India

Indian Pharma – A case of regulatory failure?

by

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.

The Victory!

by

It was the best of times, it was the worst of times; it was the age of wisdom, it was the age of foolishness; it was the epoch of belief, it was the epoch of incredulity; it was the season of Light, it was the season of Darkness; it was the spring of hope, it was the winter of despair; we had everything before us, we had nothing before us; we were all going directly to Heaven, we were all going the other way. ~ Charles Dickens

To say that past year or so has been the year of scams for India would be a gross understatement. From the CWG to the 3G, we watched in a state of suspended belief as scams got unearthed with Sachin’s consistency. The once teflon coated Manmohan Singh is in the center of such a muck that some of it is bound to stick. In fact, so numbed were we with the state of things that a new scam does not surprise anyone any more. India is getting more and more recognition around the world as a super power, both economic and political, and yet there was something missing.

In such a state of disillusionment, this World Cup victory gains a different meaning. Many see the victory as a validation of India’s growing stature, in the game and also outside it [must read], and not without reason. However, to me, this World Cup victory will be symbolic of the fact the something in this damned country works. Some Gods don’t fail us.

I distinctly remember 1996 and how much I cried as a child, along with Kambli on the screen, wishing that the idiots at Eden would at least let them complete the match. 1999 was a farce with the stupid Super 6 rule. 2003 was a heart break. I sat there, front row in the Audi, cheering so hard that I felt that my veins would pop. But after the first 3-4 overs something in me gave up hope and I went and slept. I haven’t still watched that match – not a single ball. It felt like fate had cheated us out of the cup then. 2007 was a blink and miss. And add on this the disillusionment with the politicians, the feeling that we were being cheated out of everything. We needed something to restore our faith in the country. There had to be someone who would make you believe. For the past couple of decades Sachin had been that man who had us believing.

Sometimes, truth isn’t good enough, sometimes people deserve more. Sometimes people deserve to have their faith rewarded. ~ Batman, in The Dark Knight.

You had this distinct feeling that it would be now or never. The one God we have might not win this cup – and its not that we care – its because some idiots would consider him a lesser batsman because he hadn’t won this one.

As the tournament progressed, the team took me on an emotional roller coaster ride, winning and losing at will. I did not know if we would win, or fall apart at the key moment. The quarterfinals restored some calm. India had chased down a decent total against a decent attack. The semifinals saw us defending a decent total (respect for Afridi – you rock! Why you ask? Here.).

And then it was the time for the big one. The final. We begun like never before. Zaheer – you beauty. Sree – you jack ass! Yuvi – you rock! Gambhir and Dhoni – respect!! People throwing themselves around. We conceded a little more than we would have liked in the last 10, and the momentum was with Lanka going in to the break. And then Sachin (did you see the straight drive??) and Sehwag got out cheaply, and I thought we would unravel quickly again. TV was switched off (I am superstitious – when I watched wickets fell), and turned on every now and then and I could see India building a few partnerships.  Maybe we could win. Thanks to Anubhav for making me watch. From then on it was a display of serene batting – except that one run – and we reached home quite comfortably. And the final shot by Dhoni, as Rahul put it, “”Uses it well, his bat he does.. hmmmm” – very Jedi like.

This victory will re-instill the much needed faith in a country bereft of heroes. There are some people we can still look up to. The ’83 World Cup gave us Sachin (and Sourav, Dravid, Laxman, and Kumble). Can’t wait to see what the ’11 World Cup brings us!!

We won!!

PS: In this entire media orgy, please don’t forget the Leander and Bhupati are also again the best in the World! Good going you guys!!

The one that matters!

by

I loved the way India played in this series.

In the first test they showed that they had the balls! The fought back in a manner reminiscent of the Aussies of yore! Till the last wicket fell you Australia never gave up (remember those Steve Waugh innings?), and India seems to be learning that lesson, slowly but steadily. Even bowlers seem to value their wickets, and are trying to make the opposition earn it.

In the second test, India played like a number one team should play. With assurance. Like the toss didn’t matter. Like losing Sehwag early didn’t matter. If it had been more than 5 years back we would be talking of the Indian team shutting shop to prevent a defeat. Now India went for an outright victory. Commentators said that the SG ball would reverse after 40 overs – they said lets do it before that. Sachin playing like he always does nowadays. M Vijay and Pujara playing really well. The bowlers doing an exceptional job – all of them. Remember that the tail wasn’t allowed to wag. Stuff good teams are made of.

We still have some distance to go to be ranked alongside the West Indies of 80’s or the Aussies (of 1940s and 2000s). The fielding needs to go up by many a notches. The batting, the middle and lower order, still tends to collapse every once in a while. And our biggest worry, our bowlers. They need to be more consistent and injury free. Harbhajan needs to rediscover his mojo and compliment the tight lines of Ojha with wicket taking. Zaheer needs a couple of good partners. I am believe that we have the ability to get there – all it needs is nurturing by the BCCI, instead of them focusing all their energy in going kinky on Lalit Modi’s ass.

Finally, a lot of people talked of Australia losing three in a row. What I am more interested in is seeing when was the last time a team won three in a row scoring more than 200 in the fourth innings!

Team India with the Border Gavaskar Trophy
We won!!