Ambala (Haryana): Haryana government has ordered a halt of total production of cough syrups from Sonipat-based company Maiden Pharmaceuticals Limited, which was recently flagged by the World Health Organisation (WHO) following the deaths of 66 children in The Gambia.
The company has also been issued a show cause notice for 12 violations 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 were mentioned by WHO, 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 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
World Health Organization (WHO) on October 5 issued a medical product alert over four India-made cough and cold syrups manufactured by Maiden Pharmaceuticals. WHO has also notified that the same cough and cold syrups could be linked to deaths of 66 children in The Gambia.
It said that it was conducting further investigation with the company and regulatory authorities in India. “This WHO Medical Product Alert refers to four substandard products, identified in The Gambia and reported to WHO in September 2022. Substandard medical products are products that fail to meet either their quality standards or specifications and are, therefore “out of specification,” the WHO said.
According to the WHO, the four cough syrups linked to the deaths in The Gambia are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Laboratory analysis of samples of each of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, the WHO had said.
The company was issued a show cause notice on October 7 after a joint inspection with the Central Drugs Standard Control Organisation. The pharma company has to reply to the notice by October 14, failing which action may be taken against it.
The Haryana drug controller has listed the contraventions detected during inspections of the pharma company’s facility on October 1 and October 3. They include that complete plant found under renovation. The firm failed to produce the log books of equipments and instruments regarding manufacturing and testing for the drugs in question.
It said the batch number of propylene glycol, sorbitol solution and sodium methyl paraben used in the manufacturing of the drugs in question were not mentioned in the certificate of analysis report.
“The firm has not performed process validation and analytical method validation for the drug products in question,” it said in the notice.
“The firm has submitted six month real time and accelerated stability data of drugs in question. However, at the time of investigation none of above said products were found to be charged in stability chamber,” the state drug controller said in the notice.
The notice to the pharma company stated that manufacturing and expiry dates were missing on the certificate of analysis of certain batches of propylene glycol. “Propylene glycol (batch number E1007/UP, E1105149) had failed as per certificate of analysis for the test in respect of water but was declared as of standard quality,” the notice added.
Also, batch numbers, manufacturer name, and manufacturing and expiry dates were not found on purchase invoices of items used, including propylene glycol.
The firm has also not performed the quality testing of Propylene Glycol for Diethylene Glycol and Ethylene Glycol, the notice said.
The show cause notice to the pharma company has “served under Rule 85(2) of Drug Rules, 1945 as to why your manufacturing license may not be suspended/cancelled. Your reply to this show cause notice must reach this office within 7 days of the receipt of this notice, failing which ex-parte action shall be liable to be taken against you as per the Drugs and Cosmetics Act, 1940 & Rules, 1945.”
Maiden Pharmaceuticals on October 8 in an exclusive input to ANI said: “We are shocked to hear the media reports regarding the deaths and deeply saddened on this incident but we received the official information from our agent at the gambia”>Gambia on October 5, 2022, and on the subsequent date, World Health Organisation alert was issued against us.”
In an official statement the company’s Director, Vivek Goyal said, “We are in the field of medicines for over three decades and have been diligently following the protocols of the health authorities including Drugs Controller General (India) and the State Drugs Controllers, Haryana.”
He further said that they have valid drug approvals for the export of the products and his company is not selling anything in the domestic market. He also added that his company is obtaining raw materials from certified and reputed companies.
“The government agencies visited our factory on October 1 and October 3, October 6 and 7 October and the samples were drawn by the Central Drugs Standard Control Organisation (CDSCO) along with all relevant documents in question in presence of our directors,” Goyal said in the statement.
The drug regulators had collected the samples of cold and cough syrup from the manufacturing facility of Maiden Pharmaceuticals, after WHO issued a medical alert.
“The samples have been drawn by the CDSCO officials and we are awaiting the results and since the matter is already pending investigation and subjudice, we cannot comment on any other issues and shall update you in future as and when we receive the information,” he added.
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