BT REGN CIRCULAR

Speed Post/By Registered Post A. D. BT/BTU/Registration/(3)/2002/A-7685

H. O. CIRCULAR No - 21/2002 Directorate of Industries,

New Administrative Bldg.,

Opp.Mantralaya, Mumbai-32.

E.mail:- dcind@vsnl.com(registry)

Fax No. 202 6826

Date : 23/08/2002

1. Joint Director of Industries

Mumbai/Nagpur / Aurangabad / Pune / Nasik Region,

2. Technical Advisor

Maharashtra Industries Development Corporation,

Mahakali Caves Road, Andheri (E),

Mumbai - 400 093.

3. Convenor,

Udyog Mitra,

' Nirmal ', 12^th floor,

Nariman point,

Mumbai - 400 021.

4. Supdt. Industries Officer,

Kokan / Amravati Region,

Thane / Amravati

5. General Manager,

District Industries Center.

(All)

Sub: - Maharashtra Biotechnology Policy 2001 -

Letter of Intent / Registration of Bio Technology (BT) Units for availing of various State incentives.

Ref. :- Government (I E & L D) Resolution No. BTH-2001 / 5058 / Ind-2, dated 29 January, 2002

1. The State Government have announced various fiscal and non-fiscal incentives to give an impetus to Bio-Technology (BT) in the State. In order to enable identification of BT units so that these incentives can be applied to them, BT units need to obtain a Letter of Intent (LOI) /Registration from the designated Registering Authorities listed at Para 5. The procedure for grant of LOI /Registration has been finalized in consultation with the Task Force constituted to formulate the Maharashtra Bio-Technology Policy 2001.

2. Definition of BT Unit.

2.1 '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. Bio-Diagnostics - ( The use of molecular characterization to provide more accurate and rapid identification of pathogens and other organisms)

13. Bio-Immunology ( Vaccine Technology ) - ( The use of modern immunology to develop recombinant DNA vaccines for improving control against lethal diseases)

14. Embryo Manipulations

15. Pharmacogenomics

16. Proteomics

17. Allo-transplantation

18. Xeno Transplantation

19. Bio Chips.

20. Gene Therapy

2.2 The term 'unit' refers to a legal / corporate entity (e.g. a Public or Pvt. Limited Company / Partnership or Proprietorship Firm / Registered Society or Trust/Cooperative Society), or a distinct locationally separate facility of such an entity.

3. Classification of Bio-Technology Units:

3.1 BT units are classified into four groups depending on their focus field, namely (a) Human and Animal Health Bio-Tech products and processes unit, (b) Agricultural Bio-Tech products and processes unit, (c) Industrial and other Bio-Tech products and processes unit, (d) Composite Bio-Tech unit undertaking Bio-Tech activities covered under two or more of the above categories. (In the case of Agricultural Bio-Tech units, some of the incentives under the Bio-Technology policy are distinct from those for other categories)

3.2 LOI / Registration as a BT unit under any of these categories requires that the unit's annual turnover of BT products (projected or proposed, depending on whether the unit is already established or not) should exceed 75% of its total annual turnover in value terms. The activities / products under each of the first three categories are listed at Annexe-I. This list is illustrative and not exhaustive.

4. Certification as Bio-Technology Unit :

BT products and processes are varied, and it is not possible to draw up a comprehensive list in view of the nature and continuing new developments in this sector. Therefore, BT units which are certified as such, keeping in view the illustrative lists, by the designated Certifying Agencies mentioned at Annexe-II, would be considered for LOI/Registration as Bio-Tech unit. The formats for Certification are at Annexe-VI & VIII

5. Registration Authorities:

5.1 The following agencies are designated as Registering Authorities for issue of Letter of Intent and Registration to different categories of BT units.

Sr. No	Scale of BT Unit	Registering Authority
1.	Large Scale Units	Joint Director of Industries (MMR) for units in Mumbai Metropolitan Region (outside MIDC area) Joint Director of Industries, Nagpur/Aurangabad/Pune/ Nashik Region. Supdtg. Industries Officer Konkan/Amravati Region ( In their respective jurisdictions)
2.	Large and Small-Scale Units located in MIDC areas of Mumbai Metropolitan Region	Technical Advisor, MIDC
3.	Small Scale Units in areas other than the above	Joint Director of Industries(MMR) And General Manager, DIC (In their respective jurisdictions)
4	Both large and Small BT units in SEZs	Development Commissioner, SEZ,

5.2 Large and Small - Scale BT units will be distinguished on the basis of the level of investment in plant and machinery. Small - Scale units will be those with investment in plant and machinery not exceeding Rs. 1 Crore, on the analogy of the ceiling laid down by Government of India for classification as Small - Scale Industry. (Any change in this ceiling in respect of SSI would apply automatically to BT units also). All other BT units (other than small scale BT units) would be considered to be Large -Scale units. The items to be included in the computation of investment in plant and machinery as per GoI guidelines for SSI are listed at Annexe-III

6. BT Letter of Intent (LOI):

6.1 Proposed units / existing units engaged in other (i.e. non-BT) activities, and now proposing to enter the BT field, will be granted Letter of Intent by the Registering Authority. The Letter of Intent will be valid for a period of three years in the first instance.

6.2 The proposed BT Units shall apply for Letter of Intent along with the following documents:

(a) Application in the prescribed form (Annexe-IV)

(b) Affidavit ( Annexe-V )

(d) Locational clearance from DI/JDI,MMR/MIDC/Local Authority, as the case may be;

6.3 The LOI will be valid for a period of three years from the date of issue. The unit may apply to the Registration Authority for revalidation of the LOI for a further period of three years indicating the effective steps taken for starting the activities, and why such activities could not be started so far. The application should be accompanied by a revalidated certificate from the designated Certifying Agency (Annexe-VI).

7. Registration:

7.1 As mentioned at para 6, a Letter of Intent will be granted to proposed BT units. After the BT Unit commences its activities, it would apply for Registration as BT Unit. BT Units which are already in operation, but do not hold LOI, can apply directly for Registration also.

7.2 Existing BT Units (those which have started their BT activities / production) should apply for BT Registration with the following documents.

(a)Application for Registration in the prescribed form (Annexe-IV).

(b) Affidavit ( Annexe-V )

(d) C.A's certificate regarding turnover of Bio-Tech products / activities exceeding 75 % of total turnover (Annexe-VII)

(e)BT Letter of Intent ( if obtained )

(f) Certificate from designated Certifying Agency

( Annexe-VIII for existing BT unit ).

8. CERTIFICATION BY DESIGNATED AGENCY:

8.1 Proposed and existing BT Units must obtain a certificate from the designated Certifying Agencies before applying for LOI / Registration. The Certifying Agency will issue a Certificate keeping in view the classification and illustrative lists mentioned at para 3, after examining the project report and taking into consideration the background, and qualifications, of the promoters. If required, the Agency may invite the Unit's representative / entrepreneur for discussion. Such certificate should be issued in the format at Annexe-VIII. Applications for such a certificate may be made on plain paper.

8.2 Certification Agencies are allowed to charge service fee of upto Rs.1000 per application

9. CHARTERED ACCOUNTANT’S CERTIFICATE:

A bio-tech unit may not be carrying out only bio-tech activities. But to get registered as a BT units, more than 75% of its annual turn over should be from BT activities. The C.A. should examine this and certify to this effect. The format of the C.A. certificate is at Annexe–VII.

10. REGISTERS AND LOI / REGISTRATION NUMBERS:

10.1 The Registering Authorities should maintain Registers for grant of LOI and Registration to Bio-Tech units of different categories in the formats at Annexe-XI.

10.2 The Registering Authorities should assign a unique chronological reference number to the LOI/Registration Certificate as follows:

'BT' /

followed by

'Health Bio-Tech' ( for Human and Animal Health Bio-Tech Products and Processes units/ 'Agro Bio-Tech' ( for Agriculture Bio-Tech products and processes units), 'Industrial and other Bio-Tech' ( for Industrial and other Bio-Tech products and processes units ) or 'Composite Bio-Tech' ( for composite Bio-Tech units) as the case may be.

followed by

‘LOI’ or ‘Registration’, as the case may be

followed by

‘No.11’/ (the State Code for Maharashtra)

followed by

'District Code' ( As per Annexe-X )

followed by

the name of the issuing authority 'D.C.(Industries)', ’MIDC’,’JDI’/SIO or ‘DIC’, as the case may be, with the name of the relevant Region / District in the case of the last two

followed by

the Serial No. in the relevant running Register.

11. SUBMISSION OF REPORTS:

Quarterly report of issue of LOI / Registration should be submitted by the registering authority to Joint Director of Industries (BT) in the prescribed format at Annexe-XI.

12. GOVT OF INDIA REQUIRMENT FOR REGISTRATION OF INDUSTRIAL UNITS -

12.1 For the proposes of guidance, it may be mentioned that industries are defined and governed inter alia, by Govt. of India stipulations under the Industries (Development & Regulation) Act, 1951.

Govt. of India have notified three schedules under the Act:-

Schedule I - Lists the industries reserved for public sector

Schedule II- Lists the industries which are subject to compulsory licensing, i.e. an Industrial license has to be obtain from Ministry of Industries & Commerce, GOI.

Schedule III - Lists the articles reserved for small-scale sector

12.2 The list given in Schedule II follow the Indian Trade classification (Harmonious System). For any Bio-Tech Product / activity that may be covered under the list, the manufacturer will have to apply to GOI for an Industrial License, whether it is In the Small or Large Scale.

12.3 In respect of new Large scale projects for manufacture of products not covered by compulsory licensing (Schedule II) the only requirement is that the industrial undertaking shall file an Industrial Entrepreneur's Memorandum (IEM) in the prescribed form to the Secretariat for Industrial approvals (SIA) in the Ministry of Commerce & Industry. The acknowledgment of the Memorandum from SIA should be enclosed with the application for BT LOI / Registration, in case the product/activity is covered under the Act.

12.4 Small Scale Industrial units in sector which do not requires compulsory license are not required to file Memoranda with SIA. However, it is likely that many of BT products / activities may be registrable as SSI. Such units can consider getting themselves registered as SSI with Directorate of Industries or registering authority designated for the purpose, because such Registration is often useful for other purposes also. However, such SSI registration is not mandatory.

12.5 In case of doubt, the Registration Authorities for BT units are advised to guide the application for BT LOI / Registration suitably.

Sd/-

(S. T. DABHADE)

Joint Director of Industries (BT)

For Development Commissioner (Inds).

Copy submitted for information (through E-mail) to:

1. Secretary (Industries), I.E. & L. department, Mantralaya, Mumbai

- 400 032.

2. Secretary (Trade & Commerce) department, Mantralaya, Mumbai

400 032.

Copy for information (through E-mail) to:

1. Development Commissioner, Office of Development Commissioner, Ministry of Commerce, Santacruz Electronics Export Promotion Zone, Andheri (E), Mumbai - 400 093

2. Managing Director, SICOM Ltd., Nirmal, Nariman Point, Mumbai-21.

3. Chief Executive Officer, MIDC, Mahakali Caves Road, Andheri (E), Mumbai

400 093.

4. Additional Director of Industries, Head Office, Mumbai - 400 032.

5. Dy. Secretary to Govt., I.E. & L. dept., Mantralaya, Mumbai - 400 032.

6. Joint Director of Industries, CSPO / SSIP / IT, Head Office, Mumbai - 400 032

7. Officer on Special Duty, Head Office, Mumbai - 400 032.

8. Supdt. Industries Officer (SUC), Head Office, Mumbai - 400 032.

9. Dy. Director of Industries, SSIP / CSPO / LIC /Chem /DIC Br., Head Office, Mumbai - 400 032.

10. Industries Officer, SSIP/ DIC / Export / NOC / LIC / IE Br., Head Office, Mumbai - 400 32.

11. All Associations.

12. All designated Competent Certifying Agencies

Annexe-I

ILLUSTRATIVE LIST OF PRODUCTS / ACTIVITIES UNDER DIFFERENT BT CATOGORIES (PARA 3) -

(a) HUMAN AND ANIMAL HEALTH BIO-TECH PRODUCTS AND PROCESSES

1. Cocktail Vaccines of DPT with Hepatitis-B

2. Tetanus toxoids with Hepatitis-B

3. Hepatitis-A with B

4. Influenza vaccines

5. Vericella and Meningitis vaccine

6. Typhoid Vaccines

7. Animal & Poultry Vaccine

8. Vaccine for protection against Hepatitis C, Hepatitis-E, HIV, Malaria, Tuberculosis. and Leishmaniasis

9. Recombinant viral vector vaccines

10. DNA Vaccines

11. Diagnostic based on Monoclonals

12. Fermentation derived or Semi- Synthetic peptides

13. Recombinant antigens or antibodies

14. Membranes of different molecular weight cut off

15. Diagnostic devices (antigen-antibody reaction)

16. Biotech Kits for estimation

17. Monoclonals

18. Monoclonal antigens/Antibodies

19. Recombinant Antigens / antibodies for various conditions

20. Specialty enzymes

21. Nucleotides

22. Therapeutic recombinant proteins

23. Interferon's

24. Human Growth Hormone

25. G-CSF

26. GM-CSF

27. Erythropoietin (EPO)

28. Skin bank

29. Tissue bank

30. Cell Transplantation Centres

31. Polyclonal antisera

32. Insulin

33. Blood factors VIII and IX

34. Urokinase

35. Tissue Plasminogen activator

36. Streptokinase

37. Drugs of therapeutic value

38. Interleukins and Tissue necrosis factors

39. Antibiotics

40. Fractionation of blood and blood products into cellular and non-cellular products

41. Sensitised immunoglobulins

42. Hyaluranic acid

(b) AGRICULTURE BIO-TECH PRODUCTS AND PROCESSES

1. Hybrid Seeds and High yielding varieties

2. Genetically modified plants

3. Genetically modified seeds

4. Bio-pesticides

5. Botanical pesticides

6. Bio-fertilizers

7. Pheromones

8. Growth stimulants with biological origin

9. Agriculture bio-tech food

10. Agriculture bio-tech feed

11. Probiotic aqua feed production

12. Micropropogation of Bamboo and forest plants

13. Waste Land Development through integrated bio-technology

14. Production of edible flavors with colours from fermentation process

15. Enzyme modified bread Technology

16. Freshwater pearl production

(c) INDUSTRIAL AND OTHER BIO-TECH PRODUCTS AND PROCESSES

1. Recombinant microbial strains

2. Bio-catalysts

3. Industrial enzymes

4. Food-grade enzymes

5. Simple microbial metabolites such as Organic acids and Amino acids

6. Specialty enzymes and Oligo nucleotides in molecular biology research

7. Analytical materials and reagents of biological origin

8. Application of biological materials in electronic devices

9. Fresh compressed yeast

10. Recovery of value added products from wastes such as proteins from milk whey, Bio-gas

11. Composted fertilizers from Municipal or Agriculture wastes

12. Better methods of recycling of organic wastes,

13. Specialty bio-chemicals if derived from fermentation processes

14. Value added NAD/NADH and specialty enzymes

15. Specialty plastics that are bio degradable

16. Biodegradation of waste by specific organisms for solid waste and wastewater management.

17. Environmental control by bioremediation using specific microorganisms grown for that purpose.

18. Recovery of materials in conventional processes using microbes or other biotech techniques.

19. Production of conventional chemicals utilizing fermentation or similar biotech techniques.

Annexe-II

List of Designated Certifying Agencies (paras. 4 & 8)

Head of Biotech Department,

Bhabha Atomic Research Centre,

Trombay, Mumbai 400 085

Tel : 5505002/5563128

Fax : 5505151

Head of Biotech Department,

Indian Institute of Technology,

Powai ,

Mumbai 400 076

Tel. : 5722545

Fax:5723480(G)/5723546 (P)

Head of Biotech Department,

Tata Institute of Fundamental Research,

Dr. Homi Bhabha Rd.,

Nevy Nagar, Colaba,

Mumbai 400 005.

Tel : 2172971

Fax 2152110/81

Head of Biotech Department,

University Department of Chemical Technology,

Nathalal Parikh Marg, Opp. Khalsa College, Matunga (East), Mumbai 400 019.

Tel : 4145616

Fax : 4145614

Head of Biotech Department,

Cancer Research Institute,

Tata Memorial Centre,

Mumbai 400 012.

Tel : 4136304/4184579

Head of Biotech Department,

National Centre for Cell Science,

N.C.C.S.Complex, Ganeshkhind

Pune 411 007.

E-mail - infonccs @ giaspnol.vsnl.net.in

Tel : 5690922/5690931/

5690941/5690951/

5692256/5692257

Head of Biotech Department,

National Institute of Virology

20-A, Dr. Ambedkar Road,Post Box No.11,

Pune 411001.

Tel : 6127301/2/3/4

Fax : 6122669.

Biochemical Sciences & Plant

Molecular Biology Unit,

National Chemical Laboratory,

Dr. Homi Bhabha Rd., Pune 411008

Maharashtra, India.

E-mail pkr @ evns.ncl.res.in.

Tel & Fax : 5893034

Head of Biotech Department,

Haffkin Institute,

Acharya Donde Marg, Parel,

Mumbai 400 012.

Tel : 4150826

Fax : 4161787

Head of Biotech Department,

Agharkar Research Institute

Agarkar Road, Pune 411 004.

Tel : 5652970/5654831

Fax : 5651542.

Director of Bio-Technology Deptt.,

Vasant Dada Sugar Institute,

Manjari Budruk,Tq.Haweli,

Distt. Pune 412 307

Tel: 9520 6993988/6993989 /94/95

Fax : 9520 6992735

Head of Biotech Department,

National Environmental & Engineering Research Institute, (NEERI), Nehru Marg,Nagpur 440020.

Tel: 0712 226071 Extn.205

Head of Biotech Department,

Vidyapratisthan School in Bio-Technology,

Vidya-Nagari, Bhigwad Road,

Baramath 413133

Tel : (02112) 43714/43489

Fax: 44800

Head of the Department of Bio-Technology, Dr. Punjabrao Deshmukh Krishi Vishwa Vidhyalaya (PKV)

Krishi Nagar Akola, Maharashtra.

Fax (0724) 58218/58219

58201/158091

Bio-informatics,

University of Pune, Pune 411007

Maharashtra, India.

E-mail director @ bioinfo.ernet.in

Tel : 5692039/5690195

Fax: 5690087

Head of the

Department of Bio-Technology Amravati University,

Amravati 444602, Maharashtra

Tel : 662206 to 8

Fax : 662135,660949

Head of the Department of Bio-Technology,

Konkan Krishi Vidyapeeth (KKV),

Dapoli, Distt. Ratnagiri,

Maharashtra 415712

Fax : ( 02358) 82074

Head of the Department of Bio-Technology,

Marathwada Agricultural University (MAU)

Parbhani, Distt. Parbhani,

Maharashtra 431402.

Fax : (02452) 235812.

Head of the Department of Bio-Technology, ( Tissue Culture Lab ),

Mahatma Phule Krishi Vidyapeeth (MPKV),

Rahuri, Distt. Ahmednagar, Maharashtra.

Tel : (02426) 43252

Head of the Department of Bio-Technology,

Director, Govt. Institute of Science,

Nipat Niranjan Nagar, Caves Road,

Aurangabad 431004, Maharashtra.

e-mail : institute_o1@ satyam.net.in

Tel : 331586,354814

Fax : 332103.

Head of Biotech Department,

Central Institute of Fisheries Education,

Versova, Mumbai 400 061.

Head of Biotech Department,

Institute for Research in Reproduction,

Jehangir Merwanji Street, Parel,

Mumbai 400 012.

Tel : 4148427/4144926

Head of the Department of Bio-Technology, University of Pune,

University Road, Pune 411 007.

Tel : 5695179

Fax : 5695179

Head of Biotech Department,

Department of Bio-Technology,

Rajiv Gandhi Bi-Technology Research

Institute, LIT Campus,

Amravati Road, Nagpur.

Tel : 560620

Fax 536223

Head of Biotech Department,

Faculty of Agricultural Sciences,

Yashwantrao Chavan Maharashtra Open University

Dnyan Gangotri, Near Gangapur Dam,

Nashik 422 222.

Tel : (0253) 230236

Fax : 231716

Head of Biotech Department,

Bio Informatics Centre,

University of Pune,

Pune - 411 007.

Tel.: 265 0087

Head of Biotech Department,

Food and Drugs Administration,

Bandra (East), Mumbai-400 051.

Tel.: 6592364/65, 6591820

Fax: 6591959

Head of Biotech Department,

Medical Education and Research,

St. Gorge Hospital Compound,

Mumbai-400 001.

Tel.: 2620363/2620735

Fax: 2620562/2652168

Annuxre-III

Computation of Investment in Plant and Machinery (Para-5.2)

1. While calculating the value of plant and machinery for the purpose of SSI limit, the original price irrespective of whether the plant and machinery are new or second hand, shall be taken into account.

2. While calculating the value of plant and machinery, the following shall be excluded -

i) the cost of equipment such as tools, jigs, dies, moulds and spare parts for maintenance and the cost of consumable stores,

ii) the cost of installation of plant and machinery,

iii) the cost of research and development equipment and pollution control equipment,

iv) the cost of generation sets and extra transformer installed by the undertaking as per the regulation of the Maharashtra State Electricity Board,

v) the bank charges and service charger paid to the National Small Industries Corporation or the Maharashtra Small Scale Industries Corporation,

vi) the cost involved in procurement or installation of cables wiring, bus bars, electrical control panels ( not those mounted on individual machines), oil circuit breakers or miniature circuit breakers which are necessarily to be used for providing electrical power to the plant and machinery or for safety measures,

vii) the cost of gas producer plants,

viii) transportation charges (excluding of sales-tax and excise) for indigenous machinery from the place of manufacturing to the sites of the factory,

ix) charges paid for technical know-how for erection of plant and machinery

x) cost of such storage tanks which store raw materials, finished products only and are not linked with the manufacturing process, and

xi) cost of fire fighting equipments.

3. In the case of imported machinery, the following shall be included while in calculating the value, namely -

i) import duty (excluding miscellaneous expenses as transportation from the port to the site of the factory , demurrage paid at the port.),

ii) the shipping charges,

iii) customs clearance charges, and

iv) Sales Tax.

Annexure IV

Form of Application for Letter of Intent / Registration of Bio-Tech unit to be made to the Registering Agency –(Paras-6&7):

1. Name of Unit / Applicant : M/s.

2. a) Address for communication :

Pincode :

i) Telephone No. :

ii) Fax No. :

iii) E-mail address :

3. Location of the unit

i) Address :

Pincode:

ii) Tel No. :

iii) Fax No. :

iv) E-mail Address :

2. Type of Organisation

Proprietary Firm ƒ

Partnership Firm ƒ

Pvt.Ltd. Company ƒ

Public Ltd. Company ƒ

Others ƒ

(Pl. specify, e.g. Trust/ Society/Cooperative Society etc.)

3. Type of unit :

Small Scale ƒ

Large Scale ƒ

* A BT unit would be considered to be in the small - scale if investment in plant & machinery (proposed or actual) does not exceed Rs. 1 crore.

4. Category of Bio-Tech Unit :

Human & Animal Health Bio-Tech Products & Processes unit ƒ

Agriculture Bio Tech products & processes unit ƒ

Industrial & other Bio-Tech products & processes unit ƒ

Composite Bio-Tech unit (i.e. engaged in a combination of ƒ

two or more of the above)

7. SSI Registration Number : 11/ / / /SSI

(if obtained) dated

(Please enclose copy of SSI Registration

Certificate)

8. IEM/Industrial License granted by SIA, Ministry of : No.

Industry, Govt. of India (if obtained/applicable) : Dated -

(Please enclose copy of IEM/ Industrial License)

9. Products / Activities undertaken :

(Upto last 2 years or, if for a lesser period, as may be relevant)

a) Existing Bio Technology :

products / activities

Sr.No. Item Annual Production / turnover

Quantity Value (Rs.)

b) Existing Non-Bio-Tech Products :

Sr.No. Item Annual Production

Quantity Value (Rs.)

10. Proposed Products/ Activities :

Proposed Bio-Tech Products :

Sr.No. Item Projected Annual average Production /

Capacity for first 3 years of operation

Quantity Value (Rs.)

11.. Brief details of manufacturing process / activity in respect of items at 9(a) and 10.

(Enclose separate sheet if necessary)

12. Investment in Plant & Machinery :

a) Existing for Bio-Tech products : Rs.(Lakhs)

b) Existing for Non-Bio-Tech products : Rs.(Lakhs)

c) Proposed for Bio-Tech products : Rs.(Lakhs)

13. Employment :

Managerial :

Supervisory :

Others :

Signature of applicant

Date:

Place

Name of Prop./Partner/Director

Annexe– V

Format of the affidavit to be submitted by a BT unit with Application for Letter of Intent / Registration as a Bio - Tech Unit -

AFFIDAVIT

(on Rs. 20 non-judicial stamp paper)

Deponent Shri/Smt./Kum_____________________________________________ , Aged ____________ years Occupation ________________________, Resident of__________________________________________________________________.

I, the above named deponent, do hereby state on oath/solemn affirmation as under:-

(1) That I am proprietor/partner/director of

M/s. _________________________________________________________

and am authorised to execute this affidavit on their behalf,

(2) That I/we have already setup/propose to start a Bio-Tech unit for manufacture of following BT products and / or BT activities.

(i)

(ii)

(iii)

(3) That the location of the unit is at/is proposed at (full address) _____________

*(which is in industrial zone/not in industrial zone but does not violate any other Locational restrictions for the time being in force.)

[* - not required in case the unit already holds provisional or permanent SSI Registration Certificate in the same name and for the same location (copy to be enclosed), for the same or any other activity. ]

(4) That land/premises for the factory /facility of the unit are owned by the firm / by M/s. / Shri / Smt. That M/s /Shri/Smt. has given

consent for its use for the proposed/existing BT activity. (Manufacture and or Research and Development)

(5) That it will be our responsibility to obtain all the statutory NOCs/permissions required to carry out this BT activity.

(6) Since location of my/our Unit falls within Zone-l/Zone-II of Mumbai Metropolitan

Region, I have obtained NOC/Locational Clearance from Directorate of Industries, Mumbai, under No. dt. (Copy of which is enclosed).

(7) That I/we undertake that the annual turnover of Bio-Technology products/activities shall exceed 75% of the total annual turnover of the unit for the next 3 years.

(8) I/We undertake to refund to the State Government all financial incentive/benefits under schemes of assistance to BT Units along with interest as may be applicable and as demanded by the appropriate authority of the State Government, in case it is found that the information submitted for obtaining the LOI / Registration is fraudulent.

(9) That the unit is a Bio-Technology unit under the category ____________ and I/we have obtained certification to that effect from the Certifying Agency designated by the Government of Maharashtra. Attested copy of the Certificate is enclosed.

(10) That all the information/particulars submitted in the application for BT LOI / Registration form and in this affidavit are factual and correct and I/we shall be fully responsible for any discrepancy found later.

Signature

DEPONENT'S NAME

Place:

Date:

VERIFICATION

VERIFIED and signed on this day of 2002

That the contents of this affidavit are true and correct to the best of my knowledge and belief.

Deponent

I know the deponent. Advocate

Note : Strike out whichever is not applicable.

Annexe -VI

Format of the Certificate to be issued by the designated Certifying Agencies for proposed Bio-Tech Units. (Paras-4&8)

(On the letter head of the designated Certifying Agency)

This is to certify that M/s. having their

Office Address: ……………………………………………

……………………………………………

Telephone No. :

Fax No.:

E-mail :

Unit Address: ………………………………………………

……………………………………………….

Telephone No.:

Fax No.:

E-mail:

Propose to set up a Unit named --------------------------- to produce following items/products :

i) ---------------------------------

ii) ---------------------------------

iii) --------------------------------

iv) --------------------------------

On the basis of the project report submitted, it is to certify that the proposed product/Service/research activity qualifies to be a biotechnology product/item/activity under category ---------------------------------------------------------------.

Oval: Seal

For( Name of the designated Agency )

(Signature and name of the signatory with official seal of the Agency )

Place :.

Date :

ANNEXURE - VII

Format of the C.A. certificate to be submitted by the BT unit alongwith application for registration to certify the turnover of Bio-Tech and non-Bio-Tech products.(Paras-7&9)

(On the letter head of the Chartered Accountant firm)

C E R T I F I C A T E

This is to certify that the books of account of the unit of M/s. Located at

Office Address:- ---------------------------------------

---------------------------------------

Business Address:- ---------------------------------------

of Unit ---------------------------------------

---------------------------------------

have been examined by us. The annual turnover of the unit from Health Bio-Tech/Agro Bio-Tech/Industrial and other Bio-Tech/Composite Bio-Tech * products/activities for the past 3 years (or lesser period of at least 3 months, in case such activity is of lesser period) is as under.

T U R N O V E R (Rs. In Lakhs)

Year/Month	Total Turnover ( Rs.)	Turnover for Health Bio-Tech/Agro Bio-Tech / Industrial and other Bio-Tech (Categorywise)	% of Health Bio-Tech /Agro Bio-Tech / Industrial and other Bio-Tech to Total Turnover.

Oval: Seal with Registration
Number
Date

For Name of CA firm.

Place: (Name and Signature of

Date: Proprietor/Partner/ Director with official seal)

*Strike out whichever is not applicable.
Annexure - VIII

Format of the Certificate to be issued by the designated Certifying agencies for existing Bio-Tech units. (to accompany application for BT Registration) (paras-4,7&8):

(On the letter head of the designated agency)

This is to certify that M/s. having their

Office Address: ……………………………………………

……………………………………………

Telephone No. :

Fax No.:

E-mail Address :

Business Address: ………………………………………………

……………………………………………….

………………………………………………..

Telephone No.:

Fax No.:

E-mail Address:

are bonafide manufacturers of the following Bio-Technology products and /or are engaged in the following BT activities.

1) _____________________

2) _____________________

3) _____________________

4) _____________________

This is certified on the basis of availability of machinery and equipment, technical manpower and competence of the unit.

For ( Name of the designated Agency )

Oval: Seal

(Signature and name of the signatory with official seal of the Agency)

ANNEXURE - IX

Format of the Letter of Intent / Registration to be issued by Registering Agency. (Paras-6&7)

Government of Maharashtra

Office of the Joint Director of Industries ( MMR)/

District Industries Center…./ Development Commissioner (Industries)/Maharashtra Industrial Development Corporation…..

BT (Health Bio-Tech/Agro Bio-Tech/Industrial & Other Bio-Tech/Composite Bio-Tech)/ LOI or Registration (specify)/11/(DIST. Code)/(MIDC/DC(I)/JDI /SIO / DIC ) NO.--------

This is to certify that M/s.

having their

Office Address ____________________________

_____________________________

Telephone No.:

Fax No. :

E-mail :

Business Address ___________________________

___________________________

Telephone No.:

Fax No. :

E-mail :

is given this Letter of Intent / Registration for their proposed / existing Health Bio-Tech/Agro Bio-Tech/Industrial and other Bio-Tech/Composite Bio-Tech unit * for following items / activities -

1)____________________________

2)____________________________

3)____________________________

4)____________________________

Seal (Signature)

(Name and Designation of the Registering Authority with official seal)

Place:

Date:

* Strike out whichever is not applicable.

Annexure X

District codes to be used for issue of letter of intent and Bio-Technology registration to Bio- Technology units for State of Maharashtra.

State Code-(11)

Sr.No.	Name of the district	District Code No.
1	Ahmednagar	01
2	Akola	02
3	Amravati	03
4	Aurangabad	04
5	Bhandara	05
6	Beed	06
7	Greater Mumbai (MMR)	07
8	Buldhana	08
9	Chandrapur	09
10	Dhule	10
11	Jalgaon	11
12	Raigad	12
13	Kolhapur	13
14	Nagpur	14
15	Nanded	15
16	Nashik	16
17	Osmanabad	17
18	Parbhani	18
19	Pune	19
20	Ratnagiri	20
21	Sangli	21
22	Satara	22
23	Solapur	23
24	Thane	24
25	Wardha	25
26	Yeotmal	26
27	Jalna	27
28	Sindhudurg	28
29	Gadchiroli	29
30	Latur	30
31	Vashim	31
32	Nandurbar	32
33	Hingoli	33
34	Gondia	34