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: these polypills cost-effective? It is likely that some people will develop side effects. Would these have advantages over strict diet and exercise? Should we give it to all people, say those above 50 years? Why should a non-obese person with normal blood cholesterol, no family history of heart disease, taking balanced diet and doing regular exercise, take such a pill for several decades till he dies?” His argument in a nutshell—To give it to the population and considering the costs involved, data from large scale trials are needed.

Without any doubt,

practical issues that have to be addressed with the polypills will include clinical trials, the commercial incentive—polypills will be a high-volume, low-margin product—regulatory approvals, and clinician and patient acceptance. There are several varieties of polypills under development around the world for primary and secondary prevention of cardiovascular diseases, informs Misra.

Irrespective of who launches first, the good news is that those who are working on the product have low- and middle-income countries very much on their radar, and are trying to ensure that the products are affordable and widely adopted in those parts of the world where they can have the greatest impact.

Tracing its genesis, two British researchers, NJ Wald and MR Law, were the first to put forward the idea of a polypill—a combination of three or more drugs in a single pill for the prevention of cardiovascular disease. Based on theoretical considerations, they projected that such a pharmaceutical product should enable the world’s healthcare systems to decrease the incidence of heart diseases by more than 80%.

Although the initial publication was met with a degree of skepticism, it appears that the concept was premature at that time.

Over the next 10 years, many different versions of the polypill will become available, say analysts.

With research and clinical trials in full swing on innovative and varied polypill formulations, combination therapies hold significant potential to fill the requirement for simpler and less expensive treatment regimens.

“Though the current focus is on the treatment of cardiovascular disease, the polypill approach is also being directed towards HIV, malaria and tuberculosis. Sustaining the success of this therapy would require the manufacturer to overcome potential hurdles of efficacy, safety and cost-effectiveness with robust clinical evidence,” says Sandhya Kamath, senior research analyst (healthcare), Frost & Sullivan.