Indian pharmaceutical companies have received 29 per cent of US FDA warning letters in 2017 as compared to 50 per cent warning letters in 2015 due to improvement in quality standards and regulatory compliance.
In 2016 India accounted for 29 per cent of US FDA warning letters which remained the same last year as well. In 2017 US FDA had issued 49 warning letters to non US sites as compared to 16 letters in 2015. In 2016 non US FDA plants received 35 warning letters.
India has received 30 per cent import alerts in 2017 as against China's 50 per cent import letters and ROW's 20 per cent.
To tide over the quality compliance issues raised by US FDA, six drug makers – Cipla, Zydus Cadila, Dr Reddy's, Torrent, Sun Pharma which accounted for significant chunk of pharma export in US market had three 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 Indian Pharmaceutical Alliance. The pharma lobby called on Indian Pharmaceutical Alliance and non Indian Pharmaceutical Alliance members to implement the guidelines to enhance safety, quality and efficacy of drugs.
Over the last couple of years there has been a significant improvement in quality standards of India pharmaceutical companies despite rise in regulatory scrutiny, said Vikas Bhadoria, senior partner of McKinsey& Company.
There has been a reduction in data related errors, gap in investigations of root cause assessments is now a leading source of non-compliance, he said.
Replying to a query he said “Building capacity of human resource at shop floor of a plant will help pharma firms fill gap in investigations of root cause assessments. Digitisation and automation introduced in manufacturing plants along with capacity building of human power would lead to further decline in regulatory challenges faced by Indian pharm industry.”
He added the companies have introduced digitisation and automation in new plants to tide over regulatory challenges but its adoption in traditional plants is not much significant.
To attain quality excellence, and thereby address various regulatory issues faced by the Indian pharmaceutical industry, Indian Pharmaceutical Alliance Quality Forum along with US FDA, EMA, MHRA & CDSCO will hold meet on Towards Excellence in Quality in Mumbai on February 22-23, 2018.
Indian Pharmaceutical Alliance Quality Forum has made significant progress in defining best practices. The Quality Forum achieved remarkable success in three focus areas which were outlined by it last year-developing best practice guidelines for Indian pharma companies, expanding reach of QF activities within Indian Pharmaceutical Alliance QF members and other Indian Pharmaceutical Alliance members, driving capacity building and training at scale.