FDA Collaborates to Promote Safety, Quality in Clinical Trials Done in India

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By Leslie Ball, M.D., Letitia Robinson, Ph.D., R.N, and Elizabeth Wiley, M.D., J.D., M.P.H.

After more than 16 hours of travel, we touch down in Mumbai late in the evening and are greeted by a wave of heat and humidity as we exit the airport terminal. As we drive from the airport to the hotel, the vast Mumbai skyline is striking. India is home to 17% of the world’s population but accounts for about 20% of the global disease burden including both communicable and non-communicable diseases.

As a result, India holds a vast potential for clinical research and has become a global leader in the production of generic drugs. An estimated 40% of generic drugs imported into the U.S and used by American consumers are manufactured in India. Generic medications play a critical role in reducing drug costs for both patients and payers.

Leslie Ball, M.D., FDA Assistant Commissioner of International Programs and Elizabeth Wiley, M.D., J.D., M.P.H., AAAS Science and Technology Policy Fellow

Leslie Ball, M.D., Assistant Commissioner of International Programs (left), and Elizabeth Wiley, M.D., J.D., M.P.H., AAAS Science and Technology Policy Fellow, share some highlights from their recent training trip to India.

In an effort to promote the safety and efficacy of imported drugs, the FDA’s Office of International Programs (OIP) and the agency’s India Foreign Office have adopted a strategic engagement approach which includes inspections, targeted engagements including training, and the collection and use of data to inform FDA decision-making.

The purpose of our trip in mid-May was to participate in a joint training workshop for Indian regulators, academic representatives, and the drug industry on scientific and ethical standards for clinical trials. In addition to representatives from FDA, the European Medicines Agency, the Indian Central Drugs Standard Control Organization, and the Drug Information Association (DIA) were part of this first joint training.

FDA presenters included Jennifer Adams, M.P.H., Assistant Director, FDA India Office, and Sam Haider, Ph.D., Deputy Director of FDA’s Center for Drug Evaluation and Research (CDER) Office of Study Integrity and Surveillance. Sean Kassim, Director, CDER’s Office of Study Integrity and Surveillance, and Mathew T. Thomas, M.B., M.S., Senior Advisor, CDER’s Office of Scientific Investigations, provided critical planning for the event.

Recent changes in Indian regulation of clinical trials have seemingly impacted the number of registered drug clinical trials. Based on data from clinicaltrials.gov, registered drug clinical trials in India declined from 2010 to 2015. These numbers are predicted to increase in response to recent regulatory changes in an effort to create a more supportive regulatory environment in India. Moreover, there has been a sharp increase in the number of bioavailability or bioequivalence studies in India over the last decade as India has become the world’s largest supplier of generic drugs.

Letitia Robinson, Ph.D., R.N., Director of the FDA India Office.

The collaborative workshop, hosted by DIA, included an intensive two-day whirlwind of sessions, discussions, and case studies addressing key quality and ethical issues in clinical trials. Workshop participants included sponsors, contract research organizations, firms conducting bioavailability or bioequivalence studies, clinical investigators, regulators and academic researchers. These joint workshops sought to provide practical training on emerging issues, regulatory updates, clinical trial data integrity and inspectional methods. The specific goals of these workshops include:

  • Identifying general concepts in inspections of clinical investigators, clinical trial sites, ethics committees, and bioanalytical study sites;
  • Identifying techniques for maintaining data integrity in clinical trials; and
  • Reviewing inspections to develop evidence and determining appropriate observations to include in inspection reports.

The panels featured regulators from India, Europe, and the United States, as well as industry representatives. Participants fielded many questions on inspections, regulations, and standards – all in an effort to promote data integrity, credible and accurate results, and protection of subjects in clinical trials.

These questions helped clarify areas of harmonization among far-flung regulatory authorities, as well as differences such as the requirements for compensation of clinical trial participants after injury in India.

A second training in mid-May in Hyderabad, known as the City of Pearls and a technology center within India, began with a new audience of industry, academic and regulatory representatives. And, much like Mumbai, participants quickly engaged in two days of intense lectures, case studies and discussions with no shortage of questions and comments.

Informal feedback from participants was overwhelmingly positive and suggested that significant progress toward the goal of FDA participation in these workshops, including ensuring necessary capacity within regulatory and academic communities is developed and contributes to a sustainable training curricula, had been achieved.

Leslie Ball, M.D., is FDA Assistant Commissioner for International Programs; Letitia Robinson, Ph.D., R.N., is the incoming Director, FDA India Office; and Elizabeth Wiley, M.D., J.D., M.P.H., is an AAAS Science & Technology Fellow, Office for International Programs

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

Practical Applications of FDA Regulations for the Indian Food Industry

By: Dean Rugnetta

Dean RugnettaGlobalization of the food supply chain and advances in food processing technologies have led American consumers to develop a taste for a variety of foods and cuisines from different countries. Increasingly, U.S. grocery stores sell foods from Asia, Latin America, and many other parts of the world. Indian exporters have recognized this marketing opportunity, and FDA information shows an increase in U.S. imports from India over the past 10 years. A wealth of ready-to-eat Indian specialties can be found in cans and bottles on U.S. store shelves including Indian curries (a.k.a. gravies), canned sweets, pickled cucumbers, and Indian pickles (chopped fruits and vegetables marinated in brine).

A serious potential health risk in canned and bottled foods

FDA’s regulations for processing shelf-stable or commercially sterile food — such as certain canned and bottled foods — were promulgated in the 1970’s in response to deaths related to botulism poisoning. Botulism is a muscle-paralyzing disease caused by a toxin made by the bacterium called Clostridium botulinum.  FDA’s regulations require that processors heat and/or formulate low acid canned foods and acidified foods in a manner that eliminates favorable growth conditions for such toxins.

The regulations also require that supervisors in plants that manufacture such products be trained in appropriate processing methods. In the United States, FDA collaborates with industry groups, academia and other stakeholders to offer “Better Process Control Schools,” which typically provide two to five days of training.

Better Process Control School in India

Better Process Control School Class Group Photo

Students attending Better Process Control School in India

India now has a Better Process Control School where supervisors at any of the 300 FDA-registered facilities can attend training on how to safely process low acid canned foods and acidified foods. The school was established in 2010 when FDA’s India Office partnered with FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and a local university in New Delhi, India. The school has convened three separate times since then, most recently this spring. The training helps local processors learn FDA’s regulatory requirements and fulfill a regulatory mandate. Processors that successfully complete the course receive a certificate.

The long-term goal of the training partnership in India is to establish a locally sponsored, self-sustaining class and demonstrates how FDA’s international outreach efforts are improving the safety of imported food products.

Dean Rugnetta is the Deputy Director of FDA’s India Office in New Delhi, India 

Links to other FDA Voice Blogs:

A FSMA Update for our Stakeholders in India

By: Howard Sklamberg

Rice at India Spice Market

Deputy Commissioner Howard Sklamberg, Dr. Mathew Thomas, FDA India Office Country Director, and Ritu Nalubola, Ph.D., Senior Policy Advisor, Office of the Commissioner, observing different varieties of rice offered at a whole produce and spice market near Mumbai, India

In an effort to complement our conversations about the FDA Food Safety and Modernization Act (FSMA) in the United States, FDA is reaching out to our international partners and stakeholders to discuss implementation of this historic food safety law.

I recently visited India, accompanied by Andrew Stephens from the Office of Food and Veterinary Medicine, and Ritu Nalubola, Ph.D., with the Commissioner’s Office of Policy. We had extensive discussions with our regulatory counterparts in the Indian government and with key food industry officials.

Spice Market near Mumbai, India

A Mumbai spice wholesaler describing a range of spices available to Deputy Commissioner Howard Sklamberg and Dr. Mathew Thomas, FDA India Office Country Director, at a whole produce and spice market near Mumbai, India

India is the seventh largest supplier of food to the United States. The Indian food products that end up on the dinner tables of Americans every night — including shrimp, spices, and rice — reflect the increasing globalization of our country’s food supply.

Many of these goods come from any of India’s 29 states, produced by thousands of different companies. Such dispersion and volume makes FDA’s close engagement with our Indian counterparts necessary, especially on the export-related parts of FSMA.

Our most recent trip to India follows a similar trip in March 2015 when Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, joined me to introduce FSMA to a wide variety of Indian stakeholders.

On that trip, we explained that FSMA mandates a food safety system that is preventive, rather than reactive. FSMA requires that foreign food producers meet U.S. safety standards.

A variety of spices in India

A selection of spice offerings at a whole produce and spice market near Mumbai, India

At that time, we also signed a Memorandum of Understanding (MOU) with the government of India to engage in regulatory, scientific, and public health protection matters related to food products.

Building upon our 2015 trip, and upon the great work of FDA’s India office, our recent meetings focused on three FSMA rules of vital significance to India stakeholders: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; and Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications. The overview my FDA team provided was very useful to our Indian counterparts, many of whom have been engaged with FDA’s India Office in learning the details of the new mandates for exporters.

Howard Sklamberg speaking at the World Spice Congress in India

Deputy Commissioner Howard Sklamberg delivering remarks on FDA’s final FSMA rules at the World Spice Congress in Ahmedabad, India

I finished my trip with remarks to the World Spice Congress. As I noted there, the food system grows more global and trade-driven every year, which means we grow more dependent every year on collaboration and real partnership between government and industry across national boundaries.

We all have three goals: We want food to be safe. We want consumers to have confidence. And we want food safety and consumer confidence to enhance trade between nations. FSMA will help us achieve all three.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Strengthening our Regulatory Relationships in India

By: Mathew T. Thomas and Dean Rugnetta

India’s economic expansion is in part due to the tremendous growth in the pharmaceutical industry. The United States is a large consumer of medical products, and India is one of the largest suppliers of its drug products. And our important work together remains an FDA priority.

Investigator Daniel Roberts

Investigator Daniel Roberts (FDA India Office) and an Indian Regulator sharing inspectional approaches for current good manufacturing practices for pharmaceuticals during the workshop in Ahmedabad

We are working with our counterparts in the Indian government to ensure the medical products manufactured there, especially those for export to the U.S., meet FDA’s safety and quality requirements. FDA established an office in India in 2008, in part to promote government-to-government interactions like these and to keep pace with rapid developments and innovations in the pharmaceutical sector.

In November 2015, representatives from FDA’s India Office, our Center for Drug Evaluation and Research (CDER), Office of Regulatory Affairs (ORA), and Office of International Programs (OIP), partnered with the India Government’s Central Drug Standards Control Organization (CDSCO), to share inspectional techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities.

Carmelo Rosa and Denise DeGiulio

Carmelo Rosa (CDER), Denise DiGiulio (CDER), and an Indian Regulator discuss Quality By Design guidance with the workshop participants in Ahmedabad

Training sessions were provided in two cities (Ahmedabad and Bengaluru) for about 200 Indian regulators representing CDSCO and some of the State drug control agencies. The training was an example of the cooperation by both agencies to increase knowledge and skills, thereby contributing to the health and welfare of citizens in both countries.

The collaboration resulted in representatives from both agencies learning more about the regulatory perspectives of the other – and doing so first-hand. It was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections. The FDA representatives at the sessions benefited from input regarding the differences between FDA and Indian legislation and regulations. And as new inspectors comprised the majority of attendees, there was the opportunity for learning on both sides.

FDA Workshop Team in India

FDA Workshop Team in Bangaluru. Front Row – Denise DiGiulio (CDER), Carmelo Rosa (CDER), Leslie Ball (Office of International Programs), Mathew Thomas (India Office), Thomas Cosgrove (CDER), Thomas Arista (ORA). Back Row: Shiva Prasad (India Office), Daniel Roberts (India Office), Solomon Yimam (India Office)

Senior officials from the Government of India attended both events and affirmed their goals of ensuring patient safety and of collaborating with FDA to make sure that products from India are safe and meet appropriate quality standards.

FDA and Government of India regulators will continue leveraging knowledge and strengths to ensure patient safety in India and product quality of FDA-regulated pharmaceuticals.

Mathew T. Thomas is the Director of FDA’s India Office in New Delhi, India

Dean Rugnetta is the Deputy Director in FDA’s India Office in New Delhi, India

In India, With Our Sleeves Rolled Up

By: Howard Sklamberg and Michael Taylor

Howard Sklamberg

Howard Sklamberg

These facts surprise many people, but roughly 80 percent of active pharmaceutical ingredients, 40 percent of finished drugs, 80 percent of seafood, 50 percent of fresh fruit and 20 percent of fresh vegetables come from outside of the U.S.

Each year, the FDA has to assess millions of products grown, harvested, processed, manufactured and shipped from outside of the U.S. And one of the most impressive examples of how this globalization of production, consumption and trade has altered the regulatory landscape is India.

India is quickly becoming a significant player in the global marketplace, representing an important source of FDA‐regulated products. With a diverse population, highly skilled work force, and favorable economic conditions, India has become an increasingly attractive location for companies to operate.

Michael Taylor

Michael Taylor

And with that, Indian regulators have become important strategic partners for FDA. Today, we regularly engage with them on everything from sharing information on clinical trials to collaboratively addressing product safety issues that may harm American consumers.

When Commissioner Hamburg visited the country last year, she remarked that the “rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of suppliers entering the U.S. has increased.” On her visit she signed a milestone Statement of Intent between our two countries  seeking to “collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.”

We are eager to continue the work she started. And improving the lines of communication of which she spoke is the purpose  of our working visit to India. Before the trip we discussed with our teams what we expect from our journey. Our top goal is to listen and learn. We want to understand what challenges the Indian government is facing with regard to drug and food safety. We want to hear from both American companies operating in India, as well as Indian manufacturers. And we want to discuss with our Indian counterparts a number of significant changes in the American regulatory system that affect our relationship.

FDA’s Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations & Policy, and Cynthia Schnedar, Director, Office of Compliance at CDER, meet with Dr. G.N. Singh, Drugs Controller General of India.

FDA’s Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations & Policy, and Cynthia Schnedar, Director, Office of Compliance at CDER, meet with Dr. G.N. Singh, Drugs Controller General of India. Get this and other photos from FDA’s trip to India on Flickr.

It is no secret that relationship has been challenged in the recent past by lapses of quality at a handful of pharmaceutical firms. And while our first regulatory responsibility is to protect the American patient and consumer, we are also very willing to collaborate with Indian regulators and other stakeholders to ensure the achievement of highest standards of safety and quality, something we feel only benefits both nations.

We have harvested some of the fruits of this cooperation already. A significant example of collaboration between the U.S. and India occurred in 2012, when a Salmonella outbreak was traced to a manufacturer in India. An FDA inspection confirmed that the tuna product implicated in the outbreak came from the suspect facility, and the Indian government revoked the manufacturer’s license.

In yet another case, FDA’s India office worked with other United States government agencies to inform industry and Indian regulators about issues associated with an import alert for Basmati rice from India. The FDA office shared laboratory procedures for testing of pesticides.

More recently, in November of 2014, as a continuation of FDA’s efforts to strengthen the quality, safety and integrity of imported drugs, the FDA India Office, in collaboration with our Center for Drug Evaluation and Research’s Office of Compliance and the Office of Regulatory Affairs, held four workshops in India.  The workshops were held in partnership with European Directorate for the Quality of Medicines and Drug Information Association and involved the Indian Drug Manufacturers Association, Parenteral Drug Association and Organization of Pharmaceutical Producers of India. Over 560 participants from the pharmaceutical industry attended the four two-day workshops.

We are confident our trip will yield more examples of such fruitful collaboration, moving the regulatory relationship between two of the world’s largest democracies to the next stage, from the intention to work together, to the ability to work together to solve the complex globalization issues facing both nations.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory Operations and Policy

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

Visiting India: The Importance of Biomedical Research and Quality

By: Margaret A. Hamburg, M.D.

As my busy and productive trip to India drew to a close, I had the opportunity for one final meeting and one last memory with a group of some of the country’s most extraordinary women. The occasion was a Women’s Roundtable in Mumbai, organized by the Confederation of Indian Industry (CII). It brought together a diverse collection of female industry and academic leaders in India for a thought-provoking discussion and a wonderful chance to share perspectives with these accomplished women.

Commissioner Hamburg and members of the Women's Roundtable in Mumbai

Commissioner Margaret A. Hamburg, M.D. and members of Women’s Roundtable in Mumbai, India.

We covered a wide range of important and timely topics and could have gone on for much longer had time allowed. We discussed the many challenges that professional women often face in today’s workplace including efforts to achieve work-life balance and the importance of educating, motivating, mentoring and empowering women at every stage of both their professional and personal development. We also focused on a number of pressing issues in biomedical research, clinical trials and the regulatory framework for food and drugs.

What was most striking about this remarkable group of women is the commitment each has made not only to support one another in their diverse professional endeavors, but also to work to improve the lives of people living in India and around the world.

Two themes emerged during our discussion: the importance of biomedical research in India, specifically clinical trial design and enrollment; and the importance of quality and the role these prominent leaders in the pharmaceutical and food production sectors can play in communicating why quality matters.

The group expressed concern about the status of the clinical trial system in India. Many Indians have been wary of the way clinical trials have been conducted and how trial participants are chosen and informed. India has been in the midst of a significant re-examination of its clinical trial infrastructure and the legal, regulatory, ethical and scientific required for future research.

Certainly, we understand the importance of a vibrant, reliable and transparent clinical trials system. The information FDA receives and reviews from clinical trials conducted in the U.S. and abroad is an essential part of the agency’s decision-making for all new and existing drugs. Without it, we would not have important information such as how a drug works, whether it is reasonably safe for patients, and how the human body metabolizes the drug. Additionally, clinical trials may represent a vital mechanism to access an investigational drug for patients living with serious and life-threatening diseases.

Over the years, the FDA has worked closely with academia, industry and the advocacy community to improve transparency around the design and conduct of the clinical trials used to generate data for medical product review and approval. The agency has been working with the health care and research community to improve a clinical trial subject’s understanding of what it means to participate in a clinical trial, as well as the specifics of the trial in which they are considering enrollment.

Because the information we learn from clinical trials has the potential to benefit people living around the world – and the trials may be conducted in a wide range of countries – it is important that government officials, industry, the research community and patient organizations work together to ensure appropriate human subject protections, rigorous clinical trial design, and needed health care. We look forward to continuing our discussions with government, industry and academia on these important topics.

Quality was a recurring theme during my visit to India. I was pleased that the women who participated in the roundtable were as committed to quality as I am.  As leaders in their industries and academic institutions, these women are uniquely positioned to help reinforce the message that quality matters and to educate the next generation of leaders in their respective industries and organizations about the importance of building quality into everything they do. And I was delighted that the group appreciated how smart regulation can help shape, support, and strengthen the product development and manufacturing processes that can help ensure continuous quality. In the words of moderator Swati Piramal, one of the highest ranking and most eminent leaders in Indian Pharma today, “good regulators make good companies.” And that combination can lead to better, safer and higher quality products – which benefits the health of people in both our nations and around the world.

Margaret A. Hamburg, M.D., is Commissioner of Food and Drugs

Quality: A Recurring Theme During My Visit to India

By: Margaret A. Hamburg, M.D.

As one of the Seven Wonders of the World, the Taj Mahal is not only one of India’s most sacred symbols, but one of the finest, most carefully designed architectural structures in the world. As I studied the details of the marble and embedded precious stones of the mausoleum during a recent visit to the city of Agra, I could not help but reflect on the care, craftsmanship and quality of the work that took just over two decades to complete. It was evident as I walked along with hundreds of other visitors in socked feet that those responsible for building the Taj and those that are preserving the centuries old structure are committed to extraordinary quality.

Commissioner Hamburg with A Didar Singh

FDA Commissioner Margaret A. Hamburg, M.D., and A Didar Singh of the Federation of Indian Chambers of Commerce and Industries.

This vision of quality and care remained with me when I met with executives from pharmaceutical and food exporting companies operating in India. The roundtable meetings, organized by the Federation of Indian Chambers of Commerce and Industries, were an opportunity for me to learn about two of the largest business sectors in India and to hear from business leaders about the challenges they are facing as a result of globalization.

One of the challenges cited by the pharmaceutical leaders is approval times for abbreviated new drug applications – the applications filed for generic drugs. I am happy to report that the FDA is working quickly to fulfil one of our commitments under the Generic Drug User Fee Act (GDUFA) – reducing the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012.  As of the end of January 2014, our Center for Drug Evaluation and Research had taken a formal action on 45 percent of backlogged generic drug applications. In December 2013 alone, the center completed 174 actions, including 30 full approvals for generic drugs.

GDUFA also requires that we step up our number of foreign inspections and gives us the funding to do so. Companies participating in both the pharmaceutical and drug roundtables said they were challenged by our heightened inspectional activities. I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality.

In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly.

In recent years the FDA has identified significant lapses in quality by some companies operating in the U.S. and around the world. As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable.

Regulatory agencies around the world share my vision for ensuring that consumers, patients and healthcare providers in all of our nations have access to high quality products. I am pleased that, as a global leader in the pharmaceutical and foods sectors, India will continue partnering with us to ensure that the companies exporting products to the U.S. are adhering to established quality standards.

On the home front, we at the FDA will also continue to increase our focus on quality. One way we are doing this is through the creation of a new Office of Pharmaceutical Quality that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product.

All companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

 

Visiting India: Sharing a Vision for Strengthening Food and Medical Product Safety

By: Margaret A. Hamburg, M.D.

Fresh mangos, bananas and other native fruits add a pop of color and provide the backdrop while we ride along the busy streets of Delhi. While en route to the first of several meetings I held with Indian regulators, I can’t help but marvel at the vibrant buzz of India’s capital and the progress that has been made since I traveled here years ago as a young woman. Since that time, the rapid globalization of commerce has posed significant challenges to ensuring consumer safety as the number of products and suppliers entering the U.S. has increased. India now represents the 3rd largest trade partner, 2nd largest supplier of over-the-counter and prescription drugs, and 8th largest supplier of food to the United States.

Margaret Hamburg and officials in India

(L-to-R) Arun Panda, Joint Secretary, Ministry of Health and Family Welfare; Shri Keshav Desiraju, Secretary, Ministry of Health and Family Welfare; Shri Ghulam Nabi Azad, Minister, Ministry of Health and Family Welfare; Dr. Margaret A. Hamburg, M.D., Commissioner of the U.S. Food and Drug Administration; Dr. Altaf Lal, Director of U.S. FDA’s India Office; Nancy Powell, U.S. Ambassador to India.

On Monday, I began my first official visit to the country as Commissioner of the FDA. I met with officials from the Indian government who oversee the country’s health-related matters as well as those responsible for overseeing the export of foods to the U.S. and more than 200 countries around the world. These meetings provided the opportunity for me to discuss our shared vision for strengthening the quality of the foods and medical products exported from India to the United States. Ultimately this vision is intended to enhance consumer confidence in these products both at home and abroad.

As two of the largest democracies in the world, our countries have enjoyed an enduring partnership and commitment to collaborate on initiatives designed to enhance both our economies and the lives of the people in our respective countries.

Ensuring that the products distributed in the United States meet our requirements for product safety and quality is among my top priorities as Commissioner. Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.

While the FDA will take appropriate action against any company that doesn’t meet our requirements, we are also willing to work with them to address their issues. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that.

Officials at India’s Ministry of Health and Family Welfare share this goal. In the spirit of continued collaboration and a commitment to quality, our agencies signed the first-ever Statement of Intent. Our organizations plan to collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality.

While the Statement of Intent is an important milestone, I am proud to report that FDA’s Office in India has already been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. Drug and food regulators in India have participated in FDA-hosted workshops and observed FDA inspections of manufacturing facilities and clinical sites with operations in India.

During my visit I am eager to learn more about the industries that produce products for the United States and to meet with business leaders where I will reinforce our expectations that they meet our requirements for ensuring that consumers here and around the world have access to safe and high-quality products.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration

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.