Need to tighten compliance procedures: Pharma cos
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Rajesh Desai
Sep 25, 2013, 2:18:35 AM9/25/13
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Leading Indian pharmaceutical companies are worried about increasing global enforcements faced by domestic manufacturing facilities and say there is a need for the industry to tighten its compliance procedures and invest more in quality to ensure the share remains intact in the global market.
“There are concerns as well as awareness due to the stringency in regulations. Quality and compliance is a continuous process. It is certainly important for the industry to focus on making sure that there are robust systems in place for compliance,” says Biocon CMD Kiran Mazumdar-Shaw.
According to Shaw, the sudden rise in enforcements is because of the growing market share of Indian drug manufacturers globally. “Domestic companies represent a significant part of the global drug industry and therefore, there is an increase in scrutiny of these companies. Also, with the presence of US FDA in India, now there are frequent audits as compared to periodic reviews earlier,” she added.
While the total number of US import alerts, imposed on domestic manufacturing facilities, has increased significantly during 2013, of late some facilities of major drug makers such as Ranbaxy, Wockhardt and RPG Life Sciences were barred from supplying their products to the world’s largest pharmaceutical market.
Wockhardt’s Waluj facility also received enforcements from the UK drug regulator and since been barred from supplying medicines to the whole of Europe. In 2013 so far, manufacturing facilities in India received a total of 13 import alerts, as compared to seven in China, two each in Australia, Canada and Japan.
However, drug makers, analysts and other stakeholders, Business Standard spoke to, brushed aside arguments that the enforcements are targeted specifically towards Indian drug makers.
“The bottom-line is compliance and there are no short cuts to ensuring quality. I don’t think that recent regulatory actions by USFDA are directed against Indian pharmaceutical companies alone. I have seen the warning letters issued to the US and other companies globally and all the FDA is trying to do is differentiate the good manufacturers from the not-so-good ones globally,” Vinita Gupta, CEO, Lupin Pharmaceuticals Inc.
Industry officials and experts also emphasized that while some violations have been highlighted recently by many international regulators, it does not imply that all Indian manufacturing facilities are non-compliant.
According to an industry analyst, the stringent checks by the US regulator could also be due to a few past experiences.
“Previous experiences are reflected in a person’s behavior. It is possible that because a few cases have gone worse in past years, the regulator is adopting a stricter check to ensure that companies fall in line. This is also important as Indian drug makers have a significant foothold in international markets,” he said.
India, with almost 200 US FDA-approved drug manufacturing facilities, is the biggest foreign supplier of medicines to the US. Pharmaceutical exports from India to the US rose nearly 32% last year to $4.23 billion. India accounts for nearly 40% of generic drugs and over-the-counter products and 10% of finished dosages used in the US.
According to Dr Reddy’s Labs vice chairman and managing director K Satish Reddy, import alerts are often the result of pharmaceutical companies not paying adequate attention to the fact that there has been an increased scrutiny of manufacturing practices by the US FDA.
Nirmal Bang senior pharma analyst said there is an urgent need for domestic companies to invest in systems and procedures to ensure compliance. “Companies must take it seriously because pharma is a export oriented sector and enforcements are a serious threat directly to revenues. While supplies get ceased because of import alerts, companies also have to incur an additional remediation cost,” he said.
However, the industry feels there is no need for an alarm. “Indian companies are not used to such alerts and therefore there is a concern but I am sure with proper systems and procedures in place, the industry will manage to protect its reputation as well as market share,” Shaw said.
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CA. Rajesh Desai
“There are concerns as well as awareness due to the stringency in regulations. Quality and compliance is a continuous process. It is certainly important for the industry to focus on making sure that there are robust systems in place for compliance,” says Biocon CMD Kiran Mazumdar-Shaw.
According to Shaw, the sudden rise in enforcements is because of the growing market share of Indian drug manufacturers globally. “Domestic companies represent a significant part of the global drug industry and therefore, there is an increase in scrutiny of these companies. Also, with the presence of US FDA in India, now there are frequent audits as compared to periodic reviews earlier,” she added.
While the total number of US import alerts, imposed on domestic manufacturing facilities, has increased significantly during 2013, of late some facilities of major drug makers such as Ranbaxy, Wockhardt and RPG Life Sciences were barred from supplying their products to the world’s largest pharmaceutical market.
Wockhardt’s Waluj facility also received enforcements from the UK drug regulator and since been barred from supplying medicines to the whole of Europe. In 2013 so far, manufacturing facilities in India received a total of 13 import alerts, as compared to seven in China, two each in Australia, Canada and Japan.
However, drug makers, analysts and other stakeholders, Business Standard spoke to, brushed aside arguments that the enforcements are targeted specifically towards Indian drug makers.
“The bottom-line is compliance and there are no short cuts to ensuring quality. I don’t think that recent regulatory actions by USFDA are directed against Indian pharmaceutical companies alone. I have seen the warning letters issued to the US and other companies globally and all the FDA is trying to do is differentiate the good manufacturers from the not-so-good ones globally,” Vinita Gupta, CEO, Lupin Pharmaceuticals Inc.
Industry officials and experts also emphasized that while some violations have been highlighted recently by many international regulators, it does not imply that all Indian manufacturing facilities are non-compliant.
According to an industry analyst, the stringent checks by the US regulator could also be due to a few past experiences.
“Previous experiences are reflected in a person’s behavior. It is possible that because a few cases have gone worse in past years, the regulator is adopting a stricter check to ensure that companies fall in line. This is also important as Indian drug makers have a significant foothold in international markets,” he said.
India, with almost 200 US FDA-approved drug manufacturing facilities, is the biggest foreign supplier of medicines to the US. Pharmaceutical exports from India to the US rose nearly 32% last year to $4.23 billion. India accounts for nearly 40% of generic drugs and over-the-counter products and 10% of finished dosages used in the US.
According to Dr Reddy’s Labs vice chairman and managing director K Satish Reddy, import alerts are often the result of pharmaceutical companies not paying adequate attention to the fact that there has been an increased scrutiny of manufacturing practices by the US FDA.
Nirmal Bang senior pharma analyst said there is an urgent need for domestic companies to invest in systems and procedures to ensure compliance. “Companies must take it seriously because pharma is a export oriented sector and enforcements are a serious threat directly to revenues. While supplies get ceased because of import alerts, companies also have to incur an additional remediation cost,” he said.
However, the industry feels there is no need for an alarm. “Indian companies are not used to such alerts and therefore there is a concern but I am sure with proper systems and procedures in place, the industry will manage to protect its reputation as well as market share,” Shaw said.
CA. Rajesh Desai
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