A cough syrup manufactured in Himachal Pradesh which was initially believed to have caused renal failure in a two-year-old patient has cleared quality tests by the government analyst, state drug authorities said. Cofset AT, a syrup produced by Sirmaur-based Digital Vision, was withdrawn from the market in August after PGI hospital authorities flagged the presence of a toxic compound called diethylene glycol (DEG) in the syrup.
However, the state drug authorities have ruled out the presence of DEG in the particular batch of the syrup, which was manufactured in September last year. “Laboratory tests have not found DEG in samples of the syrup. The drug has also cleared other quality tests,” said Nahan drug inspector Lalit Kumar.
The syrup was analysed by PGI after a two-year-old girl from Baddi was admitted to the hospital on July 22 with acute kidney injury and other complications. Doctors were told that she was initially suffering from cough and fever, but her condition worsened after she consumed several oral medications administered by a local doctor.
The paediatric biochemistry lab of PGI then tested all the medicines she had consumed, analysing them qualititavely for the presence of DEG by using the Gas Chromatography-Mass Spectrometry (GCMS) technique.
The lab detected DEG in Cofset AT, following which the PGI authorities wrote to the Central Drugs Standard Control Organisation (CDSCO).
CDSCO asked the state drugs controller in Himachal to withdraw the drug from the market and initiative the necessary investigation. The drug authorities seized samples from the manufacturing unit at Kala Amb and sent them for a quantitative test to the Regional Drugs Testing Laboratory in Chandigarh. Meanwhile, Radhika, the two-year-old patient, passed away during treatment.
Earlier this year, the drug authorities detected DEG in another cough syrup made by the same pharmaceutical manufacturer, which was linked to the death of several infants in Jammu.