The Pharmaceutical Export Promotion Council of India (Pharmexcil) has suspended the registration certificate of Marion Biotech Pvt. Ltd, the producer of the cough syrup linked to the deaths of 18 children in Uzbekistan.
The decision comes after Marion Biotech failed to respond within time to a 28 December Pharmexcil request for information about the toxic Doc-1 Max cough syrup.
Exporters of pharmaceutical products from India are required to hold a valid registration-cum-membership certificate issued by Pharmexcil, a body set up by the ministry of commerce and industry to promote drug exports.
Marion Biotech was registered with Pharmexcil as a small-scale manufacturer in 2010 and a merchant exporter since 2016.
“We requested Marion Biotech to submit the information on the licensees to whom it supplied the subject drug, importers’ details with name and contact particulars, manufacturing licence copies and product permissions of subject products and also advised them to investigate the reasons for the alleged serious adverse events and update the council with the findings to take necessary further action. The firm was asked to submit its response by the end of business day of 29 December. However, the council is not in receipt of any inputs/reports on the adverse events and hereby states that the membership of Marion Biotech Pvt. Ltd with Pharmexcil is suspended with immediate effect," Udaya Bhaskar, director general of Pharmexcil, said in an interview.
The incident follows a similar controversy over the deaths of 66 children in Gambia allegedly due to contaminated cough syrup.
Calls made to Marion Biotech’s landline number posted on LinkedIn remained unanswered.
The Indian government has already initiated an inquiry into the matter. Officials from the Central Drugs Standard Control Organisation (CDSCO) and the Uttar Pradesh drug regulator visited the Noida facility, collected drug samples and sent them for testing at the Regional Drugs Testing Laboratory, Chandigarh. The government has also ordered Marion Biotech to stop all manufacturing activity at the plant until the investigation is on.
Pharmexcil, in its letter to Marion Biotech chairman and managing director Sachin Jain, said, “UzPharmAgency (Agency on Development of Pharmaceutical industries under the health ministry of Uzbekistan), 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 regarding 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".
“Alleged supply of substandard medicines by your company led to the death of 18 children has brought bad reputation to the Indian pharma industry and is also likely to have an impact on the trust of international agencies on Indian pharma exports," Bhaskar said in the letter.
On 27 December, Uzbekistan’s health ministry said on its website, “We reported the occurrence of side effects in children as a result of taking the drug Doc-1 Max in the city of Samarkand. Tablets and syrup Doc-1 Max manufactured by the Indian company Marion Biotech Pvt. Ltd in our country were registered in 2012 and went on sale in the same year. To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup." The drugs were distributed in Uzbekistan by Quramax Medical.
Preliminary studies showed that this series of Doc-1 Max syrup contained ethylene glycol, it said, adding, “This substance is toxic, and about 1-2 ml/kg of a 95% concentrated solution can cause serious changes in the patient’s health, such as vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure."
Uzbekistan is 44th largest export destination for India and second largest in CIS region for pharmaceuticals items.
The pharma exports during FY21-22 stood at $142million. For FY22-23, from April to Nov, the pharma export is reported $84.6 million.
