Haryana Pharmaceutical Policy-2019

Mar 15, 2019 | by Avantis RegTech Legal Research Team

The Department of Industries & Commerce, State Government of Haryana on March 06, 2019, has notified Haryana Pharmaceutical Policy-2019 at Annexure A (Page 2). 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’. Generic drugs or formulations produced in India are not only consumed domestically, but also in developed and developing countries across the globe. This sector is one of the nation’s prestigious sectors with a global reputation for its cost-effective quality. India has emerged as a key manufacturing hub for generic formulations by producing cost-effective and quality drugs. As a result, the demand for input chemicals has increased. This policy targets to transform Haryana into a hub for the Pharmaceutical industry to do business by facilitating a conducive industrial ecosystem comprising robust infrastructure, financial assistance and a simplified regulatory regime. This policy will be valid for five years from the date of Notification or till the time any new policy or amendment is introduced by Government of Haryana.

This Policy aims to:

•Implement an enabling regulatory environment for Pharmaceutical sector, with investor friendly and time-bound clearance delivery system,

•Focus on holistic Pharmaceutical cluster development,

•Provide fiscal and non-fiscal benefits to units setting up in the Pharma Park, in a dedicated and streamlined manner,

•Develop quality industrial infrastructure to support entrepreneurs in the State,

•Enhance human capital and effectively bridge the gap between academia and industry to optimally utilize resources,

•Provide land at subsidized rates to entrepreneurs for establishing Pharma units, 

•Encourage environment friendly activities in the Pharma industry,

•Effectively utilize the Single Window clearance mechanism, providing clearances in a time-bound manner, 

•Ensure time-bound implementation and effective monitoring of the Pharmaceutical policy.

Regulatory Regime:

1.The Government of Haryana will integrate all Pharma sector related clearances with the Single Window portal of the State to provide clearances in a time-bound, completely online, and streamlined manner.

2.Auto or deemed renewal of licenses.

3.All Pharma manufacturing licenses in the purview of the State will be integrated in the Invest Haryana (HEPC) portal.

4.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 are not banned or prohibited by Government of India under Section 26-A of Drugs Act.

[Notification No.25/04/2019-41B-I.]

Click here to download the Notification.


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