Close on heels of US FDA India office raising concerns over the quality of medicines marketed in India, pharma leaders came together to defend the quality of their products. There is no question of compromising quality of Indian products meant for domestic market and export, they pointed out.

US FDA India director Mathew Thomas speaking at a two-day annual conference held by Indian Pharmaceutical Alliance (IPA) in Mumbai recently said that he checked quality of some of the drugs marketed in India with the help of a rapid test tool following complaints from US embassy health unit in Delhi and found that the products lack quality and efficacy. He clarified that further tests need to be conducted to make sure that pharmaceutical products are not of standard quality.

Replying to Mathew's concern, pharma heads Sun Pharma, Zydus Cadila, Lupin, Cipla, Dr Reddy's taking part in CEO panel discussion at the event strongly emphasised the need for strengthening regulatory system in the country to ensure the quality of medicines in domestic market.

Sun Pharma, Zydus Cadila, Lupin, Cipla, Dr Reddy's, Torrent, part of IPA's quality forum have undertaken massive exercise to improve quality of their manufacturing sites with an aim to comply with data integrity norms of foreign drug regulators including US FDA, MHRA, EDQM etc.

India has about 570 US FDA approved plants. Of the 19 warning letters issued by USFDA in 2014, 10 were related to data integrity violations. 9 out of 10 warning letters issued by US FDA till August 2015 also raised concern over data reliability.

To tide over the quality compliance issues raised by US FDA, these six drug makers had two years back started work on improving data reliability at their sites focusing on technology systems, process design, risk management, governance, culture and capability. These six elements are also part of data reliability guidelines issued by IPA. The pharma lobby called on IPA and non IPA members to implement the guidelines to enhance safety, quality and efficacy of drugs.

Talking about their journey towards quality management, Sun Pharma managing director Dilip Sanghvi said “Post Ranbaxy acquisition we became double in size, so we redesigned our organisation, started using technology and ensure that we review our plants consistently with an aim to improve our capability at par with global standards. We have standardised quality matix across all plants to address issues pertaining to quality, productivity. It allows us to make inter plant and same plant comparisons. We have also undertaken implementation of paperless laboratory which is 12-15 months behind the schedule. We have also stopped filing products to semi regulated markets from regulated market plants.”

Satish Reddy, chairman, Dr Reddy's Laboratories said “Our three API plants are undergoing US FDA inspections. Our focus is on preventing things from going wrong. We have increased communication at various levels about quality and stopped investing in old plants. We may consider shutting down some old plants. Training and skill development needed to improve quality standards. The number of batch failures incidents has declined due to implementation of quality management system across the board.”

Cipla’s global chief executive officer Umang Vohra emphasised the need for automation in laboratories in line with manufacturing. The company stepped up efforts to automate its system, he said.

In a bid to overcome quality issues, it has set up a ‘root cause identification’ process and put in place a solution finding teams at each plant. Besides this, there needs to be a vendor-audit body to decrease duplication of efforts taken up by drug makers to audit common vendors that companies may have, he stated.

Nilesh Gupta, managing director, Lupin said “There is a need to use technology and data to improve compliance. We have been focusing on putting in place an early warning system. We started looking at reviews and stopped addressing irrelevant complaints.”

Zydus Cadila chairman and managing director Pankaj Patel said “We have focused on automation, setting up tracking systems but maintaining quality standards continues to be an issue. We are communicating with employees at all levels to make sure that quality standards are maintained. With an aim to reduce unwanted pressure on plant managers, we don't allow the marketing teams to directly communicate with plant managers.”