The Indian drug industry has been on the wrong side of the USFDA in the recent past. While the FDA has increased its presence and vigilance in India, it is also engaging with the industry on training. In its first ever such engagement, the USFDA and the Indian drug regulator CDSCO have collaborated in association with the Indian Pharmaceutical Alliance for a series of workshops for the Indian drug industry, reports Archana Shukla.
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This is the first of four such workshops. It is focusing on the quality systems at drug firms. USFDA and CDSCO have collaborated to engage with the industry to help outline the framework of what really are the requirements of a regulator from drug manufacturers when it comes to quality of drugs.
This one is very important and interesting because this is the first such workshop that the USFDA is conducting for drugs. They have had similar engagements in China and Latin America but they have all focused on food. For drug quality compliance this is the first such workshop and is being conducted in India. It is also important because India is the second-largest exporter of generic drugs to the US market and in the coming times these numbers are only expected to go up.
Also in the backdrop of the recent regulatory action by the USFDA on Indian companies where companies like Ranbaxy , Wockhardt , Fresenius Kabi , Strides Arcolab have either had their facilities banned for supplies in the US market or have been served warning letters for non-compliance to GMP standards at their manufacturing or quality facilities.
These workshops also take forward the MoU that the USFDA commissioner Margaret Hamburg had signed with the Indian health ministry to engage and collaborate with the Indian regulator as well as the industry for quality systems and strengthening of quality systems.
The biggest key takeaway from Monday's workshop was the call for involvement of senior management in quality system. The Deputy Commissioner of the USFDA spoke about how the senior management is not only responsible for drafting policies but is also responsible for finding out the root cause of issues and for a faster resolution of these issues.
He also said, repeated cases of failure indicates that quality is not a priority of the senior management and called for a change in mindset and called for a change in the culture of the company.
Most of the issues in the recent past that the Indian companies have faced have been based on data integrity issues. Experts point out that data integrity issues can only be solved if the culture of the companies change. Hence the comment from the USFDA Deputy Commissioner fits very well in that regard.
Going forward, the USFDA is increasing its presence in countries like India, although they say that the number of domestic inspections as well as the inspections internationally would remain the same. However, the need for increasing inspector is also there with the increase in number of facilities in India.
Going forward these workshops would be taken to Goa, Ahmedabad and Chandigarh and would involve about 400 delegates that would participate in such workshops.
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