Pharma policy is not a panacea to address all related issues, neither for the patients nor the industry, in general. As I see it, it’s no more than a critical cog in the wheel of the overall macro and the micro health care environment in India. Regardless of this fact, and notwithstanding virtually inept handling of previous pharma policies in many critical areas, each time a new policy surfaces, it generates enough heat for discussion.
Interestingly, that happens even without taking stock in detail of the success or failure of the previous one. A similar raging debate maintaining the same old tradition, has begun yet again with the Draft Pharma Policy 2017. This debate predominantly revolves around the direct or indirect interests of the industry, and its host of other associates of various hues and scale.
Having said that, the broad outline of the 18-page draft policy 2017 appears bolder than previous ones in several areas, and has ticked mostly the right boxes, deserving immediate attention of the Government. One such aspect I discussed in my previous article, titled “Draft Pharma Policy 2017 And Branded Generics,” published in this blog on August 28, 2017.
There are obviously some loose knots in this draft policy, a few are contentious too, such as the changing role of National Pharmaceutical Pricing Authority (NPPA), which apparently is doing a reasonably good job. I also find its link with several important national initiatives, especially ‘Make in India’, ‘Digital India’ and ‘Skill development’. Above all, the draft policy reflects an unambiguous intent to stop several widely-alleged business malpractices – deeply ingrained in various common, but important industry processes and practices that include, pharma sales and marketing, serious quality concern with many loan licensing manufacturers, and even in the issues related to ‘Product to Product (P2P) manufacturing.
The Department of Pharmaceuticals (DoP) reportedly commenced the preliminary rounds of discussion on August 30, 2017, where the Ministry of Health, the Ministry of Environment and the Department of Commerce also participated in the deliberation. In this article, I shall not go into the speculative areas of what ought to or ought not to come finally, instead focus on the key challenges in making the pharma policy meaningful, especially for the patients, besides the industry.
Policy implementation capability:
Whatever may be the net outcome of these discussions, and the final contours of the National Pharma Policy 2017, the implementation capability of the DoP calls for a thorough overhaul, being the primary challenge in its effective implementation. Since 2008, several illustrious bureaucrats have been at the helm of this important department, but nothing substantial seems to have changed in the comprehensive implementation of pharma policies, just yet. Concerned stakeholders continue to wait for a robust patented drug pricing policy, or for that matter even making the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory, which, going by what the DoP officials had reportedly hinted at many times, should have been in place by now.
The core reason for the same could well be due to a structural flaw in the constitution of DoP under the Ministry of Chemicals and Fertilizers, instead of making it a part of the Ministry of Health. The reason being to create a greater synergy in the implementation of both the Pharma and Health Policies, in a more meaningful way. But, that could be a topic of a separate discussion, altogether.
Initial adverse impact on the pharma industry:
Some of the following proposals, as articulated in the draft pharma policy 2017, are likely to cause initial adverse impact on the performance of the industry, especially considering the way the industry, in general, has been operating over a long time:
- No brand names for single molecule drugs
- Mandatory UCPMP with heavy penal provisions
- e-prescriptions facilitating greater usage of less expensive high quality drugs with only generic names
- Mandatory BE/BA studies for all generic drug approvals
- GMP and GLP requirements in all manufacturing facilities
- Restrictions on loan-licensing and P2P manufacturing.
Initial retarding impact, out of the above measures, may be felt on pharma revenue and profit growth, increase in overall manufacturing cost, and more importantly on the long term strategic game plans of most pharma players, in one way or the other.
The Government is aware of it:
Nevertheless, to make a significant course correction through policy interventions, in curbing widely reported alleged marketing and other malpractices, dubious quality standards of many drugs, and sufferings of many patients with high out of pocket drug expenditure, the Government apparently firmly believes that such an outcome is unavoidable, although need to be minimized. The following paragraph detailed in the Annual Report 2016-17 of the Department of Pharmaceuticals, vindicates the point …Continue reading
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