DCGI slams drugmaker Digital Vision over contaminated Cofset AT syrup, issues stop-sale order
New Delhi: In a major setback to Himachal Pradesh-based drug maker Digital Vision, the Drugs Controller General of India (DCGI) has directed all state drug controllers (SDCs) to stop sale and distribution of drug Cofset AT syrup adulterated with Diethylene Glycol (DEG).
The order came following a complaint moved by a professor of the department of paediatrics at the Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh.
On July 22, a two-year-old child was admitted to the hospital. Doctors attributed renal failure in the child due to the presence of DEG in the cough syrup Cofset AT syrup having ingredients of ambroxol hydrochloride, terbutaline sulphate, guaiphenesin and menthol.
Taking strict cognizance of the complaint, the apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO) wrote to the Himachal Pradesh's drug controller.
To avoid further fatalities, the DCGI also requested the drug controllers of all the states and union territories to alert their field staff for necessary action and take appropriate steps immediately for stopping further sale and distribution of Cofset AT. Besides this, the letter also highlighted that the action taken in the matter should be intimated to the office.
"In the view of the seriousness of the issue, the office has directed the drug inspectors of this office to look for the alleged drug in the region. You are also requested to alert your field staff for necessary action in the matter," Arvind Kukrety, Deputy Drug Controller India, CDSCO, wrote in the letter to the HP's drug controller.
"It is requested that the current status of the case and manufacturing status of Digital Vision may also be communicated to this office and to associate this office in the investigation of the said manufacturer…," read the letter dated 5 August.
Acting on the same, a joint investigation team of officers from Haryana and two officers from the Central Drugs Standard Control Organisation collected sale purchase records of Cofset AT in Ambala and samples of the syrup for analysis.
About 2,997 bottles of the syrup, manufactured in September 2019, were sold to Ambala-based Shiva Medical Hall from where these were supplied to Bengaluru, Kolkata, Jagadhri, Jalgaon, Nabha and Sikar.
Letters have been reportedly sent to drug controllers in Punjab, Rajasthan, Maharashtra, Tamil Nadu and West Bengal, with the sales records showing that the drug in question was sold to companies in these states.
Digital Vision had fallen under the drug regulator's scanner earlier this year as well, after another "contaminated cough syrup" — ColdBest-PC cough syrup — which allegedly led to the death of nine infants in Jammu & Kashmir and one in Haryana. The Himachal government had in February booked the same company, Digital Vision, for selling the "contaminated cough syrup".
"The same firm and supply chain was found indulging in the similar activity of manufacturing adulterated drug called Coldbest, which allegedly cost the lives of many children at Udhampur, Jammu. After that various FIRs were filed against Digital Vision and Orison Pharma at Kala-amb, Himachal Pradesh, Ambala and Panipat and their licenses of manufacturing and marketing were suspended by the concerned competent authority i.e., state drug controller of Himachal Pradesh, however, now a similar allegation has been labeled against them," Narendra Ahooja, State Drug Controller, Haryana stated.
Commenting on the instant case, Konic Goyal, managing director of Digital Vision told ET, "The samples were taken from an open bottle. So, saying that it was contaminated is wrong."
"The drug department has picked up sealed bottles from the market and sent it for further investigation. Till then, we should wait. I also don't know whether the product which was prescribed and given to the child was my company's product. Till all these things become clear, we should wait, " he added.
"The joint investigation team has asked the police to register FIRs or add fresh offences in the earlier FIRs against the violators. Action has also been initiated to prosecute the firm," Ahooja told the daily.