FDA in India – Championing a Culture of Quality

By: Mary Lou Valdez

One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of medical products exported from India to the U.S.

Mary Lou Valdez with India Office Staff

from left: Dean Rugnetta, FDA Deputy Director, India Office; Mary Lou Valdez, FDA Associate Commissioner for International Programs; Mathew Thomas, FDA Director, India Office

To achieve that goal, the India Office, directed by Mathew Thomas, conducts inspections of Indian medical products and foods facilities that export to the U.S. The office also assists and trains regulators, industry, and other stakeholders in developing and maintaining the quality, safety, and effectiveness of the FDA-regulated products they export.

It’s important for the office to consult regulatory authorities in India to build confidence in each other and to develop quality standards that both countries can trust.

I had the privilege of joining Director Thomas last month for meetings with our regulatory counterparts – the Indian Export Inspection Council (EIC), the Food Safety Standards Agency of India (FSSAI), the Drugs Controller General of India (DCGI), and the Joint Secretary of the Ministry of Health and Family Welfare.

Despite the diversity of these agencies’ mandates and priorities, a common theme coming out of these meetings was the recognition of the mutual benefits we realize by working together to enhance the effectiveness of our regulatory systems and to advance risk-based and science-based approaches to food and medical product regulation.

Along with other FDA experts, I also participated in a Global Food Safety Partnership (GFSP) Governing Council meeting and the Indian Pharmaceutical Alliance (IPA) Second Forum, titled “Towards Excellence in Quality.” Hosted by the Word Bank, the GFSP is a public private partnership, established in 2012, which brings together governments, industry, multilateral organizations, and other stakeholders in support of stronger food safety systems. Since its founding, the GFSP has worked with China, Indonesia, and Vietnam. During my visit, we had initial GFSP meetings with Indian regulators, to explore potential synergies as they look to bolster their food safety systems and maximize their investments. FDA’s India Office is well-positioned to help the Partnership and India explore how best to meet these goals.

The IPA Forum brings together CEOs of pharmaceutical firms, manufacturers, regulators, and other national and global stakeholders who have a role in shaping India’s complex and diverse manufacturing environment to produce safe, effective, high-quality medical products.

Over the past decade, the Indian pharmaceutical market has grown by nearly 14 percent and continues to experience massive growth. However, in order to fully realize the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace to ensure that global quality and safety demands are met. Quality issues are an ongoing challenge for the Indian pharmaceutical industry. Of 42 warning letters issued by FDA’s Office of Manufacturing Quality last year, nine went to Indian facilities. The IPA is working to communicate to its diverse members why quality matters and how to achieve it. Thus, the general theme of its Second Forum “Towards Excellence in Quality,” was an incredibly relevant topic if the global market for FDA-regulated products is to be strong and secure.

No one wants resources wasted on ineffectual development and weak processing or manufacturing systems that could actually impede product success. We all want greater competition, increased options for consumers and patients, and more affordable alternatives to comparable products.

Participants agreed that achieving quality requires regulators and industry alike to champion and advance a quality culture throughout the product life-cycle, by effectively employing the use of data and science and requiring greater transparency.

While I was in India, it was really gratifying to witness the high-esteem and trust Indian regulators and industry have for FDA, and our India Office. In turn, whether it is through their response to inspectional observations, their participation in trainings and seminars or their readiness to share strategic information, we see India committing to quality and compliance. Indian regulators and industry both recognize that a quality culture is imperative if India is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public health.

This greater emphasis on quality will also allow India to participate more fully in existing global venues such as the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – which will enable stronger collaboration and synergies among regulators.

Quality is good for economic development, the market, and most importantly, patients and consumers everywhere. FDA’s Office in New Delhi looks forward to continued collaboration with our Indian regulatory colleagues to champion a culture of quality.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

FDA In India: Going Global, Coming Home

By: Altaf Ahmed Lal, Ph.D. 

What is it like to be starting my new position as director of FDA’s office in India

It’s like coming home. 

My new tenure at FDA began in June, but as a former health attaché in the U.S. Embassy, I played an enthusiastic role in helping to establish FDA in my native country. 

I was born in Kashmir, India, and though I left the country in 1980 to explore new professional opportunities in the United States, I have since been drawn back again and again. 

It’s a beautiful, vibrant and interesting country, a unique mix of cultures, languages, and political viewpoints. It’s a country rich in agriculture, information technology and education that is constantly expanding its reach in industry, including the pharmaceutical and biotechnology sectors. It’s second only to Canada as the United States’ largest supplier of pharmaceutical products and in 2011 was the seventh largest exporter of foods to the U.S.

Accepting the responsibility to assume the helm of FDA’s office in India presents a rather daunting challenge. But as my colleagues, and most certainly my wife and three children will tell you, I am not one to shy away from a challenge – quite the opposite. 

In India, it begins with the recognition that FDA, which started as a domestic regulatory agency, has now, by necessity, become a global one. A large part FDA’s role in overseas offices is helping to ensure that products bound for export to the U.S. are safe, of high quality and effective. 

I see our mission in India as three-fold: first, to work closely with FDA’s Indian counterparts, establishing a relationship based on trust and regulations built on solid, scientific evidence; second, to conduct prompt and thorough inspections, when needed, of firms producing products for U.S. export. And third, to help industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential. These three criteria cannot be ranked; each is as important as the next. 

Over the next 12 to 24 months, I look forward to hosting several workshops for open, transparent discussions with industry and regulators on what systems of preventive controls need to be in place throughout the lifecycle of any manufacturing process. What controls do we need to guarantee that at the end of the day, products are safe and effective? Which checks and balances should be standard procedure across the board? 

Part of the challenge is to define those milestones by which we can measure success. I want a manufacturer to ask – and be able to answer – the questions, “Why are we failing inspections?” And “What specific controls do we still need to put into place on a 24/7 basis so that on the next FDA inspection we will pass?” 

I think the answers to those questions can be found in three words: collaboration, coordination and commitment. 

A colleague recently likened my new role at FDA to scaling Mount Everest. But you know, I’m fond of trekking and climbing, and view this next challenge much as I do those activities, as both a challenge and an adventure. I’m eager to be a part of it. 

Altaf Ahmed Lal, Ph.D. is the Director of FDA’s office in India.