EMA recommends drug suspension due to unreliable studies from Micro Therapeutic Research Labs
EMA – Comunicato Stampa – 24/03/2017
L' list of recommended medications for discontinuation can be found here . Suspensions can be lifted once alternative data has been established bioequivalence.
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L’Agenzia ha inoltre raccomandato che i medicinali non ancora autorizzati ma che sono in corso di valutazione sulla base di studi di bioequivalence carried out by these Indian sites should not be allowed until the bioequivalence is not demonstrated by alternative data.
Micro Therapeutic Research Labs è un’organizzazione di ricerca a contratto (CRO), che conduce parti di studi analitici e clinici di bioequivalence, alcuni dei quali vengono utilizzati per supportare l’autorizzazione all’immissione in commercio dei medicinali nell’UE.
The review of the drugs studied by Micro Therapeutic Research Labs was initiated after inspections carried out by the Austrian and Dutch authorities in February 2016 to verify compliance of good clinical practice (GCP). Inspections identified several concerns at the Indian company's sites regarding misrepresentation of study data and deficiencies in documentation and data management.
The review carried out by Committee for Medicinal Products for Human Use (CHMP extension) dell’EMA, ha concluso che i dati provenienti dagli studi condotti presso i siti indiani tra giugno 2012 e giugno 2016 sono inaffidabili e non possono essere accettati come base per un’autorizzazione all’immissione in commercio nell’UE. However, there is no evidence of harm or lack of efficacy of medicines licensed and under evaluation in Europe, based on studies at Indian sites.
Alcuni dei farmaci che sono stati consigliati per la sospensione possono essere di importanza critica (ad esempio a causa della mancanza di alternative disponibili) in alcuni Stati membri dell’UE. Pertanto le autorità nazionali possono rinviare temporaneamente la sospensione nell’interesse dei pazienti. Gli Stati membri devono anche decidere se i richiami dei farmaci interessati sono necessari nei loro territori.
There raccomandazione del CHMP per quanto riguarda questi farmaci sarà ora inviata alla Commissione europea per una decisione giuridicamente vincolante valida in tutta l’UE.
Information for patients and healthcare professionals
- Un certo numero di farmaci in uso nell’UE sono stati approvati in basa a studi condotti in due siti della Micro Therapeutic Research Labs in India. Gli studi non sono affidabili a causa di problemi nel modo in cui i dati e i documenti sono stati gestiti nei siti. Di conseguenza, diversi farmaci approvati nell’UE sono stati sospesi.
- L' list of recommended medications for discontinuation can be found here .
- There is currently no evidence of unanticipated harm or lack of efficacy with any drug approved based on studies conducted at Micro Therapeutic Research Labs.
- Several medicines that have been approved based on studies conducted at Micro Therapeutic Research Labs may remain on the market in the EU. This is because during this review, alternative data were provided for these drugs.
- L' list of recommended drugs to stay on the market can be found here .
- Le autorità nazionali nella UE prenderà in considerazione quanto siano critici i farmaci raccomandati per la sospensione nei loro paesi e di prendere decisioni finali sull’opportunità di sospendere o permettere loro di restare a disposizione, in attesa che vengano prodotti nuovi dati.
- Patients should continue to take their medications as prescribed and contact their physician if they have any questions or concerns.
La revisione riguarda un medicinale autorizzato centralmente attraverso EMA (Tadalafil Mylan), così come i medicinali autorizzati dalle procedure nazionali negli Stati membri dell’UE (tra cui procedure decentrate o of mutual recognition), whose autorizzazione all’immissione in commercio includes data from studies conducted by Micro Therapeutic Research Labs at two sites in India:
- Micro Therapeutic Research Labs Pvt. Ltd Rajam Bhavanam, No. 6, Kamarajar Salai, Selaiyur, East Tambaram, Chennai-600 059, Tamil Nadu.
- Micro Therapeutics Research Labs, No. 29 A, Krishna Madhuravanam, Vellokinar Pirivu, Thudiyalur, Coimbatore-641 029, Tamil Nadu.
The review also included current medications di autorizzazione all’immissione using study data from these sites.
More about the procedure
Il riesame è stato avviato il 15 dicembre, 2016 da diverse Agenzie Regolatorie per i medicinali – Austria, Bulgaria, Croazia, Danimarca, Estonia, Finlandia, Germania, Ungheria, Islanda, Lettonia, Paesi Bassi, Norvegia, Romania, Slovacchia, Slovenia, Spagna, Svezia e Regno Unito – ai sensi dell’articolo 31 della direttiva 2001/83 / CE .
The review was carried out by Committee for Medicinal Products for Human Use ( CHMP extension ), responsible for all matters concerning medicinal products for human use, which gave its opinion. The opinion of CHMP extension sarà ora trasmesso alla Commissione Europea, che emetterà una decisione finale giuridicamente vincolante applicabile in ciascuno degli Stati membri dell’UE.
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From Aboutpharma dated 03/27/2017. Therefore, Indian companies dealing with bioequivalence are back in the limelight. In the February issue of AboutPharma and Medical Devices, the topic was explored by describing a disturbing scenario. Numerous Cros (Contract Research Organizations) active in India and China have been accused of having provided clinical results that are deficient or even without scientific basis because the test data was incomplete when not manipulated.
In 2011 “data integrity” was mentioned in the 43% of the cases in the warning letters (letters of warning from the regulatory bodies) of which a 31% Indian and Chinese. In 2015, the percentage rose to 78% and of these letters 70% was sent to the Far East. The 40% of the generics circulating in the American market comes from India which, together with China, controls the 80% of the production of generics in the world. Numbers that make you think, but it would be alarming. Often these data are "manipulated" due to the simple fact that they do not perfectly meet the requirements of bioequivalence, thus not constituting an actual danger to the health of patients.
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Ed: I farmaci equivalenti, meglio noti come generici, al momento della scadenza di un brevetto contribuiscono all’abbattimento del prezzo del farmaco di marca, possono offrire qualche risparmio per i pazienti e potrebbero incentivare le aziende farmaceutiche a fare ricerca per commercializzare nuovi farmaci e come tali con copertura brevettuale.
That said, the system in force in Italy leaves open some doubts. Among many of these doubts, we point out at least two here. The Italian generics market is dominated by an oligopoly of 5 companies and the insistent state propaganda is free advertising for these companies, to the detriment of the more than 200 companies present in Italy. It should be noted that the relative higher cost of branded drugs weighs on the citizen and not on the State, so there is no savings for the NHS coffers.
Furthermore, beyond the propaganda that tells us that the safety of these drugs is controlled by the regulatory authorities, in reality bioequivalence studies do not use clinical efficacy parameters and studies are carried out to ascertain the close similarity between the equivalent drug and the originator self-produced and self-certified that analyze the bioavailability of the drug, a parameter that indicates how quickly and in what quantity the active ingredient is distributed (and is therefore made available) in the body.
If the self-certified bioavailability of the equivalent drug has the same values (±20%) than the original, then it can be said that the two drugs are bioequivalent. To give greater value to self-certification, active ingredients from Asian countries are imported into a European country and then imported into Italy with the European imprimatur. Based on these self-produced studies, these generics are authorized for marketing. Thus damaging the Italian quality producers of principles.
The checks are carried out a posteriori, on reports or inspections in the places of production or where the bioequivalence studies are carried out. The case that the EMA has reported is an example of this.
