This formulation needs a second look

Biomedical innovation from India is in need of a policy boost

Published - June 11, 2017 02:02 am IST

At the fulcrum:  “India is increasingly becoming a hub for product development, aimed at innovation into meeting the public health needs of developing countries.”

At the fulcrum: “India is increasingly becoming a hub for product development, aimed at innovation into meeting the public health needs of developing countries.”

The development and registration of a child-friendly and heat-stable formulation of HIV drug lopinavir/ritonavir by an Indian generic company will not only save lives but also ease procurement woes of the National AIDS Control Programme. A 4-in-1 fixed-dose combination of HIV medicines is in the pipeline which aims at further reducing mortality in infants diagnosed with HIV. Globally, one in every 10 HIV-related deaths is of a child, something which can be easily prevented if infants are started early on treatment.

Multinational pharmaceutical corporations — which are quick to criticise India’s intellectual property system — rarely develop such formulations for infants. In the developed world, few children are born with HIV. Such corporations are not interested in developing paediatric formulations for HIV and TB because it’s in the developed world that they get their profits.

Because appropriate formulations have not been available for young children we’ve had to treat them by crushing adult tablets or giving them syrups that are hard to store and foul-tasting. However, Indian generic manufacturers have consistently developed better HIV and TB medicines for children which are not just saving lives but also easing the burden on caregivers and the health-care system.

A development hub

India is not just a hub for pharmaceutical production but is also increasingly becoming a hub for product development aimed at innovation in meeting the public health needs of developing countries.

Like the oral pellet, another innovation from the Indian industry was the meningococcal conjugate vaccine, MenAfriVac from the Serum Institute of India, now meeting the needs of the African meningitis belt. Several product development partnerships (PDPs) such as the Drugs for Neglected Diseases Initiative (DNDi) have been quietly working for over a decade with researchers and the Indian industry to develop treatments which are affordable and accessible. But investments from PDPs and generic companies are not enough. Financing and support from the highest level of the Indian government is urgently required.

For this to happen, a policy on neglected disease innovation should be jointly developed by the Indian Ministries of Health, and Science & Technology. Both are key stakeholders.

The Ministry of Science & Technology finances biomedical research and development and has been consistently investing in building up institutions such as the Translational Health Science and Technology Institute (THSTI), which is engaged in biomedical research activities. It is also a key member of the newly formed Coalition for Epidemic Preparedness Innovations (CEPI) which will play a crucial role in vaccine development for epidemics guided by the World Health Organization’s R&D blueprint (2016).

The Indian Health Ministry has programmes to address treatment needs of neglected diseases such as tuberculosis, leishmaniasis, malaria and paediatric AIDS. It is in charge of the crucial regulatory process for product development and has been participating in international debates at the World Health Assembly on greater financing and reform for a needs-driven R&D system.

Leena Menghaney is a lawyer and activist working on access to medicines

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