What do you understand by data exclusivity in pharma sector? Critically analyse how the recent proposal of the government to change the four-year time limit for State-level drug regulatory approvals to 10 years would affect various stakeholders.

Data Exclusivity is a form of Intellectual Property Right protection where in clinical trials and other data submitted by Originator drug company can not be used to approve or rely upon by Drug regulatory authority to approve the generic version of drug for a certain period of time.

At present according to the Drug and cosmetics Act, a drug will continue to be  “new” even after the approval of the Central Drug regulatory authority by submitting the local clinical trails and other required data for a period of 4 years and after four years any drug manufacture can short circuit the manufacturing process and can get the approval of state drug regulatory authority.This 4 year terms has been increases to 10 years by the government.

It can have below impacts:

  1. For large pharma s and MNCs , it will become an incentive as the local clinical trials date protection is increased from 4 years to 10 years period , they will have sole rights over manufacturing of the drug for a period of 10 years
  2. This will increase the capacity and incentive for the pharma s to spend on more R&D of newer drugs for various diseases
  3. For the generic drug manufactures, it impacts negatively since they can not manufacture the original drug for a period of 10 years
  4. Monopoly over the drugs manufactured by the originator pharmas will have effect on prices and the prices may go up
  5. Availability of generic drugs will take a hit in which case large number of people will be affected negatively

The move to increase period from 4 to 10 years might increase the R&D in the pharma sector i.e. new and effective drugs at the same time it will have negative effect on genric drug manufacturing,its prices and availability.

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