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The Indian government has ordered a Madhya Pradesh-based drugmaker, whose cough syrup was linked to child deaths in Cameroon, to stop manufacturing activities.
This is the fourth Indian company to face a government crackdown over poor-quality and adulterated medicines in recent times.
According to Dr Bharati Pravin Pawar, Union Minister of State for Health and Family Welfare, the Central Drugs Standard Control Organization (CDSCO) and state drug controllers carried out a joint investigation following which Riemann Labs – suspected to be associated with the manufacture cough syrup, Naturcold – was asked to stop manufacturing activities.
The cough syrup, Naturcold, is allegedly linked with the deaths of 12 children in Cameroon in March. Following this, the World Health Organization (WHO) in an investigation report mentioned that a batch of cough and cold syrup sold in Cameroon (under Naturcold brand name) contained extremely high levels of a toxic ingredient. It sought help from India and other agencies to seek details of the origin of the syrup.
“In case of Cameroon, a joint inspection was conducted by CDSCO, Sub-Zone Indore with SLA, Madhya Pradesh at Riemann Labs., Indore and based on the findings the State Drugs Controller MP directed the firm to stop the manufacturing activities,” she told the Rajya Sabha on Tuesday.
Pawar’s response does not mention that the MP-based firm was manufacturing Naturcold; but she did acknowledge that WHO has issued alerts “and asked various information in four cases of syrup products exported from India”.
Other pharma companies that faced a crackdown included Maiden Pharma which was linked to child death in Gambia. It was found that the company had violated good manufacturing practices (GMP) and was asked to stop manufacturing activities.
“In case of Gambia…. based on investigations conducted, State Drugs Controller, Haryana issued show cause notice and order has been issued for stopping all the manufacturing activities of Maiden Pharmaceuticals at Sonipat,” Dr Pawar said.
With relation to deaths of children in Uzbekistan, the CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at Marion Biotech in Noida. “Manufacturing license of the firm has been suspended by State Licensing Authority, Uttar Pradesh on January 9, 2023. Further, an FIR has been lodged and three persons have been arrested,” she said.
In case of Marshall Islands & Federated States of Micronesia, a joint investigation was carried out at QP Pharmachem in Punjab. Drug samples drawn from the manufacturing premises and analysed reveal they were “Not of Standard Quality” and manufacuturing activities were stopped “with immediate effect”, the Minister mentioned in her response.
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