Drug regulator initiates probe
After WHO links children deaths in Gambia to cough syrup made in India
New Delhi (PTI): A probe has been initiated by India's drug regulator after the WHO issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The Gambia, official sources said.
The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation.
The sources said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
"Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana.
"While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," the sources said.
According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia.
It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested.
The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority.
A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained.
From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the 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 The Gambia so far," the source said.
It is a practice that the importing country tests the products for quality before sanctioning their usage there.
As per the 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 WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
"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 official source stated.
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Report on Sambhal mosque survey likely to be submitted to local court; security tight in district
Sambhal(UP) (PTI): Security was stepped up across the district ahead of Friday prayers and the likely submission of a report on the survey of the Shahi Jama Masjid here by the court-appointed ASI team following claims that a temple once stood at the spot.
Tension has been brewing in Sambhal since November 19 when the court-ordered survey of the Shahi Jama Masjid was carried out following claims that a Harihar temple previously stood at the site.
Divisional Commissioner of Moradabad, Aunjaneya Kumar Singh said security measures have been reinforced at sensitive religious sites in the area and around the court in Chandausi.
The lawyer for the Hindu side, Gopal Sharma, said the court hearing on Friday will see the plaintiff's side present their reply, and the court commissioner is expected to submit the findings from the survey conducted on the disputed site.
"Our further action will be determined after the survey report is reviewed," Sharma said.
Shakeel Ahmed Warsi, the lawyer representing the Muslim side, said they are fully prepared to present their case.
"We have all the necessary evidence, and we will first request a copy of the survey report before strongly presenting our side in court," Warsi stated.
Violence erupted on November 24 as protesters gathered near the mosque and clashed with security personnel, leading to stone pelting and arson. Four people died and scores of others were injured in the violence.
The situation remains tense, and local authorities are closely monitoring the developments to maintain peace and order.
