Notice inviting applications for Registration of Pharmaceuticals Firms
in the office of Chief Medical Director, South Eastern Railway.
Date: 28-04-2015
- REGISTRATIONS OF PHARMACEUTICALS FIRMS FOR SUPPLY OF MEDICINE TO S.E.RLY.
Interested Manufacturing/Marketing/Importing pharmaceutical firms preferably with Head Office/Registered Office in West Bengal/Jharkhand/Orissa are requested to register with S.E. Railway.
The registration criteria and the form (as per Annexure A & E 2014) is available in S.E.Rly. website and office of the C.M.D./S.E.Rly./Kolkata- 43.
The firm who are already registered they are also requested to apply for renewal if their registration is expired or going to expire with next 6 months.
The firms are also to be registered at Indian Railway e- procurement system(IREPS).
- REGISTRATIONS OF FIRMS FOR SUPPLY OF NON MEDICINAL ITEMS/MEDICAL STORES & CONSUMABLES TO S.E.RLY.
Interested Manufacturing/Marketing firms/authorized stockiest or dealers/Importers in West Bengal/Jharkhand/Orissa are requested to register with S.E. Railway.
The registration criteria and the form (as per Annexure A 2014) is available in S.E.Rly. website and office of the C.M.D./S.E.Rly./Kolkata- 43.
The firm who are already registered they are also requested to apply for renewal if their registration is expired or going to expire with next 6 months.
The firms are also to be registered at Indian Railway e- procurement system (IREPS).
- Criteria for registration/renewal for firms manufacturing/importing drugs (Medicines)
i.To submit duly filled, signed, and stamped Registration/Renewal application form (Annexure A,E attached with signature and stamp. On acceptance of application for registration, firm will be asked to submit fees for registration Rs. 5000/- valid for 3 yrs. And renewal fee will also be Rs. 5000/- for 3 yrs.
ii.Market standing of 5 yrs. – the pharmaceuticals firm should have atleast 5 yrs. of market standing in the field of manufacturing/marketing of medicines. A certificate in a format from State Drug Controller, Certifying and Licensing Authority, Director General Health to be submitted.
iii.GMP certificate is mandatory.
iv.Turn over- minimum turn over of Rs. 50 crore per year (on average), for last 3 years. But it may be relaxed upto 20 crores. Turn over to be supported by copy of Audit statement of the firm.
v.Firm should registered individually for each sister concern. Firm should give declaration to this effect.
vi.In case the firm is marketing products manufactured on loan licensing from other firms or by any other arrangement than own manufacturing units the list of all such manufacturing units should be supplied.
vii.The firm will only be allowed to supply products which are manufactured by the manufacturing units which have been inspected and approved by competent authority.
viii.Additional documents
1.ISO 9000 certification
2.WHO/GMP certificate
3.Market share of the items. As supporting documents, the latest ORG-MARG NIELSEN analysis or Nation/Central Health Ministry report for registration of the firms can be taken into consideration. The firm can be asked to submit details of their supply orders for the previous 3 yrs to get an idea of the market share.
4.High value order from the Rly./other Govt. Organisations for similar items.
5.Performance report issued by the other Govt. Organisation may be submitted by the firm when applying for registration.
ix.Firm should submit declaration and documents whether they are registered to any other zonal Rly. or not.
x.Firm should declare that they would supply only medicines manufactured at those manufacturing units which had been inspected and passed by zonal Rly., where the manufacturing units is situated and no punitive action taken by any Government Organisation against those units in last 5 years.
xi.The firm must give an undertaking that it will submit testing protocols/Reference standards of the supplied Medicine whenever asked for by the consignee or any of the Chief Medical Director’s office.
- Criteria for registration of manufacturing/marketing firms/authorized stockiest or dealers/importers for procurement of non drug Medical stores/consumables.
i.The firm should submit duly filled application form as per Annexure A & E with signature and stamp. On acceptance of application for registration, firm will be asked to submit fees for registration Rs. 5000/- valid for 3 yrs and renewal fee will also be Rs. 5000/- for 3 yrs.
ii.The firm which apply for registration/renewal should submit a declaration that there was no punitive action by any Rly./State Government and if the declaration provided is found wrong the firm can be delisted for 3 yrs. for all over Indian Railways.
iii.Desirable conditions
1.ISO , BIS, CE, FDA or equivalent certificates, if available.
iv.The average annual turn over (over last 3 yrs.)
v.If CMD wants the firm may be inspected by a CMD nominated team of 3 officials from Rly.
- Mandatory requirement for registration for imported raw/finished products.
i.The source of products and quality report.
ii.Relation of Indian stockiest/authorized importer with the foreign company in past 3 years.
iii.Ensure that same product is also being sold in USA/Europe or other developed countries and produce approval of the local drug authority (for e.g. FDA etc.) of that country.
iv.Authorization letter from original manufacturer or supplier to Indian stockiest/authorized importer.
v.The importer of drug will be licensed by the Drug Controller of India or other such statutory authorities to import the said drug in Indiafor the original manufacturer.
NB:Application along with Annexure-A should be duly signed with stamp, contact details (mobile no., phone no. Fax no. & e-mail id) of the authorized signatory and sent.
Click here to download Annexure A & E
