Meeting US FDA Standards Across the Board in India


In a context where even well-established, multi-billion-dollar domestic companies have received warning letters from the US FDA, quality compliance has clearly become strategically important across all layers of Indian organizations, including formulation and API companies as well as both B2B and B2C players.


My approach is extremely simple: quality is everyone’s responsibility

Vivek Sharma, Piramal Pharma Solutions

“My approach is extremely simple: quality is everyone’s responsibility. As a matter of fact, it has been integrated as a Key Result Area for all of our 4,000 employees, regardless of the function they hold. In my eyes, risk exposure in terms of quality compliance is actually the most crucial metric for our organization, and we have made huge investments to ensure our company remains ahead of the curve,” explains Vivek Sharma, CEO of Piramal Pharma Solutions, which displays one of the best track records in this area. “You truly have to ensure that from top to bottom everyone understands that integrity, ethics and compliance are binary: they are either maintained or they are not. [Companies’ heads] have to create a healthy paranoia in regard to these standards and we build that into every individual job,” confirms Jonathan Hunt of Syngene International, one of the fastest-growing CRAM organizations in the world.


“In this regard, I believe that quality compliance truly comes as a top-down endeavor, which has to be generated by the company’s heads before flowing throughout all layers of the organization. Indian CEOs with global aspirations know that they cannot take any shortcuts when it comes to quality standards and regulatory compliance, but the trickiest part is to convey and nurture this approach to their teams: in a vast and highly populated country like India, the paramount importance of quality and regulatory standards might not be obvious to all layers of our population,” adds Satish Varma of Fermenta Biotech, one of the world’s largest and leading producers of Vitamin D3.


When it comes to the overarching goal of avoiding regulatory and compliance issues, Indian CEOs may benefit from the cross-border, collaborative spirit that has been gaining traction across the country’s pharma ecosystem. “We assist and train both Indian regulators and the Indian pharmaceutical industry on developing and maintaining the quality, safety and effectiveness of medical products, which includes addressing regulatory compliance issues. In this regard, Indian regulators have become important strategic partners for the US FDA, we regularly engage with them and also aim to build confidence in each other, develop quality standards and bilateral initiatives,” reveals Dr. Letitia Robinson of the US FDA India Office.


“In an effort to adopt the best regulatory practices implemented in the world’s most advanced ecosystems, we closely and regularly interact with our peers from the US FDA, UK MHRA, Health Canada, and the WHO – among others. We are closely working towards capacity building, training, networking and knowledge sharing with the US FDA through one-to-one meetings conducted on a regular basis,” highlights Dr. Hemant Koshia, commissioner of FDCA Gujarat, the regulatory authority of the state of Gujarat, which accounts for over 33 percent of India’s pharmaceutical turnover and 28 percent of its pharmaceutical exports.


Writer: Laurent Pichotzki-Libano

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