‘Specific duration’ clause in draft India-EFTA pact may affect drug industry

Contact Counsellor

Last Updated15/02/2024

A clause in a draft free trade agreement text being negotiated between India and the European Free Trade Association (EFTA) Switzerland, Iceland, Liechtenstein and Norway
It could delay access to affordable, generic versions of patented drugs in India by a minimum of six years

There is also a line that suggests this should apply not only to ‘new’ chemical drugs but also a class of drugs called ‘biologics drugs,
- Monoclonal antibodies, vaccine formulations — that involve complex mixtures of organic and inorganic entities, and are harder to make copies of.
Many Indian biotechnology companies are developing biologics drugs.
This is mostly because India’s generic drug industry has over the years made affordable versions of expensive drugs and become a large global supply itself.
The Indian pharma industry is the third largest in the world and produces over 60,000 generic drugs across 60 therapeutic categories and had an annual turnover of ₹3.4 lakh crore,
“These effectively means that drugs such as bedaquiline (for TB) under provisions of data exclusivity wouldn’t be available

India’s Commerce Minister for negotiations on the TEPA, following which they had reached “balanced solutions” to concerns around the agreement.
While details of these solutions are not public, intellectual property (IPR) concerns are a major sticking point.
Patented drugs give exclusive marketing rights to the inventor, or whoever files for the patent first, for 20 years.
This has often resulted in essential drugs and medicines being unaffordable in several countries, including in India.

He current practice, whereby generic drug makers make a copy-cat, establish that it’s for all practical purposes the same drug
- Rely on the published clinical trial data to prove that it is safe and effective, ceases to be legal.
Even extend to drugs that have not been patented in India and require generic manufacturers to either wait out the exclusivity period or repeat expensive clinical trials.
For instance, Colchicine, a traditional medicine used for gout saw its price rise by 5000% in the United States
- After one company was granted data exclusivity rights blocking other companies’ rights to manufacture it.
The India EFTA text is a broad-ranging agreement that has been negotiated between India and the four countries since 2008
- To increase investment by these countries in India and reduce tariffs, on a range of exports from these countries.