The US FDA is restructuring its field activities. Photo: AP
The US FDA is restructuring its field activities. Photo: AP

Indian drug makers need to raise quality bar as US strengthens audits

The US FDA is taking measures to strengthen inspections and oversight of drug manufacturing units, which will force Indian pharmaceutical forms to take greater efforts to improve quality standards

Mumbai: The US Food and Drug Administration (FDA) is taking measures to strengthen inspections and oversight of drug manufacturing units, which will force Indian pharmaceutical companies to take greater efforts to improve quality standards.

In an official blog dated 31 August, US FDA commissioner Scott Gottlieb said manufacturing of drugs has become increasingly complex and global, requiring the agency to remodel oversight of these tasks to improve its efficiency and reach. To achieve this, FDA is restructuring its field activities.

The US FDA’s Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA) are implementing a new agreement to fully integrate the drug review programmes with facility evaluations and inspections. This agreement will ensure alignment between FDA’s field professionals and its review staff, Gottlieb said.

The new measures will improve efficiency of the US agency but it could also mean stricter inspections for pharma companies, D.G. Shah, secretary general of industry lobby group Indian Pharmaceutical Alliance, said.

Rahul Guha, partner and director at the Boston Consulting Group, said, “US FDA’s inspections are likely to get more coordinated and broader. For companies, this further emphasises the need for tighter integration between manufacturing and development to ensure feedback from challenges in manufacturing form part of the learning process for development."

Cipla Ltd’s global chief financial officer Kedar Upadhye expects the integration of the drug application review team and site inspections team at US FDA to be positive for companies. “It is a good thing. There will be internal alignment within the agency and hence, firms will get to know where they stand faster and in totality and not piecemeal," he said.

India accounts more than 40% of generic formulations supplied to the US. Inspections rose from 108 in 2009 to 290 in 2015. India has the highest number of US FDA-approved plants outside the US, with the total at 572 currently, compared with 433 in 2013.

Over the last seven to eight years, many big and small companies have received warning letters and import alerts from the US FDA for violation of current good manufacturing practices (cGMP).

For example, import alerts issued between 2009 and 2016 on three units of Ranbaxy (now Sun Pharmaceutical Industries Ltd), one unit of Sun Pharma, three plants of Ipca Laboratories Ltd, three units of Wockhardt Ltd and one unit of Aarti Drugs Ltd, have not been lifted yet.

Top companies like Sun Pharma and Dr. Reddy’s Laboratories Ltd have also not been able to fully resolve issues flagged by the US FDA in warning letters for some of their important manufacturing facilities in nearly two years.

Indian pharmaceutical companies must take a holistic approach to raise quality standards rather than focusing too much on improving documentation and should learn from mistakes of each other, Ajaz Hussain, senior advisor, KPMG India had told Mint in an interview in May.

Hussain, also a former deputy director at office of pharmaceutical science under US FDA’s Center for Drug Evaluation and Research (CDER), said, “cGMP remediations don’t work often because you are not getting into the root cause. Root cause investigation deviations is the poorest thing that FDA has pointed out in India. People don’t even know how to do it."

Data reliability, non-adherence to standard operating procedures, batch failures, contamination, and insufficient investigation of problems are some of the major non-compliance issues observed at Indian manufacturing facilities.

Companies have taken steps to improve quality compliance such as automation of processes in manufacturing units and laboratories to reduce human error and maintain data integrity and training programmes for employees to build a culture of best practices.

However, the key change required is the change in mindset, particularly at the top management level, as that will drive investments for upgrading quality standards.

“Companies have to go through a transformation that moves from short term compliance goals to long term, dynamic, strategic goals. The leadership team must steer a change in the culture of the organization by investing in people, processes and technology. This requires a paradigm shift in the mindset of the leadership," said Peeyush Gupta, director, sales and marketing, South Asia at UL, a global independent inspection and certification firm.