BABE-study and research in Nepal began in 2005 with the establishment of the Bioavailability and Bioequivalence Study Center in conjunction with Nepal Pharmaceutical Lab (Pvt.) Ltd. by the Department of Pharmacy at Kathmandu University. Due to a lack of resources and experts, the high cost of designing a BABE-study bioanalytical laboratory, the fact that BABE-studies are not mandatory for domestic generic products, a lack of authority monitoring, and noncompliance with the requirements of the US FDA, WHO, and other regulatory authorities, only a few pharmaceuticals in Nepal have completed the BABE-studies as required by the DDA. Nepal, on the other hand, could be a potential global pharmaceuticals center for BABE-studies to its low labor costs, easy availability of a big number of native diverse Caucasian volunteers, and weak legal and regulatory restrictions.
Bioavailability/Bioequivalence
requirement for domestic/imported medicine as per DDA
1.
For drugs which have low therapeutic
index, low bioavailability, non linear kinetics, poor dissolution profile,
variable bioavailability/bioequivalence, modified release dosage form having
blood steady state concentration such as sodium valproate, valproic acid, carbamazepine,
antibiotics etc, the comparative in-vivo bioequivalence test profile should be
submitted during registration.
2.
For drugs which are comparatively
safer and have wider therapeutic index such as NSAIDs, analgesic, antipyretic
and OTC products, the comparative in-vitro dissolution test profile along with
real time stability data may be accepted instead of BA/BE study report.
3.
For molecules having modified release
API (pellets) like Omeprazole, Indomethacin,Tamsulosin etc, bioequivalence test
profile from API manufacturers can be submitted. If BA/BE test profile from API
manufacturer could not be made available then depending upon the nature of
drugs decision will be made by DDA during registration whether to submit BA/BE
test profile as mentioned in point I or dissolution test profile as mentioned
in point II above.
4.
In-vivo BA/BE profile or in-vitro
dissolution profile should be compared with Innovator/leading/comparator brand
of the product. Leading/comparator brands should be approved from DDA.
4.https://www.dda.gov.np/content/drug-registration-guidance-2073
Prepared by:
Phr. Namuna Adhikari