My earlier post on the Mashelkar committee report garnered lots of interest, and the ensuing discussion has raised many issues, noted several aspects of the problem that I have missed, and, also made me aware of some myths. So, here is an update. In Part I of the update, I discuss the Mashelkar committee related issues; Part II is about the associated general issues.

Note: Most of the links in this post have been pointed out to me in the comments section of my post.

Part I

On plagiarism and conflict of interest accusations

In my original post, I reserved my comments on these two issues since I did not have access to the paper in question. However, one of the readers of this blog has been kind enough to mail me some links:

  1. A flow chart (pdf) highlighting the comparison between the report and the paper (as well as the chronology of events and interconnections between the players in the field)
  2. The IPI paper in question (pdf), and
  3. Some background information

As Abi notes in his update, the information is quite revealing. However, it should be noted that the committee does include the IPI submission in its annexure.

Capabilities of the Indian drug industry

Both the IPI report and the Mashelkar committee recommendations seem to take the view that Indian pharma industry is not capable of innovative research.

The Mashelkar committee report seems to indicate that it is in the national interest to allow incremental innovations since:

The group examined the current level and type of R&D innovations that the Indian drugs and Pharma industry was undertaking. Annexure IV and V provide some representative samples of international patents filed by the Indian industry. It is clearly seen that most of them are based on incremental inventions.

On the other hand, IPI report (page 48) is more direct:

It has been the case so far that most R&D activities that Indian firms engage in are minor modifications of pharmaceutical products developed in foreign (mainly western) countries, and that very little R&D effort has been devoted towards the development of any new drugs.

And, the footnote to the above sentence (in part), says:

… It is pertinent to note in this regard that, during the course of Parliamentary debates, Shri Kharabela Swain, a member of Parliament, opined that patents ought to be given for incremental innovations as Indian scientists did not have the know-how or capital to come up with new chemical entities, but do have the know how to make the improvements.

However, using the (in-)capabilities of the pharma industry for innovation to argue that incremental innovations should be allowed to be patented looks like a no-brainer to me. At some point or other, we have to innovate. So, why not now?

Costs of drug research

While the issue of the cost of drug research appears in the Mashelkar committee report only through one of the submissions (of Crop Life), the IPI report (page 47 — footnote 149) says (in part):

It needs to be noted however that basic reverse engineering skills (organic chemistry skills) are different from the skills required to arrive at new drugs (medicinal chemistry skills). Besides, the costs of researching upon and introducing a new drug into the marker are colossal.

This reminded me of a story I read about ISRO (pdf):

We worked through the night to come out with a budget figure Rs. 50-60 lakh that looked ridiculously low. We decided to multiply all our estimates by 6 and the total outlay came to a respectable Rs. 3 Crore.

Probably, we are waiting for the Dhawans, U R Raos, Kasturirangans and M G K Menons of Indian pharmaceutical industry?

The bottom-line on the Mashelkar committee recommendations

The issue at stake is a legal one; from the submissions made to the committee, it is clear that the legal opinion is divided; there is no clear discussion/exposition as to why the committee took the stands it did. On the other hand, the reasons of national interest that the committee propounds (which is not relevant to the legal issue at hand) are not completely convincing to me.

Part II

Myth 1: The high cost of drugs is due to the investments in research per se

While some (like Marcia Angell) attribute the high costs to the practices of the drug companies, some others (like Malcolm Gladwell) indicate that doctors, insurance companies, and end users along with drug companies are to be blamed (at least in the US) for the same.

Myth 2: IP and copyright essential for innovation to occur

IP/patents/copyright are in the long run are not innovation friendly — see this and this, for example. The drug industry itself is going the open source way (while academics are trying to keep their research findings in the public domain).

Are there alternatives to patenting?

One of reasons given in support of patenting regimes is as follows: the monopoly that patenting bestows on the drug companies compensates them monetarily for the investment they made in researching for the drugs. However, the monopoly is one of the reasons for the high drug prices. Is there a way of decoupling monopoly and monetary benefits? For example, would it help if a company that comes up with a new drug is given a tax exemption? Are there any other alternatives that have been suggested? Probably, some economist somewhere has come up with a model? I would love to hear about such alternatives, if any!