The Department of Pharmaceuticals (DoP) has issued revised guidelines for the production-linked incentive (PLI) scheme, envisaged to encourage encouraging domestic manufacturing of medical devices.

According to the revised guidelines, applicants can now claim the cost of conducting clinical trials as investments, though it will be capped at 10% of the committed investments.

“The cost incurred by the applicant towards clinical trials of eligible products in India shall be eligible towards investment. However, the investment on clinical trials (mentioned above) shall be capped at a maximum of 10% of the committed investment for an approved applicant, irrespective of capitalised or not, in the books of accounts,” the revised guideline read.

According to the revised guidelines, companies who have made investments on or after April 1, 2021, will be eligible to apply for incentives in the fourth round of invitations from the department.

The department has invited applications from eligible companies for Category B devices, with revised guidelines and investment timelines in place.

It may be recalled that the DoP notified guidelines for the production-linked incentive for medical devices scheme on July 18, 2020, and revised it twice, first on October 29, 2020, and then on August 18, 2022, the latter being made the basis of  invitation for the fourth round of applications.

However, given the requirements, the Empowered Committee approved the revised guidelines on January 10, 2023.

The DoP informed that it has also invited applications from eligible Category B applicants for medical devices for the eligible products, as per the guidelines revised now, stating that the investment for this round of applications shall be considered for determining eligibility under the Scheme, provided the such investment is made on or after April 1, 2021.