Quality isn’t assured by inspections alone: Bruce Ross

The US Food and Drug Administration (FDA), a government agency responsible for regulating and supervising the safety of foods, prescription and non-prescription medication, vaccines and biopharmaceuticals, has set up its operations in India. Bruce Ross, country head - India, US FDA talked to DNA on the sidelines of an industry event. Excerpts:Can you tell us about your operations here?There are many issues here and quality is not merely assured by inspection. It is a mistake by you in the media to assume that inspection is quality. There are ways by which FDA conducts inspection. What we do in India is document what the Indian industry sends to us. We are not here to increase the level of inspections. We assume that manufacturers built in quality, whether in clinical practices or laboratory practices associated with their products, so these inspections are validation to assure ourselves.All the decisions are being taken at the headquarters in the US and that is not going to shift to Delhi or Mumbai because we have an office here. We are here to make ourselves available for communication to be able identify and give answers to companies.So, any warning letters or notices do not come to you and go directly to the US?Yes, the resolution of issues is directly between the firms and the headquarters. We do not have any role in that and do not intend to.How many companies are you currently inspecting in India for regulatory non-compliance?We cannot talk about numbers because of lack of intent to emphasise inspection as it is not a good measure of how a firm is doing. So, passing off an inspection or having an inspection is not a good measure of quality. What matters is what the firms are doing themselves.How frequently do you inspect companies?We use risk assessment and management for inspection as we possibly cannot inspect everything. We only have 300 inspectors worldwide and in India we only have around 12 inspectors. So we go into places where there are potentially greatest risks for the greatest time to see for ourselves that firms maintain quality. So we confirm the documentation and materials that firm wishes to send to the US. As a regulator it is our duty to make sure that our citizens in the US are safe. So if a firm is chosen to produce a product in India to export to the US, we just want to see how the firms are going about with their job. US FDA has no jurisdiction in India. It is between your government and your citizens. But if any firm wants to export to the US, then they have to be in compliance to our rules and regulations.Do you think cases of regulatory non-compliance have been going up in India?No, we have regulatory actions against US firms almost on a daily basis, so what we do is share information with the companies and tell them that these are problems and that they should fix it by way of dialogue before taking any enforcement action.