Medical Device Manufacturing Schemes.

The Indian government has identified medical devices as a priority sector for the flagship "Make in India" programme and is committed to strengthening the manufacturing ecosystem.

Medical Device Manufacturing Schemes.

Schemes for the Promotion of Medical Device Manufacturing:

India is the fourth largest medical device market in Asia. Currently, the Indian market has a high reliance on imports, but in recent times exports have seen a surge. Currently, the Indian market has a high reliance on imports, but in recent times exports have seen a surge.

The 'Atma Nirbhar’ Bharat Mission is providing an impetus to India’s vision of becoming a global manufacturing hub for medical devices. Recent initiatives, for instance, the Production Linked Incentive Scheme (PLI) and the Promotion of Medical Device Parks Scheme, are a testimony to this. These schemes have been cogently constructed to incentivize large-scale manufacturing and to build the required infrastructure for developing manufacturing clusters within India.

Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices

The Production Linked Incentives Scheme (PLI) Scheme for Medical Devices Manufacturing provides a financial incentive to grow domestic manufacturing and attract significant investment in medical device segments like implants, radiology and imaging devices, anaesthetics, ICS devices, and cancer care devices.

1. Production Link Incentives under the Scheme of INR 3,420 Crore

2. A pledged investment of INR 1,059.33 crore has been given approval for 21 applications.

3. The plan aims to advance the Make in India, Make for the World initiative to produce world-class athletes from India.

4. The Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices is now accepting applications from qualified Category B candidates. Applications must be received by October 31, 2022, the deadline.

Other Criteria for Eligibility:

1. Support will be provided to companies registered in India that are manufacturing in target segments and have a net worth (of the applicant company plus group companies) of more than Rs. 18 crores.

2. The scheme is exclusive to greenfield projects as defined under the guidelines.

3. The applicant should not have been declared bankrupt or defaulter or reported as fraud by any financial institution.

4. Eligibility under the PLI Scheme will not affect eligibility under any other scheme and vice-versa.

5. Companies meeting the committed investment and minimum threshold sales will be eligible for the disbursement of investment. The subject thresholds are detailed in the table as above.

Selection: 

Applicants will be evaluated and ranked based on factors including manufacturing turnover, existing patents/technology, R & D expenses, existing ISO 13485 certification, and regulatory approvals.

1. A maximum of 28 applicants shall be selected under the scheme based on the score obtained as per the evaluation.

2. A maximum of ten applicants will be chosen from each target segment.

3. A minimum of 3 applicants, if available, shall be selected under each Target Segment.

DISBURSEMENT PROCESS:

Incentive Submission Applicant's Claim for Payment 

1. A claim must be submitted nine months after the end of the fiscal year to which it relates. 

Verification of Claims and Incentives Application-PMA 

2. PMA shall process the claim for the payment of incentives and provide the Empowered Committee with the necessary recommendations within 60 days of the date the claim was submitted. 

3. Claims for the payment of incentives shall be reviewed and approved by the Empowered Committee.

4. Funds will be distributed by PMA PMA upon the applicant's fulfilment of all pre-disbursal requirements and the Empowered Committee's approval.