US health regulator likely to send more inspectors to India
WHILE INDIA AND CHINA REMAIN THE MAJOR EXPORTERS OF DRUGS IN THE US, THE PRESENCE OF PERMANENT INSPECTORS AT BOTH LOCATIONS REMAIN NOTICEABLY LESS.
NEW DELHI: While the US lawmakers are pushing the American health watchdog to increase presence in China and India following the rising cases of counterfeit and substandard drugs, the Food and Drug Administration is likely to add five more inspectors in India.
“Headquarters is planning to add five more inspectors to look after the Indian drug units considering the presence of almost 900 plants exporting drugs to the US,” two senior officials engaged at FDA’S New Delhi and Mumbai office told HT.
The FDA presently employees only two full-time inspectors for China’s 708 plants, and three inspectors for 850 plants in India.
However, the FDA neither confirmed nor denied the intentions to increase staff. “We are awaiting the deployment of three others to China who have been hired. However, the FDA is not in a position at this time to discuss future staffing plans in foreign offices (including India),” said Christopher C Kelly, press officer at the US FDA told HT.
Last year, the FDA had hiked the fee for drug approvals to $76,030 (₹45,61,800) from $58,730. “Undoubtedly, the FDA needs manpower for India units and the extra fees was meant for buying more infrastructure, manpower and resources,” said Sujay Shetty, head of pharmavertical at consultancy Pricewaterhousecoopers.
However, the FDA had defended itself by claiming that they employ field investigators, who are not full time employee. “Field investigators from the office of regulatory affairs frequently travel to foreign facilities to carry out inspections throughout the year. As a result, the number of FDA investigators p at foreign facilities will vary throughout the year,” Kelly said.
Last month, two American Congressmen wrote to the US government highlighting concerns that “there is still inadequate oversight with regard to these (India and China) foreign drug plants.”