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Two months ago, four brands of Indian-manufactured cough syrups by a Haryana-based company Maiden Pharmaceuticals were accused of causing diethylene glycol (DEG) and ethylene glycol (EG) poisoning, which killed nearly 70 children in the Gambia.
Instead of taking action against the perpetrators and identifying the root cause of the incident that led to this tragedy, the Indian regulators focused on protecting the reputation of the Indian pharma market.
This month, the Central Drugs Standard Control Organisation (CDSCO) denied any allegations that the Indian-manufactured cough syrup was responsible for the deaths in Gambia, despite the World Health Organization (WHO) clearly establishing such links through laboratory tests.
A cough syrup manufactured by Noida-based pharma company Marion Biotech has been found to be contaminated with EG and is believed to have killed 18 children in Uzbekistan, according to tests conducted by the Health Ministry there.
There are several issues that contribute to such tragedies.
Firstly, Indian pharmaceutical companies often skip testing raw materials and finished products before marketing them, despite the requirement for such testing as per the good manufacturing practices (GMP) prescribed under the Drugs and Cosmetics Act, 1940.
The regulators, however, often fail to spot these gaps during the GMP inspections of manufacturing units.
A similar incident in Jammu in January 2020 led to the death of 11 children due to a DEG-contaminated syrup manufactured by a Himachal Pradesh pharmaceutical company Digital Vision. The state drug regulator in this case submitted before the Himachal Pradesh High Court that the manufacturing unit lacked adequate facilities to test the final product for any form of contamination.
Secondly, drug regulators fail to investigate the root causes of such incidents. Future instances linked to the cause can be prevented if the source of the contaminated industrial solvents can be traced and made public.
In the Jammu incident, the drug regulator only focused on the alleged cough syrup as an isolated incident without looking into the origination of Propylene Glycol (PG), which possibly contaminated all different cough syrups produced by Digital Vision.
Eight months after the Jammu incident, in August 2020, the death of another child was found to be linked to consuming a different brand of cough syrup produced by the same company, possibly manufactured with the same contaminated PG.
Thirdly, the lack of a drug recall law in India results in uncoordinated and ineffective actions in recalling contaminated batches of drugs.
There are no legal mechanisms forcing the manufacturer to immediately make efforts to withdraw tainted batches or obligating the CDSCO to coordinate nationwide recall or public communication to prevent more people from consuming the contaminated drug.
Finally, the fragmented regulatory system in India between 38 drug regulators across states and union territories adds to the problem.
Since drug manufacturing licenses are issued by state drug regulators, drugs manufactured and licensed in different states do not go through a uniform level of scrutiny despite centrally prescribed standards.
This leaves other state drug regulators dependent on them to take action despite being able to spot non-standard drugs by a manufacturer outside their state. As per the eXtended Licensing, Laboratory, and Legal Node (XLN) database maintained by the Government of India, quality violations were reported by state drug controllers in Maharashtra, Gujarat, and Kerala against Digital Vision at least 13 times.
Incidents like these are bound to happen unless the Ministry of Health and Family Welfare and the CDSCO respond with the intention of protecting public health rather than protecting the pharmaceutical industry and India’s reputation as the pharmacy of the world.
While immediate measures should be taken in response to such crises by identifying the root cause of individual instances to prevent further damage, systemic changes are needed to prevent such incidents from happening.
On the other hand, India has so far witnessed seven incidents of mass deaths due to DEG-contaminated drugs. This should be treated as a wake-up call for the government to bring in a stringent drug recall law and centralise the process of issuing manufacturing licenses in India.
Amending the draft Drugs, Medical Devices and Cosmetics Bill can be a step in the right direction.
(Shreya Shrivastava is Senior Resident Fellow at the Vidhi Centre for Legal Policy. This is an opinion article and the views expressed are the author’s own. The Quint neither endorses nor is responsible for them.)
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