With FDASIA, FDA Increases Inspections of Indian Drug Facilities
September 25th, 2013 // 11:01 pm @ jmpickett
FDA has boosted the cGMP inspections of drug firms in India, which is the second biggest manufacturer of finished dose forms to the United States, which will help to increase compliance of approved cGMP regulations.
FDA, which has cracked down on many pharma companies in India, which includes Wockhardt and Ranbaxy Labs, also is recruiting and training more FDA drug auditors in India.
Food and Drug Administration Safety and Innovation Act (FDASIA) Steps Up Foreign Inspections
To meet the new requirements of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA is increasing inspections in India.
In March of this year FDA got approval from the government in India to add more drug investigators in that country. It currently is recruiting and teaching staff for the new positions. FDA’s presence in that country is going to increase from 12 to 19 Americans who are based in the country. Ten of them will work specifically on medical products.
Under FDASIA, FDA has to achieve the exact same schedule of inspections for foreign companies as those based in the US. It also must clear any backlog of drug applications by the end of the initial five year user fee period.
India is the second biggest provider of all finished dose drugs to the US, with about 10% of that market. It also has been providing lower cost drugs for many countries around the world for many years.
FDA, through FDASIA, is building up its Indian presence so that it can more effectively collaborate with their regulatory counterparts in India. It will allow FDA to better leverage its resources and to boost regulatory capacities.
