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Galeano on Di Stefano

The entire playing field fit inside his shoes. From his feet it sprouted and grew. Alfredo Di Stefano ran and re-ran the field from net to net. He would change flanks and rhythm with the ball, from a lazy trot to an unstoppable cyclone; without the ball he’d evade his marker to gain open space, seeking air whenever a play would get choked off.

He never stood still. Holding his head high, he could see the entire playing field and cross it at a gallop to pry open the defense and launch the attack. He was there at the beginning, the during and the end of every scoring play, and he scored goals of all colors:

Watch out, watch out,

here comes the arrow

faster than all get out.

The crowd would carry him off on their shoulders.

Di Stefano was the engine behind three teams that amazed the world in the forties: River Plate, where he took Pedernera’s place; Millonarios from Bogota, where he sparkled alongside Pedernera; and Real Madrid, where he was Spain’s leading scorer for five years in a row. In 1991, years after he retired, the magazine France Football bestowed on this Buenos Aires boy the title of “best European player of all time.”

MNC Pharma Companies & the Indian Market

“Is this going to have a big effect on our business model? No, because we did not develop this product for the Indian market, let’s be honest. We developed this product for Western patients who can afford this product, quite honestly. It is an expensive product, being an oncology product.” ~ Marijn Dekkers, Bayer Chief Executive Officer

The global pharma industry’s reputation is getting worse, and is only slightly better than health insurers. Statements, like the one above, do not help.

This statement, made by none less than the CEO of a major MNC pharmaceutical player, while being incredibly insensitive, is also alarmingly honest.

At ~$12bn and double digit growth the Indian pharma market seems incredibly attractive. However, according to industry estimates, only about 1-2% of this market is accounted for by patented products, which is what most MNC players are interested in.

Pricing is the key issue

A large part of the patented drug market is contributed by the DPP-IV inhibitors, anti-diabetes drugs, and they continue to grow rapidly. One of the key reason for the quick uptake and growth of this class of molecules is their pricing. Priced at around Rs 50 per day, they are priced at around 60-70% of their price in Europe. While it seems high at a first glance, they still appear affordable for a large number of middle class consumer in terms of daily cost. However, industry insiders mention that the price impacts long term compliance and most patients drop-off therapy in a few months, in the largely self pay Indian market.

Contrast this with the price of Sprycel (dasatinib) promoted by Bristol-Myers Squibb. The drug is being considered for a compulsory license by the government. The drug is priced at Rs 1.65 Lacs a month, less than a third of its price in the US – well within the PPP price. At this price and despite the generous access program that the company has, a very small part of the Indian population, including the author, would be able to afford the drug.

India is facing a double whammy of not having reduced its load of acute illnesses while still facing growth of chronic diseases including CVDs and cancers. It is this disease burden which when combined with the pricing that scares a lot of policy makers.

Lack of transparency doesn’t help

A large part of the dissatisfaction of the MNC players is driven by the unilateral actions of the government and any clarity of thinking on the part of the government. The compulsory license of dasatinib is a case-in-point. Compulsory licenses are generally granted under Section 92 of the 1970 Patents Act for “public health crises, relating to Acquired Immuno Deficiency Syndrome, Human Immuno Deficiency Virus, tuberculosis, malaria or other epidemics“. First, I do not believe that CML  is a public emergency or their is an epidemic of CML. Second, Sprycel is not the drug of choice for first line treatment of CML. Gleevec (another litigated upon drug) is the standard of care and is widely available at affordable prices. Hence, a compulsory license for the drug does not make much sense.

On this regard, it would be wise of the government to lay out its method of evaluating drugs for compulsory license and the framework being used.

Final thoughts

Gilead recently announced its plan to license its Hep-C wonder drug, Solvaldi (Sofosbuvir), (priced at $1000 per pill) to Indian generic manufacturers for ensuring affordable access to the drug. The unilateral and proactive move by the company is sure to be cited by many as perhaps one of the way to go.

As George Merck once said, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.

Disclaimer: I have worked at BMS India earlier, and currently work for Novartis. The views are my own and do not reflect those of my employers.

Indian Pharma – A case of regulatory failure?

Disclaimer: I work for Novartis, an MNC pharmaceutical player. However, the view expressed in the post are my own, and do not reflect those of my employer.

Indian pharmaceutical companies cannot be judged by American standards. – GN Singh, Drug Controller General of India [source]

If you are looking for one reason for the mess that the Indian pharma industry is in, you do not need to look further than the statement above. This is a statement made by the head of the body responsible for ensuring the quality of drugs manufactured and sold in the country.

As any physician will tell you, one of the prime reasons for them prescribing higher priced brand of generic medicines is that the quality of those brands can be trusted. Call them fake, spurious, or poor quality drugs, it is one of the worst kept secrets of the Indian pharma industry. While the US FDA imposes stringent norms on the quality of drugs sold in US, such enforcement of standards is missing in India. The DGCI is severely understaffed and enforcement of manufacturing norms questionable. Manufacturers often get away using approvals from state FDAs which are even more limited than the DGCI in terms of resources for checking the quality of drugs.

For example, there are 200 brands available for  Metformin 500 mg (a common drug for diabetes) and the price of a strip of 10 tablets varies between Rs. 8 to Rs. 80 per tablet, with an average price of Rs. 17. In fact, brands by reputed manufacturers like USV, Abbott, and Glenmark are available for around the average price of Rs 17. Brands by Emcure and Torrent are available at Rs 12. In fact, most manufacturers have multiple brands at different price points. For example, Cipla has a brand at Rs. 7 and another at Rs. 18. Same drug, same composition. [Source: HealthKart Plus]

While theoretically you should be able to switch medicine brands, as long as they have the same composition and formulation, without change in efficacy, it is not true in practice in India. I have personally heard from a number of physicians that the quality of drugs, especially those supplied to the government, is highly questionable and that they often suggest their patients to procure the drugs from open market as those supplied for free at the hospital may not be efficacious. If the DGCI and state FDAs ensures quality, the price variances would come down and the premium charged by major trusted manufacturers decrease making medicines more affordable.

While a lot of people blame big pharma players and MNCs of having hidden interest in raising quality issues, do we not agree that the problem is not just access to medicines, but access to quality medicines.

Dilli ki sardi & Biking

A random discussion on Delhi winters with some colleagues reminded of the joys of riding on a winter evening in Delhi. The cold, slightly damp, wind across your face. The fog. The warmth of the engine. And the fog that doesn’t let you see too far in the distance, and because you are riding slowly you are actually enjoying the view. Missing my bike and those rides with Tk so much!

These lines by Robert Pirsig in Zen and the Art of Motorcycle Maintenance are just so apt.

You see things vacationing on a motorcycle in a way that is completely different from any other. In a car you’re always in a compartment, and because you’re used to it you don’t realize that through that car window everything you see is just more TV. You’re a passive observer and it is all moving by you boringly in a frame.

On a cycle the frame is gone. You’re completely in contact with it all. You’re in the scene, not just watching it anymore, and the sense of presence is overwhelming. That concrete whizzing by five inches below your foot is the real thing, the same stuff you walk on, it’s right there, so blurred you can’t focus on it, yet you can put your foot down and touch it anytime, and the whole thing, the whole experience, is never removed from immediate consciousness.