BASAI STATEMENT

ON

BIOCHEMICAL EQUIVALENCE UNDER
GOOD LABORATORY PRACTICE

PROCEEDURE OF ESTABLISHING BIOCHEMICAL EQUIVALENCE AS PER FAO UNDER GLP SCHEME

AND
ADHERENCE TO MUTUAL ACCEPTANCE OF DATA ( MAD )

The joint FAO/WHO recommends a scientific procedure for the establishment of equivalence between active ingredients coming from different sources ( different source from in different countries, or different manufacturing sites within a country ).

A Material Accountability Report ( MRN ) is generated containing identification of all impurities present at concentrations greater than 0.1 mg/kg and identification and quantification of any relevant impurities, supported by analytical data for at least five typical batches analyzed under GLP norms as stated below:

Establishing minimum purity of active ingredient
Establishes maximum level for relevant impurities (whether less than or greater than 0.1%)
Establishes maximum level for non-relevant impurities only those > 0.1% (1g/kg) are listed
Additionally, details on manufacturing process is sought

Product is considered chemically equivalent if:

NO reduction in minimum purity of active ingredient
NO new relevant impurities
NO increase in existing relevant impurities
NO increase in non-relevant impurities unless meets equivalency test
– an increase of 50% or 3g/kg (whichever is greater compared to Registered Specification) in non-
relevant impurities is considered equivalent)
Decrease in impurity levels (higher purity of the active ingredient) is considered not of concern
Where there is NO Change in Registered Specifications, no additional studies, except for a required
Ames Test. In case of any new identified impurity of toxicological significance being detected during the
five batch analysis procedure, some additional toxicological tests may be required.
Where there is a change in the Registered Specification and equivalence cannot be demonstrated – additional testing is necessary as per Tier Approach of toxicological data requirement as recommended
by FAO/WHO in line with OECD principles of the 3 R principle minimizing animals kill.

Further, five batch samples from small lab scale production or pilot scale production can be accepted for generating 5 batch impurity profiling Material Accountability Report.

The above process of chemical equivalence necessarily/mandatorily as per GLP analysis, is believed to be followed in most of the countries globally while India remains yet an exception. BIOLOGICAL AGRI SOLUTIONS ASSOCIATION OF INDIA fully supports this internationally accepted norm of FAO scheme of chemical equivalence. Acceptance of chemical equivalence analysis under GLP norms will also demonstrate India’s adherence to the Mutual Acceptance Data ( MAD ) principles of OECD of which India is signatory.

We invite companies who operate in Biostimulants & Biological products for Agriculture sector. (No pharmaceutical, vet or any allied sectors) to join hands with us to take this initiative forward and jointly raise voice against common issues faced for the segment.

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