Rupal Panchal of Hemophilia Society hopes that Prime Minister Modi would do for people with hemophilia what Chief Minister Modi did in Gujarat years ago.

As Gujarat’s CM, Modi had made a state budgetary allocation for hemophilia, making medicines to treat this blood-disorder more accessible, says Panchal, unhappy with the Centre’s latest move to remove customs duty exemption on a couple of critical hemophilia medicines.

Last week, the Centre removed customs duty waivers on 76 imported drugs, ostensibly with an eye on encouraging local producers to make these medicines in India. The list included cancer and HIV drugs, some of which are being locally produced. But that was not the case with anti-haeomophilic factor (AHF) concentrate (VIII and IX), that had a single company importing it and possibly a couple of local producers making it.

The removal of the waiver could not have come at a worse time, says Panchal.

Supply woes

Even in a developed state like Maharashtra, supplies are erratic and there are little or no supplies of this medicine in the last six months.

“A person with hemophilia becomes progressively disabled and they need to treat their joint bleeds with AHF,” says Panchal.

Adding to this medicine shortage is the squeeze in State fund allocations. The Centre’s policy is to allocate funds to the States to support such programmes. But there still is a shortage of funds, he alleges.

Hemophilia is a genetic disorder where the blood does not clot and an adult needs about four infusions a month to stay active or go to work, he explains. The medicine’s cost to patient is about Rs 6 lakh a year.

Following public interest litigations about five years ago in Mumbai, hemophilia patients now get the medicine free from designated centres in the State. About 23 States support people with hemophilia, says Panchal, adding that it has also been included in the draft Disabilities Bill.

With this being reality for 16,000 people with hemophilia in India, the Centre’s latest move on the medicine is “unethical”, reiterates Pancal.

The hemophilia fallout, in fact, exposes chinks in the Government’s “Make in India” campaign. In little over a month, the Government has withdrawn customs duty waivers on some medicines and medical devices.

And though drugs and medical devices cannot be viewed by the same lens, the rationale behind the Government’s move on both these health-related segments impacts patients, directly. Removal of tax incentives will result in the cost being passed on to the patient, caution industry and pro-patient representatives.

Quality mark

Besides price increase, Panchal points out, that the Government should not lose sight of the quality of products, in its “Make in India” pursuit.

In complex biological drugs and recombinant technology - it is both difficult to make and many products are patent-protected, he says. “The DCGI (drug regulator) should look at the quality of medicines made here and certify it,” he says.

The hemophilia fallout opens the door on a range of issues from whether local producers are equipped to make these new technologies to how Government can make these new products and technologies affordable to patients who need it.

Government should have an “Orphan disease” policy to get local makers to make drugs for diseases that get little attention, says Panchal. Government’s own reduced fund allocations for health (at about one percent of GDP) comes in for criticism, when it comes to making medicines and devices accessible and affordable.

On quality, Rajiv Nath with the Association of Indian Medical Device Industry agrees that an Indian equivalent of an internationally acceptable safety and quality certification is required on devices as well. Clear reference benchmarks should be outlined on clinical data requirements, for example, to inspire faith in doctors and other markets in Indian products and their safety and reliability, he says.

Device differentiation

Nath, however, is not unhappy with removal of customs duty waivers on medical devices and in fact calls for similar action on certain diagnostic products and reagents too.

Domestic makers face duties on raw materials, while importers were getting concessions on the finished goods, he says, alleging that concessions did not always translate into reduced prices for patients. This lop-sided duty structure works as a disincentive for local producers and made it easy for traders to import products from China or Taiwan at one-tenth the capital cost, he explains.

Nath suggests that the government impose a one percent excise on the final retail price (MRP), which would work as an inherent disincentive for companies to increase prices.

The view is quite different from AdvaMed, a platform for foreign medical device companies. The highly import-dependent devices sector would suffer by raising duties on imported life-saving and enhancing medical devices, it says. Such a move will obstruct the process the Government seeks to facilitate – to bring in foreign investment into medical devices, it points out.

“Right now, the domestic industry is at a very nascent stage and has limited capacity to meet patient needs of quality devices due to lack of product know how and the right technology. Therefore besides financial support, government needs to invest in training and capacity building of local manufacturers. This is a gradual process and will take time,” they say.

This being the complex reality in making both medicines and medical devices locally, the Government will have to tread more carefully in pushing its “Make in India” campaign, ensuring that it does not end up hurting patients or the industry that brings these products to them.