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13210
Mon, 07/21/2008 - 10:02
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http://m.oananews.org//node/13210
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U.S.F.D.A. plans to set up offices in India
New Delhi, July 21 (PTI) With a view to make inspection of drug production in a more efficient manner, American health regulator U.S. Food and Drug Administration is looking to setup offices in different parts of India.
According to sources, the U.S. Food and Drug Administration (U.S.F.D.A.) has submitted a proposal to the government for setting up offices in three cities Mumbai, Delhi and Hyderabad and at the same time it is interested in working in collaboration with its Indian counterpart DrugController General of India.
"Presently, U.S.F.D.A. is waiting for the HealthMinistry's response," a source added.
Confirming the developments, Indian Pharmaceutical Alliance (I.P.A.) General Secretory DG Shah said the U.S.F.D.A. officials had discussions with the the industryassociations.
In February, the officials had come to India for a follow up visits after their trip to the country in September lastyear.
The delegation also met senior Health Ministry officials, including health secretary and discussed the plan to establish three offices in the country. The delegation has initiatedthese activities in China also.
The American regulator has expressed desire to work in close cooperation with the drug regulator D.C.G.I. and both are planning to made joint inspections in the country, thesources added.
Currently, U.S.F.D.A. inspects facilities in India on periodic basis and comes with prior notices to ensure thatthese units comply with the good manufacturing practices.
Establishing its own presence in India would help the U.S.F.D.A. to even carry out surprise checks, the sourcesadded.
The step is seen significant considering the intense pressure the American regulator is facing for regular checking of production facilities located outside the US for the GoodManufacturing Practice (G.M.P.) compliance.
Generic drugs accounts for approximately 60 percent of prescriptions filled in US. Manufacturing facilities located in India and China together accounts for more than 20 percent of the generic drugs and 40 percent of active pharmaceuticalingredients (A.P.I.) supplied in U.S.
Within 15 years, it is projected that as much as 80 percent of the A.P.I. used in the US will be derived from sources in India and China. PTI
According to sources, the U.S. Food and Drug Administration (U.S.F.D.A.) has submitted a proposal to the government for setting up offices in three cities Mumbai, Delhi and Hyderabad and at the same time it is interested in working in collaboration with its Indian counterpart DrugController General of India.
"Presently, U.S.F.D.A. is waiting for the HealthMinistry's response," a source added.
Confirming the developments, Indian Pharmaceutical Alliance (I.P.A.) General Secretory DG Shah said the U.S.F.D.A. officials had discussions with the the industryassociations.
In February, the officials had come to India for a follow up visits after their trip to the country in September lastyear.
The delegation also met senior Health Ministry officials, including health secretary and discussed the plan to establish three offices in the country. The delegation has initiatedthese activities in China also.
The American regulator has expressed desire to work in close cooperation with the drug regulator D.C.G.I. and both are planning to made joint inspections in the country, thesources added.
Currently, U.S.F.D.A. inspects facilities in India on periodic basis and comes with prior notices to ensure thatthese units comply with the good manufacturing practices.
Establishing its own presence in India would help the U.S.F.D.A. to even carry out surprise checks, the sourcesadded.
The step is seen significant considering the intense pressure the American regulator is facing for regular checking of production facilities located outside the US for the GoodManufacturing Practice (G.M.P.) compliance.
Generic drugs accounts for approximately 60 percent of prescriptions filled in US. Manufacturing facilities located in India and China together accounts for more than 20 percent of the generic drugs and 40 percent of active pharmaceuticalingredients (A.P.I.) supplied in U.S.
Within 15 years, it is projected that as much as 80 percent of the A.P.I. used in the US will be derived from sources in India and China. PTI
