Source: Business Standard, Feb 24, 2017
Investment in automation is one of the step undertaken by Indian companies who have come under the scanner of overseas drug regulators. Violations in good manufacturing practices have resulted in warning letters and delayed product approvals for Indian companies. To overcome this pharma companies are investing in both technology and staff training.
“We have invested around Rs 450 crore in automation and technology improvements. We have introduced laboratory information management system and a software which tracks deviations in manufacturing. We have also implemented electronic batch records system in our new plants in Ahmedabad SEZ and Vadodara and will be rolling out the electronic system in all other plants in next few years,” said Sharvil Patel, deputy managing director of Cadila Healthcare.
Cipla too plans to introduce the electronic batch records system over the next two-three years.
While production data is recorded manually in the existing system the new system records data electronically. This improves data integrity as erasing and editing of records will get captured in a data trail.
“We are already working on measures for increased compliance and efficiencies at our manufacturing plants and we are improving our quality culture,” said Dr Ranjana Pathak, global head of quality of Cipla on the sidelines of Indian Pharmaceutical Alliance event today.
Last year six members of the Indian Pharmaceutical Alliance (IPA) initiated the Quality Forum to address issues of data integrity and quality culture. Data reliability guidelines have been framed in partnership with consultancy firm McKinsey & Co and have already been rolled out in twelve manufacturing units of six participating IPA members.
While the companies have taken the first steps to improve quality, concerns continue to persist on the overall compliance level of the industry. According to European Medical Agency head of manufacturing and quality compliance Brendan Cuddy, the number of non compliant sites increased 100% in 2016 on over the previous year. Active pharmaceutical ingredient manufacturing units topped the list of non compliance, he said.
On ground however companies are taking firm steps. A survey was held to measure quality culture at the companies and now a human resources council has been formed to address issues like managerial skills and staff behaviour, said D G Shah, secretary general of Indian Pharmaceutical Alliance.
Companies have already beginning to take initiatives to improve quality culture. This includes regular visits and interactions with workers on the shop floor by members of the senior management. “Companies realise that the cost of poor quality is high and that directly impacts their revenue and profit,” said Vikas Bhadoria, senior partner of McKinsey & Co.
“While companies celebrated records in production and sales there was no reward or recognition for initiatives in quality and that attitude too is changing, ” said Vivek Arora, associate partner, McKinsey & Co.