Haryana Government rolls Haryana Pharmaceutical Policy-2019; aims to build a robust infrastructure, give financial assistance & have simplified regulatory regime for both existing and new units
The Department of Industries & Commerce, Government of Haryana has on 6th March, notified the Haryana Pharmaceutical Policy-2019 (“Policy”). The Policy will be valid for 5 years or till the time any new policy/amendment is introduced by Government of Haryana, whichever is earlier.
The Pharmaceutical industry is one of the fastest growing industrial sectors and India is among the leading countries for producing generic drugs and is known as the ‘Pharmacy of the World’ because of its cost-effectiveness and quality. Generic drugs/Formulations produced in India are not only consumed domestically, but also in several countries across the globe.
The Policy aims to transform Haryana into a hub for the Pharmaceutical industry to do business easily. This will be done by facilitating a holistic industrial ecosystem comprising a robust infrastructure, financial assistance and a simplified regulatory regime.
- The Government of Haryana has taken key initiatives in developing enabling industrial infrastructure to support new entrepreneurs.
- The State intends to establish a Pharma Park at Karnal with two separate zones. One for Formulation manufacturing and the other for Active Pharmaceutical Ingredients manufacturing.
- State government will also provide common facilities such as Common Cluster Lab and Common Effluent Treatment Plant for this Park (in the formulations manufacturing zone) with guidelines and designs provided by the Haryana State Pollution Control Board.
- Setting up in the Pharma Park at Karnal will be eligible for a special package of incentives, in addition to benefits as per Haryana Enterprises Promotion Policy 2015.
- Fiscal incentives for new units will be applicable as per investment category, as mentioned in the Haryana Enterprises Promotion Policy 2015.
- Incentives will be applicable for units setting up in the upcoming Pharma clusters and Parks (i.e Karnal).
- Capital Subsidy would include Reimbursement of 25% of cost of plant and machinery subject to a maximum of INR 50 lakh.
- Interest Subsidy will be to the extent of 5% per annum for 5 years in the form of reimbursement of interest paid on loan taken to meet the working capital requirements, subject to annual ceiling of INR 25 lakh per annum per unit.
Simplified Regulatory Regime:
- Integration of Pharma related clearances in the Single Window
Government of Haryana will integrate all Pharma sector related clearances with the Single Window portal of the State i.e HEPC (Invest Haryana-www.investharyana.in), to provide clearances in a time-bound, completely online, and streamlined manner.
- Auto/deemed renewal of licenses
For the purpose of Ease of Doing Business drug manufacturing licenses/approvals for entrepreneurs to remain valid for lifetime unless and until suspended or cancelled.
- Timely grant of manufacturing licenses
All Pharma manufacturing licenses in the purview of the State will be integrated in the Invest Haryana (HEPC) portal. Timelines for granting of clearances will be 30 days and deemed clearances in 45 days.
- Approval for manufacturing and sale of all rational drugs that have been approved by neighbouring state licensing authorities/expert committees
Approvals will be granted by the Government of Haryana to all rational drugs which have been approved by neighbouring State licensing authorities and declared rational by the expert committees constituted by Government of India and are not banned/prohibited by under Section 26-A of Drugs Act.