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, as of December 21, 2012,  according to data shared by the …

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India’s new drug pricing policy : will data be the stumbling block?

On December 7, India's National Pharmaceutical Pricing Policy 2012 was finally tabled in Parliament. Assuming that this policy does get rolled out irrespective of a Supreme Court hearing on drug pricing playing out in parallel, the cornerstone of the policy i.e.data may create some vexing issues. The Policy envisages fixing ceiling prices of specified strengths …

India’s move to vanilla generics : Don’t hold your breath

By now, the news that India wants to move away from branded generics and encourage vanilla generics to bring down drug prices has gone around the world.  But all those who think a structural reform of the Indian drug industry is around the corner : stop. And breathe. First, for the record, the news. The …

White knight : Takeda advance gives Advinus reprieve

Japanese drug maker Takeda has come to the rescue of the beleaguered  Advinus Therapeutics, a Tata group company, according to two persons familiar with the development.  Takeda has advanced in the region of $5mn (Rs 28 crore) to Advinus' drug discovery unit in Pune and will get the 'right of first look' at any resulting …

FDI in pharma : another punch

The issue of controlling foreign direct investment (FDI) in the Indian pharmaceutical sector continues to make headlines with various arms of the government putting forth their own formulas to tame the grasping foreign hand. The Indian Express reports that the ministry of commerce under Anand Sharma would like all FDI proposals - including where foreign …

FDI in pharma : India’s quick fix

India seems set to reverse a ten year-old policy governing foreign direct investment (FDI) in pharmaceuticals.  If Prime Minister Manmohan Singh gives his nod to the recommendations of an inter-ministerial group then automatic approval for FDI in Indian drug companies will be capped at 49 per cent.  Beyond this limit, a foreign investor will have …

India drags its feet on a marketing code for drug companies

Online and offline media have extensively covered the $3bn fine levied by the US government on UK's GlaxoSmithKline for illegal and unethical marketing of a clutch of brands. See here. Back in India, drug companies are apparently above reproach. It's over a year since India's department of pharmaceuticals (DoP) published a draft code of marketing …

Cipla hires former Teva/GSK honcho to head global respiratory

Mumbai-based generic drugs producer Cipla has recruited Frank Pieters a former senior vice-president at global generics leader Teva of Israel to head its European business, said two persons familiar with the development. India's third-largest drug maker by sales has also put Pieters in charge of its global respiratory portfolio which has a pipeline of high-potential …

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

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 - …

Straws in the wind? Sandoz to shut API devt centre in India

Sandoz, the world's second-largest generic drugs company and a unit of Swiss drug maker Novartis has decided to shut its active pharmaceutical ingredients or API development facility near Mumbai.  A Novartis spokesperson said in an e-mail to this writer that this was part of "recent project portfolio optimization within Sandoz Global Development." The spokesperson added …