. Indian Pharma Stands Strong in Global markets

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Indian Pharma Stands Strong in Global markets

In the Year 2017, Indian pharma companies received 29% USFDA warning letters as compared to 50% in the year 2015. The Indian pharma companies register marked improvement in quality standards and regulatory compliance. US FDA had released 49 warning letters to non US sites as compared to 16 letters in 2015. In 2016 non US FDA plants received 35 warning letters.

Overall, Indian Pharma Companies received 30% import alerts in 2017 as compared to China's 50% import letters and Rest of World's (ROW) received 20%.

Six Indian Pharma companies, which are drug exporters to US markets – Cipla, ZydusCadila, Dr Reddy's, Torrent, Sun Pharma accounted for major chunk of pharmaceuticals exports to other markets, chunk of pharma had 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. Therefore a conjunction between the pharma lobbies on Indian Pharmaceutical Alliance and non-Indian Pharmaceutical Alliance members to implement the guidelines to enhance safety, quality and efficacy of drugs lead to more quality and reliable drugs. Over the last couple of years there has been a significant reduction in data related errors, and gap in investigations of root cause assessments.

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 pharma industry. With the introduction of digitisation and automation in new plants the companies can tide over regulatory challenges; however its adoption in traditional plants is not much significant.

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.