Manifestos duck core pharma issues

Manifestos are promises about how the future will be fashioned for the better if you elect a particular party to power. At the minimum, any manifesto on medicines must contain ideally the party’s stand on at least four measures: drug price control, marketing of medicines only under a generic name, banning all irrational fixed dose combinations, and implementation in all States of the Tamil Nadu/Rajasthan model of free medicines and diagnostics.

Both the Congress and BJP manifestos say nothing about any of these basic pharma policy issues.

BJP manifesto

The BJP manifesto’s “Health for All” section says: “In addition (to Ayushman Bharat Programme) we have conceived and implemented programmes for controlling prices of medicines…”

The programmes related to controlling prices of medicines were conceived in 2013 (the Drug Price Control Order 2013), and not by the BJP/NDA. But affordable medicines are necessary to ‘Making Healthcare Accessible’, the first goal outlined in the BJP manifesto under ‘Health for All’.

The BJP (and the Congress) must realise that DPCO 2013 covers only 10 per cent of the pharma market of India, and this needs to be expanded to all essential and life-saving medicines, going beyond those mentioned in the National List of Essential Medicines.

The last few years under the NDA Government saw considerable dilution of powers of the National Pharmaceutical Pricing Authority (NPPA). This needs to be reversed. Ideally, NPPA must be transferred to the Ministry of Health, out of the Department of Pharmaceuticals.

The manifestos should have considered the following aspects:

All irrational and unscientific FDCs (Fixed Dose Combinations) of drugs should be banned, not just the ones recommended for ban by the Kokate and Nilima Kshirsagar Committees.

These FDCs recommended for ban account for not more than ₹800 crore, whereas the total irrational FDC market is in the region of ₹25,000 crore. Measures to minimise vexatious litigation by pharma companies to filibuster banning of irrational FDCs must be devised.

Price ceiling must be based on a cost-plus margin and not by merely reducing trade margins (as was done in the recent anti-cancer drugs). Nor should it be fixed on the basis of a simple average of retail prices (as in DPCO 2013).

The BJP/NDA government can claim some agency in NPPA’s significant reductions in prices of cardiac stents and knee implants. But further measures on capping of prices of cochlear and hip implants and a host of medical devices were stalled by the NDA Government for reasons best known to it.

These price cap measures need to be revived if the manifesto’s promise is to come true: “We will create an essential devices list and a separate pricing policy for medical devices to ensure their accessibility and affordability to masses.”

The BJP manifesto says TB will be eliminated by 2025. A welcome move. But why only TB? Why not even deaths of women in childbirth due to post partum bleeding — mostly due to lack of oxytocin on time? A new government should withdraw the special leave petition in the Supreme Court, and not insist on banning private production of oxytocin.

A matter not mentioned is some of the patient-unfriendly provisions in the new clinical trial rules, and provisions that can compromise safety to trial participants and patients, must be revisited and removed.

The Congress manifesto

At Para 2 of its section on Healthcare, the Congress manifesto declares: “Congress promises to enact the Right to Healthcare Act that will guarantee to every citizen the right to healthcare services, including free diagnostics, out-patient care, medicines and hospitalisation through a network of public hospitals and enlisted private hospitals.”

But devices and diagnostics need to be added in its promise — the current list of devices defined as drugs (under the Drugs and Cosmetics Act) is not enough. All of them need to be put under price cap.

Para 3 of the Congress manifesto promises “to vigorously promote and implement the free public hospitals-model to provide universal healthcare.” If 80 per cent of doctors and specialists in India today are in the private sector, a suitable model of how these doctors are going to be enlisted in the free public hospitals model, needs to be thought through.

Para 7 of the Congress manifesto says: “We will implement the Clinical Establishments Act, 2010 to bring accountability to the functioning of private and public clinical establishments.” This is important because even after medicine and stent/knee implant price caps, the final bill to the patient has not reduced. Attempts at standardising costs of various procedures and treatments in meetings held to operationalise the Clinical Establishments Act have come a cropper basically due to objections from the associations of doctors.

Affordability and free care will be a dream if an upper limit on costs of treatment is not specified and agreed upon. The Congress manifesto has otherwise nothing to say about medicines per se , price regulation, the scope of price regulation or weeding out irrational medicines and FDCs. Irrational medicines and irrational prescriptions add substantially to patient costs.

Both the manifestos have sidestepped the issue of how to reduce costs of patented drugs and the need to issue CLs (Compulsory Licences) for government use.

India’s pharma boom — and its subsequent designation as pharmacy of the developing world — owes much to Indira Gandhi’s decision to introduce the Patents Act 1970 to provide only process patents for medicines. This is something the Congress manifesto could have mentioned in answer to BJP’s claims.

The public health situation in India is so dismal that the masses will be glad even if 50 per cent of the promises in these manifestos are fully implemented.

As for achieving ‘health for all’, these manifestos barely scratch the surface.

The writer is affiliated with the All-India Drug Action Network and LOCOST, Vadodara

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