Haryana-based Maiden Pharmaceutical is under the scanner of India’s drug regulator after the World Health Organisation (WHO) raised red flags, sources in the know indicated.
On September 29, WHO informed the Drugs Controller General of India (DCGI) that it is currently providing technical assistance and advice to Gambia, where children have been suspected to have died where a significant contributing factor is suspected to be the use of medicines. The medicines may have been contaminated with Diethylene Glycol or Ethylene Glycol, something that has been confirmed in some of the samples by further analysis conducted by WHO.
A government source indicated that the Central Drug Standards Control Organisation (CDSCO) while responding to WHO, took up the matter immediately thereafter with the concerned State Regulatory Authority, under whose jurisdiction the drug manufacturing unit is located.
“Further, a detailed investigation was launched to ascertain the facts/ details in the matter in collaboration with State Drugs Controller, Haryana (the concerned State Drug Control Authority),” said the source, adding that the CDSCO responded to WHO within an hour and half of receiving the communication from the global agency.
Sources further added that from the preliminary enquiry, it has been made out that Maiden Pharmaceutical Limited, Sonepat, Haryana is a manufacturer licensed by the State Drug Controller for the products under reference, and holds manufacturing permission for these products. The company has manufactured and exported these products only to Gambia so far.
It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country.
As per the tentative results received by WHO out of the 23 samples tested, 4 samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated, the source added.
The certificate of analysis will be made available to WHO in near future and WHO will share it with India, the person cited above claimed.
“At the same time, the exact one to one causal relation of death has not yet been provided by WHO, nor have the details of Labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” the source added.
Urgent investigation in the matter has been already taken up by CDSCO with the State Regulatory Authorities immediately after receiving communication from WHO based on the available information. India has requested for the report on establishment of causal relation to death with the medical products in question, photographs of labels/ products etc, which is awaited.