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

Better Process Control Schools Around the World

By: Irene Chan

When you open a can of creamed corn soup, your expectation is that you can consume it without fear of getting sick. We rely on commercially sterile foods, such as canned foods and other shelf-stable vacuum packaged foods, for everyday meals, as well as for emergency situations, such as natural disasters. In all of these situations, the safety of food is vital. The airtight, low-acid environment of many commercially-sterile foods is a prime target for the growth of bacteria that can produce a lethal toxin that causes botulism.

Irene ChanFortunately, since FDA established low-acid canned food (LACF) and acidified food (AF) regulations in the 1970’s, the commercial processing of commercially sterile foods in the United States has become much safer. One of FDA’s requirements is that, with few exceptions, manufacturing supervisors at canneries must have taken an appropriate training course to understand how to make a safe commercially-sterile product. FDA must approve these so-called Better Process Control Schools (BPCS), which numerous large universities throughout the United States offer. These courses provide essential information about how to effectively control the risks associated with the manufacturing of commercially-sterile foods, and how to comply with U.S. law.

With the increasing globalization of the food supply, FDA has recognized that the need for BPCS training has gone beyond our shores. And until recently, it was a challenge for foreign manufacturers to send persons to attend BPCS in the United States because of travel and language barriers. But through FDA’s foreign offices, we have supported local universities throughout the world with the capability to host approved BPCS training courses right where they are needed.

China, where there are several hundred establishments registered with FDA to export canned foods to the United States, is a prime example of a robust food export market. In September 2011, through collaboration between FDA’s China Office and experts in FDA’s Center for Food Safety and Applied Nutrition (CFSAN), the first-ever, locally sponsored BPCS course in China was conducted at China Ocean University in Qingdao, Shandong Province. Attendees were able to obtain the content of the course in Mandarin Chinese from local food technology professors, while an FDA technical advisor was available for questions. This June, the university held its second course, with eager attendees coming from mainland China as well as Taiwan.

Closer to home, the Latin American region has established itself as the pantry for the United States, supplying a myriad of food products throughout the year. There are hundreds of food manufacturers in the region that would greatly benefit from the opportunity to send supervisors to a local, approved BPCS. The Latin America Office has identified three universities as having the knowledge base and infrastructure to conduct BPCS courses: Costa Rica’s Center for Food Technology Research (CITA), Guatemala’s Del Valle University, and Peru’s National Agrarian University- La Molina.  In addition, FDA’s Latin America Office worked with the Inter-American Developmental Bank to obtain funding to provide the approved course materials for the universities in Guatemala and Peru to conduct their own BPCS. These universities will soon provide these courses at a low cost, with capable instructors who speak the local language and understand the local realities of the industry. In Peru, the university recently completed their first BPCS on August 17th, 2012. Representatives from FDA’s Latin America office, FDA’s Office of Regulatory Affairs, and CFSAN were present to answer questions and assist with the delivery of the class. In Costa Rica, CITA has scheduled their first BPCS for August 27-31, 2012, and expects attendees from the Caribbean and Central America region.  These are pilot programs, and we have already heard from other countries and institutions that want to participate in similar efforts.

Indian manufacturers produce hundreds of different varieties of vacuum packed ready-to-eat dinner entrees that are imported into the United States. Before 2011, no in-country BPCS was available for these manufacturers. In March 2011, local faculty at Bhaskaracharya College of Applied Sciences in New Delhi taught a BPCS course for the first time. The course cost each student only about $200—this sum paid for instruction, catering for meals and course materials. Students came from throughout India to attend the course.  A FDA technical advisor’s participation in the course allowed students to ask questions about process filings and engage in technical discussions with FDA. This year, the college held a second class in Sri Lanka for LACF and AF producers located in that country.  A third class is planned for later this year.

The FDA overseas offices are proud to have helped stand up these important training events in various parts of the world, and to support local universities as they develop the capacity to put on these courses. And the next time we open that pouch of vacuum-packed curry lentils, we will know that the effort to keep our food safe is truly global.

Irene Chan is the Deputy Country Director of FDA’s China Office. Edmundo Garcia, Jr., Assistant Regional Director for FDA’s Latin America Office, Daniel Geffin, Food Technologist in FDA’s Office of Food Safety, Food Process Evaluation Team, CFSAN, and Bruce Ross, Country Director of FDA’s India Office, contributed to this post.