Generic Medicines in Nepal

 There are lots of questions regarding the quality and standards of generic medicines in Nepal.

All the generic players try to claim that the generic medicines that are available in Nepali market are as standard as the innovator medicine.

But, we failed to prove it..

Yes, we can't ensure that, some pharmacopeial test can prove the generic are pharmaceutical equivalent.

Had, the release media, pharmacopeial test was sufficient, there is no concept of differential media, multimedia, alcohol dose Dumping, and in-vivo testing.

So, regulatory bodies should take into consideration about such parameters, particularly for those molecules which comes under class 4/2 of BCS classification.

Let's put our words from doctors perspective, when a doctor prescribes medicine, he/she is treating his or her patients. And it's his or her responsibility to ensure the health of patient. If those medications available in Nepali market are not pharmaceutical equivalent to innovator, how they can be ensured for the quality of generic medicines!

So, what a regulatory bodies should do?

They should first identify reference medicine, probably from innovator companies or any companies which are equivalent to innovator and set guidelines for multimedia dissolution.

As of now, these preliminary step can technically improve the quality and remove/ filter those products which can fail the in-
vivo testing.