Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Contamination of medicine: India; The Pharmacy of the world needs a relook in drug regulations

Note4Students

From UPSC perspective, the following things are important :

Prelims level : NA

Mains level : Contamination of medicines and drug regulations in India

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Context

  • Merely two months after the World Health Organisation (WHO) sounded an alert over deadly contamination in four brands of cough syrup manufactured by a Sonepat-based pharmaceutical company that were subsequently linked to the deaths of 72 children in Gambia, another Indian pharmaceutical company stands accused of a similar crime. This time, it is Uzbekistan which has accused a Noida-based pharmaceutical company of selling contaminated cough syrup that has allegedly killed 18 children in that country.

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Thorough analysis

  • Unacceptable levels of Ethylene/ Diethylene glycol: In both cases, lab tests reportedly found unacceptable levels of diethylene glycol (DEG) or ethylene glycol (EG) or both in the cough syrups.
  • Ideally these chemicals should not be found in any medicine: Both DEG and EG are deadly chemicals that should not be found in any medicine.
  • Then how these chemicals end up in medicines: The typical reason these chemicals end up in medicine is because pharmaceutical manufacturers do not adequately test industrial solvents purchased from chemical traders and used to manufacture cough syrups despite the fact that the law mandates such testing for contamination.
  • Proximity in two cases: Given the physical proximity of the manufacturers implicated in the Gambian and Uzbekistan cases, there is a very high possibility that the same batch of contaminated industrial solvent was used by both companies.

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Contamination of medicines in India

  • India has a tumultuous history of DEG contamination in medicines: Between 1972 and 2020, India has seen at least five mass DEG poisonings in Chennai, Mumbai, Bihar, Gurgaon and Jammu. The incident in Gurgaon led to the death of 33 children and the incident in Jammu of at least 11 children.
  • Difficult to diagnose deaths due to adulterated medicine: The final reported toll in such cases is definitely an undercount because it is notoriously difficult for doctors to diagnose such deaths and attribute them to adulterated medicine.
  • Lethargy and denial is a pattern with drug regulators in India: In August 2020, about eight months after the DEG-related deaths of the children in Jammu were first reported by PGIMER, Chandigarh, the same hospital reported that another two-year-old child from Baddi had died in its facility after consuming a different brand of cough syrup manufactured by the same company that was responsible for the deaths earlier in Jammu. This was a death that could have been easily avoided if the regulators had conducted and published a thorough root cause analysis after the Jammu incident and followed it up by a nationwide recall of all cough syrups manufactured at the same facility. This never happened.

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Critique: Whether the Ministry of Health and the Central Drugs Standard Control Organization have learnt their lessons from these previous incidents?

  • Government will handle the issue just as any other public relation crisis: The present government is likely to handle this crisis as yet another public relations crisis instead of a public health crisis. Assumption is based on the observation of the official response from the government to the tragedy in Gambia.
  • Instead of condoling, accused them for not testing before prescribing: Far from condoling the deaths of 72 Gambians, the initial press release from the Ministry of Health gaslit the Gambians by accusing them of not testing the cough syrups before prescribing them to patients.
  • False presumption that the drug regulator is doing its job well: This was an absurd allegation because nobody tests drugs that are purchased before releasing them for patient use, even in India. The presumption is that the drug regulator is doing its job to ensure quality control.
  • Government’s information czars accusing WHO: The first step of this PR strategy was to keep leaking to journalists that the WHO was not co-operating with the information requests made by an expert committee set up by the Government of India to investigate the deaths in Gambia. This despite the government fully knowing that the responsibility of investigating the deaths lay not with the WHO but with the sovereign authorities in Gambia.
  • Rare mention of sympathy: The common thread running through these events is a communications strategy aimed at denial and intimidation. There is rarely a mention of sympathy for lives lost or a commitment to protect public health.
  • Even China does better than India: An iron fist in a titanium glove is the best way to describe the government’s response to any allegations of quality issues afflicting the Indian pharmaceutical industry. In 2007, when a Chinese chemicals manufacturer was implicated in the deaths of 365 people in Panama who consumed cough syrup manufactured with an adulterated industrial solvent, the Chinese arrested the manufacturer and publicly promised to punish him.

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What should be done immediately?

  • The immediate public health response in these cases of DEG contamination should be aimed at limiting further deaths.
  • This means tracing the origins of the contaminated industrial solvent used to manufacture the syrups.

Conclusion

  • What India needs right at the moment is to accept the fact that there is a major quality problem with the Indian pharmaceutical industry. Allegations cannot be morphed from one to another. Perhaps the need of the hour is to have meaningful and comprehensive conversation on actual regulatory reform.

Mains question

Q. It is said that India has a tumultuous history of DEG contamination in medicines. The recent deaths in Gambia and Uzbekistan supports this statement. What the critique has to say over India’s response in such cases.

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