The Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has recommended the suspension the sale of about fifty generic drugs because their approvals were allegedly based on clinical trials conducted in an irregular manner by a contract research organization (CRO) based in Hyderabad (India).
The drugs listed (including candesartan, escitalopram, donepezil, esomeprazole, metformin) are marketed in several countries of the European Union (EU) in various doses. France, Germany, Belgium and Luxembourg have already suspended the sales of 25 drugs but the EMA, pending new data, leaves the decision on the possible adoption of suspensive measures to the individual national regulatory authorities.
As a precautionary measure, the AIFA Technical-Scientific Commission has decided to initiate the suspension procedures for the drugs indicated by the EMA on the market in our country, while emphasizing that in Italy there is no risk of harmful effects or lack of efficacy of the medicinal products concerned, which however concern a marginal share of the market. "The measure suggested by the EMA Committee is dutifully based on the utmost caution but there are no elements to suggest the presence of dangers for patients" he confirms Enrique Häusermann, president of AssoGenerici.
"In the case of Italy," he adds, "the products concerned concern 9 active ingredients for a total of about twenty medicines, some of which are not even currently on the market." The FDA has not yet taken any action in this regard. The inspection by the French Medicines Agency (Ansm) had detected in the Indian Cro - to which various European and non-European manufacturers of equivalent drugs had relied - "manipulation of electrocardiogram data in the performance of some studies of generic drugs" for at least 5 years, causing the EMA to question the integrity of the methodology of the studies and the reliability of the data generated. The accused company replies that the EMA's reaction is disproportionate: ECGs are not indispensable once bioequivalence has been demonstrated and the remarks made cannot be extended to the bioanalytical, pharmacokinetic and statistical aspects of the research.
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