The banning of diabetes drug pioglitazone (now looking set to be revoked) has put Merck’s patented drug sitagliptin or Januvia back into the limelight in India. Critics of the ban have highlighted the added expense of moving patients from pio to sitagliptin, a possible alternative. This is a good time to take another look at a patent infringement lawsuit currently pending between Merck and Mumbai’s Glenmark which launched a generic of sitagliptin in India some months ago. Continue reading
So 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.
For a while it was beginning to look as if you couldn’t patent a drug in India without being opposed tooth and nail by local companies or non-profits (with good reason in a number of cases). Some innovators complained of the Indian patent law being too pro-generics. Others said – and Apothecurry agrees – that parts of India’s patents law are vague and open to interpretation.
There were also fears that patented drugs would be hugely expensive and have a limited market.
Januvia and Galvus are India’s first patented diabetes drugs. They launched in April and September last year respectively. And they surprise on a number of counts.
One, they’ve got their patents and I don’t see anyone complaining.
Two, they are competing for volumes. Why do I say that? First, Januvia launched at a fifth of its US price – Rs 43 a day. Then Galvus launched even lower – Rs 38 a day. So both cost less than a dollar a day. Recall that generics companies got hosannas when they agreed to provide HIV AIDS cocktails to Africa at that price some years ago.
Why did they do that? Market dynamics. One, diabetes is a large market in India not just in current numbers but also the potential. Everyone knows about India’s dubious distinction as the diabetes capital of the world. Two, the earlier patents law (of 1970 which got amended in 2005), has resulted in 700 brands of diabetes medicines in the market and they all retail at far less. Three, and this is important, Januvia and Galvus are not just competing with older drugs, but with each other. The fact is that both are from the same class of drugs – known as gliptins or DPP4 inhibitors – that have the same method of action in the body. Based on existing scientific and clinical data, there are no substantial differences in the safety and efficacy of the two drugs. But with more clinical experience and studies, this may change.
Doctors still think the drugs premium. But they are writing them nonetheless. Some 70,000 prescriptions were written in June alone.
This suggests several things. One, drug patents are being granted in India without controversy when everyone including civil society sees them as being well-deserved. When companies see the potential of volumes, they will charge a price the market can bear. Three, India’s 1970 patents law was a truly far-sighted move as it has led to a thriving generics industry that will continue to act as a moderator of prices for a good number of years.
Of course, there will always be some drugs – like for cancer and HIV – where market economics and the presence of generics alone will not do the trick. For these, a separate model where the government either steps in to moderate price or procure assured volumes at a negotiated price has to be put into place. It won’t be right in such cases to look for answers in the patents law alone.