India’s lax drug regulatory mechanism under spotlight after 69 killed in Gambia
The drug regulatory mechanism in India, which bills itself as the “pharmacy of the world”, has come under the spotlight with a revelation that four India-made cough syrups may have killed at least 69 children in the Gambia, a west African nation.
An alert issued by the World Health Organisation (WHO) on Oct 5 said analysis of samples of the four products, made by Maiden Pharmaceuticals in India’s Haryana state, had confirmed “unacceptable amounts” of diethylene glycol and ethylene glycol as contaminants.
These two compounds are added as cheap adulterants in propylene glycol used as a solvent in cough syrups. The metabolism of these two compounds causes significant liver and kidney damage.
This is not the first time that India-made cough syrups have been found to be contaminated with diethylene glycol.
Between December 2019 and January 2020, 12 children from Jammu region died after consuming a diethylene glycol-laced cough syrup made by Digital Vision.
In 1998, the worst such cough syrup poisoning was reported from Gurgaon with 33 deaths.
These two incidents are among five such fatal episodes that have been documented in India since August 1973, when 14 children died in Madras.
The recent recurrence of this problem has drawn attention yet again to India’s drug regulatory mechanism that has been plagued by poor oversight, understaffing, weak implementation of laws and corruption.
Dr Anant Bhan, a health policy and bioethics researcher, said: “That there is a pattern here indicates regulatory capture by vested private interests and this could impact how Indian regulation in the sector is viewed externally.”
Manufacturers of cough syrup have to buy medical-grade propylene glycol from approved vendors and test the product for contamination before use, but these rules are flouted.
An investigation in September last year reported that the authorities had found glaring violations by Digital Vision.
The firm had procured propylene glycol from a dealer that had no pharmaceutical license. It also had no records of having dispatched samples for testing.
Meanwhile, a probe has been initiated by India’s Central Drugs Standard Control Organisation (CDSCO) against Maiden Pharmaceuticals.
The firm, however, claimed it obtained raw materials from “certified and reputed companies”.
Maiden’s past track record has been controversial.
Dinesh S. Thakur, a public health activist, put out a series of tweets on Oct 6 detailing its wrongdoings.
A central government drug inspector prosecuted the company in 2018 for quality violations, and at least two Indian states, Kerala and Gujarat, flagged its products to be of substandard quality.
The firm’s products had even been blacklisted by Vietnam in 2011.
Yet, said Thakur, Maiden had been certified by the CDSCO through the Certificate of Pharmaceutical Product process, assuring buyers overseas it had inspected and ensured that the company complies with WHO’s current good manufacturing practices.
Thakur said that the CDSCO “continues to operate in an opaque, ineffective, and corrupt manner”.
Dr Bhan said the latest crisis should be viewed as an opportunity to plug the gaps.
“There should be a prioritized independent and transparent probe to understand what went wrong, fix accountability, identify and respond to the gap areas, and ensure all of this is communicated to all relevant stakeholders,” he added.