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.
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.
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