Uzbekistan Cough Syrup Deaths: Pharmexcil suspends membership of Marion Biotech

Marion Biotech is a licensed manufacturer and holds license for manufacturing of Dok1 Max syrup and Tablet for export purpose granted by Drugs Controller, Uttar Pradesh.

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) on December 30 suspended the membership of Marion Biotech Pvt Ltd with immediate effect after the company failed to reply to the council on the report on childrens' death allegedly caused by their cough syrups in Uzbekistan.

The suspension means that the company's exports will become ineligible for incentives under the Market Access Initiative Scheme.

Also read: Cough syrup deaths: India seeks details from Uzbekistan on investigations

Pharmexcil in a notice sent to Marion Biotech said the alleged supply of substandard medicines by the firm led to the death of 18 children; it brought ill repute to the Indian pharma industry and is likely to have an impact on the trust of international agencies on Indian pharma exports.

Uday Bhaskar, Director General, Pharmexcil, asked the Noida-based firm to provide the details of the licensees to whom the cough syrups were supplied along with the importer's details along with manufacturing license copies and product permissions of the cough syrups.

“It is understood that UzPharmAgency (Agency on Development of Pharmaceutical industries), which has been entrusted to take control of the situation, has taken serious cognizance of the matter. The embassy officials were informed by the UzPharmAgency about the "presence of Ethylene Glycol in the composition of the batch of drugs to the level of 300 times of what is normally permitted as per the medical regulations. The correct drug in the composition was to be Propylene Glycol,” the letter from DG, Pharmexcil to Marion Biotech said.

According to the letter, seen by Moneycontrol, Sachin Jain, Chairman and Managing Director, Marion Biotech, was asked to investigate the reasons behind the alleged serious adverse events and update the council with the findings for further action.

The company however didn’t reply to the queries raised by the council.

“We regret to inform that Council is not in receipt of any inputs/report on the adverse events and hereby state that the membership of  Marion Biotech Pvt Ltd with Pharmexcil are suspended with immediate effect,” DG Bhaskar said in a letter to Jain.

Marion Biotech was registered with Pharmexcil as a small scale manufacturer since 2010 and merchant exporter since 2016.

This is the second country alleging India-made drugs caused the death of children. The first one involved Maiden Pharmaceuticals, which was blamed for supplying contaminated drugs that killed 70 kids in Gambia. In the recent case, Uzbekistan’s Health Ministry has claimed that at least 18 children with acute respiratory disease died after drinking the cough syrup manufactured by Noida-based Marion Biotech.

“To date, 18 out of 21 children with acute respiratory disease have died as a result of taking the Doc-1 Max syrup. It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children,” the Health Ministry of Uzbekistan said in a release.

The Ministry of Health of Uzbekistan also said that preliminary laboratory studies have shown that this series of Doc-1 Max syrup contained ethylene glycol.