Udhampur deaths: 2 other drugs made same pharma failed test
A cough syrup made by HP-based Digital Vision, that led to the death of 9 Jammu children, was recently prohibited on the orders of DCGI
Two other drugs manufactured by Himachal Pradesh-based drug manufacturer—Digital Vision Pharma—have failed the drug quality test conducted in 2018 and 2019. The firm came under the scanner after PGIMER, Chandigarh, found the presence of poisonous compound— diethylene glycol— in their cough syrup Coldbest PC, which allegedly led to eleven deaths in Udhampur district of J&K.
In a recent drug alert list, circulated by Central Drugs Standard Control Organisation (CDSCO) under the directorate general of health services, ministry of health and family in December 2019, which tested 1,336 samples across the country, as many as 49 were declared of substandard quality.
One drug, rabeprozole sodium, sold under the name Rebz 20 and registered under batch number DVTE679B, was manufactured in June 2018 by the same manufacturer. The drug control department in Assam had drawn the sample, while Guwahati’s Regional Drugs Testing Lab found that the sample was not standard quality, as it failed the dissolution test.
Similarly, in March 2019, glimepiride tablets, sold under the name Glimith 2, registered under batch number DVTD1500, and manufactured in September 2017, were not found to be of standard quality in March 2019. The samples, this time, were drawn by the drug control department, Arunachal Pradesh, while the RDTL Guwahati found the drug of substandard quality. The sample of the same drug failed the test, as per the drug alert list of September 2018.
Dr VG Somani, the drugs controller general of India (DCGI), has written to all state drug controllers about infant mortality caused by Coldbest-PC syrup, manufactured by Digital Vision, and asked them to take immediate action that includes prohibiting sale and distribution of the cough syrup.
Nine deaths took place between December-end 2019 and January 17 in Ramnagar block of Udhampur, wherein the patients were hospitalised with acute kidney failure. The common factor found in the cases was that they all had taken Coldbest-PC.
“The PGIMER, Chandigarh, had collected 33 drug samples during their team visit to Ramnagar district in Udhampur, and they had detected diethylene glycol (DEG) in ColdBest-PC Syrup,” reads the DCGI’s letter dated Saturday, February 15.
The letter further says that the presence of DEG in ColdBest-PC Syrup is believed to have caused infant mortality in the reported cases. Further, a fresh case of DEG poisoning was also reported on Feb 15 from Haryana, too. The DCGI wrote asking them to take all necessary steps immediately, to stop further sale and distribution of the drug to avoid more fatalities.
“The drug controllers of HP and Haryana are requested to obtain the distribution particulars and supply them to all the concerned states to facilitate immediate stoppage of the drug and its recall. Samples of other batches of ColdBest-PC Syrup may also be tested for DEG. Action taken may be informed to this office for further action in this regard,” the letter further reads.
The CDSCO is also closely monitoring the investigation in this regard.
“This is a very serious issue as we understand 12 children have died that too in a particular UT. The state drug controllers, especially HP where the unit is located, have been asked to investigate on priority while the rest have been asked to recall the product,” said a CDSCO official, requesting anonymity, as the person was not authorised to speak to the media.
“It is a matter of grave concern as they seem to be regular offenders, so the investigation must wrap up fast. State authorities are on the case,” the official added.
Parshottam Goyal, managing director of Digital Vision Pharma said that they have taken corrective measures every time an issue was flagged them. “We are not issuing any statement to the media, but I can assure you that we constantly approve quality of drugs. Regarding these two instances, we would have taken corrective steps as is the procedure in any firm,” he said.