FDA Commissioner Margaret A. Hamburg, M.D., contrasted the craftsmanship and beauty of India’s Taj Mahal with recent lapses in quality by “a handful” of the country’s drug manufacturers during a recent visit there. If the comparison was meant to flatter the domestic pharma executives and regulators with whom she met, they didn’t appear to think so.
Dr. Hamburg and officials from India’s Ministry of Health and Family Welfare pledged cooperation in data sharing and even “medical and cosmetic product and inspections conducted by the other Participant.” That’s no small promise since India is the world’s second largest exporter of prescription and over-the-counter drugs. Yet their formal Statement of Intent conditioned such cooperation “as time and resources allow” and didn’t set specific terms.
In a conference call with reporters today, Dr. Hamburg said implementing the statement was a five-year commitment “already under way” as both countries “have already embarked upon some cross-training activities and started to identify some critical areas for future activities together, so I think progress will be made.”
India’s ultimate cooperation with FDA is hard to predict given public uneasiness by Indian officials and drug companies about agency scrutiny. Days before Hamburg’s visit, India’s chief pharma industry regulator, Drug Controller General G. N. Singh, Ph.D., told India’s Business Standard: “If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those.”
Asked by GEN today how she could be confident of Indian cooperation based on the statement, Dr. Hamburg said Dr. Singh “discussed with me his eagerness to work closely with us and interest, in fact, in getting technical assistance and training opportunities” for his regulators to observe FDA’s Indian inspections. FDA stations 12 staffers in India—a number she said is expected to rise to 19.
“I think he also understands that every regulatory authority must work within their own national laws and regulatory framework,” Dr. Hamburg added. “When products are sold in the United States for use by American citizens, then those products do have to meet our standards.”
Indian drugmaker Ranbaxy has come under repeated FDA scrutiny. It agreed last year to pay a $500 million fine for safety and record-keeping violations. More recently, it urged Dr. Hamburg to lift the FDA’s consent decree. Extended as of January, this decree effectively bans four of Ranbaxy’s Indian plants from exporting active pharmaceutical ingredients to the United States. Although Ranbaxy contended that it needed the export activity to fund FDA-sought quality improvements, Dr. Hamburg declined the company’s request.
Dr. Hamburg’s visit highlighted the challenges Washington perceives from India’s growing domestic biopharma industry, which exports some $15 billion in drugs each year. As far as the FDA is concerned, these challenges pertain to product quality. But there are other challenges that lie beyond the FDA’s purview, as global pharma giants have found in their pursuit of business opportunities in India.
Do you think the U.S. concern over pharmaceutical manufacturing operations in India might be more motivated by competitive issues rather than quality control problems?