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The drug price regulator’s move to withdraw internal guidelines that it had issued in May has industry-watchers a trifle puzzled.
Was it done to send “the right signals” on the eve of Prime Minister Narendra Modi’s trip to the US, or is it “course correction” and fresh guidelines are in the offing?
Well, the National Pharmaceutical Pricing Authority (NPPA) is certainly not letting on the precise reason for withdrawal, except to say that it was being done “in compliance” with directions from the Government.
What is further intriguing is the timing of the decision to withdraw the earlier guideline that was issued clearly in “public interest”, as the NPPA indicates by underling its mention in the May directive.
The NPPA had reduced the prices on an additional set of 100-odd drugs, including diabetes and cardiac medicines, using these guidelines. And this had resulted in both local and multinational players in the industry approaching the Courts.
Industry’s plaint was that it was difficult to plan for the local market, if Government in a sense, kept changing the goal-post. The Government’s tool to control medicine prices – the revised Drug Price Control Order – had been brought in after discussions with all stake-holders, they point out.
And while there continues to be unhappiness in some quarters against the DPCO 2013, the fact is that it is the prevailing law and industry and civil society needed to adhere to it, an industry-watcher explained. By trying to smooth ruffled feathers, the Government may be trying to have a lesser number of contentious issues on its plate – as the PM heads to the US. India already has to deal with the US’ criticism of its laws to protect intellectual property (data generated during research, for example).
The NPPA’s latest move also opens up interpretations of “course correction” – so that future decisions on curbing medicine prices will be undertaken only after consultation with the parent Chemicals and Fertilizers Ministry.
An NPPA official indicated that its earlier decision to curb prices on additional 100 drugs is not revoked, despite today’s developments. However, what is still unclear is how NPPA’s decision to withdraw its earlier guideline will impact ongoing Court cases that industry had filed against the price reduction on diabetes and cardiac drugs.
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