Status of GMOs and Products
Healthcare Applications
Under Clinical Trials
List of recombinant pharmaceutical/therapeutic products  recommended by RCGM for clinical trials to be conducted with the permission of Drug Controller General of India

S.No.

Product

  YEAR 2011
89
Darbepoetin alfa
88
H1N1-09 Influenza VLP (Virus Like Particles) Vaccine manufactured indigenously
87
Clot Specific Streptokinase
86
Infliximab-monoclonal antibody
85
Enfuvirtide internally coded as VB 20
84
MAB-1, Trastuzumab
83
Human parathyroid hormone (rh-PTH 1-34)
82
Rituximab
81
Bevacizumab-monoclonal antibody
80
Trastuzumab-monoclonal antibody
79
Live recombinant vaccine of Vibrio cholerae VA 1.4
78
Filgrastim (rDNA origin) Injection (300mcg/vial)
77
Pegylated Erythropoietin
76
Darbopoetin alfa
75
Pegylated GCSF
  YEAR 2010
74
Bmab100 monoclonal antibody
73
Pegylated recombinant human erythropoietin (PEGEPO)
72
Polysialylated erythropoietin
71
Anthrax vaccine
70
Peg-Interferon alfa-2b
69
Follitropin alfa (Follicle Stimulating Hormone)
68
rh-GCSF (Filgrastim)
67
BVX20 monoclonal antibody
66
Insulin-Aspart R and Insulin-Aspart 30/70
65
Rituximab-monoclonal antibody
64
Chimeric monoclonal antibody (IgG1k) Abciximab
63
Palivizumab
62
Pandemic H1N1 and seasonal trivalent influenza VLP vaccines.
61
Anti Rho (D) immunoglobulin
60
Human Insulin API (r-DNA origin)
59
Salmonella typhi strain expressing HPV18 L1 and HPV16 L1 VLPs for Oral Vaccine
58
Human Chorionic Gonadotropin (rHCG)
57
Human B-type Natriuretic peptide (rhBNP, VB17)
56
BioChaperone 1 (PDGF-BB+DMCTrp)

 

YEAR 2009

55
Human Interferon gamma-1b (IFNg)
54
Human Parathyroid Hormone (rHu PTH)
53
Combination Malaria Vaccine Composed of Recombinant PfMSP-119 and PfF2
52
Darbepoetin-alpha
51
Etanercept (TNFr-antibody fusion protein)
50
Teriparatide (rDNA origin) Injection (750 mcg/vial)
49
Human Follicle Stimulating Hormone (rFSH)
48
Human Platelet Derived Growth Factor-BB (PDGF-BB)
47
Human Interleukin 2 (r-hu-IL-2)

 

YEAR 2008

46
Bevacizumab
45
Trastuzumab
44
Human Parathyroid Hormone (rhPTH1-34)
43
THR-100 (recombinant staphylokinase)
42
Hepatitis B antigen in novel formulation
41

Tetravalent vaccines (DPT+HEP-B)

40

Pegylated Human IFN alpha- 2b [PegIFN alpha2b]

39

Urate Oxidase (VB 37)

38
Anti Rabies Human Monoclonal Antibody (SII RMab)

 

YEAR 2007

37

Human G-CSF

36

Somatropin

35

Pegylated recombinant methionyl human Granulocyte Colony Stimulating Factor (PEG-r-met hu G-CSF)

34

rh-Tissue Plasminogen Activator (tPA)

33

Polysialated Erythropoietin

32

Darbopoetin

31

Nesiritide

30

Insulin Glargine

29

IN-105 (Oral insulin)

YEAR 2006

28

Human tissue Plasminogen Activator (rh-TPA)

27

Pegylated r-h-erythropoietin

26

Pentavalent vaccine (Diphtheria, Tetanus, Pertusis, recombinant Hepatitis B and Haemophilus influenzae type B conjugate vaccine)

25

Rituximab (monoclonal antibody)

24

“BIOMAb EGFR” Humanized Anti-EGFR monoclonal antibody: Generic name Nimotuzumab injection) and Nimotuzumab-Bulk BIOMAb EGFR™-Bulk.

23

Monoclonal Tetanus Immunoglobulin

22

Human MAB RM1 IgGI.k

21

Human Granulocyte Colony Stimulating Factor (rh-G-CSF)

20

Hepatitis B antigen

19

Clinical evaluation of Relivax-DC for immunotherapy of prostate cancer

18

Tetravalent combination vaccine (DPT-r-Hepatitis B) and pantavalent combination vaccine (DPT-r-Hepatitis B + HIB)

17

Human Interferon alpha 2b (rh-IFNá2b)

16

Human Erythropoietin (rh-EPO)

YEAR 2005

15

Pegylated Granulocyte Colony Stimulating Factor (r-h-peg-G-CSF)

14

Lysostaphin gel

13

Granulocyte Colony Stimulating Factor (r-h-G-CSF)

12

streptokinase

11

Human Granulocyte-Macrophase Colony Stimulating Factor (r-hu-GM-CSF)

10

Pegylated Human Interferon Alfa 2b

9

Pentavalent combination vaccine consisting of Diphtheria, Tetanus, whole cell Pertussis, r-Hepatitis B & Hemophilus Influenzae type B (DTwPH-Hib)

8

TNK-t-PA

7

Human Follicle Stimulating Hormone (rh-FSH)

6

Interferon a2a

5

pegylated Interferon a2a

4

Interferon a2b

3

Pegylated Interferon a2b

2

Human interferon alpha 2b (rh-IFN  2b)

1

Erythropoietin