Indian Pharmaceutical Companies Received Warning Letters From US FDA

Indian pharmaceutical companies have received 29 percent of US FDA warning letters in 2017 when compared with 50 percent warning letters in 2015 because of improvement in quality standards and regulatory consistency. In 2016 India accounted 29 percent of US FDA warning letters which remained as before a year ago too.

In 2017 US FDA had issued 49 warning letters to non-US sites when compared with 16 letters in 2015. In 2016 non-US FDA plants received 35 warning letters. India has received 30 percent import alerts in 2017 as against China’s 50 percent import letters and ROW’s 20 percent.

To tide over the quality compliance issues raised by US FDA, six drug makers – Cipla, Zydus Cadila, Dr Reddy’s, Torrent, Sun Pharma which represented for significant chunk of pharma export in US market had three years back began work away at improving information reliability at their sites focusing on technology systems, process design, risk management, governance, culture and capacity.

These six elements are also part of information reliability guidelines rules issued by Indian Pharmaceutical Alliance. The pharma lobby approached Indian Pharmaceutical Alliance and non-Indian Pharmaceutical Alliance members to implement the guidelines to enhance safety, quality and viability of drugs.

Over the most recent few years there has been an improvement in quality standards of India pharmaceutical companies despite rising in administrative scrutiny, said Vikas Bhadoria, senior partner of McKinsey& Company.

There has been a reduction in data related errors, the gap in investigations of root cause assessments is currently a main wellspring of resistance, he said.

Answering to a question he said “Building capacity of human resource at shop floor of a plant will help pharma firms fill the gap in investigations of root cause assessments.

Digitisation and automation introduced in manufacturing plants along with limit working of human power would lead further decrease in regulatory challenges looked by Indian pharma industry.”

He included the companies have introduced digitization and automation in new plants to hold over regulatory challenges yet its adoption in traditional plants aren’t much critical.

To achieve quality excellence, and in this manner address different regulatory issues looked by the Indian pharmaceutical industry, Indian Pharmaceutical Alliance Quality Forum along with US FDA, EMA, MHRA and CDSCO will hold meet on Towards Excellence in Quality in Mumbai on February 22-23, 2018. Indian Pharmaceutical Alliance Quality Forum has gained huge progress in characterizing best practices.

The Quality Forum made remarkable progress in three focus areas which were outlined by it a year ago developing best practice rules for Indian pharma companies, expanding the reach of QF activities within Indian Pharmaceutical Alliance QF members and other Indian Pharmaceutical Alliance members, driving capacity building and training at scale.


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