New Delhi: The Pharmaceuticals Export Promotion Council (Pharmexcil), part of the Ministry of Commerce & Industry, on Friday suspended the membership of the Noida-based Marion Biotech, making its exports ineligible to access incentives under the Market Access Initiative Scheme by the government.
Pharmexcil director general Udaya Bhaskar told ET that the suspension was necessitated as Marion Biotech failed to provide the information sought by the council within the deadline.
“The council has requested you to submit the information on the licensees to whom you have supplied the subject drug (Doc-1 Max), importers details (name & contact particulars), manufacturing license copies and product permissions of subject products and also advised you to investigate the reasons of the alleged serious adverse events and update the council with the findings to take necessary further action,” said Bhaskar in an email sent to the Marion Biotech.
“You were asked to submit your response by the end of business day of December 29th, 2022. 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 suspended with immediate effect,” Bhaskar added. ET saw a copy of the email.
UP Drug Controller who is probing the Marion Biotech’s facilities that manufactured the alleged contaminated cough syrup linked to death of 18 children in Uzbekistan, said it has found certain lapses in the compliance to current good manufacturing practices (cGMP) and asked the company to halt manufacturing immediately.
The UP Drug Controller and CDSCO team have launched a joint probe of the Noida-based Marion Biotech facilities that manufactured the Dok-1-Max syrup cough syrup, following Uzbekistan’s health ministry flagging the issue on Wednesday.
Marion holds an export licence from the Drugs Controller, Uttar Pradesh, to manufacture the Dok-1-Max syrup and tablets.
The Uzbekistan health ministry has allegedly linked the deaths of 18 children to the Dok-1-Max cough syrup manufactured by the Noida-based Marion Biotech. Uzbekistan had said that a chemical – ethylene glycol – was found in a batch of the cough syrup during laboratory tests.
Samples of the cough syrup have been taken from the manufacturing unit and sent to the Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing.