To make the inspections and other related activities in the country more frequent and foolproof, the US FDA may soon establish its offices in Delhi, Mumbai and Hyderabad in India.
According to sources, the proposal to establish US FDA offices in the country is in an advanced stage and it may see the light of the day soon. A US FDA delegation had recently visited India and had held detailed discussions with Union health minister Dr Anbumani Ramadoss in this regard. The delegation also met senior health ministry officials including Drug Controller General of India (DCGI) Dr Surinder Singh and discussed the plan to establish three offices in India. Earlier, the proposal was to establish only one office in Delhi, but it has been changed to set up two more offices in Mumbai and Hyderabad, sources said.
The establishment of the US FDA offices in the country will result in the frequent inspection of the US FDA approved plants in the country. There are around 100 US FDA approved plants in different parts of the country. With offices in Delhi, Mumbai and Hyderabad, the US FDA officials can audit these facilities, even without any notice. There can be surprise visits also by these officials. At present the US FDA officials inspect these facilities periodically to ensure that these units comply with the good manufacturing practices to maintain the quality of the products. Usually, they come for audit with prior notice.
After the establishment of US FDA offices in India, the inspections will be carried out jointly by the officials of US FDA and the DCGI office. Apart from the approved plants, the joint team will audit the facilities which will apply for US FDA approval. The Health Ministry may make the joint inspection mandatory, sources said.