Pharma industry needs to adopt more IT tools to upgrade quality standards
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Mumbai: Indian pharmaceutical industry needs to enhance the use of information technology (IT) tools to upgrade its quality standards, key executives of drug companies said during a panel discussion at a quality excellence conference in Mumbai on Friday.
Over the last two years, pharma companies have put in efforts to improve quality compliance after several manufacturing plants came under the glare of global regulators due to violations of norms.
Data reliability, non-adherence to standard operating procedures, batch failures, contamination, and insufficient investigation of problems identified in the quality process are some of the major non-compliance issues observed at manufacturing plants.
Drug makers have started automating processes in manufacturing units and laboratories to reduce human error and maintain data integrity but the firms have not yet reached optimum levels in technology adoption.
“What has not gone up to the level that we would like is use of technology. This is a much more digital world than from where pharma companies are and certainly from where generic companies are. I think we should use technology and data a lot more,” Nilesh Gupta, managing director of Lupin Ltd, said.
“As a country we have the technology and capability to develop IT tools. We need to use those capabilities to ensure that all the data that is generated are captured electronically, so that the potential risks we carry as an industry can be significantly reduced,” Dilip Shanghvi, managing director of Sun Pharmaceutical Industries Ltd, said.
He added that one of the key challenges the company faced in its quality enhancement programme was creation of a paperless laboratory.
“We underestimated the complexity and enormity of what we were trying to do. So that project as I see is almost 12-15 months behind schedule,” Shanghvi said.
Cipla Ltd’s managing director and global chief executive officer Umang Vohra said the automation in laboratories was not as much as in manufacturing and the company has been working to address this issue.
Another area of concern remains building a culture of best practices within the organisation to improve quality standards. Companies have started training programmes for employees and increased communication on quality enhancement.
“The biggest threat to quality culture in an organisation is attrition,” Cipla’s Vohra said.
Each of the leading pharma firms has begun work to raise the quality bar. Sun Pharma has standardised quality metrics across all its plants and stopped filing products to semi-regulated markets from the plants that supply to regulated markets, Shanghvi said.
Dr. Reddy’s Laboratories Ltd has strengthened IT systems, review processes and governance, and stopped investing in older manufacturing plants, the company’s chairman Satish Reddy, said.
Meanwhile, Cadila Healthcare Ltd started a programme for cultural transformation in the company, initiated a good tracking system and discouraged marketing team to interact directly to employees in the plant in order to avoid any kind of unwanted pressure regarding product sales on plant workers, chairman and managing director Pankaj Patel, said.