Amid the allegations of death of 18 children in Uzbekistan caused by syrups manufactured by Noida-based Marion Biotech, India’s apex pharma export council has decided to suspend the membership of the firm, News18.com has learnt.
Pharmexcil— an arm that functions under the ministry of commerce and industry — has told the company that allegations have brought “bad name” to the entire pharma industry in the global arena and may lead to “trust issues” as well.
Pharmexcil was set up under the provisions of the Foreign Trade Policy in 2004 to promote pharmaceutical exports from India.
The council had on December 28 and December 30 written to Sachin Jain, chairman and managing director of the company, to seek further information on the incident. The copy of both letters, accessed by News18.com, are also marked to the drug controller general of India (DCGI) VG Somani and Manish Prabhat, Ambassador of India to Uzbekistan.
According to the first letter shot by the council to Marion’s Jain, Udaya Bhaskar, director general at Pharmexcil, said, “Alleged supply of substandard medicines by your company led to the death of 18 children 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 had asked the firm to submit the information on details about the licensee to whom the company has supplied the drugs along with importers details. He had also asked to furnish manufacturing licence, and product permissions to export the medicines in question.
“You are further advised to investigate the reasons of the alleged serious adverse events at your end and update us with your findings at the earliest to take necessary further action,” said the letter sent on December 28, the day after the issue came into the spotlight.
Bhaskar had written that “upon failure of submission of requested information by December 29, 2022, your Registration-cum-Membership Certificates (RCMC) will be suspended without any further notice”.
As Pharmexcil did not receive any response till the given timeline, Pharmexcil further informed the company that the council has decided to suspend the advantages and incentives given to the firm until the further course of action.
According to the letter sent by Pharmexcil on December 30, it said, “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 M/s. Marion Biotech Pvt Ltd with Pharmexcil i.e are suspended with immediate effect.”
News18.com had first reported the matter shared by Uzbekistan with the Union health ministry in India.
The World Health Organization told News18.com that “WHO is in contact with health authorities in Uzbekistan and is ready to assist in further investigations”.
‘Ethylene Glycol 300 Times More Than Normal Found in Drugs’
Pharmexcil has informed the company that the apex export-import agency of Uzbekistan has taken the matter “seriously”.
“It is understood that UzPharmAgency (Agency on Development of Pharmaceutical industries), who has been entrusted to take control of the situation, has taken serious cognizance of the matter,” the letter sent to Jain said.
The (Indian) 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”.
Marion Biotech has been registered with Pharmexcil as a small-scale manufacturer since 2016.
According to Uzbekistan media reports, the Dok-1 Max syrup manufactured by UP-based Marion Biotech showed the presence of ethylene glycol, the deadly chemical, which was held responsible for deaths in The Gambia.
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