Express News Service
NEW DELHI: The Centre on Wednesday formed a four-member technical committee to examine the details and adverse event reports received from the World Health Organisation on the deaths of 66 children in The Gambia being linked to four cough syrups manufactured by New Delhi-based Maiden Pharmaceuticals.
The committee will advise and recommend further action to India’s Drugs Controller General of India (DCGI) after the WHO submits all details.
The move came following the Haryana government’s order asking the pharma company, whose two manufacturing units are based in the state, two halt all production. The state also asked the company to explain within a week “many contraventions” found during a recent inspection or face suspension or cancellation of license.
The state government decided on a global alert by WHO on October 5 about the India-made four cough syrups and linked it with the deaths of 66 children in The Gambia. The world body also said syrups have been “potentially linked with acute kidney injuries and 66 deaths among children.” It said that laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of Diethylene glycol and ethylene glycol as contaminants.
The four-member technical committee members are Dr Y K Gupta, vice-chairperson, Standing National Committee on Medicines; Dr Pragya D Yadav, noted scientist from National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Pune; Dr Arti Bahl, division of epidemiology, National Centre for Disease Control (NCDC), and A K Pradhan, Joint Drugs Controller, CDSCO.
In the office memorandum, the Union Health Ministry said that on September 29, WHO had informed CDSCO that they were providing technical assistance and advice to The Gambia, where children have died and where a contributing factor was suspected to be the use of medicines manufactured by Maiden Pharmaceuticals.
The ministry said the CDSCO took up the matter with the Haryana State Regulatory Authority, where the pharma company was.
“The CDSCO had requested WHO to provide relevant analysis/report indicating/ establishing one-to-one casual relation of said deaths with the alleged adulteration of the drugs referred to above. The same is yet to be provided by WHO, the letter said. On further follow-up by CDSCO with the WHO, the certificate of analysis (COAS) of the sampled products and the summary of the adverse events were shared by the world health body on October 11.
The WHO has also informed that they are in the process of taking forward the investigation.
The controversial syrups – are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The Haryana government said that they conducted inspections and found that the pharma company has been manufacturing and testing drugs without adhering to and in contravention of the various Good Manufacturing Practices (GMP) requirements of Schedule M and Schedule U of the Drugs Rules. They also said that the company has not maintained and not produced complete records of manufacturing and testing as per rules.
“Given the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm are being stopped with immediate effect under section 22(1d) of Drugs and Cosmetics Act 1940, and Rules framed there under till further order, in the public interest, without prejudice to further action in the matter,” the order said.
The pharma company issued a media statement on October 8 saying that they were “shocked and deeply saddened.”
The company also said that they have been in the field of medicine for over three decades and have diligently followed the protocols of the health authorities. “We have valid drug approvals for the export of the products in question, and we are not selling anything in the domestic market, so it is for export only,” it added.
NEW DELHI: The Centre on Wednesday formed a four-member technical committee to examine the details and adverse event reports received from the World Health Organisation on the deaths of 66 children in The Gambia being linked to four cough syrups manufactured by New Delhi-based Maiden Pharmaceuticals.
The committee will advise and recommend further action to India’s Drugs Controller General of India (DCGI) after the WHO submits all details.
The move came following the Haryana government’s order asking the pharma company, whose two manufacturing units are based in the state, two halt all production. The state also asked the company to explain within a week “many contraventions” found during a recent inspection or face suspension or cancellation of license.
The state government decided on a global alert by WHO on October 5 about the India-made four cough syrups and linked it with the deaths of 66 children in The Gambia. The world body also said syrups have been “potentially linked with acute kidney injuries and 66 deaths among children.” It said that laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of Diethylene glycol and ethylene glycol as contaminants.
The four-member technical committee members are Dr Y K Gupta, vice-chairperson, Standing National Committee on Medicines; Dr Pragya D Yadav, noted scientist from National Institute of Virology (NIV), Indian Council of Medical Research (ICMR), Pune; Dr Arti Bahl, division of epidemiology, National Centre for Disease Control (NCDC), and A K Pradhan, Joint Drugs Controller, CDSCO.
In the office memorandum, the Union Health Ministry said that on September 29, WHO had informed CDSCO that they were providing technical assistance and advice to The Gambia, where children have died and where a contributing factor was suspected to be the use of medicines manufactured by Maiden Pharmaceuticals.
The ministry said the CDSCO took up the matter with the Haryana State Regulatory Authority, where the pharma company was.
“The CDSCO had requested WHO to provide relevant analysis/report indicating/ establishing one-to-one casual relation of said deaths with the alleged adulteration of the drugs referred to above. The same is yet to be provided by WHO, the letter said. On further follow-up by CDSCO with the WHO, the certificate of analysis (COAS) of the sampled products and the summary of the adverse events were shared by the world health body on October 11.
The WHO has also informed that they are in the process of taking forward the investigation.
The controversial syrups – are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
The Haryana government said that they conducted inspections and found that the pharma company has been manufacturing and testing drugs without adhering to and in contravention of the various Good Manufacturing Practices (GMP) requirements of Schedule M and Schedule U of the Drugs Rules. They also said that the company has not maintained and not produced complete records of manufacturing and testing as per rules.
“Given the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm are being stopped with immediate effect under section 22(1d) of Drugs and Cosmetics Act 1940, and Rules framed there under till further order, in the public interest, without prejudice to further action in the matter,” the order said.
The pharma company issued a media statement on October 8 saying that they were “shocked and deeply saddened.”
The company also said that they have been in the field of medicine for over three decades and have diligently followed the protocols of the health authorities. “We have valid drug approvals for the export of the products in question, and we are not selling anything in the domestic market, so it is for export only,” it added.
