In view of the rising cases of fake drugs and substandard drugs reports emerging from India, the US health regulator is expected to increase its inspection strength in India. Also, coming under the scanner is the pharma manufacturing heavy weight China.
Reportedly, an increase in budget to strengthen the infrastructure of FDA in India which includes manpower and other resources has been hiked the fee for drug approvals to $76,030 (Rs 45,61,800) from $58,730 last year.
The headquarters is now planning to add 5 more inspectors to closely inspect around 900 plants exporting drugs to the world’s largest pharma market.
However, on further probing by HT on the matter, the FDA authorities have clearly defended their likely decision as they claim they have a strong force of field investigators reporting the cause. They are not considered as full time employees of the agency, but are a part of the big monitoring workforce that visits India every year, as implied by 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.