India #Pharma 2014 : A quick look back – Part One #quality

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. In the first post, I look at developments in the regulation of Indian manufacturing. Continue reading “India #Pharma 2014 : A quick look back – Part One #quality”

India’s safety culture: an oxymoron?

The regularity with which some or the other Indian company is making news for  taking short cuts has got to be alarming. First it was pharma company Ranbaxy, then Wockhardt. And now it is auto firm -General Motors’ Indian factory.  In each case, employees took short cuts to beat the system and ended up jeopardising safety. (In GM’s case not directly but reportedly via higher-than-permitted emissions). These misdeeds aren’t occurring just in India- companies in other parts of the world have also been in the dock.  Yet, every time some Indian operation hits the headline for this reason, I can’t help thinking about the cavalier attitude to safety visible in this country on a day-to-day basis. Continue reading “India’s safety culture: an oxymoron?”

Guest column : The Ranbaxy fraud has revived the “counterfeits” debate. It shouldn’t.

In a strongly-worded opinion column for The Indian Express on the Ranbaxy fraud published last week, Amir Attaran of the University of Ottawa rightly calls on the Indian government to do more to ensure that drugs produced in India are safe and effective.

But Attaran is wrong is when he uses references to the fraud and to India’s shortcomings in drug safety improvement as a rhetorical device to delegitimize arguments that the Indian government has advanced to oppose global anti-counterfeit initiatives.

Rather than addressing these arguments, Attaran slams the Indian government’s position as “foiling global efforts to improve medicine quality,” and accuses it of “cynical diplomacy” meant to “shelter India’s pharmaceutical industry from outside scrutiny.” Continue reading “Guest column : The Ranbaxy fraud has revived the “counterfeits” debate. It shouldn’t.”

The Ranbaxy effect : My op-ed in The Indian Express

This morning’s Indian Express op-ed page carries my views on the impact of the Ranbaxy revelations on Indian generics. To read click here.  Just to clarify, I had attributed numbers on US imports of bulk drugs and finished medicines that I have cited in the column to Fortune magazine. The attribution appears to have fallen victim to the editing process so I thought fit to mention it here.

Pic sourced from

It takes a village : What Ranbaxy’s Synriam tells us

Pic sourced from

Synriam, Ranbaxy’s new anti-malarial drug combination, is the first new drug R&D project by an Indian generics company that’s yielded a marketable drug. That’s big in itself as various media reports have acknowledged.

To me, its key value lies not so much in its  “firstness.”  Its value is even greater as a case study – with one or more Indian entities at the centre – that holds multiple lessons on the nature of R&D, on the value of partnerships, on the role of governments, on the need for a competitive and heterogenous drug industry where everybody doesn’t think like everybody else. And so on.

Am sure that there are other drugs that’ve hit the market globally that can illustrate some of this even better but this is a story that India can own given that it’s played such a pivotal role in it. Continue reading “It takes a village : What Ranbaxy’s Synriam tells us”

Generic or innovator, manufacturing still make-or-break

The pharmaceutical industry puts a heavy premium on innovation – the ability to come up with new drugs. Indeed this separates the boys from the men. Generic pharmaceuticals however are seen as similar to any other commodity manufacturing sector.

However, in the last two years  one generic and one innovator have been both done in by manufacturing issues. Ranbaxy’s controlling family threw in the towel when it found it had no appetite to set right persistent quality issues at its manufacturing facility. More recently, Genzyme has become fair game to predators such as sanofi-aventis after it lost investor confidence over manufacturing problems.

More and more innovators are outsourcing manufacturing to cut costs with what some regulators believe could be inadequate oversight.  If they are not careful it might be this and not drying research pipelines that could trip them up.