To promote setting up of bulk drug parks in the country for providing easy access to world class Common Infrastructure Facilities (CIF) to bulk drug units located in the park in order to significantly bring down the manufacturing cost of bulk drugs and thereby make India self-reliant in bulk drugs by increasing the competitiveness of the domestic bulk drug industry. Promotion of Bulk Drug Parks scheme subsidy for bulk drug park
To help industry meet the standards of environment at a reduced cost through innovative methods of common waste management system.
Active Pharmaceutical Ingredient (API):
Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body.
Common Infrastructure Facility (CIF):
The Common facility with capacity commensurate with the expected number of manufacturing units in the bulk drug park, provided by the State Implementing Agency (SIA). Common facilities include:
i. Central Effluent Treatment Plant(s) (CETP)
ii. Solid waste management
iii. Storm water drains network
iv. Common Solvent Storage System, Solvent recovery and distillation plant
v. Common Warehouse
vi. Dedicated power sub-station and distribution system with the necessary transformers at factory gate
vii. Raw, Potable and Demineralised Water
viii. Steam generation and distribution system
ix. Common cooling system and distribution network
x. Internal road network, Compound Wall Note: The cost of these components (mentioned at serial no. x) shall not exceed 15% of the total project cost.
xi. Common logistics (Clearing and Forwarding, Insurance, Transportation, Customs, Weighbridges, etc.)
xii. Advanced laboratory testing Centre, suitable for even complex testing/ research needs of APIs, including microbiology laboratory and stability chambers
xiii. Emergency Response Centre
xiv. Safety! Hazardous operations audits centre
xv. Centre of Excellence:
a) Regulatory awareness facilitation Centre
b) Technology business incubator
c) Intellectual Property Rights management services
d) Process! technology development laboratory! Research Laboratory! with pilot plants run by eminent scientists with track record of such competitive technology development for import substitution
e) Industry Academia linkage Centre
f) Training centre Bulk Drug Park: For the purpose of this Scheme, a bulk drug park means a designated contiguous area of land with common infrastructure facilities for the exclusive manufacture of APIs or Dis or KSMs.
Scope of the Scheme
1. This is a Central Sector Scheme.
2. Total financial outlay of the Scheme is Rs. 3000 Crore.
3. Three bulk drug parks will be supported under the Scheme.
4. Maximum grant-in-aid for one bulk drug park will be limited to Rs 1000 crore.
5. The duration of the Scheme is from FY 2020-202 1 to FY 2024-2025.
6. Under the scheme, a one-time grant-in-aid will be provided for creation of common infrastructure facilities in selected Bulk Drug Park proposed by a State Government.
7. The scheme will be implemented through a State Implementing Agency (SIA), a legal entity, set up by the concerned State Government.
8. The grant-in-aid will be 70% of the project cost of the common infrastructure facilities (CIF). In case of North Eastern States and Hilly States (i.e Himachal Page 3 of 3:1. Pradesh, Uttarakhand, UT of Jammu & Kashmir and UT of Ladakh), the grantin-aid will be 90% of the common infrastructure facilities.
9. The Formulation units shall not be permitted in the Park.