Schedule

Schedule B : Fees Required to Pay for test or analysis by CDL/SDL

(Last Updated On: March 8, 2018)
Schedule A B C D E F G H H1J K 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:
  1. Paper
  2. Thin layer
  3. Column
  4. GLC
  5. HPLC
  6. Gel Filtration
  • Electrophoresis
  1. Paper and Cellulose acetate
  2. 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: 
  1. Tablets
  2. Capsules
  • Acid value, iodine value, peroxide value, Soponification value, acetyl value.
  • Disintegration tests:
  1. Ordinary tablets
  2. Capsule
  3. Sugar Coated tablets
  4. 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

  1. Without reference standard
  2. With reference standard

2. Gas Liquid Chromatography

  1. Without reference standard
  2. With reference standard

3. High pressure Liquid Chromatography

  1. Without reference standards
  2. With reference standards
  • Water (Karl Fisher)

Assays: 

  • General chemical methods
  • Non-aqueous/instrumental
  • Chromatography
  1. TLC
  2. Column
  3. GLC
  4. HPLC
  5. 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):
  1. Potency
  2. Identity
  3. Stability
  • Potency testing of Japanese Encephalitis Vaccine
  • Potency testing of Snake
  • Venom serum
  • Identity testing for vaccines/sera
  1. Cell culture (Other than OPV)
  2. 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

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