Pharma Fortified: India-UK FTA(Free Trade Agreement ) Delivers a Win with No Strings on Generics

Image Source: Metro Vaartha

India has firmly safeguarded its $25 billion generic drug sector in the just-concluded Free Trade Agreement (FTA) with the United Kingdom by turning down the UK's request for a 'data exclusivity' provision. This action ensures that Indian generic drug manufacturers are able to access and utilize clinical trial data of innovator pharmaceutical firms, allowing them to market affordable medicines rapidly after patents have lapsed.

Key Highlights:

India did not agree to include data exclusivity in the FTA, valuing the development and international competitiveness of its generic pharmaceutical industry, which exports almost 50% of its production.
Data exclusivity would have prohibited Indian companies from making use of clinical trial data that had been produced by patent owners, thereby potentially delaying the entry of affordable generics and lengthening the market monopoly of originator firms.
Authorities clarified there is "no risk to the Indian generic industry from this agreement," and reiterated that assisting the sector's growth is still a high priority government goal.
The refusal is in line with India's approach in its FTA with the European Free Trade Association (EFTA), where the same request was also refused.

Experts say that data exclusivity is more than what the WTO's TRIPS agreement requires, to which India is a signatory.

The FTA, which was signed on May 6, has other reciprocal advantages, including lower British Scotch whisky and automobiles in India and lower tariffs on Indian exports such as clothing and leather products to the UK.

India's consistent stand has been widely appreciated by the domestic pharma industry, which is dependent on the capability to make and export low-cost generics globally.

Sources: NDTV Profit, Financial Express, The New Indian Express