Why in news?
The European drug regulator has recommended suspension of around 300 medicines on which bio-equivalence studies were conducted by the Chennai-based Micro Therapeutic Research Labs (MTRL).
What the European Medicines Agency says?
- The European Medicines Agency (EMA) said the suspension has been ordered for all drugs for which the bio-equivalence studies were conducted by MTRL at two sites in India.
- The review concluded that the data from studies conducted at the [two] sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the EU.
- It, 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 the studies at the sites.
- The regulator also recommended that medicines should not be authorised until bio-equivalence is demonstrated with alternative data.
What is bio-equivalence study?
- Bioequivalence is a term in pharmacokinetics used to assess the expected biological equivalence of two proprietary preparations of a drug.
- If two products are said to be bioequivalent it means that they would be expected to be the same, for all intents and purposes.
- Bio-equivalence studies are the basis for approval of generic medicines.
Micro Therapeutic Research Labs (MTRL):
- MTRL is a contract research organisation which conducts analytical and clinical parts of bio-equivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.
Source: The Hindu
