Exclusive | Uzbekistan Cough Syrup Case: Drugs sold by Marion Biotech in India under scanner

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After collecting samples from the batches a cough syrup manufactured by Noida-based Marion Biotech which has been linked with the death of 18 kids in Uzbekistan, drug administrators are also moving to test other drugs made by the company and sold locally.

Top sources in the Central Drugs Standard Control Organization (CDSCO) and Uttar Pradesh Food Safety and Drug Administration told Moneycontrol that an inspection is currently underway at the company’s drug manufacturing unit to look for drugs that may be using ethylene glycol as a solvent.

Also Read | Uzbek Cough Syrup row: Drug regulators inspect Marion Biotech's manufacturing site 

“To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup manufactured by the Indian company Marion Biotech Pvt Ltd," the Uzbekistan health ministry had said in a statement on December 28.

It added that initial laboratory investigation suggests presence of ethylene glycol in the cough syrup, which is toxic and about 1-2 ml/kg of a 95 percent concentrated solution can cause serious changes in the patient's health.

Officials in India’s drug administration say that glycerin or glycerol are organic solvents used in liquid oral medications such as pediatric cough syrups, paracetamol suspension for children and sometimes in antibiotics syrups.

Also read | Uzbekistan claims cough syrup made in Noida responsible for death of 18 kids; CDSCO calls for causality assessment report

“But since there are repeat instances of diethylene glycol (DEG) or ethylene glycol, which are cheaper alternatives to glycerine, being used in medicines- we also want to check the quality of medicines being sold by the drugmaker in India” said a senior official.

The primary focus, he said, will be on syrups and suspensions being manufactured for sale in India which are likely to use DEG or ethylene glycol but an audit of the plant with respect to Good Manufacturing Practices (GMP) is also being carried out.

Authorities have also asked Marion Biotech to submit an undertaking clarifying whether Doc-1 Max syrup has been supplied in India.

Queries sent by Moneycontrol to Marion Biotech were unanswered till press time.

Indian authorities, on December 27, had collected samples of the cough syrup from the batches that had been exported to Uzbekistan. These samples will be subjected to a batch testing and a central drug testing laboratory to ascertain the claims made by the central Asian country.