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.
This lackadaisical attitude by the CDSCO and state drug regulators and the lack of strict action has led to another tragedy, this time in Uzbekistan.
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.
While the CDSCO and state drug regulator have conducted inspections of the manufacturing unit and collected samples for testing, they need to do more. Strict action must be taken in such cases, but it is also necessary to address systemic issues rather than viewing these incidents in isolation.
Indian Pharma Companies Skip Testing Raw Materials
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.
However, the Himachal Pradesh regulator failed to notice any such gaps while conducting inspections previously, which could have prevented this incident as pointed out by Dinesh Thakur and Prashant Reddy in their book The Truth Pill: The Myth of Drug Regulation in India.
Drug Regulators Fail to Investigate Root Cause
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.
This is despite the verdict of the Himachal Pradesh HC that the manufacturer failed to verify the authenticity of the supplier to be a licensed wholesaler of such chemicals.
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.
Ineffective Actions in Recalling Drugs
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.
There are Guidelines on Recall and Rapid Alert System for Drugs, which are not binding in nature. As a result, in most cases, like the one in Jammu, the CDSCO ends up only writing to the state drug regulators to take steps to withdraw such drugs from the market that often respond in discretionary and ad hoc manners.
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.
One state’s laxity nullifies stringent measures taken by other states as drugs are not restricted only to the market of the manufacturing state. Additionally, the power to suspend or cancel manufacturing licenses lies only with the license-issuing drug regulator.
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.
Similarly, there were repeated violations reported on XLN by the Kerala and Gujarat authorities against Maiden Pharmaceuticals. However, no preventive actions were taken by licensing authorities against these habitual offenders that unfolded the tragedies.
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.
India should draw inspiration from the United States drug regulatory system, where an incident of 104 deaths due to DEG poisoning in 1937 led to stringent changes in their law. The US has never witnessed another incident of mass DEG poisoning since then.
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.)