Samples sent for analysis; further action after the results: Ministry of Health on cough syrups
The Central Drugs Standard Control Organization (CDSCO) has sent the samples from the same batch of the four drugs made by Maiden Pharmaceuticals Ltd, on which the WHO has issued an alert, for testing and further action will be decided after the results are received. , the Union Health Ministry said on Thursday.
“The samples (controlled samples from the same batch manufactured by M/s. Maiden Pharmaceuticals Ltd for the four drugs in question) were collected and sent for analysis to the Regional Drug Testing Laboratory, Chandigarh, by CDSCO, the results of which will guide follow-up actions and will provide clarification on the contributions received, to be received from the WHO,” said a press release from the Ministry of Health.
The ministry said WHO has informed DCGI, India’s national drug regulatory body, that it is currently providing technical assistance and advice to The Gambia, where children have died and a factor contributory is suspected to be the use of drugs which may have been contaminated with diethylene glycol or ethylene glycol (in some of the samples this would have been confirmed by further analysis conducted by the WHO) on September 29 .
CDSCO immediately seized the Haryana State Regulatory Authority, under whose jurisdiction Maiden Pharmaceutical Ltd’s drug manufacturing unit, Sonepat, is located. Further, a detailed investigation has been launched to verify the facts/details of the case in conjunction with the National Drug Controller, Haryana, the ministry said.
He added that from CDSCO’s preliminary investigation, it was determined that Maiden Pharmaceuticals is a State Drug Controller-approved manufacturer for the products Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip. n Cold Syrup. under reference, and holds the manufacturing authorization for these products for export only. The company has manufactured and exported these products only to The Gambia.
“It is standard practice for the importing country to test these imported products on quality parameters and ensure the quality of the products before the importing country decides to release these products for use in the country,” said the Ministry.
According to the provisional results received by the WHO, of the 23 samples of the referenced products that were tested, 4 samples were found to contain diethylene glycol/ethylene glycol. WHO has also been informed that the Certificate of Analysis will be made available to WHO in the near future and they will share it with the Indian regulator. The exact causal relationship of death has not yet been provided by WHO to CDSCO, the ministry added.
However, CDSCO requested WHO to share a report as soon as possible on establishing a causal link of death with the medical products in question, etc.
“The National Drugs Controller had granted licenses to the said company only for the export of these four drugs, namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Moreover, these four drugs are manufactured only for export by M/s. Maiden Pharmaceuticals Limited is not licensed to manufacture and sell in India. Indeed, none of these four drugs from M/s. Maiden Pharmaceuticals is sold in the Indian market,” the ministry said.
