1/ 28/ 13 FDA M ahar asht r a

M onday, 2 8 - J an- 2 0 1 3

You are here -> Guidelines ->testApprove Important Content

Experience Required for Approval Notification of Adjudicating Officers
under FSSA 2006
Serial Section in which approval Rule (3) Educational Experience Panel Relaxation Notification of Food Safety Officers
No. to be sanctioned (2) Qualifications necessary Interview (7) and Designated Officers under
(1) necessary (5) (6) FSSA 2006
(4)
Raids conducted by FDA
1 Basic Drugs and Fine 71 (1) (a) Degree in 18 months Necessary Experience of
C hemicals. 76 (1) (a) Pharmacy or 1 year is US FDA - Approved Units List
Pharmaceutical sufficient if 6 Schedule M Complied Units
C hemistry. months WHO - Approved Units List
training
undergone Blood Bank
during degree Cosmetic Manufacturers
course. List of Public Testing Laboratories
2 As above .. Masters degree 1 year .. As above .. Food Labs
in Pharmacy or
Pharmaceutical
C hemistry
3 As above 71 (1) (b) Degree in 3 years .. As above In case all the What's New
76 (1) (b) Science (with subject are of
C hemistry or equal status read more ...
Microbiology as then it will be ..........................................
main subject.) sufficient if
one of the
subject s
C hemistry or
Microbiology.
4 As above .. Masters degree 2 years As above ..
in the above
subjects
5 As above 71 (1) (c) Degree in 3 years As above Nil
76 (1) (c), chemical
(d) Engineering or
chemical
Technology or
Medicine.
6 As above .. Ph.D. in Nil Not ..
C hemistry or necessary
Pharmaceutical
C hemistry

7 Disinfectants, Pesticides, Liquid 71 Degree in As above As above ..

Paraffin, Gases, Non-chemical (exemption) Pharmacy or
contraceptives, Plaster of Paris, Pharmaceutical
Surgical Dressings. C hemistry
8 As above Do. Degree in 1 year Not ..
Science necessary
9 As above Do. Masters degree Nil Do. ..
or Ph.D. in
Science.
10 Only Non-chemical Do. H.S.C . 3 years Do. ..
contraceptives, Plaster of Paris,
Surgical Dressings.
11 As above Do. S.S.C . 6 years As above ..
12 As above 71 Ph.D. Master's Nil Not ..
(exemption) degree, necessary
Degree in
Pharmacy or
Pharm.
C hemistry.
13 Tablet/C apsule/Ointment/Liquid .. Ph. D. in Nil Not ..
Oral/Powder. Pharmacy or necessary
Pharmaceutical
C hemistry.
14 As above .. Masters degree 1 year Necessary ..
in above
subjects.
15 As above 71 (1) (a) Degree in 18 months. Necessary C all for
76 (1) (a) Pharmacy or (1year in interview
Pharmaceutical case 6 after 6
C hemistry. months months
www. f da- m ah. com / appr ove. aspx 1/ 4
1/ 28/ 13 FDA M ahar asht r a

C hemistry. months months

training in additional
the course.) experience
acquired in
other section
in case
approved in
one section as
at col.(2) Sr.
No. 13.
16 As above 71 (1) (b) Degree in 3 years As above As above
76 (1) (b) Science with
C hemistry or
Microbiology as
main subject or
of the same or
equal status.
17 As above .. Masters 2 years Necessary As above
Degree in the
above subject.
18 As above .. Ph.D. in 1 year Necessary ..
Science
19 As above 71 (1) (c) Degree in 3 years Necessary As above
76 (1) (d) C hemical Eng.,
C hemical
Technology.
20 Injections/other sterile .. Ph.D. in 1 year Not ..
products. Pharmacy or necessary
Pharmaceutical
C hemistry.
21 As above .. Masters degree 15 months Necessary ..
in Pharmacy or
Pharmaceutical
C hemistry.
22 As above 76 (1) (a) Degree in 18 months Necessary Should be
Pharmacy or called for
pharmaceutical interview and
C hemistry. 1year
independent
experience
acquired is
accepted in
case
approved in
any one
section
mentioned at
Sr. No. 13.
23 As above 76 (1) (b) Degree in 3years As above As above
Science
(C hemistry or
Microbiology as
main subject)
or of equal
status.

24 As above .. Ph.D. in 1 year Necessary ..

science
25 As above 76 (1) (c) Degree in 3 years As above As above
(d) chemical Eng.,
or Medicine.
26 Repacking of drugs 71 (A) 3(a) Degree or Nil Not ..
Diploma in necessary
Pharmacy or
Pharmaceutical
C hemistry or
Registered
Pharmacist.
27 Repacking of drugs 71 (A) (3) H.S.C . Nil Not ..
(b) (C hemistry) necessary
subject.
28 As above 71 (A) (3) S. S. C . 4 years As above ..
(c)
29 Homeopathic drugs 85 E H.S.C . 5 years As above ..
(minimum)
30 As above 85 E Degree in 2 years Not ..
Science necessary
31 As above 85 E Degree in 1 years As above ..
Pharmacy or
pharmaceutical
chemistry.
32 As above 85 E Diploma in 18 months As above ..
above subject
www. f da- m ah. com / appr ove. aspx 2/ 4
1/ 28/ 13 FDA M ahar asht r a

above subject
33 As above 85 E Ph.D. or Maters 6 months Not ..
Degree in necessary
Pharmacy,
Pharmaceutical
C hemistry or
Science.
33-A C osmetic 139(1) (a) Degree or Nil As above ..
(b) Diploma in
Pharmacy or
Pharmaceutical
C hemistry or
Registered
Pharmacist.
34 As above 139 (1) (c) Degree in As above As above ..
C hemistry or
H.S.C with
C hemistry.
35 As above .. Up to S.S.C . Sufficient As above Limited to the
manufacture
of Utne, Hair
oil or
perfumes.
36 Ayurvedic medicines and 157 (2) (a) Degree in As above As above ..
Siddha and Unani. Ayurved or
Ayurvedic
Pharmacy or
Siddha or
Unani.
37 As above 157 (2) (b) Diploma in As above As above ..
Ayurveda,
Siddha or
Unani.
38 As above 157 (2) (c) Degree in 2 years As above ..
Pharmacy or
Pharmaceutical
C hemistry or
C hemistry or
Botany.
39 As above 157 (2) (d) Registered 4 years As above ..
Vaidya or
Hakim.
40 As above 157 (2) (e) Pharmacist in 8 years As above ..
Ayurvedic,
Unani or
Siddha.

41 As above .. Up to S.S.C . 4 years As above In case the

candidate is
the owner or
a partner and
manufacturing
one or two
products for
many years
these
relaxation's
may be
considered for
approval
extended to
Mfg. drugs for
external
applications.
42 C hemical and Instrumental 71 (4-A) 76 Ph.D. in Nil Not ..
Analysis (Drugs and (4-A) Pharmacy or necessary
C osmetics). Pharmaceutical
C hemistry or
Science.
43 As above As above Masters degree Nil Not ..
in Pharmacy or necessary
Pharmaceutical
C hemistry.
44 C hemicals and Instrumental 71 (4-A) 76 Degree in Nil Not ..
Analysis (Drugs and (4-A) Pharmacy or necessary
C osmetics) Pharmaceutical
C hemistry.
45 As above As above Degree in 2 years Necessary 6 months
Science with experience
C hemistry or sufficient if
Biology or holding
Botany or Diploma in
Microbiology as Drug
www. f da- m ah. com / appr ove. aspx 3/ 4
1/ 28/ 13 FDA M ahar asht r a

Microbiology as Drug
the subject or Analysis.
Degree in
Medicine.
46 As above As above Masters degree 1 years As above ..
in the above
subjects.
47 Microbiological analysis and As above Ph.D. in Nil Not ..
sterility testing Pharmacy or necessary
Pharmaceutical
C hemistry or
Microbiology.
48 As above As above Masters Nil Necessary ..
Degree in
Pharmacy,
Pharmaceutical
C hemistry or
Microbiology.
49 As above As above Degree in Nil Necessary ..
Pharmacy or
Pharmaceutical
C hemistry.
50 As above As above Degree 2 years As above Experience of
in C hemistry, 6 months
Microbiology, sufficient in
Botany or case
Degree in approved in
Medicine. the section at
Sr. No. 42.
51 Bioassays. Pyrogen Toxicity As above Degree Nil As above ( Not for
Masters degree Ph.D. ).
or Ph.D. in
Pharmacy or
Pharmaceutical
C hemistry.
52 As above As above Degree 2 years As above Experience of
in C hemistry 6 months
Microbiology or sufficient in
Botany or Drug case
analysis. approved in
the section at
Sr. No. 42 or
47.
53 As above As above Degree in Nil Necessary ..
above subjects
and Diploma in
Drug analysis.
54 Hard Gelatine C apsule 71 (1) (b) Degree or Nil Not ..
Higher degree necessary
in Pharmacy or
Pharmaceutical
C hemistry.
55 As above As above Degree in 1 year Necessary ..
Science..
56 As above As above Masters degree 6 months As above ..
in Science.
Disclaimer

www. f da- m ah. com / appr ove. aspx 4/ 4