India’s data exclusion- danger to affordable healthcare

India’s health scenario is facing a grave situation that almost no one is acquainted with. Healthcare is not a privilege but a right which general public can easily access. However, DATA EXCLUSIVITY is a rising threat to affordable healthcare for hundreds of millions in India.

A drug before it hits the market goes through numerous trials on human volunteers. With Data exclusivity, along with drug’s constituents, the results of human tests can be kept confidential so that a drug regulator cannot compare the drug & its impact to its bioequivalent by a smaller company. In India, Rule 122E of the Drugs and Cosmetics Act, states, “a new drug shall continue to be considered a new drug for a period of 4 years from the date of its first approval”. Many developed countries are now pushing to extend Data Exclusivity in developing countries on behalf of their companies. Companies complain about the efforts and cost put up by them to research on a new drug hence demand a heavy price for it. Since small companies can’t pay for same trials, they generally opt to wait for exclusivity period to end. Since Nov 2016, a team made by Drug Controller General of India is working on a proposal to extend the period to 10 years, prolonging Data Exclusivity.

The power of Data Exclusivity is that it prolongs the existing monopoly of bigger companies as the competing smaller ones stay off the market.

The power of Data Exclusivity is that it prolongs the existing monopoly of bigger companies as the competing smaller ones stay off the market. In 2015, Martin Shkreli hiked the price of an AIDS-related drug, Daraprim from 13.5$ to 750$ (FYI: 91% of HIV +ve children are living in Africa). Another case is a cancer drug, Imatinib sold at $146,000 per year supply in the US due to Novartis’s monopoly while companies in India sell them at 400$. Due to Data Exclusivity, much-needed medicine with its high price becomes unaffordable and a possible cheap alternative becomes inaccessible.

No one deserves to suffer waiting for an access to cheaper medicine.

No one deserves to suffer waiting for an access to cheaper medicine. Even the automobile companies spend millions of dollars to collect data on car crash tests involving dummies but their data is easily accessible while pharmaceutical companies that do trials on well alive humans keep the information confidential. In the name of Intellectual Property, Data Exclusivity only serves to the greed of big pharmaceuticals while there is a continuous addition to woes of the lower denominator.

When net neutrality was in danger, we stood united and stopped the bigger corporates from deciding what we surf on the internet. And now here we are poorly informed on the issue of the USA and Switzerland-based pharma companies trying to control our healthcare. Hence, it is upon us to stay vigilant about this issue.

For more information:
1. Ministry of Health and Family Welfare (Central Drugs Standard Control Organization), Drugs and Cosmetics Act, Rule 122E, Page 147:
http://www.cdsco.nic.in/…/2016Drugs%20and%20Cosmetics%20Act…
2. http://indianexpress.com/…/pharma-regulation-generic-drugs…/
3. How much are the Africans affected by HIV? –https://www.dosomething.org/…/fac…/11-facts-about-hiv-africa
4. https://qz.com/…/why-martin-shkreli-and-turings-daraprim-s…/

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