The Jammu and Kashmir has a long history of protests over counterfeit medicines, but the tragedy in Ramnagar tehsil of Udhampur district remains a particularly painful memory.
Between December 2019 and January 2020, as many as 12 children died in Ramnagar allegedly after consuming a contaminated cough syrup. Public health activist Dinesh S Thakur and lawyer Prashant Reddy T call the tragedy the “fifth mass poisoning event in India” in their book The Truth Pill.
Reddy and Thakur, known for being the whistle-blower in the Ranbaxy fraud, open their book with a prologue dedicated to the Ramnagar tragedy.
When ‘unknown’ disease struck Ramnagar
Media reports initially called the sick children suffering from an “unknown” disease, wrote Thakur and Reddy in The Truth Pill. The doctors initially were confused with the “mysterious” condition of children, note the authors.
They write, “As the year 2019 drew to a close, doctors at two North Indian hospitals were grappling with a mysterious condition that had affected approximately 21 children, several of whom were infants. The weather had started to turn as winter began to set in and all of these children had been suffering from a cough or a cold which were typical for this time of the year, but these children then progressed to vomiting and ultimately suffering from kidney failure.”
Most of these children came from Ramnagar.
The authors further wrote, “It is a remarkable medical event for a cluster of otherwise healthy children from the same neighbourhood to suddenly suffer from acute kidney failure. The first response of the government in such circumstances is to put together a team of doctors, microbiologists, and epidemiologists from various institutions to conduct an epidemiological investigation.”
Following the report of the sickness, the Government of India indeed rushed a group of experts to trace the source of the mystery affliction to prevent it from affecting more children in the region. But media reports from the time say that the high-level team of experts from Union Health Ministry decided to reach the affected villages to explore the cause and remedies after 10 deaths had occurred.
Water seen as the usual suspect
When sickness was first reported, the then-Udhampur Chief Medical Officer (CMO) Dr KC Dogra was clueless about the disease. The then-District Development Commissioner Piyush Singla decided to concentrate on the usual suspect of drinking water.
Singla directed the public health engineering department to collect samples of drinking water for laboratory testing and to “ensure safe drinking water is provided to the public presuming the water is killing children.”
Among six critically ill children, four were referred to the PGI Chandigarh and one each in Ludhiana and SMGS Hospital in Jammu. The government had issued an advisory asking people not to panic and rush their children in the wake of any symptoms to the qualified paediatricians in hospitals.
However, doctors at PGI Chandigarh conducted a series of tests on the children to diagnose the illness. They also sent medication consumed by them prior to their admission to the hospital for tests.
Thakur and Reddy note in their book, “One of these medications was a cough syrup COLDBEST having a fixed dose combination of Paracetamol, Phenylephrine, Hydrochloride and Chlorpheniramine Maleate manufactured by a Digital Vision, pharmaceutical company with its manufacturing base in Himachal Pradesh, which is the national hub for most pharmaceutical companies due generous tax exemption policy introduced by the government the hilly region. The parents of the children in Jammu had bought this cough syrup from a local pharmacy after their children had exhibited signs of fever along with either a cough or a cold.
“The Regional Drug Testing Laboratory, Chandigarh which tested three different samples of the same batch of COLDBEST alleged that the samples of the cough syrup tested positive for 34.24%, 34.97%, and 35.87% of diethyleneglycol (DEG) — which is a powerful industrial solvent that is used in the manufacture of anti-freeze, brake fluid, etc.”
Thakur and Reddy in their book The Truth Pill noted that DEG is never used in manufacturing of medicine and can cause kidney failure upon consumption.
The wrote, “It is never used in the manufacture of medicine and can be fatal to humans who consume it. It causes the kidneys to fail and that can eventually lead to death. In cases of DEG poisoning due to manufacturing errors, children tend to suffer the most because their smaller body size causes them to be more vulnerable to the toxic effects of DEG when compared to adults. Finally, the doctors at PGIMER had a probable answer to explain the renal failure leading to the death of the children from Ramnagar.”
By the time the mystery was solved by the doctors at PGI Chandigarh, 12 children from Ramnagar between the ages of two months and six years died due to renal failure.
In their book, Thakur and Reddy note India’s poor record with DEG poisoning.
They wrote, “India has the uniquely depressing record of having had at least five major DEG poisoning events. The first took place in Madras in 1972, killing 15 children after they consumed a cough syrup called Pipmol C that had been adulterated with DEG. The second event took place in Mumbai in 1986 at the famous J.J. Hospital killing 14 patients after they consumed glycerin that had been adulterated with DEG. The third mass DEG poisoning event took place in Bihar in 1988 killing 11 patients.
“The fourth event took place in Gurgaon, a district neighbouring Delhi, in 1998 when 33 children between the ages of two months and six years died after consuming a cough syrup adulterated with DEG.”
While lamenting Ramnagar deaths, Thakur and Reddy called it the “fifth such mass poisoning event in India”.
The larger tragedy
Thakur and Reddy in their book The Truth Pill note that the deaths of Ramnagar children were preventable. They write that guidelines say that ingredients and final product should be tested to rule out such contamination.
They note, “The larger tragedy was the fact that the deaths of these children from Jammu were entirely preventable. After all, DEG poisoning is a well-known and well-documented problem within the pharmaceutical industry since 1937, when the first mass DEG poisoning event took place in the United States.”
Thakur and Reddy argue that DEG adulteration occurs with such frequency in India as Indian pharmaceutical companies very often fail to test either raw materials or the final formulation before shipping it to the market.
They note, “This is despite Good Manufacturing Practices (GMP) as prescribed in Indian law requiring mandatory testing of both the raw material before it is used in production and final formulation before it is shipped to the market.
“Such testing is required to ensure that the company has in fact received the correct solvent from the supplier and that it is of the correct purity. In many of these disasters, traders responsible tor for supplying chemicals such as propylene glycol have either mislabeled DEG as propylene glycol by mistake or alternatively, have adulterated propylene glycol with DEG either on purpose to reduce costs or by mistake due to poor quality control measures.”
What happened to the case?
The Jammu and Kashmir government formed a special investigation team (SIT) to probe the case. The charge sheet has been filed in the case but a judgement is yet to come in the case.