A group of ministers (GoM) has put its weight behind a market-based pricing mechanism for 348 essential drugs, a departure from the current practice of pricing a dated list of 74 drugs based on their manufacturing costs.

The GoM decision might suggest that closure to a long-pending issue isn’t far away. But to my mind, its most noteworthy achievement, as of now, is that it lets the government belatedly wave a progress report on drug pricing in front of the Supreme Court after being slapped with a two-week deadline.  Much like an errant child warned of dire consequences by the class teacher for not doing its homework. (For more on the court proceedings see SPICY IP’s post here).

The homework’s finally in, no doubt. But have all the ‘i’s have been dotted and the ‘t’s crossed? Are the answers right and is each step taken to get to them neatly entered? Have the right text books been referred to?

You can see where I’m headed. Here are some questions that can be asked about India’s drug pricing policy review.

1. Will we get to see the homework?

The GoM says it will turn over its recommendations within a week to the Union Cabinet. It is important that these be made public to understand the GoM’s logic in preferring the market-based pricing mechanism and choosing, in particular, to fix a drug’s price at the weighted average price of all brands that own 1 per cent or more of volume market share of that drug.

The market-based pricing methodology has been advocated predominantly by the drug industry represented by associations such as the Indian Pharmaceutical Alliance (IPA) and the Organisation of Pharmaceutical Producers of India (OPPI). They prefer it to cost-based controls for obvious reasons.

In contrast, health activists such as the Jan Swasthya Abhiyan and the All India Drug Action Network have pushed for a continuation of cost-based controls or a variation on the market-based pricing formula that does not give weight to market-leading brands.

The public deserves to understand the independent and reasoned view of the GoM. To be convinced that it has weighed the pros and cons of all approaches and that on balance, the chosen one proved most effective.

It may well be that this formula is not the most effective at lowering prices, just the most practical since it helps to balance consumer and industry interests. In the absence of a robust public sector in drug manufacturing the government cannot pressurise private companies beyond a point. If that be the case, it should be said unequivocally.

Right now, more has been said in media reports about the GoM-backed formula’s ‘win-win’ nature by the drug industry than by the GoM itself. One side’s volubility cannot make up for the other’s relative silence.

2. Which data source is to be used?

Much of the debate surrounding the methodology is justifiably based on data. For instance, health activists used retail price data to suggest that the top brands by market share are usually also the most expensive since share is driven by doctor and chemist push, which can be influenced/bought with promotional spends.

On the other hand, drug industry associations such as the IPA used data to suggest this was not the case, for the most part.

The GoM’s report needs to demonstrate that it independently verified both and state what it found.

It is also relevant to ask whether India will continue to rely on the private data company that the GoM has used for numbers. Currently all calculations rely on the database of market research organisation IMS Health.  A decade ago, when this process began there was just one third-party source of audited retail sales data preferred by industry. Now there are two – the other is backed by the All India Organisation of Chemists & Druggists.  This database has gained currency.

This begs related questions : has the source of data ever been revisited? To what extent does a change in database impact price-fixing? At some point, does the government need to create it’s own database instead of relying on private providers? Is that feasible?

3. How do you keep tabs?

One of the biggest problems with executing the cost-based approach was accessing and updating manufacturing cost data. This will finally be done away with. But how easy is it going to be for the regulator to keep tabs on retail prices of all brands of 348 drugs of varying dosages? Also, companies have escaped price control in the past by combining a price-controlled drug with an ingredient that is not under control. That was when the list was frozen at 74 drugs, now it will have over 300. The pricing regulator, India’s National Pharmaceutical Pricing Authority, needs to step in at some point to tell the public how it plans to implement.

4. Is this enough?

The affordability problem cannot be solved with a formula for pricing 348 drugs. The solution has to go hand-in-hand with greater oversight on drug quality so that the country can move away from using branded generics to vanilla ones (brands will not then be proxies for quality). It has to include price negotiations on under-patent new medicines. It has to include infrastructure for efficient government procurement and distribution of life-saving medicines -old or new. In parallel, it has to curb drug companies’ largesse to doctors and chemists so that those costs aren’t borne by consumers. How much longer before all of this other stuff takes shape?

The GoM recommendations have to be cleared by the Union Cabinet and the Supreme Court where it will meet with opposition from activists.

If you consider, as a starting point, a committee set up in 1999 by the then government, it’s been twelve years since India decided to revisit drug pricing. This GoM was set up by the current government. There have been other committees in between. A decison suggests India is nearing closure.

But that just might be an illusion.

Pic courtesy eking1989′s photostream on Flickr


Reprinted with permission from Gauri Kamath and Apothecurry


About the Author: Gauri Kamath has been writing on the business of medicine for over 14 years. She has been a writer and senior editor at leading financial news publications such as The Economic Times, Business Standard and Businessworld. Gauri currently lives at Apothecurry, where she shares developments and opinion related to the pharma and healthcare sectors. Follow her onTwitter. Connect with her on Linkedin.