Drugs and Cosmetics Act, 1940 (23 of 1940).

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N o . 1 5 Poudouchéry Vendredi 22 Février 2013 (3 Phalguna 1934)

No. Puducherry Friday 22nd February 2013

GOVERNMENT OF PUDUCHERRY

HEALTH SECRETARIAT

No. 3741/CS/Health/ H7/2012.

Puducherry, the 20th February 2013.

NOTIFICATION

The notification in G.S.R. 478 (E), dated 7th August, 1998 of the Department of Health, Ministry of Health and Family Welfare, Government of India, published in the Gazette of India, Part-II, section 3 (i), dated 7th August 1998 is hereby republished for general information of the public.

M. GUNASEKARAN,

Under Secretary to Government (Health).

[ 197 ]LA GAZETTE DE L'ETAT [ PART-I 198 198

GOVERNMENT OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE

(DEPARTMENT OF HEALTH)

New Delhi, the 7th August 1998.

No. X. 11014/15/94, DM&PFA.- In exercise of the powers conferred

by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the

Central Government, after consultation with the Drugs Technical Advisory Board,

hereby makes the following rules further to amend the Drugs and Cosmetics

Rules, 1945, namely:-

1. (1) These rules may be called the Drugs and Cosmetics (Third

Amendment) Rules, 1998.

(2) They shall come into force on the date of their publication in the

official gazette.

2. In the Drugs and Cosmetic Rules, 1945, for Schedule 'B', the following

shall be substituted, namely:-

"SCHEDULE-B

(See rules 7 and 48)

1. Fees for test and assay of drugs requiring use of animals :

Rupees

Adrenocorticotrophic hormone assay . . 1,000

Gonadotrophic hormone for LH activity . . 1,000

FSH activity

. . 1,000

Posterior pituitary extract or its synthetic substitute . . 400

for oxytocin activity.

Vasopressor activity

. . 400

Insulin and insulin in combination for hypoglycaemic . . 2,000

activity.

Hyaluronidase

. . 500

Glucagon

. . 2,000

Heparin for anticoagulant activity . . 600

Protamine sulphate

. . 300

Depressor or histamine like substane . . 300

Pyrogen test

. . 500

Antigenecity or foreign protein test

. . 300

Abnormal or undue toxicity or safety test . . 200

Determination of lethal doses, LD10 or LD 50 in mice . . 800

Skin sensitivity/eye irritation

. . 250

Implantation test

. . 2,000PART-I ] LA GAZETTE DE L'ETAT 199 Rupees

2. Microbiological tests and assays :

Bioassay of antibiotic

. . 400

Microbiological assay of vitamins . . 300

Phenol coefficient

. . 300

Preservatives - Microbial challenge test . . 2,000

Sterility test - Parenteral preparations . . 100

Surgical dressings

. . 200

Syringes and needles

. . 300

Transfusion and infusion sets of assemblies . . 400

Other sterile devices.

3. Identification tests :

(a) Chemical methods

. . 50

(b) Microscopical

. . 50

. . 150

(d) UV Spectroscopy

. . 100

(e) Chromotography

(i) Paper

. . 100

(ii) Thin layer

. . 150

(iii) Column

. . 100

(iv) GLC

. . 250

(v) HPCL

. . 500

(vi) Gel filtration

. . 300

(f) Electrophoresis

(i) Paper and cellulose acetate . . 200

(ii) Polyacrylamide gel, starch gel, agar gel . . 300 each

4. Physical tests :

(a) Optical rotation, specific gravity, refractive . . 75 each

index, weight per ml, fluorescence.

(b) Viscocity

. . 100

ash, sulphated ash, etc.

(d) Absorbancy, wt/unit area (surgical), foreign . . 30 each

matter,extractive value, thread count, etc.

(e) Uniformity of weight

(i) Tablets

. . 15

(i) Capsules

. . 20

(f) Acid value, iodine value, peroxide value, . . 100 each

soponification value, acetyl value.

LA GAZETTE DE L'ETAT [ PART-I 200 200

Rupees

(g) Disintegration tests—

(i) Ordinary tablets

. . 20

(ii) Capsule

. . 30

(iii) Sugar coated tablets

. . 50

(iv) Enteric coated tablets

. . 100

(h) Dissolution test

. . 250

(i) Uniformity of content

. . 500

(j) Wt. per unit area (powder), particle size, . . 200 each

count, methoxy value.

(k) Limit test for impurities

. . 100 each

(1) Related substances

(i) TLC method–

(A) Without reference standard . . 150

(B) With reference standard . . 250

(ii) Gas Liquid Chromatography–

(A) Without reference standard . . 250

(B) With reference standard . . 350

(iii) High pressure Liquid Chromatography–

(A) Without reference standards . . 500

(B) With reference standards . . 500

(m) Water (Karl Fisher)

. . 200

(5) Assays :

(a) General chemical methods

. . 100 for

each ingredient.

(b) Non-aqueous/Instrumental

. . 200 for

each ingredient.

(i) TLC

. . 250

(ii) Column

. . 200

(iii) GLC

. . 350

(iv) HPCL

. . 500

(v) Gel filtration

. . 400

(d) Nitrogen determination . . 200

(e) Medicinal gases

. . 400PART-I ] LA GAZETTE DE L'ETAT 201 Rupees

(6) Polymorph test :

(Content of polymorph A in chloramphenicol . . 200-500

palmitate) Surgical sutures (Depending

on number of test to be carried).

Other miscellaneous tests

. . 100-500

II. Fees for Sera and Vaccine -

Sterility test

. . 100

Abnormal toxicity test

. . 400

Specific toxicity test

. . 800

Inactivation test (Rabies)

. . 200

Potency testing of rabies vaccine . . 2,025

Potency testing of pertussis fraction of DPT vaccine. . 2,025

Potency testing of tetanus fraction of DPT/DT/TT . . 2,500

vaccine.

Potency testing of diphtheria fraction of DPT/DT . . 2,700

vaccine.

Testing of antisera for the specific titre . . 1,000

Potency testing Measles/Mumps/Rubella vaccine . . 760 each

Testing of Oral Polio Vaccine (OPV)—

Potency

. . 4,550

Identity

. . 1,000

Stability

. . 800

Potency testing of Japanese encephalitis vaccine . . 3,900

Potency testing of snake

. . 400

Venom serum for each venom

Identity testing for vaccines/sera

Cell culture (Other than OPV)

. . 400

Other than cell culture

. . 100

Estimation of Volume/PH/Total solids/No. of . . 50 each

organisms/Physical checking.

Estimation of total proteins/aluminium content/ . . 200 each

phenol/formaldehyde/thiomersal/moisture.

Pyrogen testing

. . 500

Stability test for vaccines other than Oral Polio Vaccine . . 4,550

III. Cosmetics

. . 400-1,500

(The exact amount of the fee shall be determined

by the Director of Laboratory or the Government

Analyst, as the case may be).

LA GAZETTE DE L'ETAT [ PART-I 202 202

Rupees

IV. Rubber condoms

. . 1,000

V. Homoeopathic medicines–

1. Identification test for raw-material of botanical . . 125

origin (other than assay of constituents).

2. Identification test for raw material of chemical . . 100 origin (other than assay).

3. Limit test for drugs of chemical origin . . 150

4. Assay of total alkaloids or of drugs of . . 100 chemical origin.

5. Identification test for drugs of animal origins or . . 100

microbiological.

6. Fees for testing of mother tincture, lower potencies . . 100 up to 3x or equivalent.

7. Determination of biochemic drug through atomic . . 75 absorbance spectrophotometer.

Note:

1. For tests not listed in the Schedule, charges will be determined by the Director or the Government Analyst of the laboratory/institute as the case may be.

2. For the tests relating to Ayurvedic, Unani and Siddha medicines, charges will be determined by the Adviser (Indigenous System of Medicine), Director or Government Analyst of the Laboratory/Institute, as the case may be.".

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