Pharmexcil suspends membership of Marion Biotech for failing to provide information

The Prescription drugs Export Promotion Council (Pharmexcil), a part of the Ministry of Commerce & Business, on Friday has suspended the membership of the Noida-based Marion Biotech, making its exports ineligible to entry incentives beneath the Market Entry Initiative Scheme by the federal government.

Pharmexcil director basic Udaya Bhaskar advised ET that the suspension was necessitated as Marion Biotech failed to offer info sought by the council throughout the deadline.

The Story So Far:
UP Drug Controller finds lapses in Marion Biotech’s plant, halts manufacturing

“The council has requested you to submit the data on the licensees to whom you’ve provided the topic drug (Doc-1 Max), importers particulars (title & contact particulars), manufacturing license copies and product permissions of topic merchandise and in addition suggested you to research the explanations of the alleged critical opposed occasions and replace the council with the findings to take needed additional motion,” stated Bhaskar in an e-mail despatched to the Marion Biotech.

“You have been requested to submit your response by the tip of enterprise day of December twenty ninth, 2022. We remorse to tell that Council shouldn’t be in receipt of any inputs/report on the opposed occasions and hereby state that the membership of Marion Biotech Pvt Ltd with Pharmexcil suspended with rapid impact,” Bhaskar added.

ET noticed a duplicate of the e-mail.

UP Drug Controller who’s probing the Marion Biotech’s amenities that manufactured the alleged contaminated cough syrup linked to dying of 18 kids in Uzbekistan, stated it has discovered sure lapses within the compliance to present good manufacturing practices (cGMP) and requested the corporate to halt manufacturing instantly.
The UP Drug Controller and CDSCO staff have launched a joint probe of the Noida-based Marion Biotech amenities that manufactured the Dok-1-Max syrup cough syrup, following Uzbekistan’s well being ministry flagging the problem on Wednesday.

Marion holds an export licence from the Medicine Controller, Uttar Pradesh, to fabricate the Dok-1-Max syrup and tablets.

The Uzbekistan well being ministry has allegedly linked the deaths of 18 kids to the Dok-1-Max cough syrup manufactured by the Noida-based Marion Biotech. Uzbekistan had stated {that a} chemical – ethylene glycol – was present in a batch of the cough syrup throughout laboratory assessments.

Samples of the cough syrup have been taken from the manufacturing unit and despatched to the Regional Medicine Testing Laboratory (RDTL), Chandigarh for testing.