Making a good drug

Priyanka Pulla has a new blog, and in her first post, she writes about her report in Mint on nitrosamine contamination in some Indian drugs and answers two follow-up questions she received from readers. One of these answers contains the following portion, describing what exactly a drug-maker needs to do to ensure a drug in question doesn’t have any dimethylnitrosamine (also shortened as NDMA).

To do this, it must invest in expensive apparatuses – maybe a liquid chromatography-high resolution mass spectroscopy system (LC-HRMS) that costs up to Rs 2 crore. Then it must find a skilled professional to operate it, and that skilled professional must develop an appropriate method to test for NDMA in the drug. This is because a pharma company cannot directly copy publicly available testing methods: each drug and formulation requires a custom test.

This is such a good example of how lack of investment in R&D and of attention to problems in higher education can affect our research output. Many articles (including some of my own) allude to such connections but we don’t often come across such clear examples that explain how, say, not being able to access a chromatograph or mass-spectrometer in the classroom or not specifically training students to devise new solutions to new problems leads directly to low-quality drugs that endanger the lives of Indians. Priyanka’s article as well as her blog post touch on the fact that investing in an LC-HRMS device plus a suitable person to operate it will increase the price of the drug, which would be anathema in a highly price-sensitive market like India – so drug companies cut corners. But simply harping on keeping costs low doesn’t make sense when, as the nitrosamine story alone shows, there are at least two more things we can do but aren’t: a) encouraging local innovation on laboratory devices towards reducing their costs; and b) extending state subsidies to manufacturers and their quality control practices, in a way that will improve access to and affordability of high-quality drugs.