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India’s drug regulator has written to the World Health Organization (WHO), claiming samples of Maiden Pharma’s cough syrups supposedly causing the deaths of children in Gambia were not found to be contaminated with diethylene glycol (DEG) and ethylene glycol (EG) upon testing by a technical committee constituted by the Indian government.
Drugs Controller General of India V G Somani also highlighted in his letter to Rogério Gaspar, director of regulation and prequalification, WHO, that the statement issued by the global agency in October this year was ‘amplified by global media’, which led to a narrative being built internationally targeting the quality of Indian pharmaceutical (pharma) products.
“This, in turn, has adversely impacted the image of India’s pharma products across the globe, and caused irreparable damage to the supply chain of pharma products, as well as the repute of the national regulatory framework, over an assumption that has yet not been substantiated by WHO or its partners on the ground,” Somani said in a strongly worded letter.
India’s drug regulator noted that upon receiving initial reports on a possible causal relationship between drugs manufactured in India and the deaths in Gambia, the Indian government had formed a technical committee of subject experts to examine and analyse the details.
The four-member committee, headed by Y K Gupta, vice-chairperson, the standing national committee on medicines, requested specific information from WHO on further details essential to establish causality.
However, samples of Maiden Pharma’s four cough syrups under scanner that were sent to government laboratories for testing have been found to be ‘complying with specifications’, stated Somani’s letter.
DEG and EG were not detected in these products, and therefore, not contaminated by DEG and EG. The excipients, specifically propylene glycol, were sourced from New Delhi’s Goel Pharma Chem, which had imported these from South Korea. Glycerine was sourced again from Goel Pharma Chem, who had sourced it from Adani Wilmar.
Further, samples of excipients found from the manufacturing site of Maiden Pharma were also found to be complying with specifications.
Somani said it was perhaps a ‘premature deduction’ drawn on September 29 regarding the cause of death.
In November, Reuters had reported from Gambia that a representative of the country’s Medicines Control Agency (MCA) said they have not yet confirmed that toxic cough syrup was the cause of deaths of 70 children.
The agency further reported that Gambia’s MCA has not yet pinpointed the exact cause of death — a good number of children have died without taking any medication.
When the medication of some of the kids who died was tested, they were found to be of good quality. The spike in cases of acute kidney injury among children below five years was detected in July.
On September 29, WHO informed the Indian drug controller about the Gambia deaths and suspected link to Maiden Pharma.
The Haryana Food and Drug Administration (FDA) halted production at Maiden Pharma’s site on October 12. A joint inspection by the state FDA and the Central Drugs Standard Control Organisation (CDSCO) found 12 violations of good manufacturing practices at the Sonipat facility.
A team comprising senior drugs control officer (Sonipat) Rakesh Dahiya and drug inspectors from CDSCO zonal office (Ghaziabad) Sandeep Kumar and Devender Pratap Singh inspected the facilities of Maiden Pharma on October 1 and 3.
During inspection, the authorities found that batch numbers, expiry, and manufacturing dates, and the name of the manufacturer were missing from the invoices for propylene glycol — an ingredient used in cough syrups.
Drug authorities noted Maiden Pharma has not performed the quality testing of propylene glycol for DEG and EG. The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question.
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