Schedule A B C D E F G H H1 I J K L M N O P Q R S T U V W X Y Z
Schedule B:
Schedule B Describe the Fees required to pay for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories.
Few Tests that are covered under Schedule B are as Follow:
Section 1:
- Drugs Required for use of Animals
- Microbiological Tests and Assays
- Identification Tests
- Physical Tests
- Assay
- Polymorph Tests
Drugs requiring use of animals:
- Adrenocorticotrophic hormone assay
- Gonadotrophic hormone for LH activity
- FSH Activity
- Posterior pituitary extract or its synthetic substitute for
- oxytocin activity
- Vasopressor activity
- Insulin and insulin in combination for hypoglycaemic activity
- Hyaluronidase
- Glucagon
- Heparin for anticoagulant activity
- Protamine sulphate
- Depressor or Histamine like substane
- Pyrogen test
- Antigenecity or foreign protein test
- Abnormal or undue toxicity or safety test
- Determination of Lethal doses, LD10 or LD 50 in mice
- Skin sensitivity/eye irrigation
- Implantation test
Microbiological tests and assays –
- Bioassay of Antibiotic
- Microbiological assay of vitamins
- Phenol coefficient
- Preservatives – Microbial challenge test
- Sterility test – Parenteral preparations
- Surgical dressings
- Syringes and needles
- Transfusion and infusion sets or assemblies
- Other sterile devices
Identification tests –
- Chemical Methods
- Microscopical
- IR Spectroscopy
- UV Spectroscopy
- Chromotography:
- Paper
- Thin layer
- Column
- GLC
- HPLC
- Gel Filtration
- Electrophoresis
- Paper and Cellulose acetate
- Polyacrylamide Gel, starch gel, agar gel
Physical tests:
- Optical rotation, specific gravity, refractive index, weight per ml, fluorescence.
- Viscocity
- pH, Solubility, loss on drying, net content, ash, sulphated ash etc.
- Absorbancy, wt/unit area (surgical), foreign matter, extractive value, thread count etc.
- Uniformity of weight:
- Tablets
- Capsules
- Acid value, iodine value, peroxide value, Soponification value, acetyl value.
- Disintegration tests:
- Ordinary tablets
- Capsule
- Sugar Coated tablets
- Enteric coated tablets
- Dissolution test:
- Uniformity of content.
- Wt. per unit area (powder), particle size, count, methoxy value.
- Limit test for impurities:
- Related substances:
1. TLC Method
- Without reference standard
- With reference standard
2. Gas Liquid Chromatography
- Without reference standard
- With reference standard
3. High pressure Liquid Chromatography
- Without reference standards
- With reference standards
- Water (Karl Fisher)
Assays:
- General chemical methods
- Non-aqueous/instrumental
- Chromatography
- TLC
- Column
- GLC
- HPLC
- Gel filtration
- Nitrogen determination
- Medicinal gases
Polymorph test –
- (Content of polymorph A in chloramphenicol palmitate) Surgical sutures (Depending on number of tests to be carried)
- Other miscellaneous tests
Section 2:
Fees for Sera and Vaccine:
- Sterility test
- Abnormal toxicity test
- Specific toxicity test
- Inactivation test (Rabies)
- Potency testing of rabies vaccine
- Potency testing of pertussis fraction of DPT vaccine
- Potency testing of tetanus fraction of DPT/DT/TT vaccine
- Potency testing of diphtheria Fraction of DPT/DTE vaccine.
- Testing of antisera for the specific titre
- Potency testing measles/Mumps/Rubella vaccine
- Testing of Oral Polio Vaccine (OPV):
- Potency
- Identity
- Stability
- Potency testing of Japanese Encephalitis Vaccine
- Potency testing of Snake
- Venom serum
- Identity testing for vaccines/sera
- Cell culture (Other than OPV)
- Other than cell culture
- Estimation of volume/pH/total solids/No. of organisms/Physical checking.
- Estimation of total proteins/aluminium content/phenol/formaldehyde/thiomersal/moisture.
- Pyrogen testing
- Stability test for vaccines other than Oral Polio Vaccine
Section 3:
Cosmetics:
- (The exact amount of the fee shall be determined by the Director of Laboratory or the Government Analyst, as the case may be).
Section 4:
Rubber Condoms Section 5:
Homoeopathic medicines:
- Identification test for raw material of botanical origin (other than assay of constituents).
- Identification test for raw material of chemical origin (other than assay)
- Limit test for drugs of chemical origin
- Assay of total alkaloids or of drugs of chemical origin
- Identification test for drugs of animal origins or microbiological.
- Fees for testing of Mother tincture, lower potencies upto 3x or equivalent.
- U.V. or I.R. or H.P.C.L. defect determination. Determination of Biochemic drug through atomic absorbance spectrophotometer.
Tests who fees are not mentioned in Schedule B is determined by Director or Government Analyst