Gambia death case: Drug regulator finds no contamination in Sonepat syrup
New Delhi, December 16: The Indian drug regulator asserted that the samples of Maiden Pharma's cough syrups that resulted in the deaths of children in the Gambia were not contaminated with diethylene glycol (DEG) and ethylene glycol (EG). The regulator also criticised the World Health Organization (WHO) for "prematurely" attributing the deaths to an Indian company without conducting any further investigation.
Drugs Controller General VG Somani wrote to Rogerio Gaspar, the director of regulation and prequalification at the World Health Organization, stating that a technical committee formed by the Indian government had determined that "the products have been found not to have been contaminated with DEG or EG as per the test reports."
A technical committee of four subject experts was established, led by Dr Y. K. Gupta, vice chair of the Standing National Committee on Medicines, and including members from the National Institute of Virology-ICMR in Pune, the National Center for Disease Control (NCDC), and CDSCO.
This committee was formed in response to the reports of deaths in the Gambia caused by the Indian firm Maiden Pharmaceuticals' cough syrup came forefront. Till December 15, the death toll in Gambia mounted to 66.
"India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics. In the aftermath of the alerts received from WHO regarding the incidents in Gambia, an independent inspection was conducted on the premises of Maiden Pharmaceuticals, the firm in question. A show cause notice was issued to the firm under provisions of India's Drugs and Cosmetics Act for violation of various Good Manufacturing Practices (GMP), and for not producing the complete records of manufacturing and testing as per the extant rules. Considering the observations made during the inspection, the manufacturing activities of the firm were stopped forthwith in the public interest CDSCO has already Informed WHO in this regard. It is to emphasize that the above action was taken exclusively for GMP violations by the firm," the letter stated.
"Further, WHO had been informed that the samples of these 04 products in question were drawn and sent for testing to Government Laboratory as per extant rules. As per the test reports received from the Government laboratory, all the control samples of the 04 products have been found to be complying with specifications," it further read.