Why is Reddy dragging the launch of magic polypill?

A study by The George Institute for Global Health in New Zealand has found that a four-in-one pill devised by Dr Reddy’s Laboratories (DRL) cuts the risk of heart disease and stroke by half. The drug is said to have cleared all the trials required by Indian laws.

Then why is Dr Reddy’s dragging the launch?
According to sources familiar with the developments, the company has sought the Drugs Controller General of India’s (DCGI) approval to go ahead.

“No one knows why it is stuck there,” one source said.
A DRL official told DNA Money, “We are working through the regulatory process and it is not our policy to make public statements or pronouncements on regulatory matters”.
In fact, the company was working on a plan to launch it in 2009-10. The senior management of the company had also stated that the drug would be made available at a cost of less than Rs100 per month.

“It is difficult to point out the hurdles,” the source explained.
“At various World Health Organisation fora, the polypill has been identified as a priority product. Researchers in Russia, the UK, Scotland and Ireland too have been awaiting the product. It would take some more time for Dr Reddy’s to take the drug to the global markets, but there is no visible hurdle in India,” another source said.

The polypill is aimed at people who have suffered a heart attack and are on medication to avoid further strokes. The combination drug will have aspirin, statin, a beta blocker and ACE inhibitor. These are the drugs that are anyway given to patients who have suffered a heart attack.

Why’s Reddy’s dragging the launch of magic polypill?
Given as a secondary prescription, the number of patients using these drugs to help thwart any further heart problems is said to be low, and the combination drug as four-in-one pill is expected to bring more people towards continued medication.
The research to estimate the polypill’s market potential so far has been based on the available medication to the heart patients.
A senior investigator working on the project told DNA Money that the study had established the significant levels of under treatment to the patients. Just about 8% of people, who had already suffered a heart stroke, are currently being given the required medication exposing the others to a second heart stroke in about 18 months.

“The trials on the polypill have shown that the chances of immediate incidence of the second stroke are halved after the medication,” the source said.

Though initial trials had shown the reduction in the risk of a repeat heart stroke at 80%, it is now pegged at 50%.
“The side effects too were understated earlier. But the increase in side effects does not warrant discontinuance of medication,” the source said.