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EMA recommends suspension of 331 drugs over testing concerns

pharmafile | March 28, 2017 | News story | Manufacturing and Production, Sales and Marketing Aurobindo, Micro Therapeutic Research Labs, Novartis, Sandoz 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has called for the suspension of 331 drugs due to concerns over “misrepresentation of study data and deficiencies in documentation and data handling” at India’s Micro Therapeutic Research Labs (MTRL), who tested the products.

The news is yet another of its kind in the region, representing another blow to the integrity of India’s regulatory industry.

Among the highlighted therapies are those marketed by Novartis’ Sandoz and Indian firm Aurobindo. MTRL had conducted bioequivalence studies for these products prior to their approval in the country; concerns had been raised over the organisation’s compliance with Good Clinical Practice by Austrian and Dutch authorities back in February 2016 – the EMA has been investigating it since December.

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Despite the findings pointing towards MTRL’s negligence, there is no evidence to suggest the highlighted drugs lack efficacy or could cause harm to patients. The recommendation for suspension will now be reviewed by the European Commission for a final decision, which could lead to the drugs being legally withdrawn from the European market.

Matt Fellows

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