How syrup to cure cold, fever proved fatal for kids

Sushil Manav in Chandigarh

Within a span of 15 days, 10 children in the age group of six months to six years died in Ramnagar area of Jammu and Kashmir’s Udhampur district in January this year, leading to panic over outbreak of a mysterious disease.

Of the six children who were taken ill, four were hospitalised in the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. Soon, the death toll rose to 12.

In its endeavour to find the probable cause of deaths, PGI sent a team to Ramnagar. Its investigation revealed the presence of Diethylene Glycol (DEG), a highly toxic substance, in the Coldbest-PC syrup administered to cure cold and fever among these children. The syrup was manufactured by Digital Vision, a pharmaceutical unit based at Kala Amb in Sirmaur district of Himachal Pradesh.

The syrup contained paracetamol, an Active Pharmaceutical Ingredient (API) used for fever and aches.

According to experts, since paracetamol is not soluble in water, propylene glycol (PG), an organic compound, is used as a solvent while preparing any syrup containing this API.

Girdhari Lal Singal, a former State Drugs Controller, Haryana, says that DEG is an impurity in the PG and if allowed to go unchecked in the syrup, it can lead to renal failure and consequent death. For this, a pharmaceutical manufacturer is supposed to test PG to rule out DEG content before using it as solvent in any formulation.

“The first two editions of the Indian Pharmacopoeia (IP) that came in 1955 and 1966 didn’t have any test to detect DEG in the PG solution. The test was incorporated in the next edition of IP in 1977. Now, it is mandatory to conduct a pre-manufacturing test on PG to rule out the presence of DEG before using it as solvent, like it is compulsory to test all APIs and other ingredients,” Singal adds.

The tests were incorporated in the IP following the death of over 15 children of kidney failure at the Institute of Child Health at Egmore in Chennai in August 1973.

Experts maintain that the PG is also used for dissolving APIs like Diazepam and Diclofenac for manufacturing injections.

However, sources say that while all manufacturers take due precaution, some local pharma units are less cautious about safety measures when it comes to making syrups. They add that smaller units, in particular, choose to purchase cheaper quality PG when it is needed for syrups, which sometimes can be contaminated with DEG.

“In case of injections, death will come instantly and the victims can be of any age group. But paracetamol in syrup form is given only to little kids and it normally takes some days before the patient dies,” point out experts.

Taking stock of supplies

In the instant case, joint teams of the Drugs and Food Control Organisation, Jammu, State Drugs Controller, Baddi (Himachal Pradesh), Food and Drugs Administration, Haryana and the Central Drugs Standard Control Organisation (CDSCO) have revealed that the manufacturer Digital Vision, Kala Amb, supplied the entire stock of contaminated batches comprising 5,575 bottles of Coldbest-PC syrup to Ambala Cantonment-based distributor Shiva Medical Hall.

The stock statement of the distributor from April 1, 2019 till February 15, 2020, suggests that the firm purchased 5,575 bottles of Coldbest-PC syrup from Digital Vision on September 27, 2019.

It supplied 1,620 bottles to PP Laboratories at Palwal, 324 to Shiva Medical Agencies at Ambala Cantonment, 162 each to Padha Medical Hall at Panipat and Anil Medical Store at Raipur Rani, 50 to Om Medicose at Babbain, and 30 bottles each to Rana Medical Hall, Yamunanagar and Dhanvantri Nursing Home, Kalka.

Besides, the drug was supplied to three firms in Jammu, two in Saharanpur, and one firm each in Kanpur, Aurangabad, Dehradun, Baddi, Bulandshahr, Vijaywada, Trichy, Ghaziabad and Shillong.

Navneet Marwaha, State Drugs Controller, Baddi, says that within half an hour of receiving intimation from his counterpart in Jammu, teams had reached Digital Vision to take samples of the drug.

“On February 16, a joint inspection with a team from CDSCO was carried out. On February 17 again, inspections were carried out and records seized. When the manufacturer failed to provide certain records, we immediately stopped production in the unit. Samples of the drug as well of the PG were taken. The manufacturer has been told to provide a report of recall of stock of Coldbest-PC syrup,” adds Marwaha.

Since drug authorities across the country had swung into action almost simultaneously, the entire unsold stock has been sent back to the dealer or is in transit. But not before 3,450 bottles of the killer syrup have been consumed by kids across the country.

Considering that only 1,350 bottles were supplied to four medical stores in Jammu from where the stocks might have gone to Ramnagar where the tragedy unfolded, 2,100 bottles of the killer syrup have been consumed or sold elsewhere in the country.

Is there any guarantee that these 2,100 bottles do not result in more casualties? “Had this been the case, ailing children would have been brought to some or the other hospital. No such reports have been received from anywhere across the country,” maintains Marwaha.

That said, the reported case of an infant patient in Chandigarh’s Sector 32 GMCH from Patiala — with similar symptoms and probably ill under the same circumstances — points to the challenge at hand.

OTHER SUCH CASES REPORTED COUNTRYWIDE

The PG test to rule out DEG has been mandatory since 1977, but there have been several instances of children dying owing to negligence by pharmaceutical units.

1986: 21 patients died in Mumbai when they were administered glycerine, a routine anti-oedema drug used to combat swellings. The glycerine contained DEG. Doctors prescribed glycerine for its osmotic diuretic effect, but patients started to develop kidney failure. Fourteen patients received hemodialysis, but the treatment failed.

1998: In an episode of poisoning as a result of children ingesting DEG in syrup, 33 children lost their lives in and around Gurugram in Haryana. While 23 victims were from Gurugram district, nine were from the town. Some other children with symptoms were from Rewari and Faridabad districts of Haryana and from Alwar district of Rajasthan. All these children had consumed paracetamol syrup prescribed by paediatricians.

250 bottles seized by Meghalaya Govt

Shillong: The Meghalaya government has seized 250 bottles of a particular brand of cough syrup containing a poisonous compound that allegedly caused death of

children in Udhampur, state minister AL Hek has said. Doctors were asked to ensure that the drug containing diethylene glycol is not prescribed to any patient. A Himachal-based pharma company had supplied the cough syrup to several states. PTI

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