed to obtain a clean chit from the Indian drug regulators, who chose to ignore WHO’s strong caution over the matter. Subsequent test results obtained from Switzerland and Ghana confirmed the presence of toxic chemicals in the cough syrup sample from Gambia. The credibility of the Indian regulator was reduced to ashes.
Later, a detailed investigation conducted by the Gambian Parliamentary Committee and CDC Atlanta found a link between the deaths and the toxic chemicals in the cough syrups. The Indian drug exporter and the Indian drug regulators were put on the dock for being criminally negligent. The developments gave a deadly blow to India’s reputation as a pharma giant. The offending drug maker has managed to evade any serious criminal prosecution so far.
Lackadaisical approach and corruption have blighted India’s drug regulatory framework. The sooner administrative action to reverse such laxity is taken, the better for India’s aspirations to be a global drugs manufacturing hub.
(GOOD WORDS AND PHRASES ARE UNDERLINED.)