Indian drugs are often not bioequivalent
Western regulators have found evidence of it, scholars unearthed empirical support for it, but now even the lead lobbyist for its industry admits it; most Indian medicines are not equivalent to the medicines they copy.
People walk past a chemist shop at a market in Mumbai, India, June 24, 2014. REUTERS/Danish Siddiqui.
DG Shah, the head of the Indian Pharmaceutical Alliance has written an eye-opening column on the many failings of India’s laws and medicine.
As Shah explains, Indian law stipulates that products launched within four years of first approval are required to establish bioequivalence. But after four years, any manufacture can launch without bioequivalence or stability data. A quick estimate shows that only about 15% of the products in the market are launched in the first four years.
This means 85% of products sold in India have been approved for sale without any bioequivalence or stability data.
His most telling statement is this:
Thus, majority of the products in the market have not established their equivalence or proved their stability. There is an accumulated mass of more than 50 years of such products in the market. They may or may not be harmful but will certainly not cure patients.
Perhaps this explains why so many Indian companies have to fabricate data required by US FDA. They don’t have to provide it domestically and would rather fake it for us.
