SOUTH CENTRAL RAILWAY

MEDICAL DEPARTMENT

Procedure for recognition of Non-Railway Hospitals in S.C.Railway 

            The private hospitals will approach the concerned Divisional/ Central Hospital in-charges/ Local Railway Hospital  in their respective jurisdiction with the representation duly mentioning the facilities , specialties, infrastructure, diet, Ambulance Services available, discount on NIMS  tariffs etc. 

            On receipt of the representation the in-charge of the hospital will nominate doctors committee to inspect the hospital and take decision after taken into consideration of doctors' committee report.

            On his satisfaction the in-charge of the divisional hospital/ central hospital will recommend the proposal to the CMD or reject the proposal.

            CMD after taking the finance concurrence will send the proposal for DGRHS/Railway Board/New Delhi for initial recognition of the hospital. Subsequently after the expiry of initial recognition period one year, GM's are empowered to extend yearly up to 5 years.

 Procedure for Registration: The registration of drug manufacturing firms will be processed by the respective CMD of the Zone in whose jurisdiction the manufacturing plant is located so that the inspection of the manufacturing premisies etc. is convenient. Extant instructions and procedures for registration of new firms be followed. CMDs may insist that the firms seeking registration may submit documents such as certificates of good manufacturing practice (GMP), certificates as per the standards laid down by World Health Organization or ISO 9000 certificate etc. Registration of a firm by one particular Zone will not automatically entitle its registration in other Zones also, as the firm may/ may not have the capacity to supply the material to other zones. The duration of registration will be for two years initially and then it can be renewed by the zone. Renewal of registration of a firm would not call for following the entire procedure afresh and can be done on the basis of performance of the firm. CMDs at their discretion can accord registration for supply of certain specified items only and registration need not be construed as a blanket registration. Broad guidelines for registration of various fiems at Zonal Headquarter level are as follows:- 

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 manufacturer 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 Pharmacopoeial 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.               Packaging 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.