Drug cos focus on automation & work culture to meet compliance

Viswanath PillaMoneycontrol NewsFaced 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 PharmaIndia’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.

Dr.Reddy’sDr.Reddy’s – India’s second largest drug maker by sales which has been working on resolution of its warning letter on three of its facilities said the it has been working on strengthening quality systems across the company by investing on IT and cultivating culture of compliance.

“The focus is on preventing things going wrong,” said Satish Reddy, co-chairman and managing director of Dr.Reddy’s.Reddy said that his company has been nurturing a culture of courage where reporting of adverse events are encouraged without fear of retribution.The quality review starts at board level and extends up to shop floor, Reddy said. Reddy said the number of incidents reported have gone up, and there was reduction in terms of batch failures and out of specification incidents.Dr.Reddy’s said it is finding retrofitting of old plants with new technology as challenging, and is even considering shutting down some of the old plants, while the focus will be on the newer ones. LupinLupin which undergoes at least a dozen USFDA inspections every year said the eight observations it got from USFDA for its Goa plant were like a wake-up call for the company. The company said it rolled out a quality transformation exercise across organization that helped it to rationalise and document various standard operating procedures and aligned them with best regulatory practices.The company cleared the Goa plant with establishment inspection report (EIR) from USFDA subsequently.“I think we should be able to use technology and data a lot more,” said Nilesh Gupta, managing director of Lupin. “We have been trying to build an early warning system to identify issues well ahead,” Gupta said.

Cadila HealthcareCadila Healthcare, which recently completed successful USFDA re-audit indicating resolution of its Moraiya facility -- said the company has put in lot of efforts on automation and building a culture of compliance through enterprise wide training.Cadila has launched a company-wide programme called Quest to train and educate employees on quality. "Even the person working at the bottom on the shop floor should be aware of the quality," Pankaj Patel, chairman and managing director of Cadila said.“First 15 minutes of everyday were spent on training, the workers on the shop floor were trained to retrain fellow employees to bring about change in culture,” Patel said.Patel said he delinked marketing department from taking decisions with respect to shop floor, to ensure the focus is on quality versus production numbers.He further said that the major challenge for the company is to maintain the momentum it has created within the organization going forward.Cipla Cipla, which has its share of regulatory problems in the form of USFDA observations for its Goa plant said it is focusing on automation of its laboratories to reduce human errors and simplifying standard operating procedures.Umang Vohra, MD and CEO of Cipla opines that the he found the biggest threat to quality culture in an organization is attrition and getting teams across functions to work together to identify the root cause of the problem and solve them.