India to screen 7 crore for diabetes and hypertension

The Public Information Bureau recently issued a release recording Cabinet approval for a national programme to prevent and control cancer, diabetes, cardiovascular risk, and stroke.  “The programme will be implemented in 20,000 Sub-Centres and 700 Community Health Centres (CHCs) in 100 Districts across 15 States/Union Territories by promoting healthy lifestyle through massive health education and mass media efforts at country level, opportunistic screening of persons above the age of 30 years, establishment of Non Communicable Disease (NCD) clinics at community healthcare and district level, development of trained manpower and strengthening of tertiary level health facilities.”

“It is expected to screen over seven crore adult population (30 years & above) for diabetes and hypertension, early diagnosis of NCDs and treatment at early stages. To fill the gap in the health delivery system, about 32,000 health personnel would be trained at various levels to provide opportunistic and targeted screening, diagnosis and management of NCDs,” it says.

Well, sounds good. Though Vikas Dandekar of pharmasia news (whose tweet sent me to this release) thinks it may lack commitment. I for one, am surprised we even got this far. I recall the first time I wrote about India’s dual burden of communicable or infectious and non-communicable diseases with my colleague Jeetha D’Silva at The Economic Times was in the year 2002 using WHO data.

I got an extract of that article from the Internet and here’s what we said : “The chickens are coming home to roost. The first-ever global analysis of disease burden due to cardiovascular risks, conducted by the World Health Organisation (WHO), shows the burden is getting heavy in the developing world.The WHO says that while tobacco, blood pressure and cholesterol have been leading risks in the developed world, they now feature prominently in middle income countries and are beginning to show up in poorer developing countries as well. The analysis is part of the World Health Report which is to be released at the end of this month. The thrust of the analysis is that cardiovascular disease is no longer a “western” problem.”

That WHO report was probably not the the first warning either.

Of course, am happy that government is beginning to addresss the problem in what appears to be a cohesive, structured manner.  It isn’t too late – provided we don’t take the next ten years to begin implementing the programme.

India’s looming healthcare tab from lifestyle diseases

A survey by drug maker sanofi-aventis on diabetes and hypertension prevalance in outpatient settings in ten different states in India revealed some preliminary results based on findings from two states – Delhi and Maharashtra.

The study “highlights a high percentage of diabetes and hypertension patients who are suffering from associated co-morbidities such as kidney disease, dyslipidemia (uncontrolled cholesterol level), and also shows that there are a significant number of cases where patients are suffering from one or both the conditions, in spite of no family history or genetic predisposition towards either disease,” says a sanofi statement. ” The results also alarmingly show that almost a quarter of the hypertensives were still undiagnosed and unaware that they were living with a serious medical condition.”

I have no doubt in my mind that the findings from other states will not deviate hugely from the trend. This begs two questions : won’t this level of disease weigh down India’s ability to emerge rapidly as a ‘super power’ (which many of our key opinion leaders in politics, media, business and social life assume is a matter of course). And two, shouldn’t the country start addressing ways to curb the huge healthcare tab of treating all these sick Indians? We need a massive programme that combines prevention, early diagnosis and intervention and is executed with missionary zeal. Such a programme could potentially also dovetail into how best to use Indian systems of medicine to treat diseases that Indians seem to be more prone to than many other nationalities, for instance.

In the meantime, see findings below :

Parameters Maharashtra  New Delhi region
Prevalence of diabetes 40% 33%
Prevalence of hypertension 56% 48%
Prevalence of both diabetes and hypertension 29% 21%
Unaware they had diabetes 5% 3%
Diabetics with no family history 41% 32%
Patients with uncontrolled diabetes 73% 62%
Diabetics with kidney complications 31% 27%
Unaware they had hypertension 26% 24%
Hypertensives with no family history 46% 42%
Patients with uncontrolled hypertension 79% 77%
Hypertensives with kidney complications 32% 23%

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.

India’s patented diabetes drugs : proof of the pudding

galvusFor 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.