Noida-based Marion Biotech — the drug firm linked with deaths of children in Uzbekistan — has lost its manufacturing licence, sources in the Uttar Pradesh Food Safety and Drug Administration (FSDA) said.
They said after the company failed to respond to a show cause notice in violation of Good Manufacturing Practice at the site within the stipulated time, their licence has been suspended until further notice.
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A show cause notice was sent to the directors of Marion Biotech on December 30, and they were told to reply by January 5, an official in the UP FSDA said.
“We have seen violation of Schedule M of the current Good Manufacturing Practice (cGMP) at the company’s plant. Thus, a show cause notice was sent to them on December 30, and they were given seven days to respond; failing which we can suspend the license issued to the plant,” a senior official of the UP FSDA told Business Standard.
He added that production at the site has anyway been suspended.
Meanwhile, laboratory reports from testing of samples sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh, are awaited. “After we get the laboratory reports on this firm, further action will be taken, and they are likely to be prosecuted,” the source said.
The manufacturing licence of another north India firm Maiden Pharma was not cancelled or suspended by the Haryana Food and Drug Administration (FDA). After a joint inspection by the state and central regulators, the firm was sent a notice, to which it responded saying that it has taken corrective action to fix the current Good Manufacturing Practice (cGMP) violations at the site. A re-inspection of the site is now planned.
As for Marion Biotech, a joint team of four officials from both the state and central drug regulators had visited the site in Noida on December 27 and 29 after reports that 18 children died in Uzbekistan after consuming the cough medicines Dok1 Max manufactured by the firm.
On December 30, Union Health Minister Mansukh Mandaviya tweeted in the morning that following the inspection by the Central Drug Standard Control Organisation (CDSCO) team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing.
Meanwhile, on December 30, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) suspended the membership of the company making the company ineligible for incentives under the Market Access Initiative Scheme.
Uday Bhaskar, director general, Pharmexcil, asked Marion Biotech to provide details of licensees to whom the cough syrups were supplied, along with importer's details and manufacturing licence copies and product permissions of cough syrups. “Alleged Supply of Substandard medicines by your company leading to the death of 18 children has brought bad reputation to the Indian pharma industry and also likely to have an impact on the Trust of International agencies on Indian pharma exports,” Pharmexcil’s letter said.
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.
Since the company did not reply to these queries, it went ahead with suspension of membership. Marion Biotech has been registered with Pharmexcil as a small-scale manufacturer since 2010 and merchant exporter since 2016.