BROAD GUIDELINES FOR REGISTRATION OF MANUFACTURERS AND SUPPLIERS OF MEDICAL STORES

NORTH EASTERN RAILWAY

MEDICAL DEPARTMENT

BROAD GUIDELINES FOR REGISTRATION OF MANUFACTURERS AND SUPPLIERS OF MEDICAL STORES.

1. Copy of Manufacturing License issued by Local Regulatory authority.

2. Non Conviction Certificate issued by Licensing Authority.

3. WHO-GMP certificate issued to the manufacturer GMP standards met for past 2 years.

4. List of Manufacturing and QC equipment to demonstrate that necessary capability exists to manufacture products and adhering to specifications.

5. ISO-9000 Certification.

6. Installed capacity/utilized during past 2 years. Certificate of CA.

7. Audited financial statement for the last three fiscal years.

8. All products to comply with IP/USP/BP Pharmacopoeia standards.

9. Product samples and Certificate of Analysis – Indented products.

10. Income Tax Clearance Certificate.

11. Product specification as well as packaging specifications for the items.

12. Samples for packaging components specially label, foil, PVC film or other printed components.

13. Manufacturer should have produced at least 20% of product offered during last two years.

14. Packing offered should be such as to withstand rough handling, transportation and exposure to extreme temperature and climatic conditions.

15. Purchaser reserves the right to visit manufacturing facility.

16. Quality control will be checked and decided by Zonal CMDs.

The application form for registration alongwith information booklet containing the list of documents required to be submitted can be obtained from CMD Office, NE Railway, Gorakhpur on payment of Rs. 100/- only. The initial registration is done for two years which may be renewed further depending on the performance of the firm. The firm has to apply for renewal of its registration, if it desires so.

FORM OF APPLICATION FOR USE OF PHARMACEUTICALS FIRMS IN INDIA FOR ENLISTMENT AS APPROVED CONTRACTORS TO RAILWAY.

INSTRUCTIONS

Complete and definite answers to question must be given and Annexure ‘A’ should be filled in for each items separately, otherwise the application is liable to be ignored.

1. Name of firm …………………………... Telegraphic address ……….

………………………………………….. ……………………………..

Address of Head Office ………………… ……………………………..

…………………………………………… Telephone No…….………..

Address of Branches …………………….

2. Item or items of stores giving reference to the section and Serial No. of the attached list for which enlistment is desired.
3. Justification required as per Annexure‘A’.
4. (a) Is your firm incorporated under the companies Law or any other Law of India? Partners/proprietors,(please give their names and addressess.)
(b) Is your firms registered under the Indian Partnership Act, 1932?
(c) Is your factory Registered under the Indian Factories Act, 1948?.
5. Does your firm come under the scope of the Industries (Development and Regulations) Act, 1951, and if, so, the No. and date of Registration or licence held under the Act.
6. If the firm is registered under the India Companies Act, 1913/Companies Act, 1 of 1956 State : (a) The name in which it is registered.
(b) The registar with whom it is registered and his place.
(c) The date of registration and the number of registration certificate.
(d) Subscribed capital.
7. If the firm is registered under the Indian Partnership Act, 1932 or any other Act requiring the registration of firm/ Partnership-
(a) The name and/or style in which it is registered.
(b) The place of the registrar of firms with whom registered.

Annexure-A

Justification for demand of Trade groups/Additional Trade groups (Separate sheet for each trade group is required).

Trade Group
Description of trade group
Reason for demanding this trade group :- (a) What are the items offered for supply falling this trade group.
(b) If manufacturer :- (i) What are the machines available for manufacturing of above items.
(ii) Quality control arrangement
(c) In case of trade, give details of :- (i) Stock of item and value falling in the group.
(ii) Whether covered by Standard specification.
(d) Performance of supplied to this Rly. other Rlys. & other Govt. Departments.
Sl. No.	Order No. & date	Material description	Qty.	D.P.	value	Supply details

(c) The date of such registration and the number and date of registration certificate.
(d) The names and addresses of all the partners and the extent of their shares.
(e) Whether under the partnership did any one partner has been authorized to sign and bind the firm in all contractual obligations including power to refer cases for arbitration, if not, whether a separate power of Attorney exists in favour of a particular partner to perform such functions.In the latter case copy duly attested by a Notary Public should be submitted.
8. In any other case :- The name (s) and address (es) of the proprietor and or all the partners and the nature and extent of their interest in the joint Business (in the case of joint Hindu Family firm, give this information regarding all persons who have any interest in the business).
9. The income-tax circle/ward/district in which the concern and each of its proprietor(s)/partner (s) is/are assessed to income-tax and G.I.R. No. of each.
10. If you are a manufacturer :- (a) Location of manufacturing Works/ Factories owned by you (Documentary evidence of ownership must be produced).
(b) Brief description of the factory (e.g. area, covered accommodation, departments into which it is divided, laboratory, etc).
(c) Whether the firm comes under the scope of industries (Development and Regulations) Act, 1951, and if so, the No. and date of registration of licence held under the Act.
(d) Details of plant and machinery erected and functioning in each department (monographs and descriptive pamphlets should be supplied, if available).
(e) Whether the process of manufacture in the factory is carried out with the aid of power or without it.
(f) Details of stores or class of stores which the factory, as equipped, is capable of production (Specifying each item, separately).
(g) Details of arrangements for quality control of products such as laboratory etc.
(h) Whether stores were tested to any standard specification, if so, copies of original test certificate should be submitted in triplicate.

(i) In case you do not own the factory but utilize the factory of some other firm for the manufacture/ fabrication of the stores for which you apply for registration. In lease or other basis, you should furnish a valid legal agreement that the factory of $ ……………………………………………. Has been put at your disposal for the manufacture/fabrication of the stores (for which registration has been applied for).

$ Here indicate the name of the firm whose factory is being utilized.

11. If you are accredited agents of any manufacturers, give

(a) Name and address of manufacturers.

(b) Articles for which you have agencies.

12. If you are stockists :-

(a) Items stocked

(b) Approximate value of your stockes and approxi

mate value of annual sales.

(d) Address of godowns where your stocks can be inspected.

13. Classes of articles imported by the firm.

14. Classes of imported articles normally stocked by the firm.

15. State particulars with value (approximate) and date of

any contract (of considerable magnitude) executed in

the past twelve months by your firm for the industries

and supplies Deptt., Railway or Local Body.

16. Recognised cottage industries and small scale industries

units should submit a certificate form the Regional

Director of the Unit in support of their statement.

17. Are you on the approved list of Director General of

supplies and disposals, and if so, give details of items

for which enlisted and registration No. and date.

18. If you were on the approved list of any other Railway

give registration No. and items for which registered.

19. Who are your Bankers? Give complete addresses.

20. Further remarks, if any.

21. Do you pay income tax? If so, income tax clearance certificate as per form

enclosed be furnished.

I/We………………………………. do hereby declare that the entries made in this

application form are true to the best of my/our knowledge and also that we shall be

bound by the acts of my/our duly constituted attorney.

Mr. …………………………………….. who has signed this application and of any

other person who in future may be appointed by me/us in his instead to carry on the

business of the concern whether an intimation of such change is given to the

Railway or not.

I/We do hereby confirm that I/We have read the conditions governing Railway

contracts as amended from time to time and would abide by these conditions in all

respects.

(Signature of Partners,

Proprietors of Manager etc.)

All subsequent changes in the constitution or working of a firm, affecting the

accuracy of the answers now given should be promptly communicated to the Railway.

Signature

Place……………………….

Date………………………… Designation of person signing this

application form (proprietor,

partner, Manager etc.)

“INSTRUCTIONS FOR FILLING UP THE APPLICATION FORM AND SUPPLYING OF OTHER PARTICULARS REQUIRED FOR REGISTRATION”

1. Grouping of Stores - Stores are grouped in different trade groups as in the list attached, separate lists of contractors are being maintained for each item of stores.

Firms may apply on the prescribed form the registration for the supply of one or more items of stores giving reference to be group and serial number of item of the attached list.

2. Security Deposit – Firm desiring to be enlisted for the supply of stores to this Railway must complete the application form attached. No security deposits is required to be taken from contractors for which they are registered with this Railway. This is however, necessary for items for which they are not particularly registered @ 5% of the value of an order in cash subject to a maximum of Rs. 10,000/- in each case.

3. Right to refuse registration and removal from approved list- Chief Medical Director reserves the right to decline to register any firm or to remove the name of any firm either for a specific period or permanently from the approved list without assigning any reason and his decision shall be final.

4. I.R.S. Conditions of Contract – Firm will have to abide I.R.S. Conditions of Contract rules and regulations issued by the Controller of Stores from time to time in regard to the purchase of store.

5. The Cash Receipt- The cash receipt for the purchase of application form should invariably affixed thereon while submitting the application form.

However, the firm who are registered as small scale units with the National Small Industries Corporation are exempted from the payment of cost of the form and the registration fee. Such firm should, however in lieu of the cash receipt. Submit a certificate to the effect, from N.S.I.C. alongwith the application form.

6. Signing of the application form –

(a) Proprietorship firm : The application form should be signed by the proprietor.

(b) Partnership firm : The application from should be signed by all the partners or by any one of the partner who holds a general power of Attorney authorizing him to sign for and bind the firm in all contractual obligations.

(c) Limited concerns : The application form should be signed by any one of the Directors or Managing Director of the firm.

The application may also be signed b y a person other than those mentioned above, only when such a person holdes a general power of Attorney in this favour from the firm giving him authority to do so in which case such power of Attorney in original together with a copy thereof should be forwarded alongwith application.

7. Ownership Documents – All firms should produce documentary evidence

for ownership of their Godowns and factories and machineries installed therein –

(a) In case of a manufacturing firms, original rent receipts and case vouchers etc.,

together with copies there of, of the plant and machineries installed in the

factory should be forwarded.

(b) In case of stockists, rent receipts for there godowns together with proof of

ownership of the stocks, with the copies of the documents should be furnished.

Alternatively an affidavit sworn before the First Class Magistrate to the effect that

plant, machinery building etc., are owned by the applicant firms may be forwarded.

8. Income tax clearance certificate – current Income Tax Clearance

Certificate bearing the Seal and dated signature of the Income Tax Officer concerned,

should in variably accompany the application.

In the case of partnership firm the current income tax clearance certificate in respect

of each individual partner should also be furnished in addition to the Income Tax Clearance

in the name of the firm.

The Income Tax Clearance Certificate should show the details of the income

assessed, tax demanded and paid for the previous four years.

9. Other documents to be forwarded – In case of a limited company, a copy

of Memorancum and articles of association and a certificate of incorporation and in case of

a partnership concern, a copy of the entry in form ‘A’ from the Registrar of Firm concerned

should accompany the application. In addition to this list of sitting Directors in case of a

limited concern and a certified copy of the partnership deed in case of a partnership

concern should be submitted.

10. Registration of Branches – In case where the firms desire registration of

their branches in addition to their Head Office, they should forward a declaration to the

effect that the Branch Managers are competent to bind the firm in all contractual

obligations and that the Head Office will be responsible for the commitment of their

Branch Managers and for the satisfactory execution of the contracts place on them.

11. Annual Report Balance Sheets, Profit and Loss Statements – One copy

each of the following should be furnished :-

(i) Last Annual Report

(ii) Profit and Loss account and Balance sheet for and at the end of the last year.

(iii) A statement showing the results of operation and financial position of the firm during the proceeding three years in the proforma given below :-

Year Ending

1. Sales

2. Gross Profit