How is the draft pharma policy revamping drug price regulation? | Business Standard News

The draft pharmaceutical policy has been recently circulated by the Department of Pharmaceuticals (DOP) to a select group of organisations. Its concerns are spread across at least three ministries – DOP, health and commerce, the last for issues related to patents. The Wire earlier reported on the range of issues it aims to cover including the quality of Indian drugs, time taken for drug approval and reducing dependence on China for raw materials.

The draft policy spends a lot of bytes on India’s drug price regulator, the National Pharmaceutical Pricing Authority (NPPA). So let us focus on that first. The draft policy has written in features that will alter the roles and functions of the NPPA as well as its overall structure. The changes suggest that the price regulator has been underperforming, when, in fact, it has been sticking close to its government-given mandate.

It is indeed strange for a government body such as the DOP to not claim credit when it is due. Surprisingly, one does not see any mention in the policy draft of the useful capping of prices of stents and knee implants done by the NPPA and some ideas on the further road map on price capping of medical devices by NPPA.

The DOP is also planning a meeting in FICCI on medical device policy with representatives of the medical industry – none representing the public interest point of view. Does it mean that the DOP does not reinforce the initiatives proudly claimed by the PM in his several speeches?

Drug price regulation

Firstly, the new draft policy says DOP will take control over the National List of Essential Medicines (NLEM), which is used as the basis for determining which drugs the government can control the prices of. This has been rather infelicitously phrased as, “Government in the Department of Pharmaceuticals will prepare the list of medicines for price regulation and transmit them to the NPPA for fixing the price ceilings.” So is the NPPA not in or a part of the government?

The previous policy was that all NLEM drugs will automatically be under the Drug Price Control Order 2013 (DPCO). The NLEM is incidentally prepared under the aegis of the Ministry of Health. And the DPCO is under the Ministry of Chemicals and Fertilisers, along with the Department of Pharmaceuticals.

So what the draft policy appears to say is that henceforth, the health ministry will merely suggest the NLEM, and it is the DOP that will apply its mind as to what NLEM drugs to put under price control. Essentially, this means that the DOP can cut the list of drugs to even less than the current 376, say to a 100, because it thinks fit or because a set of drugs are not promoting ‘ease of business.’ Is DOP suggesting that it has the locus standi and competence to decide which drug is more essential, more than the dozens of medical experts who spend several meetings to finalise the NLEM? What should get primacy here? Is the essentiality of a drug for health of the people more important or the convenience of the pharma industry? The policy does not even explain if price control has inconvenienced the industry and how.

Read complete article here:

How is the draft pharma policy revamping drug price regulation? | Business Standard News.