India’s drug regulation system is split between the central and state governments, which often leads to confusion and weak enforcement.
According to the families of the affected children, initially, the children suffered from colds, coughs, and fevers. After that, their kidneys become affected, and their condition worsens.
Photographs of a box of Naturcold medication show a manufacturing license number matching that of Riemann Labs Pvt. Ltd., based in Indore in the Indian state of Madhya Pradesh. The photos, provided by Eko Eko Filbert, a regional health official in Cameroon, don’t show a manufacturer’s name.
The Noida police have arrested Marion Biotech’s head of operation Tuhin Bhattacharya, Atul Rawat, the manufacturing chemist, and Mool Singh, the analytical chemist, under various sections of the Indian Penal Code (IPC).
The suspension means that the company's exports will become ineligible for incentives under the Market Access Initiative Scheme.
A spate of allegations that contaminated drugs were being exported to countries with weak drug regulatory mechanisms indicates that larger reforms may be needed
The inspection at Marion Biotech started at around 12 pm and continued for over 10 hours during which six more samples of the syrup were taken, they said.
Two back-to-back cases of cough syrups from India, the first one involving Maiden Pharmaceuticals, which was blamed for supplying contaminated drugs that killed 70 kids in Gambia, have tainted India’s image as the ‘Pharmacy of the World’
MEA spokesperson Arindam Bagchi also said consular assistance is being provided to some linked to the company who are facing legal action there.
A joint inspection of Marion’s Noida facility has been carried out by the UP Drug Control and the CDSCO team and an inspection report is awaited.
Sources said that government officials inspected the manufacturing facility till late night and collected the Doc 1-Max cough syrup from the plant. Hasan Raza, Marion Biotech Pharma Company legal head also mentioned that the product has been halted.
“We have taken note of the matter and have asked for the causality assessment report of the death of children from the authorities of Uzbekistan,” a top CDSCO official told Moneycontrol.
The syrups were found to be made by New Delhi-based Maiden Pharmaceuticals Ltd, which has since had one of its factories shut down in northern India as health authorities there investigate.
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The drug regulatory system in India needs a complete overhaul, says Dinesh Thakur, author of 'The Truth Pill: The Myth of Drug Regulation in India'. At times, these quality issues manifest themselves in deaths of Indian citizens, as happened in early 2020 when 11 children died in Jammu because of an adulterated cough syrup. On other occasions, a dodgy drug approval process has led to the Indian regulator approving sales of drugs that have never been approved by regulators in the developed markets. Watch the chat with the author.
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All production activities at the factory have been stopped; staff have been told not to attend work till clarity emerges on the issue.