The first meeting of the four-membered committee to examine the World Health Organisation’s report regarding Maiden Pharmaceuticals Ltd was held on Thursday.
The committee comprises of technical experts– Dr YK Gupta, Vice Chairperson of the Standing National Committee on Medicines (chair), Dr Pragya Yadav, Indian Council of Medical Research- National Institute of Virology (ICMR -NIV) in Pune, Dr Arti Bahl, Division of Epidemiology, National Centre for Disease Control (NCDC) in New Delhi, and AK Pradhan, JDC(I) in Central Drugs Standard Control Organisation (CDSCO). According to the sources from Union Health Ministry, the experts here discussed and intensified the investigation into the matter.
Notably, the production of cough syrups by Maiden Pharmaceuticals was suspended on Wednesday, however, its lab report is awaited.
“The government is alerted and has formed a committee. Production of cough syrups by Maiden Pharmaceuticals Ltd has been suspended, and its lab report is awaited. A four-member expert committee has been formed to investigate the report sent by WHO,” official sources told ANI.
According to the media reports , Atlanta-based Atlantic Pharmaceuticals Company Ltd which has permission to export medicines to West Africa’s Gambia had ordered combined cough syrup bottles that were purchased from Maiden Pharmaceuticals limited.
“From the preliminary inquiry of CDSCO, it has been revealed that Maiden Pharmaceuticals Ltd is a manufacturer licensed by the State Drug Controller for the product’s Promethazine Oral Solution BP, Kofexnalin Baby cough syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup under reference, and holds manufacturing permission for these products for export only,” the sources said.
The company has manufactured and exported these products only to the Gambia.
“It is a usual practice that the importing country tests such medicines on quality parameters, and satisfies itself with the product’s quality before the importing country decides to release them for usage in the country. In the present case, it is not yet clear whether these medicines were tested in the Gambia before release,” they added.
As per the tentative results of WHO’s evaluation, out of the 23 samples of the products under reference were tested, of which four were found to contain Diethylene Glycol or Ethylene glycol.
“WHO has not yet made available the certificate of analysis. It has informed that the same will be provided in the near future,” the sources said.
The top officials informed that the exact “one-to-one causal relation of death” has not been provided to CDSCO by the WHO although the former has requested it twice.
On Wednesday, the Haryana government ordered a halt in the total production of cough syrups from Sonipat-based company Maiden Pharmaceuticals Limited.
The company was also issued a show cause notice for 12 violations that were found at its manufacturing plant.
State health minister Anil Vij told ANI on Wednesday, “The samples of three drugs of the Sonipat-based pharmaceutical company, which WHO mentioned, have been sent to Central Drug Laboratory in Kolkata. The report is yet to come. We will take action only after the report comes. After a joint inspection by Central and State officials, 12 violations were found in the manufacturing facility. It has been decided to shut the total production. We have sent a notice in this regard.”
The pharma company had come under scanner following the death of 66 children who had consumed the cough syrup in the Gambia.
On October 5, WHO issued a medical product alert over four India-made cough and cold syrups manufactured by Maiden Pharmaceuticals. WHO had also notified that the same cough and cold syrups could be linked to the deaths of 66 children in the Gambia. (ANI)
