The Health Ministry has asked the institutions under the government to strictly adhere to the guidelines and process while importing diagnostic kits and other biological products from other countries, especially from China.
The Ministry has also asked them to hold random testing to check the quality of the products being imported from other countries, besides fine-tuning the process. Procurement of equipment after assessment of requirements is now made through a procurement agency following Government guidelines, the ministry said.
The institutes have been advised to ensure quality of products, following allegations that sub-standard biological products and medical devices were being imported from China, both by the government-run institutions and the private players in the country.
Some administrative problems in the National Institute of Biologicals apparently affected the quality of its scientific working. Instances were brought to the notice of the Government in January, 2009 by the Director General of Audit. It was pointed out that that the Institute had issued batch release certification for certain products of Chinese origin without complying with the mandatory test parameters.
“Government has since taken several corrective measures, including change in the management of the Institute. Steps have been taken to test the biological products by the parameters specified in the pharmacopoeia / other guidelines and protocols, with proper documentation. Disciplinary action was initiated against the then Director of the Institute and he has since been repatriated to his parent Department. The procedures have since been fine-tuned so as to prevent recurrence of such incidents,” sources clarified further on the recent instances.
The Government also maintained that no further case was reported to it, but still the ministry had sent out instructions to strengthen the procedures and follow the guidelines by all institutions under the government.
Source:Pharmabiz
The Ministry has also asked them to hold random testing to check the quality of the products being imported from other countries, besides fine-tuning the process. Procurement of equipment after assessment of requirements is now made through a procurement agency following Government guidelines, the ministry said.
The institutes have been advised to ensure quality of products, following allegations that sub-standard biological products and medical devices were being imported from China, both by the government-run institutions and the private players in the country.
Some administrative problems in the National Institute of Biologicals apparently affected the quality of its scientific working. Instances were brought to the notice of the Government in January, 2009 by the Director General of Audit. It was pointed out that that the Institute had issued batch release certification for certain products of Chinese origin without complying with the mandatory test parameters.
“Government has since taken several corrective measures, including change in the management of the Institute. Steps have been taken to test the biological products by the parameters specified in the pharmacopoeia / other guidelines and protocols, with proper documentation. Disciplinary action was initiated against the then Director of the Institute and he has since been repatriated to his parent Department. The procedures have since been fine-tuned so as to prevent recurrence of such incidents,” sources clarified further on the recent instances.
The Government also maintained that no further case was reported to it, but still the ministry had sent out instructions to strengthen the procedures and follow the guidelines by all institutions under the government.
Source:Pharmabiz
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