FDA considering establishing Indian presence

By Kirsty Barnes

- Last updated on GMT

Related tags: Fda, Food and drug administration, Pharmaceutical drug, Pharmacology

The US Food and Drug Administration (FDA) is considering
establishing a presence in India, amidst the country's growing ties
with the US pharma industry.

FDA commissioner Andrew Von Eschenbach and US Health and Human Service (HHS) secretary Michael Leavitt have been visiting India to assess the manufacturing practices at some of the facilities there. The visit was largely initiated in response to mounting apprehension over the quality of both food and drugs and related ingredients being imported into the US. The current import protection system was described by Leavitt as "inadequate."​ Some Indian media reports have also claimed that the visit was made because the FDA is planning on setting up an office in the country. On the flip side, other media reports have said that the FDA is not planning such a move. Outsourcing-Pharma.com confirmed with an FDA spokesperson that at this point the agency is just offering advice and guidance to the Indian authorities who are looking at setting up a regulatory body that is comparable to that of the FDA. During his trip to India last week, Leavitt stated: "Basically, we would be glad to try to provide technical assistance to the Indian government as it further develops its new regulatory agency/ies."​ He also said that "we are considering trying to establish an FDA presence/office in India,"​ although no decision has been made as yet, the spokesperson advised. Mr Eschenbach also said that any move made by the FDA in this regard would be aimed at "building a bridge, not a barrier to bring the fruits of science and technology to people". ​ The FDA has been active of late in attempting to play catch up on keeping a watchful eye over the globalisation of drug manufacturing which has rocketed in the past 20 years. 75-80 per cent of all active pharmaceutical ingredients (APIs) used by US drug manufacturers are now imported, mainly from India and China, along with 40 per cent of finished dosage forms from various global locations. At present, however, the FDA does not regularly inspect all foreign facilities manufacturing the APIs serving them (generally only at intervals of five years or longer) and many foreign facilities have never been inspected at all, claim the Synthetic Organic Chemical Manufacturers Association (SOCMA) and the European Fine Chemicals Group (EFCG), who are demanding that regulators increase their inspections of such foreign facilities. Furthermore, 90 per cent of the inspections carried out by the FDA are pre-approval inspections, while only 10 per cent are for cGMP compliance purposes, according to Joe Acker, President of SOCMA. Moreover, A US government audit recently confirmed the FDA's continual lack of inspection of foreign drug manufacturing plants. In the Government Accountability Office (GAO) audit report, it was revealed that at present the FDA only carries out inspections of around 7 per cent of the total number of foreign drug manufacturers a year. China, which has the largest number of drug manufacturers eligible for FDA inspection (714) was earmarked for only 13 regulatory visits by the FDA in 2007, meaning only less than 2 per cent of the country's drug exporters will have had their facilities examined. The FDA has been working with its Chinese counterpart, the State Food and Drug Administration (SFDA), to address the issue, the first steps in tightening the safety controls on the pharmaceutical ingredients imported to the US from China being taken in December following months of negotiations between the regulatory bodies of the two countries. From now on, Chinese manufacturers that export to the US any of the APIs listed on a newly drawn up list are required to register with the Chinese drug regulators. Gentamicin sulphate (an antibiotic), atorvastatin (the API in Lipitor) and sildenafil (the API in Viagra), are among the big-name ingredients included on the list. The agreement is only a small step in the direction of a number of measures that need to be taken to secure the supply chain, but it will at least assist the regulatory agencies of both countries in more easily keeping track of and inspecting a larger number of manufacturers as to their regulatory compliance and hence ensure safer medicines. The FDA has already recently opened an office in China, which should also improve the situation, so an Indian office would be a likely next move.

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