Registration Of Firms In Medical Department Of South Eastern Railway
Applications are invited from interested manufacturing pharmaceutical firms for consideration of registration of their manufacturing products with Medical Department, South Eastern Railway. Application addressing Chief Medical Director with list of products for which registration required should be submitted as per following terms and conditions:
TERMS AND CONDITIONS FOR REGISTRATION OF PHARMACEUTICALS FIRMS ARE AS UNDER:
1)The firm should have valid drug license for manufacturing drugs and other medical stores from concerned drug controller for each product they wish to offer to S. E. Railway. (Photo copy should be submitted)
2)In ref. to the letter dated. 1.3.04 of Drugs controller general. (India) New Delhi, GMP certification is a must. WHO/GMP should be preferable for the product.
3)The firm should normally have at least 5 yrs. standing in manufacturing/marketing pharmaceutical products except for new molecules or newly imported medicine.
4)The average annual turnover of the firm for the previous 3 yrs. should be 50 crores and above. The annual turnover should be from each own product domestic (manufactured and marketed) market.
5)The firm, which applies for registration should submit a declaration that there was no major punitive action taken/ contemplated against the firm by any Zonal Railways/ Central Govt./ State Govt. If the information provided is found wrong the firm can be de-listed for 3 yrs. all over Indian Railways.
6)Registration fee will be chargedRs. 5,000/- for 3 yrs. and need to be deposited only after written information received from CMDs Office. The payment is to be made by draft in favour of FA & CAO, South Eastern Railway, Kolkata payable at Kolkata. This should be deposited in the office of Chief Cashier, S. E. Railway, Garden Reach. The money receipt in original to be submitted in CMDs office for final acceptance of registration.
1)ISO 9000 certification
2)As a supporting document market share of the item as per the latest ORG-MARG NEILSEN analysis or National/Central Health Ministry report can be taken into consideration for registration of the firm. In case such information is not available especially in case of expensive the firms can be asked to submit details of their supply orders for the previous 3 yrs. so that they are share in market can be assessed by CMD and also should normally not be to a single institution only.
3)Cases of high value orders covering yearly requirement for the Railway/ Unit.
4)The firm when applying for registration may submit the performance report received from by other Govt. Organization.
Mandatory requirement for registration for imported raw/ finished product:
In cases where the drugs are manufactured abroad and supplied by local firms or manufactured in India with imported raw material following information are mandatory requirement for registration.
1.The source of manufactured raw/finished products and quality report.
2.Relation of Indian agent with foreign company in 3 yrs.
3.Proof of the same product being sold in USA & EUROPE and other developed countries equivalent to EUROPIAN countries.
4.Authorization letter by OEM/abroad for local agent.
1.Chief Medical Director reserves the right to inspect the manufacturing facility of the firm by a 3 membered committee of Medical Officers for consideration of registration. Inspection team will inspect the following.
a)For the form asking for registration and having products manufactured by them/inspection to be done of manufacturing unit.
b)In case there are more than 1 manufacturing unit all will be inspected.
c)In case the firm is marketing a product manufactured by some other company then the manufacturing company and the manufacturing unit will also be inspected and passed as per criteria laid down by Indian Railways.
2.The product wise registration as applied for by the firms may be considered as follows for firms having following turnovers.
i)50 cr. upto 150 cr. maximum upto 25 products
ii)151 cr. upto 500 cr. maximum upto 50 products.
iii)501 cr. upto 1000 cr.- maximum upto 75 products.
iv)More than 1000 cr.- all products
3.Products will be registered strength wise.
4.Products being applied by firms for registration should also be available in open market for retail sale of same brand name in Kolkata region.
5.Products having paper packing for tablets syringes etc. should be avoided, as they are prone to damage. Exception can be made only by CMD personally in case other durable packing not available.
6.The strip/ package/ bottle containing drug should have a print of Indian Railways not for sale. Firms are requested to put their Holograms on their products at the time of supply.
Renewal of registration:
Renewal of registration will be done every 03 yrs. after original registration. The firm should apply for renewal of registration at least 03 months prior to the expiry of initial registration.
The performance of Company will be taken into account as per the following standards.
b)Drug analysis report
c)Response to tender enquiries
d)Proper tender process followed or not
e)Supply within time frame or not
f)Full quantity supplied as per order or not
Inspection will be done if there are some adverse reports.
Application with necessary documents as detailed in A B C D and completed in all aspects should be submitted to Chief Medical Director, S. E. Railway, Garden Reach, Kolkata- 43.
Application will be accepted upto 14.08.2008 between &
Dr. S. Ghosh
DY. C. M. D. ( H&FW) / S. E. Railway
(Application may be done in Firms letterhead as per the format given below)
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