(1043)
Haryana Government Gazette
EXTRAORDINARY
Published by Authority
© Govt. of Haryana
No. 42-2019/Ext.] CHANDIGARH, WEDNESDAY, MARCH 6, 2019 (PHALGUNA 15, 1940 SAKA)
HARYANA GOVERNMENT
INDUSTRIES AND COMMERCE DEPARTMENT
Notification
The 6th March, 2019
No. 25/04/2019-4IB-I.— The Governor of Haryana is pleased to notify Haryana Pharmaceutical Policy-2019
which will be effective from date of Notification. The Haryana Pharmaceutical Policy-2019 is placed at annexed ‘A’.
2.
This is issued with the concurrence of the Finance Department vide their U.O. No. 1/28/2019-1FD-III dated
04.02.2019.
DEVENDER SINGH,
Chandigarh:
Additional Chief Secretary to Government of Haryana,
The 6th March, 2019.
Industries and Commerce Department.
1044
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
Annexure-‘A’
Pharmaceutical Policy-2019
Department of Industries & Commerce
Government of Haryana
1
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1045
Contents
1.
Preamble: Industry overview in India…………………………………………………….. 3
2.
Policy targets……………………………………………………………………………… 4
3.
General terms and conditions……………………………………………………………... 4
4.
Industry overview: Haryana perspective………………………………………………….. 5
5.
Fiscal incentives……………………………………………………………………………6
6.
Simplified regulatory regime……………………………………………………………… 7
7.
Infrastructure augmentation and State support……………………………………………. 8
8.
Human capital development………………………………………………………………10
2
1046
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1.
Preamble: Industry overview in India
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/Formulations produced in India are not only consumed domestically, but also in
developed and developing countries across the globe. Currently topping the science-based
industries in India, the Pharmaceutical sector is an industry with over 20,000 registered units. This
sector is one of the nation’s prestigious sectors with a global reputation for its cost-effective
quality. Ranked highly specially among the developing countries, the industry in India it ranges
from generic drugs formulations to APIs (Active Pharmaceutical Ingredients), bulk drugs and
medical devices.
Majorly competitive in nature, the sector is also regulated by the Government in terms of price
controls through NPPA (National Pharmaceutical Pricing Authority). 70% of the nation’s demand
and 30% of the need of the international market is met by the domestic Pharmaceutical industry.
About 250 large enterprises and 8000 MSMEs dominate this sector in India.
India is among the top 5 emerging pharma markets in the world. With increase in health
awareness and life expectancy, the domestic consumption of medicines is also increasing.
Salient features of Pharma industry in India:
Third largest pharmaceuticals market by 2020 in terms of incremental growth
20% of global exports in generics, making it the largest provider of generic medicines
globally
Industry revenues are expected to grow by a CAGR of 12% during 2012-20 and reach USD
45 bn.
Over the years, 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. Domestic demand is expected to remain strong as number of patients having access to
healthcare services increases. With pharmaceutical companies taking steps to meet US Food and
Drug Administration (USFDA) norms, export growth is expected to pick up. Presently, it is the
need of the hour for India to focus on increasing bulk drugs and API production within the
country itself, to end the dependency on other countries.
3
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1047
2.
Policy targets
2.1
Vision
To transform Haryana in to a hub for the Pharmaceutical industry to do business and thrive;
by facilitating a conducive and holistic industrial ecosystem comprising robust
infrastructure, financial assistance and a simplified regulatory regime.
2.2
Mission
(i)
Implement an enabling regulatory environment for Pharmaceutical sector,
with investor friendly and time-bound clearance delivery system
(ii)
Focus on holistic Pharmaceutical cluster development
(iii)
Provide fiscal and non-fiscal benefits to units setting up in the Pharma Park,
in a dedicated and streamlined manner
(iv)
Develop quality industrial infrastructure to support entrepreneurs in the State
(v)
To enhance human capital and effectively bridge the gap between academia
and industry to optimally utilize resources
(vi)
Provide land at subsidized rates to entrepreneurs for establishing Pharma units
(vii)
Encourage environment friendly activities in the Pharma industry
(viii) Effectively utilize the Single Window clearance mechanism, providing
clearances in a time-bound manner
(ix)
Ensure time-bound implementation and effective monitoring of the
Pharmaceutical policy
2.3
Objectives
(i)
To attract investment in the Pharmaceutical sector to the tune of INR 2000 Cr.
(ii)
To generate 25,000 new jobs in the Pharmaceutical sector
(iii)
Successfully establish a state-of-the-art Pharma Park at Karnal
(iv)
To develop Haryana into a hub for pharmaceutical manufacturing by
facilitatingand creating a holistic industry, academia and R&D ecosystem
3.
General terms and conditions
•
For the purpose of this policy all terms and definitions shall be as per the Haryana
Enterprises Promotion Policy 2015
•
This policy will be valid for 5 years from the date of notification or till the time any
new policy/amendment is introduced by Government of Haryana, whichever is
earlier
•
Doubts relating to interpretation of any term or any provision under this policy will
be referred to the Department of Industries & Commerce, Government of Haryana,
for clarification/resolution. The decision of the State government shall be final and
binding for all stakeholders in all cases.
4
1048
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
4.
Industry overview: Haryana perspective
The Government of Haryana, under the leadership of the visionary Chief Minister, is
proactively involved in promoting the Pharmaceutical sector in Haryana.
4.1
Strategic location
Haryana’s enjoys a locational advantage, characterized by its geographical
confluence with economic corridors (DMIC, AKIC, and Eastern peripheral
corridor), Special Economic Zones, investment regions and big ticket infrastructure
projects. With a strategic location in close proximity to the National Capital
Region, excellent air, road and rail connectivity and two international airports,
Haryana is an ideal destination for new businesses to flourish. Through its
Enterprise Promotion Policy 2015, the Government of Haryana lists the
Pharmaceutical sector as one of the focus sectors for development. The State at
present, is one of the leading exporters in the nation with the total value of State
exports valued at INR 69,485 crores (3 year average-2014-2017). Therefore in line
with its global orientation towards facilitating exports in the Pharma sector, the
State Government endeavors to provide the necessary support by way of creating
the necessary land bank, technology ecosystem and transport facilities.
4.2
Quality infrastructure
The Government of Haryana has taken key initiatives in developing enabling
industrial infrastructure to support new entrepreneurs.
•
Haryana ranks 4th in the infrastructure Index developed by the Central for
Monitoring Indian Economy (CMIE) 2012
•
Approximately 2/3rd of Haryana lies in NCR region- 13 districts of the state
are part of National Capital Region (NCR)- one of largest consumption &
trade zone of India
•
The entire State is within a 250 km radius from the international airports at
New Delhi & Chandigarh
•
Industrial corridors - beltway to spur economic activity
15 National Highways pass through Haryana
Delhi - Mumbai Industrial Corridor (DMIC)
Kundli-Manesar-Palwal Expressway (KMP)
5
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1049
4.3
Upcoming Pharmaceutical Park at Karnal
•
The State intends to establish a Pharma Park at Karnal. Karnal is a centrally
located district with excellent road (situated on NH-) /rail (Delhi Ambala
broad gage line, where Delhi and Ambala are both junctions) and air
connectivity
•
The Pharma Park will comprise two separate zones for
i.
Formulation manufacturing
ii.
API manufacturing
•
The State government will 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
•
Since the State government intends to establish CETP for formulation units in
the Karnal Pharma Park, the pollution clearance will be obtained by the
SPV/implementing agency
•
For API and bulk drug units, being polluting industries in the red category,
ETP plants will be set up by the individual units themselves. However, the
technical guidance and clearances will be provided by the State Government.
•
New units 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 (as specified in section 5.2)
5.
Fiscal incentives
5.1
Incentives applicable for new units:
Fiscal incentives for new units will be applicable as per investment category, as
mentioned in the Haryana Enterprises Promotion Policy 2015.
5.2
Incentives applicable for units setting up in the upcoming Pharma clusters and
Parks:
The Government of Haryana envisages to establish a centrally located
Pharmaceutical Park at Karnal.
In addition to incentives offered under the Haryana Enterprises Promotion Policy
2015, all new units setting up in the Pharma Parks in the State will be eligible for a
special package of incentives as follows:
6
1050
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
Sr.
Parameter
Incentive
no
1
Capital
Subsidy
Reimbursement of 25% of cost of plant and machinerysubject
to a maximum of INR 50 lakh.
2
Interest
Subsidy
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.
3
Employment
generation
subsidy
*Only if
applicable
For capacity building of persons belonging to Haryana
(skilled/semi-skilled, the subsidy @ Rs. 36,000 per year for
SC/ Women and Rs. 30,000 per year for General category for
5 years.
6.
Simplified regulatory regime
6.1
Integration of Pharma related clearances in the Single Window
In order to simplify the regulatory processes for new investors in the Pharma
industry in Haryana, the 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.
6.2
Auto/deemed renewal of licenses
The Government of Haryana for the purpose of Ease of Doing Business has
omitted the word “renewal” and made the drug manufacturing licenses/approvals
for entrepreneurs to remain valid in perpetuity unless and until suspended or
cancelled. The licensee can thus retain their licenses, by payment of retention fee
online.
6.3
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 all licenses will be included in
HEPA, 2015 i.e granting of clearances in 30 days and deemed clearances in
45 days.
6.4
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 Are not
banned/prohibited by Government of India under Section 26-A of Drugs Act.
7
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1051
7.
Infrastructure augmentation and State support
7.1
Support for Developers of Pharma Park at Karnal: 100% of the cost of external
and internal infrastructure development will be borne by State Government subject to
a ceiling of 50 Cr., to develop Pharma Park in Karnal
7.2
Support for setting up of Common Effluent Treatment Plant (CETP) for
Formulations and API units in Pharma Park/Cluster: The Government of
Haryana intends to support Pharma units in the State by bearing the capex for setting
up of secondary ETP (CETP) for units in Pharma Park/Cluster. The running
expenditure for the same will be borne by the units as per their usage.
7.3
Promotion of API/Bulk Drug manufacturing Parks: The Government of Haryana,
dovetailing with the focus of the Central Government, will work towards dedicatedly
promoting and supporting the setting up of API Parks in Haryana.
7.4
State Drug Testing Laboratory: The Government will provide additional manpower
and facilities in terms of State Drug Testing Laboratories. The Government will
continuously upgrade the State Drug Testing Laboratories, which will be equipped
with state-of-the-art modern testing equipment and infrastructure. The Government
intends to establish mobile Drug Testing Laboratories to increase the confidence of
consumers and ensure easy accessibility of testing facilities for all citizens.
7.5
Common Cluster Laboratory: The Government of Haryana intends to provide
support to the Common Cluster Laboratory established at Karnal which is equipped
with modern testing equipment and facilities. This will reduce the cost of testing
borne by the units in the Pharma Park and help in assuring the quality of drugs.
7.6
Support for research companies and laboratories: The Government of Haryana
will facilitate collaborations and matchmaking between research organizations,
Pharma industry players and educational institutes.
8
1052
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
7.7
Simplification of tender processes: The Government of Haryana intends to simplify
tender processes in the State by introducing a provision of obtaining tender
participation certificates online within a timeline of 2 working days. This facility will
be integrated with the Single Window system of the State along with the provision of
e-signatures by the concerned authorities.
7.8
Promotion of Government of India- Scheme for development of Pharmaceutical
industry
In order to facilitate the growth of the domestic pharmaceutical to play a lead role in
the global market and ensure availability of good quality pharmaceuticals of mass
consumption thereby assuring drug security in the country, the Department of
Pharmaceutical, Ministry of Chemicals and Fertilizers, Government of India, has
introduced a scheme for development of the pharmaceutical industry in India which
comprises five sub-schemes namely:
(i)
Assistance to Bulk Drug Industry for Common Facility Centre (CFC):
Focused on providing easy access to standard testing and infrastructure
facilities and value addition in the domestic Bulk Drug Industry through
creation of common world class facilities, strengthening existing infrastructure
facilities and reducing the cost of production by 20-25% in the Bulk Drug
Park
(ii)
Assistance to Medical Device Industry for Common Facility Centre
Focused on providing easy access to standard testing and infrastructure
facilities and value addition in the domestic Medical Device Industry through
creation of common world class facilities, strengthening existing infrastructure
facilities and reducing the cost of production significantly in the Medical
Device Park
(iii)
Cluster Development Programme for Pharma Sector
Focused on providing easy access to standard testing facilities and value
addition in the domestic pharma industry especially to SMEs through creation
of common world class facilities
(iv)
Pharmaceuticals Technology Upgradation Assistance Scheme
Focused on promotion, development and export promotion in Pharma sector
by extending financial support for conduct of seminars, conferences,
exhibitions as well as conducting studies/consultancies for facilitating growth
(v)
Pharmaceutical Promotion and Development Scheme
Focused on providing interest subvention to the eligible Small and Medium
Scale Pharma Units having GMP compliant manufacturing facilities both for
Bulk Drugs and Pharma Formulations, which are intending to upgrade their
manufacturing infrastructure to attain WHO-GMP norms, and have to secure
loan from any Financial Institution for upgrading their infrastructure and
technology
In this regard, Government of Haryana will align with the guidelines shared by
Government of India for the aforementioned scheme comprising five sub-schemes, to
boost the Pharmaceutical industry in Haryana.
9
HARYANA GOVT. GAZ. (EXTRA.), MAR. 6, 2019 (PHGN. 15, 1940 SAKA)
1053
8.
Human capital development
8.1
Training programmes will be designed for pharma workers under the Haryana
Skill Development Mission. Under this training model, partnerships between
Universities and Pharma companies will be facilitated by the State Government.
Specific and industry-aligned job courses will be designed and introduced at Haryana
Vishwakarma Skill University, as per industry requirements, thus increasing the
competent labour pool in the State.
8.2
The Government of Haryana will facilitate industrial and regulatory trainings for
B.Pharm/M.Pharm students in industrial units of the Pharma Park at Karnal
10
56938—C.S.—H.G.P., Chd.