HQ Team
August 1, 2023: India has ordered a shutdown of a domestic pharmaceutical firm, whose cough syrup is believed to be behind the deaths of about six children in Cameroon.
The move follows three other Indian drug companies that were told to stop manufacturing their products after similar deaths in Gambia, Uzbekistan, and the Marshall Islands, and the Federated States of Micronesia.
“In the case of Cameroon, a joint inspection was conducted,” by the Indian regulator Central Drugs Standard Control Organization, in the central Indian city of Indore, Bharati Pravin Pawar, the junior health minister told the parliament.
Riemann Labs
Based on the findings, “Riemann Labs., Indore…the State Drugs Controller Madhya Pradesh (state) has directed the firm to stop the manufacturing activities.”
India prohibited the manufacture for sale, sale, or distribution for human use of 14 Fixed Dose Combinations including various cough syrup formulations in June 2023.
On the basis of the recommendation of an expert committee, there was no therapeutic justification for such FDCs and the FDCs might involve risk to human beings.
In the larger public interest, it was necessary to prohibit the manufacture, sale, or distribution of such FDCs which were agreed by the Drugs Technical Advisory Board, she told the Upper House of the Parliament.
Indian regulator probe
WHO has issued alerts and asked for various information in four cases of syrup products exported from India.
The Central Drugs Standard Control Organization in coordination with State Drug Controllers carried out joint investigations.
In the case of Gambia, a joint investigation was undertaken by CDSCO and the State Drug Controller, in northern Haryana state. The probe revealed a violation of Good Manufacturing Practices.
The State Drugs Controller, Haryana issued a show cause notice to Maiden Pharma and ordered the stoppage of all the manufacturing activities at its facility in Sonipat, Haryana.
Marion Biotech
The manufacturing license of Marion Biotech, in northern Uttar Pradesh state, was suspended on January 9, 2023. Marion was linked to cough syrup deaths in Uzbekistan.
“Three persons have been arrested,” the minister said.
QP Pharmachem, linked to cases in the Marshall Islands &and the Federated States of Micronesia, was told to shut all its manufacturing facilities in northern Punjab state.
The government has made it compulsory for cough syrup manufacturers to get a certificate of analysis from a government-approved laboratory before exporting their products with effect from June 2023, she said.
