The Drug Controller General of (India) (DCGI) has issued a letter to the drug controllers of States and Union Territories to take necessary action and appropriate steps for stopping the sale and distribution of Cofset AT syrup in the country.

In its letter to all the drug controllers, the DCGI has informed that it has received an e-mail complaint from a Professor of Department of  Paediatrics, Advanced Paediatrics Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh against Cofset AT syrup (ambroxol hydrochloride, terbutaline sulphate, guaiphenesin, menthol) batch number, DL 5200, D/M 09/19, D/E 9/21, manufacturing license number S-MNB/08/01 and S-MB/08/02 which is manufactured by Digital Vision, Sirmur, Himachal Pradesh and marketed by Orison Pharmaceuticals, Ambala.

In the complaint, the professor from PGI Chandigarh has indicated the presence of diethylene glycol (DEG) in Cofset AT syrup (ambroxol hydrochloride terbutaline sulphate, due to which a child has suffered from renal failure.

Reportedly, the firms involved in manufacturing and marketing of Cofset AT syrup are same. They were found involved in the manufacturing and marketing of Coldbest syrup in March this year. Based on the regional drug testing laboratory (RDTL) report, it was found that Coldbest was contaminated with the presence of DEG which allegedly led to the death of nine children in Jammu and Kashmir. Following, this, several FIRs have been filed against the firms in Jammu and Kashmir, Himachal Pradesh and Punjab.

At that time itself, based on the report, the competent authority of the state had taken necessary actions against the firms like suspending their manufacturing and marketing license. The recent complaint raised by PGIMER, Chandigarh points out the presence of a similar composition in another cough syrup affecting the child with renal failure. To assure regulatory authorities about the adulteration in the said drug, PGI Chandigarh has also submitted an analyst report of consumed drugs by two years old child who was admitted in the PGI Chandigarh with renal failure. After analysing a number of drugs consumed by the patient in its paediatric biochemistry lab for the presence of DEG qualitatively using gas chromatography-mass spectrometry (GCMS), it was confirmed by searching on NIST library.

A source from PGIMER, Chandigarh informed that the aim was to bring into the notice of the state as well as central drug authorities about the contaminated presence of DEG in the drug. Therefore, we have flagged off the issue to the concern authorities and informed about the product availability in the market.”

Narendra Ahooja, State Drug Controller, Haryana, commented, “The same firm and supply chain was found indulging in 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 labelled against them.”

Ahooja informed, “Our joint investigation team has conducted an investigation at Orison Pharma, Ambala and Shiva Medical Hall, Ambala Cant and the investigation team collected sale purchase records of the drug in question. For detailed inspection, the team collected samples which were sent for analysis and the collected sample got analysed for diethylene gycol.”

“We have sent the letters to drugs controller Punjab, Rajasthan, Maharashtra, Tamilnadu and West Bengal as sale records revealed that the drug in question was sold to firms in these states. The investigation was also conducted at Thakur Enterprises, who has allegedly sold Propylene Glycol to Digital Vision at Kala Amb Himachal. Therefore, it is requested to stop consumption of this drug,” shared Ahooja.

Dr Hemant Koshia, Commissioner, FDCA Gujarat commented, “Since the Coldbest syrup issue came to light and reports indicated the presence of diethylene glycol (DEG) in Coldbest syrup,  we took all measures in withdrawing the said drugs from the market, hence in our state, we do not have the availability of that product. However, as per recent communication from the DCGI pertaining to Cofset AT syrup, we will initiate the required measures.”

To avoid further fatalities, the DCGI has 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.