Drug cos focus on automation & work culture to meet compliance
Faced with increasing regulatory scrutiny -- Indian drug makers working more closely then ever before on Friday said they have been investing on automation, simplifying and standardizing systems and working on building culture of compliance within their organizations -- as they don’t want to be seen as outliers in terms of regulatory compliance. Viswanath Pilla Faced with increasing regulatory scrutiny, Indian drug makers who are working together more closely then ever, on Friday said that they have been investing in automation, simplifying and standardizing systems and working on building culture of compliance within their organizations -- as they don’t want to be seen as outliers in terms of regulatory compliance. Here is what heads of top five Indian pharmaceutical companies had to say at IPA’s second edition of India Pharmaceutical Forum 2017 on the quality measures implemented at their individual companies, and what still needs to be done in terms of becoming fully compliant with US FDA regulatory expectations. Sun Pharma India’s largest drug maker by sales --
Sun Pharma’s future growth and profitability hinges on its ability to complete successful resolution of its key Halol plant in Gujarat and clean up the regulatory mess it acquired through Ranbaxy acquisition. Sun Pharma, which wants to lead the industry by example - isn’t taking any chances, the company has been investing significantly on automation and standardizing quality metrics across its plants. “We became almost twice the size overnight,” said Dilip Shangvi, chairman of Sun Pharma referring to Ranbaxy acquisition. “So we realized we need very different organization to manage increasing complexity,” Shanghvi said. “We redesigned our organization using technology to ensure that we review and manage all our plants with more or less consistent processes and standards,” he added. With acquisition of Ranbaxy – Sun Pharma has as many as 40 manufacturing sites globally, including the most in India. Shanghvi said his company was able to standardize quality metrics across all plants on various issues which impact product quality, productivity and throughput. Shanghvi added that the company stopped filing products to less regulated markets from plants approved for regulated markets like US, as they found -- efforts to manage multiple audits from varied regulators not justifying the business case. He further said that making entire lab processes paperless to improve data reliability to be challenge due to underestimation of the complexity and enormity of the task. “That project has been 12-15 months behind schedule,” he said.
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Faced with increasing regulatory scrutiny -- Indian drug makers working more closely then ever before on Friday said they have been investing on automation, simplifying and standardizing systems and working on building culture of compliance within their organizations -- as they don’t want to be seen as outliers in terms of regulatory compliance. Viswanath Pilla Faced with increasing regulatory scrutiny, Indian drug makers who are working together more closely then ever, on Friday said that they have been investing in automation, simplifying and standardizing systems and working on building culture of compliance within their organizations -- as they don’t want to be seen as outliers in terms of regulatory compliance. Here is what heads of top five Indian pharmaceutical companies had to say at IPA’s second edition of India Pharmaceutical Forum 2017 on the quality measures implemented at their individual companies, and what still needs to be done in terms of becoming fully compliant with US FDA regulatory expectations. Sun Pharma India’s largest drug maker by sales --
Sun Pharma’s future growth and profitability hinges on its ability to complete successful resolution of its key Halol plant in Gujarat and clean up the regulatory mess it acquired through Ranbaxy acquisition. Sun Pharma, which wants to lead the industry by example - isn’t taking any chances, the company has been investing significantly on automation and standardizing quality metrics across its plants. “We became almost twice the size overnight,” said Dilip Shangvi, chairman of Sun Pharma referring to Ranbaxy acquisition. “So we realized we need very different organization to manage increasing complexity,” Shanghvi said. “We redesigned our organization using technology to ensure that we review and manage all our plants with more or less consistent processes and standards,” he added. With acquisition of Ranbaxy – Sun Pharma has as many as 40 manufacturing sites globally, including the most in India. Shanghvi said his company was able to standardize quality metrics across all plants on various issues which impact product quality, productivity and throughput. Shanghvi added that the company stopped filing products to less regulated markets from plants approved for regulated markets like US, as they found -- efforts to manage multiple audits from varied regulators not justifying the business case. He further said that making entire lab processes paperless to improve data reliability to be challenge due to underestimation of the complexity and enormity of the task. “That project has been 12-15 months behind schedule,” he said.
Read more for Indian Stock Tips- http://bit.ly/ace_services
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