MONOGRAPHS ON BIOLOGICAL PRODUCTS FOR INCORPORATION IN IP-2014

S.

No.

PRODUCT NAME

STEPWISE PHASES OF PROGRESS

POINT PERSON

Step 1

Step 2

Step 3

NIB Lab

Manufacturer

& Academia

Expert Review

at NIB

Review  by

expert committee*

1 month

Hosting at

IPC website

45days

1

Insulin Aspart

over

over

15 Mar 2012

over

Recombinant Product lab

NovoNordisk, Eli Lilly, Aventis, Wockhardt, Biocon, MJ Biopharma,

2

Insulin Aspart inj.

 

over

over

14  Apr 2012

over

-do-

3

Biphasic Insulin Aspart inj.

over

over

14  Apr 2012

over

-do-

4

Insulin Lispro

 

over

over

15 Mar 2012

over

-do-

5

Insulin Lispro inj.

 

over

over

14  Apr 2012

over

-do-

6

Biphasic Insulin Lispro inj.

 

over

over

14  Apr 2012

over

-do-

7

r- Streptokinase

over

over

15 Mar 2012

over

Enzyme & Hormone Lab

Biocon, Shasun,

Bharat Biotech

8

r- Streptokinase inj.

over

over

15 Mar 2012

over

Biocon, Shasun,

Bharat Biotech

9

Filgrastim inj.

 

over

over

Oct 2012

over

Recombinant Product lab

Intas

10

Erythropoietin inj.

 

over

over

Oct 2012

over

Intas

11

Erythropoietin for inj.

 

over

over

Oct 2012

over

Intas

12

Interferon α 2a inj.

 

over

over

Oct 2012

over

Reliance

13

Interferon α 2b inj.

 

over

over

Oct 2012

over

Reliance

14

Interferon β 1a

conc. solution

over

over

Oct 2012

over

Biogen Idec, Gennova,

Reliance, Roche

15

rh-PTH

 

over

over

Oct 2012

over

Enzyme & Hormone Lab

Zydus, Eli Lilly

16

rh-PTH injection

Draft yet to be received from IPC

-

-

17

Interferon β 1a inj.

Draft yet to be received from IPC

-

-

Recombinant Product lab

Biogen Idec, Gennova,

Reliance, Roche

18

Rituximab

over

over

-

Therapeutic Monoclonal Antibody Lab

Intas, Zydus, Reddy, Reliance, Roche

19

Rituximab inj.

 

P 

P

-

Reddy, Roche

20

General Chapter MAbs

over

over

-

Biocon, Reliance,

Intas, Zydus, Roche,

SII , IIT -D

* Development of Biological monographs by:

1. IPC constituted r-DNA Committee

2. Expert members are from- IPC, NIB, CDSCO, Manufacturer, IIT-D  

Total product monographs =19, & General Chapter=1  

MONOGRAPHS ON BIOLOGICAL PRODUCTS FOR INCORPORATION IN IP-2016 ADDENDUM

S.No Name of Monograph NIB Lab
1.

Monographs for Anti-AB(Monoclonal) in Indian Pharmacopoeia

Blood Reagent Lab

      

  Monographs  Under Development

S.No Name of Monograph NIB Lab
1.

Monographs of IP 2010 for Human Albumin, Human Normal Immunoglobulin IV, Human Normal Immunoglobulin IM, Human Plasma Protein Fraction, Dried Human Antihaemophilic Fraction (Coagulation Factor VIII), Human Coagulation Factor IX and Fibrin Sealant Kit  under review by committee members constituted by the Director  In-Charge NIB

Blood Products Lab
2.

Comments / recommendations on Rituximab (MAb) monograph forwarded to Indian Pharmacopoeia Commission,  Ghaziabad

Therapeutic Monoclonal Antibody Lab
3. Technically evaluated the r-PTH monograph received from IPC Enzymes & Hormones Lab
4. Comments for Sterility General Chapter in IP 2010 for its upgradation furnished Viral Vaccine  & sterility Lab
5. Comments for replacement of Pyrogen test with BET in parenterals, Vaccines and Blood Products in IP 2010. Viral Vaccine  & sterility Lab
6. Comments in IP2014 Vol. I Page 292 2.7.7 Tests on chicken flocks free from specified Pathogens for the Production and Quality control of Vaccines Vaccine Division
7. Anti-D IgM (Monoclonal) Blood Reagents Lab
8. Developed monograph for Insulin Glargine (DS & DP) published in IP Addendum 2016 Recombinant Products Lab
9. Development and incorporation of 05 monographs in Indian Pharmacopoeia

1. Somatropin

2. Somatropin concentrated Solution

3. Somatropin for Injection

4. Menotropin

5. Menotropin for Injection

Enzymes & Hormones Lab
10. First Indian Monograph on "Allergen Products" has been prepared by Allergen Lab and updated / approved by National Expert Committee.  Allergen Lab
11. The Laboratory is contributing for preparation of 03 monographs with IPC and the same are uploaded in the official website of IPC for Stakeholders views/comments

1. Follicle Stimulating Hormone Concentrated Solution

2. Follicle Stimulating Hormone Injection

3. Follicle Stimulating Hormone

Enzymes & Hormones Lab
12.

The draft monograph for Rituximab (DS & DP) has been prepared and submitted to IPC in Last QTR

of December, 2016 

Therapeutic Monoclonal Antibody Lab
13. Monograph on Anti-A1 (Lectin) and Anti-H (Lectin) Blood Reagents Lab

 

 

REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013

 

Turnaround time for testing 

PROPOSED FOR COMMENTS :

 

 

   

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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