Chennai-based Micro Therapeutic Research Labs today said it is taking remedial measures by working with pharma firms affected by European drug regulator EMA's recommendation to suspend over 300 medicines.
Last week, EMA had recommended suspension of all the medicines on which bioequivalence studies were conducted by Micro Therapeutic Research Labs at its two sites in India, citing unreliability of data.
"We are working closely with the MA (marketing authorisation) holders whose studies have been affected by the decision, including performing of a new study and submission, as directed by EMA in its decision," a Micro Therapeutic Research Labs said in an e-mailed response to PTI.
The contract research organisation (CRO) said while it was yet to receive an official communication from EMA, "the agency in its decision has not condemned it of any data manipulation".
"The context in which the agency claims 'unreliable' tests conducted at our sites is not very clear," Micro Therapeutic Research Labs said.
Aurobindo Pharma, Zydus, Sandoz, Sanofi and Mylan are among the major pharmaceutical firms that will be affected by the suspension.
The company considers this decision "as a set back to our values for which we have been striving for. Nevertheless, it would abide by the final decision and recommendations of the agency...," it added.
While recommending suspension of the medicines evaluated by Micro Therapeutic Research Labs, EMA had said a review by its Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the (two) sites between June 2012 and June 2016 were "unreliable".
Therefore they cannot be accepted as a basis for marketing authorisation in the EU, it added.
EMA, however, said there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites.
The regulator also recommended that medicines not yet authorised but which are being evaluated on the basis of studies from the two sites should not be authorised until bioequivalence is demonstrated using alternative data.
In 2015, the EU had banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by GVK Biosciences.
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