Applicant for the purpose of the Scheme is a Company/ LLP/ Partneship firm/ proprietorship firm registered in India, proposing to manufacture eligible pharmaceutical products covered under the scheme as defined in the guidelines, and making an application seeking approval under the Scheme. The Applicant can set up new or use existing manufacturing facility(ies) to manufacture eligible pharmaceutical products. The aforesaid manufacturing can be carried out at one or more locations in India, which will however be prior intimated to Department of Pharmaceuticals (DoP). The Applicants whose accounts are declared as Non-Performing Asset (NPA) as per RBI guidelines or wilful defaulter or reported as fraud by any bank, financial institution or non-banking financial company etc. would be considered as ineligible. Further, there should not be any insolvency proceedings admitted against the Applicant in the National Company Law Tribunal (NCLT) etc.

The Eligible Products under the Scheme consist of Specified Pharmaceuticals Products which will be allowed to be manufactured under this PLI Scheme. The list of products has been classified under 3 categories mentioned below:

1. Category 1-
   1. Bio-pharmaceuticals
   2. Complex generic drugs
   3. Patented drugs or drugs nearing patent expiry
   4. Cell based or gene therapy drugs
   5. Orphan drugs
   6. Special empty capsules like HPMC, Pullulan, enteric etc.
   7. Complex excipients
   8. Phyto-pharmaceuticals
   9. Other drugs as approved
2. Category 2-
   1. Active Pharmaceutical Ingredients/ Key Starting Materials/ Drug Intermediates
3. Category 3-
   1. Repurposed drugs
   2. Auto immune drugs, anti-cancer drugs, anti-diabetic drugs, anti- infective drugs, cardiovascular drugs, psychotropic drugs and anti- retroviral drugs
   3. In-vitro diagnostic devices
   4. Other drugs as approved
   5. Other drugs not manufactured in India.

Applicants have to satisfy the following criteria to be eligible under the PLI Scheme for Pharmaceuticals:

1. Global Manufacturing Revenue defined as per the Scheme Guidelines for Group A (` 5000 crores or more), Group B (` 500 crore and above, upto ` 5000 cr) and Group C (less than ` 500 crore) applicants.
   
2. Eligibility will be subject to achievement of a minimum cumulative incremental investment over a period of five years and percentage growth in sales of manufactured goods (of Eligible Products covered under the Scheme) net of taxes (as distinct from traded goods). The cumulative investment can be made at one go, subject to annual cumulative threshold as prescribed for four years being met. An applicant is expected to meet all the minimum threshold conditions to be eligible for disbursement of incentive. The Company/ entity may invest in single or multiple eligible products to meet minimum incremental investment and sales threshold.
   
3. There will be a minimum investment threshold of ₹ 1000 Crores for Group A, ` 250 Crores for Group B and ₹ 50 Crores for Group C. Cost of land will not be counted as investment. For MSME participants in Group C, the threshold minimum cumulative investment shall be as committed by the participant in application form.
   
4. Total number of beneficiaries will be limited owing to the fixed ceiling of the budgetary outlay.

Applicant can be considered ineligible for the PLI Scheme for Pharmaceuticals Products manufacturing in India under the following conditions:

1. The Applicants are declared as Non-Performing Asset (NPA) as per RBI guidelines or wilful defaulter or reported as fraud by any bank, financial institution or non-banking financial company etc. Further, there should not be any insolvency proceedings admitted against the Applicant in the National Company Law Tribunal (NCLT) etc.
2. An Applicant who has applied/availed benefits under any other PLI Scheme of the Central Government for the same product. However, eligibility under PLI Scheme will not affect eligibility under any other Scheme being implemented by State/UT Governments and vice-versa. Further, for the purpose of determining eligibility of an Applicant with respect to incremental investment, the investment covered under the Scheme may not be considered for determining eligibility under any other PLI Scheme and vice-versa.
3. Deficiencies, if any, found in the application submitted by Applicant shall be intimated to them by PMA and the same has to be rectified by the Applicant within 10 working days’ time from the date of intimation of the deficiency, failing which the application may be marked ineligible for the Scheme.

The Scheme will be implemented within the overall financial limits of Rs 15000 Crores only (Rupees Fifteen Thousand Crore only) over a period of 6 years.

The scheme will be effective from 1st April 2021. The investment will be permitted to be made in four years, subject to qualifying incremental annual thresholds, the support under the Scheme shall be provided for a period of six (6) years.