The recently unveiled draft Pharmaceutical Policy 2017 seems to have few supporters as advocacy groups and industry representatives worry, albeit for very different reasons, on the impact this document would have in its present avatar.
The over-arching concern is that the draft policy does not create an enabling environment for the pharma industry nor does it break new ground on patient access efforts. These concerns are expected to come up at an interaction with the Department of Pharmaceuticals (DoP) later this week.
The draft policy does not layout a futurist vision in areas like biologics, nor does it incentivise local drug makers to take advantage of the flexibilities in TRIPS (Trade Related aspects of Intellectual Property Rights) to make affordable medicines, says KM Gopakumar with Third World Network.
“People of India seem to be the victims of India being the pharmacy to the world,” he says, referring to how local companies are unable to leverage the local advantage, while foreign companies do so, making their revenues in other markets. Be it large, medium or small drug companies, all are required in India to spur competition and bring in greater affordability, he says.
The draft's proposal to do away with loan licensing (except in bio-pharmaceuticals) and bring in the World Health Organisation's Good Manufacturing Practices standards, he said, needed discussion as it could affect jobs in the sector. “We need to have Indian standards with a focus on quality and evidence based medicine,” he said.
The proposed policy echoes the NITI Aayog's view on the National Pharmaceutical Pricing Authority in terms of recasting it with structural changes and aligning it with DoP's thinking. That has an inherent conflict of interest, say industry watchers, as the NPPA is a regulator while the DoP's mandate is to keep the pharma industry's interest at the centre.
Speaking for domestic drug makers, DG Shah of the Indian Pharmaceutical Alliance says that the policy seems to want to do away with retail prices by sticking to ceiling prices. Pointing to the policy's exclamation that India had 2500 pharmacopeial salts, but 60000 brands at different prices, he says, “What's wrong with that? It's competition that keeps prices down.”
“The policy is ill-conceived and poorly drafted,” he says, adding that the loan licensing system infact helps optimise production facilities.
Agreeing that the draft policy does little more than state the obvious, Amit Sengupa with Jan Swasthya Abhiyan says that the concern on India's overdependance on China for Active Pharmaceutical Ingredients (API) is mentioned, but little is offered to incentivise local production. There is no mention of rational use of medicines, on beefing up the quality and the regulatory infrastructure or revival of public sector units. And pricing discussions continue in the realm of market prices without taking up the original argument on pegging prices on the cost of production. “The draft has general assertions with no depth,” he says.
There is no enabling ecosystem to support what the draft policy sets out to do, observesPwC India Partner Sujay Shetty pointing out that indigenisation of APIs or promotion of generic drugs (that need to be of standardised quality) require supporting infrastructure. The draft policy statement also remains silent on clinical trials, intellectual property and health insurance, all of which tie into the bigger industry picture, he says, echoing the view of many industry-watchers that much more work was required on this draft document.
jyothi.datta@thehindu.co.in