'Bio-Technology (BT) Unit' means a unit engaged in Research and Development and/or manufacture of products which use or are derived by using (a) living systems, (b) enzymes, (c) Bio-catalysts derived therefrom, in any of the following fields:

1. Genetic Engineering/ Gene Engineering
2. Cell Engineering/ Cell Culture
3. Bio process engineering
4. Protein Engineering
5. Tissue Engineering
6. Microbiology
7. Bio-chemistry
8. Bio-Informatics - Assembly of data from genomic analysis into accessible form
9. Genomics - The molecular characterization of all species
10. Bio-Transformation - The introduction of one or more genes conferring potentially useful traits into plants, livestock fish and tree species
11. Molecular breeding - The identification and evaluation of desirable traits in breeding programs by the use of marker assisted selection for plants, trees, animals and fish
12. Embryo Manipulations
13. Pharmacogenomics
14. Proteomics
15. Allo-transplantation
16. Xeno Transplantation
17. Bio Chips
18. Gene Therapy
19. Bio-instrumentation
20. Regeneration technology
21. Biological Drugs

The BT Park should have minimum land area of 2 acres or 20000 Sq.ft. of Built Up Area (BUA).

1. For getting LOI as BT unit

One has to apply in prescribed application form along with following documents to Competent Authority

1. Affidavit (Annexure-V)
2. Certificate from designated Certifying Agency (Annexure -VI)
3. Locational clearance from DI/JDI,MMR/MIDC/Local Authority, as the case may be.
2. Existing BT Units

Those which have started their BT activities / production should apply for BT Registration with the following documents to Competent Authority.

1. Application for Registration in the prescribed form (Annexure-IV)
2. Affidavit (Annexure-V)
3. Locational clearance from Directorate of Industries / MIDC Local/ Authority as the case may be
4. C.A's certificate regarding turnover of Bio-Tech products / activities exceeding 75% of total turnover (Annexure-VII)
5. BT Letter of Intent (if obtained)
6. Certificate from designated Certifying Agency (Annexure-VIII) for existing BT unit

For getting LOI/ Registration as BT Park, one has to apply in prescribed application form along with following documents to Competent Authority.

1. Developer company constitution documents.
1. For Private Limited Company
1. Certificate of incorporation with memorandum & Article of Association.
2. Board resolution for development of BT Park
3. Letter of Authority for application (Authorized signatory)
2. For Public Ltd. Company
1. Certificate of incorporation with memorandum & Article of Association.
2. Board resolution for development of BT Park
3. Letter of Authority for application
3. For partnership Firm
1. Copy of partnership deed
2. Copy of firm registration
3. Letter of authority for application
4. Cooperative Society
1. Registration under Society Act
2. Letter of authority for application
5. Charitable Trust
1. Registration under Public Charitable Trust Act
2. Letter of authority for application
2. Land Documents
1. For own Land
1. Copies of 7/12 abstract of Land
2. Copy of index
3. Copy of Property Card
4. ULC /MTAL Permission if applicable
2. For lease/Development Agreement land
1. Copy of Agreement executed with the Landlord
2. Power of authority to leases
3. Copy of Land possession letter
4. ULC Permission if applicable
3. Copy of Challan of fee deposited in Govt. treasury for ₹ 5000/
4. Copy of Zone confirmation certificate issued by appropriate authority
5. Building Plan approval copy with letter of approval
6. Copy of Building construction commencement certificate issued by appropriate authority
7. MPCB consent for establishment of BT Park
1. Permission for CETP
2. Solid Hazardous waste disposal agreement approval
8. Copy of receipt of application submitted to (Whichever is applicable)
1. Ministry of Environment and Forests (MoEF)
2. Genetic Engineering Approval Committee (GEAC)
3. Indian Council of Medical Research (ICMR)
4. Maharashtra Pollution Control Board (MPCB)
5. Drugs and Cosmetics Act, Ministry of Health and Family Welfare
6. Atomic Energy Regulatory Board (AERB)] Govt. of India
7. CPCSEA (Committee on Prevention of Cruelty and Supervision of Experiments on Animals)
9. Water supply arrangement made
1. Proof of Water supply arrangement for BT Park
2. Provision of common supply for distilled water / chilling plant requirement of laboratories likely to be established in BT Park.
10. Motive Power
1. Agreement made for dedicated substation for required motive power
2. Separate feeder for dedicated substation
3. Standby arrangement for not less than 30% of total power requirement
11. Affidavit in prescribed form provided with application form.
12. Agreement made for utilities
1. Chilling plant
2. Steam generation
3. Storage facility (Raw material and finished product)
13. Building plan approval from Department of Industrial Safety and Health.

For Greater Mumbai, the Competent Authority is Joint Director of Industries, Mumbai Metropolitan Region and for rest of the Districts, the Competent Authority is General Manager, District Industries Centre of respective District.

For BT Parks located within Mumbai Metropolitan Region, the Competent Authority is Development Commissioner (Inds.), Directorate of Industries, Mumbai. For BT Parks located outside Mumbai Metropolitan Region, the Competent Authority is the General Manager, District Industries Centre of respective District.

Once the BT unit gets LOI / Registration, it is entitled to get various incentives such as Industrial Promotion subsidy, Stamp duty exemption and Electricity duty exemption, etc. under Package Scheme of Incentives.

Once the BT Park gets LOI / Registration, it is entitled to get double floor space index from respective Planning Authority, upon payment of 25% premium of the present day market value of the land under reference as indicated in the Ready Reckoner.

Following is the List of Designated Certifying Agencies:

For granting LOI / Registration as BT unit, no fees is charged. However, for getting LOI / Registration as BT park, the applicant has to pay ₹ 5000/- as processing fees in the prescribed challan to RBI under following head :
Head of the Account
“0851 Village & Small Industries 102,
Small Scale Industries Cottage & Small Industries
00851-002-6”

Yes, provided the existing BT unit / units outside park should have minimum land area of 2 acres or 20000 Sq.ft. of Built Up Area (BUA).

Out of total Builtup area of BT park, minimum 90% should be used for Biotechnology purpose and maximum 10% can be used for support services such as Cafeteria, Small Club House and Conference and Video Conferencing Hall.