After the World Health Organization (WHO) issued a medical product alert on four cough and cold syrups manufactured by New Delhi-based Maiden Pharmaceuticals, the Central Drugs Standard Control Organisation (CDSCO) is planning to send a show-cause notice to the drug-maker, News18 has learnt.
“Multiple meetings are going on at CDSCO and a show-cause notice to the company is likely to be sent by evening,” a government official privy to the development told News18.
The government has launched investigation into the matter after the WHO raised concern.
“A thorough investigation has been ordered into the matter which will begin with the raids on the manufacturing sites and random sample checks across India. All samples picked so far have already been sent to the lab for testing,” the official further said.
Meanwhile, Gambia has recalled cough and cold syrups blamed for the children’s deaths, by launching an urgent door-to-door campaign. Director of Health Dr Mustapha Bittaye confirmed to the AP the wave of child deaths from acute kidney injury, sending shockwaves across the country of 2.4 million people and around the world.
Syrup-maker had exported the products only to The Gambia: Govt
According to a government release, WHO had on Sept 29 informed DCGI that it was currently providing technical assistance and advice to Gambia, where children have died and where a contributing factor, is suspected to be the use of medicines which may have been contaminated with Diethylene glycol or Ethylene glycol.
CDSCO took up the matter immediately with the Haryana State Regulatory Authority, under whose jurisdiction the drug manufacturing unit of M/s Maiden Pharmaceutical Limited, Sonepat is located. Further, a detailed investigation was launched to ascertain the facts in collaboration with State Drugs Controller, Haryana, the statement added.
The government also added that after a preliminary enquiry by CDSCO, it has been found that Maiden Pharmaceutical Limited held manufacturing permission for export only. The company has manufactured and exported the products only to The Gambia.
“It is a usual practice that the importing country tests these imported products on quality parameters, and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country,” the statement further said.
According to tentative results received by WHO, out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by the WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India, the government statement said.
WHO suspects similar products may have been distributed to other countries
WHO said on Wednesday the deaths of dozens of young children in Gambia from acute kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer, Maiden Pharmaceuticals.
It is a damning claim as it hit the reputation of the Indian pharmaceutical market globally, which until now has been known as the pharmacy to the world.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, during a press conference on Wednesday said, “WHO has today issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children.”
“The loss of these young lives is beyond heart-breaking for their families. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India.”
While the contaminated products have so far only been detected in Gambia, the WHO suspects that such products may have been distributed to other countries as well. Hence, the UN agency recommends all countries detect and remove these products from circulation to prevent further harm to patients.
He also told reporters that the WHO was conducting an investigation with Indian regulators and the company that made the syrups.
Read all the Latest News India and Breaking News here
Comments
0 comment