Just over a year after the outgoing U.S. FDA commissioner made a precedent-setting visit to meet her counterparts, India is getting its second visit by high-ranking agency officials. The three officials plan to make the rounds of New Delhi, Goa, Chennai and Mumbai.
The FDA's deputy commissioner for global regulatory operations, the chief compliance officer and the head of food and veterinary medicine are expected to sign a memorandum of understanding for the FDA and the Central Drugs Standard has Control Organisation (CDSCO) to share information, training and similar common oversight responsibilities, newspapers reported.
Commissioner Margaret Hamburg, who has announced her resignation, visited the country in February of last year. There, she signed an agreement arranging for the exchanges of officials and offered training of India drug inspectors in U.S. methods, but there was no word if that would be done during the current visit.
It has been a rocky year for U.S.-India regulators as the FDA continues to crack down on India plants exporting what the agency considered substandard goods to the United States.
The visiting officials are Deputy Commissioner Howard Sklamberg, Compliance Office Director Cynthia Schnedar and Michael Taylor, deputy commissioner for food and animal drugs.