Question : BIOEQUIVALENCE AND BIOAVAILABILITY CENTRES

(a) the year in which bioequivalence and bioavailability centres were established in the National Institute of Pharmaceutical Education and Research (NIPER), Mohali in Punjab;

(b) the manpower strength and annual expenditure directly and indirectly spent by NIPER on each such centre along with the projects undertaken and revenue generated therefrom so far;

(c) whether medicines manufactured in India are given support of bioequivalence and bioavailability tests so that the quality of Indian medicines would be at par with those manufactured in developed countries and there will be further global confidence in the Indian medicines;

(d) if so, the details thereof; and

(e) if not, the reasons therefor?

THE MINISTER OF STATE (INDEPENDENT CHARGE) IN THE MINISTRY OF CHEMICALS AND FERTILIZERS AND IN THE MINISTRY OF STATISTICS AND PROGRAMME IMPLEMENTATION (SHRI SRIKANT KUMAR JENA).

(a) Bioavailability centre was initially set up in January, 1998 at NIPER, Mohali. However as a separate entity National Bioavailability Centre (NBC) was established in April, 2004. Bioequivalence study is a type of bioavailability study and involves comparison of bioavailability of a drug from two drug products (formulations).

(b) There is strength of three persons in the centre. As per records available with NIPER, Mohali total expenditure and revenue generation over the years are as enclosed at Annexure- I.

(c)& (d) Yes, Madam. Details are enclosed at Annexure- II.

(e) Not applicable.