New Industrial Policy 2020-25 - Pharmaceutical Industry - Clinical Trials Incentive
The Karnataka Industrial Policy 2020-25, issued by the Department of Industries & Commerce, Government of Karnataka,The policy identifies the pharmaceutical industry (including the clinical trials/ bio-availability / bio-equivalence segment) as a key thrust area. The purpose of the Clinical Trials Incentive is to encourage pharmaceutical/biotech firms in Karnataka to undertake bio-availability, bio-equivalence and clinical trial studies by offering a financial subsidy. For your business, if you are investing in clinical trials infrastructure or conducting trials in the state under the approved policy, you can benefit by receiving subsidy support which reduces your cost burden and supports your R&D/validation activities.
Key Features
- Applicable only in Zone 1 & Zone 2: The policy restricts the clinical trial subsidy component to industrial units located in lesser-developed zones of Karnataka in order to encourage spread of investment beyond more developed areas.
- Subsidy of 20% of eligible cost: The policy mentions that for clinical trials (bio-availability / bio-equivalence), the incentive rate is 20% of the cost incurred in the approved trial. This means if your cost is ₹ 50 lakh, you may get ₹ 10 lakh subsidy.
- Maximum subsidy amount ₹ 1 crore per trial: Regardless of the cost, the maximum subsidy for one trial is capped at ₹ 1 crore under this incentive.
- Applies to pharmaceutical/med-device enterprises: The incentive is part of the policy’s section on Pharmaceuticals & Medical Devices – meaning only enterprises in these sectors are covered.
- Requires compliance with policy conditions: To avail this benefit you must make new investment under the policy, locate in the correct zone, apply for in-principle approval, and later submit claim documentation as per policy guidelines.
Financial Assistance
Eligibility Criteria
Who can apply:
- The enterprise must be registered under the Industrial Policy 2020-25 as a pharmaceutical / med-device company and must locate the clinical trial facility in Karnataka.
- The unit must locate in Zone 1 or Zone 2 of Karnataka to avail this specific incentive.
- The cost must relate to a bio-availability / bio-equivalence / clinical trial programme as defined within the policy.
- The investment must fall within the policy period and must receive in-principle approval under the policy.
- The unit must apply and follow the claim process as defined in the policy guidelines.
Who cannot apply:
- Units located in Zone 3 or Zone 4 will not be eligible for this subsidy under the clinical trials incentive component.
- Trials that do not fall under the eligible categories (bio-availability/bio-equivalence or defined clinical trial scope) may not qualify.
- Costs incurred before obtaining in-principle approval under the policy may not be eligible.
- Entities availing incentives under another state policy may not double-dip unless allowed by the state guidelines.
Documents Required
- Unit registration certificate (pharma manufacturing/R&D unit) in Karnataka.
- In-principle approval letter under the Karnataka Industrial Policy 2020-25 .
- Details of the trial: scope (bio-availability/bio-equivalence), agreement with CRO, trial protocol.
- Cost invoices/receipts for trial expenditure .
- Zone classification certificate indicating the unit is in Zone 1 or Zone 2.
- Bank account details for reimbursement credit.
Application Process for the Scheme
Option 1: Apply with Bullit
Click here to start with guided support. Our team verifies eligibility, compiles documents, and handles application & follow-ups on your behalf. You can monitor progress while focusing on operations.
Recommended for: Pharma/R&D units seeking streamlined filing of this specific incentive and expert support.
Option 2: Direct Application via Karnataka Udyog Mitra / Single Window System
- Ensure your unit is registered and eligible under the policy sector list .
- Conduct the bio-availability / bio-equivalence trial in Karnataka and incur expenditure.
- Collect all cost invoices, trial certificates, CRO agreements, zone classification certificate and other supporting documents.
- Submit a claim for reimbursement (20% of cost, up to ₹ 1 crore) via the Single Window portal – select the “Clinical Trials” incentive head under Pharma sector.
- After verification by the nodal agency, reimbursement will be released into the unit’s bank account.
Option 3: Via Ecosystem Partner / Pharma Cluster Facilitation
- Join a recognized pharma cluster or corridor in Karnataka where trial infrastructure/CROs exist.
- Collaborate with them and ensure your trial is located in Karnataka, meets eligible criteria, and your documentation is ready.
- Use the cluster facilitator’s support to apply for the incentive via the Single Window system following steps in Option 2.