cdl kasauli

testing support services

Central Drugs Standard Control Organisation has Designated Central Drugs Laboratory (CDL), Kasauli, as the National Control Laboratory for testing of Immunobiologicals (vaccines and antisera) meant for human use in India under the Rules & provisions of Drugs and Cosmetics Act 1940

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testing support services

Testing of Immunobiologicals at CDL Kasauli for Human Use

Central Drugs Standard Control Organisation has Designated Central Drugs Laboratory (CDL), Kasauli, as the National Control Laboratory for testing of Immunobiologicals (vaccines and antisera) meant for human use in India under the Rules & provisions of Drugs and Cosmetics Act 1940

The lab has the mandate of National Regulations of Vaccines produced indigenously for the domestic market, immunization programme of the Government. of India, export and for those imported to the country. 

The lab receives around 7000 batches of Immunobiologicals per year for testing & /or pre-release certification for testing of Immunobiologicals for Human Use only.

MINIMUM SAMPLE QUANTITY REQUIRED FOR TESTING

1

Antitoxin /Anti serum

10 ml x 10 vials / ampoules

1 ml x 50 vials / ampoules

2

Anti Snake Venom Serum /Anti Rabies Serum

10 ml x 5 vials / ampoules

5 ml x 10 vials / ampoules

3

Bacterial Vaccine

BCG

1 dose x 50 vials /ampoules / PFS

5 doses x 20 vials /ampoules

10 doses x 10 vials /ampoules

20 doses x 10 vials

10/20 doses x 40 vials

4

Viral Vaccine

OPV

1 dose x 50 vials /ampoules / PFS

5 doses x 20 vials /ampoules

10 doses x 10 vials /ampoules

20 doses x 20 vials

5

Blood Products

3 containers of 50 ml above.

5 vials of 10 ml each

10 vials of 5 ml each

25 vials of 2 ml each

50 vials of 1 ml each

6

Surgical Sutures

50 stands

how can we help?

NKG experts have a good track record and sound experience in understanding the steps and processes of successful submission of samples to CDL Kasauli Laboratory as well as efficient tracking of testing procedure and issuance of test reports.

NKG team has a cumulative experience of more than 50 Years in Regulatory affairs and have been Behind Breakthrough products and approvals helping Various Clients with a clear  Regulatory Pathwork for Successful Launch and continuous import/export or manufacture of Immunobiologicals (vaccines and antisera) meant for human use in India.

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