Updated: May 29, 2012 (Initial publication: May 16, 2012)

Breaking news

In India, a special Department of the Ministry of Health control the drug sector and issue market authorisations for medicines, the Central Drugs Standard Control Organization (CDSCO). A report of the Indian Parliament has concluded that responsibilities within the Organisation had not respected the rules of regulation and not required that drugs are subject to mandatory tests before issuing to them an authorisation on the market, and even if some of them are banned in other countries. The conclusion of the report is that such a breach cannot be only explained by collusion between regulator and pharmaceutical industry. The Government will initiate an investigation.

Updated: May 23, 2012 (Initial publication: May 9, 2012)

Breaking news

In response to the scandal of the drug called the" Médiator", politics, believing that the regulatory authority of medicinal product had not correctly done his job, responded by an act on December, 29 2011 providing the replacement of Agence française de sécurité sanitaire des produits de santé (Afssaps-) (French Agency for the Safety of Health Product) by The Agence Nationale de Sécurité du Médicament (ANSM) (National Agency for safety of medicinal product). The implementing decree organising the regulatory authority was released on April 29, 2012, that allowing the effective implementation of the new authority on the scheduled date: 1 may 2012. There is continuity between the two authorities: it is the same Professor of medicine who is the executive chairman, who was appointed at the head of the Agence française de sécurité sanitaire des produits de santé (Afssaps-) (French Agency for the Safety of Health Product) following the case of the" Médiator", and became the executive chairman of the (National Agency for safety of medicinal product). But the new authority must strengthen its own expertise; this allows therefore an increased autonomy to avoid capture by asymmetry of information for the benefit of pharmaceutical laboratories. The new Act also wants to avoid the links of interests, which lead to the same result of ineffectiveness of the control, and with a focus on transparency as an operating principle.

May 26, 2010

Thesaurus : Doctrine