The absence of a quality mindset

"It took several years of bad publicity - ranging from non-standard quality (NSQ) drugs and counterfeit medicines being sold freely in the domestic market to pharmaceuticals exported by Indian firms resulting in hundreds of deaths across multiple countries—before the Indian drug regulator decided to act.

- PROSENJIT DATTA

At the fag end of 2023, the government and the regulator the Drug Controller General of India (DCGI) mandated that all drug manufacturers, irrespective of their size, would have to comply with the World Health Organization's (WHO's) Good Manufacturing Practices (GMP) norms. The manufacturers will need to obtain WHO GMP certification by this year.

Before this change, only Indian drugs meant for the US or European countries needed to ensure that they met the quality standards of developed countries. The US Food and Drug Administration (FDA) inspected manufacturing facilities of Indian drug manufacturers wanting to export to that country. Without its certification, drug manufacturers in India could not sell in the US.

Meanwhile, bad publicity is dogging another Indian manufacturing sector. Singapore and Hong Kong recently banned certain spice blends from two prominent Indian brands MDH and Everest - saying that they contained unacceptable levels of ethylene oxide (ETO), a carcinogen.