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
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.
|
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 |
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.
NKG keeps in Close communications with various Trade Commissions, Business Chambers, embassies of many countries on various existing & new Rules & Regulations of government of India
NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
