The trip couldn’t come at a more opportune moment for India, which is struggling to come to grips with its new compensation formula for clinical trial participants, oversight from the Supreme Court, as well as its failure to properly regulate multiple companies’ manufacturing sites.
During the trip, which will include visits to Delhi, Cochin, and Mumbai, Hamburg will meet with Indian policy and government leaders involved in the regulation of medical and food products exported to the United States.
In October, Outsourcing-Pharma.com caught up with a number of these policy and industry leaders in Delhi, Mumbai and Hyderabad, though none offered explanations for what is delaying the onset of their expected overhaul of their clinical trials, nor did they offer any explanations on how these improvements would take shape.
“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” said Hamburg. “I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
Multiple deadlines have been set for manufacturers to meet new regulations, money has been promised, but it’s difficult to gauge the extent to which these policy changes and expected changes have had on the drug industry in India. It seems as though more CROs and large pharmaceutical companies are moving their trials away from the subcontinent as new manufacturing sites continue to crop up despite troubles from existing ones.
In addition, IPEC (International Pharmaceutical Excipients Council) India was slated to launch before the end of 2013 but that does not seem to have materialized.
The cooperation of US and Indian drug officials currently ranges from sharing information on the conduct of clinical trials to jointly addressing product safety issues that may impact American and Indian consumers. Hamburg will also meet with industry leaders in India to discuss the importance of maintaining high-quality standards.
This is Hamburg’s first official trip to India.