India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance

The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. The first post was on the regulation of Indian manufacturing. In this second post, I look at developments in the regulation of clinical trials. Continue reading “India #Pharma 2014 : A quick look back. Part Two #clinicaltrials #pharmacovigilance”

India and drug safety : Latest PVig attempt showing promise

India seems to be making slow but sure progress towards reversing its abysmal track record in pharmacovigilance – medical jargon for monitoring the safety of marketed medicines. The country has reported 33,702 adverse drug reactions (ADRs),  side-effects arising from a host of marketed drugs, Continue reading “India and drug safety : Latest PVig attempt showing promise”

Januvia and Galvus : a different take

packshot_januvia_N1So here’s the thing. While I was waxing eloquent about how Januvia and Galvus were proof that India’s patent laws work, and of differential pricing blah,  blah, blah I got a call that spun me around a bit..

A very senior drug safety expert based in New Delhi seemed rather disturbed by the popularity of these medicines. He felt it was alarming that two new drugs with a safety and efficacy track record that is still being established in clinical practice should be so well-received by the medical community.  He also believed that in the absence of a pharmacovigilance system in India that keeps tabs on drug side-effects, doctors will know little about the side-effects that may surface once the drugs are widely-marketed.

For instance, he referred to the fact that the US FDA had reported receiving 88 reports of pancreatitis between October 2006 and February 2009 from Januvia users. (Merck dismissed any cause-effect relationship).  He wanted to know whether the DCGI had reacted to this piece of information by requiring its marketer to inform doctors. I don’t know that it has. (Merck -called MSD Pharma in India – has probably reached out in order to quell any fears, though I haven’t checked).

Of course, he also admitted that this has been historically true with a number of new drugs in India.

In deferrence to his very valid concerns,  I thought it is fit to make a quick note of them here, just after my previous post on the gliptins’ sucess.