India’s critical role and contribution to global health care since decades came into prominence when American President Donald Trump sought the export of anti-malarial drug hydroxychloroquine to the US, as a possible cure for COVID-19. Prime Minister Narendra Modi in his magnanimity agreed to lift the ban on the export of the medicine to the US.
Since decades India has made an important contribution to global health care. Medicines made by the pharmaceutical sector in India are found in almost every country. Indian companies develop and manufacture formulations for most countries in the world and al make active pharma ingredients for other pharma companies. These medicines are in demand all over the world.
In the 1970s the Indian Government stopped issuing patents for drugs. As a result, India’s drug producers could happily make copies of drugs (or ‘generic drugs’) which were under patent in other countries. Generic drugs were cheaper to make because no money had to be spent to develop them. India quickly became the major player in the world.
Most procurement agencies for developing countries depend on India. UNICEF sources 50% of its medicines for developing countries from India. As much as 80% of the AIDS treatment drugs that Medecins Sans Frontieres (Doctors without Borders) issues in over 30 countries are from India. Every fifth generic drug in the world comes from India.“Generic” drugs are chemically the same as brand-name drugs, and they are produced once patents expire or no exclusivity exists.
Hydroxychloroquine has been identified by the US Food and Drug Administration as a possible treatment for the Covid-19 and it is being tested on more than 1,500 coronavirus patients in New York. India manufactures 70% of the world’s supply of hydroxychloroquine, according to Indian Pharmaceutical Alliance.
India has a production capacity of 40 tonnes of hydroxychloroquine (HCQ) every month, implying 20 crore tablets of 200 mg each. And since the drug is also used for auto-immune diseases like rheumatoid arthritis and lupus, manufacturers have good production capacities that can also be ramped up.
However, India’s status has come under threat. In 1995, the international agreement on Trade-related aspects of Intellectual Property Rights (or TRIPS) came into force. The World Trade Organisation put strong pressure on member countries to change their laws to bring them into line with this agreement which put forward a common set of rules for intellectual property rights, including rules on patents.
In 2005 India introduced its new patenting laws in line with TRIPS. The WTO agreed that drugs patented in their original country of manufacture before the TRIPS agreement were exempt, So India can carry on making copies of these drugs. But any company that has produced or patented new drugs since 1995 is now able to apply for a patent in India as well. If the Indian Government issues a patent for a particular drug, then Indian drug producers cannot produce copies of it.
Organisations like Doctors Without Frontiers are worried that the new laws will threaten the supply of cheap drugs for the treatment of AIDS and other diseased in the developing world. It is not so much of a problem for the standard first-choice drug. India can continue to produce these because they initially came into the market before 1995. In fact, even the international drug companies now produce these cheaply for poor countries.
The concerns lie with new drugs. Drug companies will produce more effective treatments that under the new patenting laws others will not be able to copy. Also as HIV becomes resistant to standard treatments, HIV infected individuals will need access to different ‘second-line’ drugs, and these two will be unavailable in a generic form.
However, it is also possible that the fears are unfounded. It is said that the new patenting laws will not necessarily make future drugs more expensive for the developing world. It is argued that large drug companies as a result of competition with the producers of generic drugs and of growing international pressure have accepted the need for two markets for their drugs.
They charge high prices to customers in the developed world so that they can cover the costs of the research and development work that goes into producing new drugs while charging lower prices for essential drugs in the developing world.
In the past three decades, India has become the “pill factory” to the world. With COVID-19 rampant across the world, the Indian pharma sector is all set to perform ever more demanding tasks and they are ready to co-operate internationally with governments, international organisations, service providers and pharma companies. The endeavour is not just making health care cheaper, but also making high quality, difficult to make medicine more accessible and available to a large mass of people all over the world.