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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-30052026-272962
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 366] | NEW DELHI, MONDAY, MAY 25, 2026/JYAISTHA 4, 1948
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd May, 2026
G.S.R. 407(E).— Whereas, a draft of certain rules further to amend the Drugs Rules, 1945 was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) (here in after referred to as the said Act) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare), number G.S.R. 52(E), dated the 22nd January, 2026, published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the said Official Gazette containing the said notification were made available to the public;
And, whereas, copies of the said Gazette were made available to the public on 27th January, 2026;
And whereas, no objections or suggestions were received from the public on the said rules for consideration by the Central Government;
Now, therefore, 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 Rules, 1945, namely:—
1. | (1) These rules may be called the Drugs (Third Amendment) Rules, 2026.
(2) | They shall come into force after three months from the date of their publication in the Official Gazette.
2. | In the Drugs Rules, 1945, —
(i). | for Schedule B, the following schedule shall be substituted, namely:—
THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(i)]
"SCHEDULE B
(See rules 7 and 48)
FEES FOR TEST OR ANALYSIS BY THE CENTRAL DRUGS
LABORATORIES OR STATE DRUGS LABORATORIES
PART-A
S. No. | Name of test and assay of drugs | Rupees
(1) | (2) | (3)
1. Fees for test and assay of Drugs requiring use of animals—
(1) | Adrenocorticotrophic hormone assay | 3000
(2) | Gonadotrophic hormone for LH activity | 3000
(3) | FSH activity | 3000
(4) | Posterior Pituitary extract or its synthetic substitute for oxytocin activity | 3000
(5) | Vasopressor activity | 3000
(6) | Insulin and insulin in combination for hypoglycaemic activity | 6000
(7) | Hyaluronidase | 1500
(8) | Glucagon | 6000
(9) | Heparin for anticoagulant activity | 2000
(10) | Protamine sulphate | 1500
(11) | Depressor or Histamine like substance | 1500
(12) | Pyrogen test | 2000
(13) | Antigenecity or foreign protein test | 2000
(14) | Abnormal or undue toxicity or safety test | 5000
(15) | Determination of Lethal doses, LD10 or LD50 in mice | 25000
(16) | Skin sensitivity/eye irritation | 1000
(17) | Implantation test | 5000
2. Microbiological tests and assays—
(1) | Bioassay of Antibiotic | 1000
(2) | Microbiological assay of vitamins and amino acids | 1000 each
(3) | Rideal walker coefficient and stability | 1000
(4) | Preservatives- Microbial challenge test | 5000
(5) | Sterility test- Parenteral preparations
(a) | Parenteral preparations (without membrane filtration) | 1000
(b) | Parenteral preparations (with membrane filtration) | 2000
(c) | Surgical Dressings | 1000
[PART II—SEC. 3(i)] | THE GAZETTE OF INDIA : EXTRAORDINARY
(d) | Ophthalmic ointment | 1000
(e) | Syringes & needles | 1000
(f) | Transfusion and infusion sets or assemblies, other sterile devices | 2000
(g) | Other sterile preparations/items | 2000
(6) | Microbial limit tests
(a) | For absence of each pathogenic organism | 1000
(b) | Total count | 1000
(7) | Antisera
(a) | For specific titre | 1000
(b) | Avidity | 1000
(8) | Lactobacillus/Viable cell count | 1000
(9) | Heparin assay | 1500
(10) | Bacterial Endotoxin Test
(a) | Qualitative | 2000
(b) | Quantitative | 4500
(11) | Identification
(a) | Biochemical | 500 each
(b) | Serological Method | 500 each
(c) | Molecular Biological Method
(i) | Thermal cycler (PCR) | 1000
(ii) | RFLP (Restriction Fragment Length polymorphism) | 1000
(iii) | PCR followed by RFLP | 2000
(12) | Particle count by Microscope | 500
3. Identification tests---
(1) | Chemical Methods | 150
(2) | Microscopical | 150
(3) | IR Spectroscopy | 450
(4) | UV Spectroscopy | 300
(5) | Chromatography
(a) | Paper | 300
(b) | Thin layer | 450
(c) | Column | 300
(d) | GLC | 500
(e) | HPLC | 1000
(f) | Gel filtration | 600
14 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(i)]
(6) | Melting point /Boiling Point | 150
(7) | Electrophoresis
(a) | Paper and Cellulose Acetate | 600
(b) | Polyacrylamide Gel, Starch Gel, Agar gel | 900 each
4. Physical tests---
(1) | Optical rotation, Specific gravity, Refractive index, weight per ml, Fluorescence etc. | 200 each
(2) | Viscosity | 200
(3) | pH, Solubility, Loss on drying, Net content, Ash, Sulphated ash, Description etc. | 100 each
(4) | Uniformity of dispersion | 150
(5) | Minimum fill | 150
(6) | Absorbency, Weight per unit area (Surgical), Foreign matter, Extractive value, Threads count, Length & Width (Surgical), Surface active substances, Acidity or alkalinity, Neps, Setting time etc. | 150 each
(7) | Uniformity of weight
(a) | Tablets | 100
(b) | Capsules | 150
(c) | Injections/ RSD | 200
(d) | Extractable Volume | 100
(8) | Acid value, Iodine value, Peroxide value, Saponification value, Acetyl value, Methoxy value | 500 each
(9) | Disintegration tests
(a) | Uncoated or film coated tablets | 100
(b) | Capsules | 150
(c) | Sugar-coated tablets | 200
(d) | Enteric-coated tablets | 400
(10) | Dissolution test
(a) | U.V. | 500
(b) | H.P.L.C. | 1500
(c) | Modified release
(i) | U.V. each stage | 500+300 per subsequent stage
(ii) | HPLC each stage | 1500+1000 per subsequent stage
(11) | Uniformity of content
(a) | H.P.L.C. | 2500
[PART II—SEC. 3(i)] | THE GAZETTE OF INDIA : EXTRAORDINARY
(b) | Other than H.P.L.C | 1000
(12) | Weight per unit area (powder), Particle size, Particle count | 1000
(13) | Limit test for impurities without impurity standard | 500
| Limit test for impurities with impurity standard | 1000 each
(14) | Related substances
(a) | TLC methods —
(i) | Without reference standards | 300
(ii) | With reference standards | 500 each
(b) | GLC —
(i) | Without reference standards | 750
(ii) | With reference standards | 1000 each
(c) | H.P.L.C. —
(i) | Without reference standards | 1000
(ii) | With reference standards | 1500 each
(d) | Polymorph Test (IR) | 500
(15) | Water (Karl Fisher) | 600
5. Assays--
(1) | Chemical methods (Visual Titration) | 300 each
(2) | Chemical methods (Instrumental) | 600 each
(3) | Chromatography
(a) | T.L.C. | 500
(b) | H.P.T.L.C. | 1500
(c) | G.L.C. | 1200
(d) | H.P.L.C. | 1500
(4) | A.A.S/I.C.P. | 1000 each
(5) | Polarimeter | 750
(6) | Spectrofluorometer | 1000
(7) | Gravimetric | 250
(8) | UV | 750
6.Other miscellaneous tests | 300-1500
16 | THE GAZETTE OF INDIA: EXTRAORDINARY | [PART II-SEC. 3(i)]
PART-B
S.No. | Tests | Rupees
(1) | (2) | (3)
1. | Fees for sera and vaccine
(1) | Sterility Test | 1000
(2) | Physical Aspects | 300
(3) | Endotoxin Content | 4500
(4) | Abnormal Toxicity Test | 5000
(5) | Moisture Content | 1500
(6) | Potency / Stability / Identity of Measles component | 10000
(7) | Potency / Stability / Identity of Rubella component | 10000
(8) | Potency / Stability / Identity of Mumps component | 10000
(9) | Potency Hepatitis B component | 12000
(10) | Biochemical Testing for Hepatitis B Vaccine | 4000
(11) | Biochemical Testing for Hepatitis A Vaccine | 3500
(12) | Biochemical Testing for Hepatitis A+ B Vaccine | 4500
(13) | Virius Inactivation for influenza Vaccine | 2000
(14) | Biochemical testing for Influenzae Vaccine | 6500
(15) | Biochemical testing for J.E. vaccine Inactivated | 2000
(16) | NVT test in Mice | 20000
(17) | Biochemical testing for HPV Vaccine | 3000
(18) | Potency / Stability of Rabies Vaccine | 20000
(19) | Virus Inactivation Test | 2000
(20) | Biochemical Test for Rabies Vaccine | 1500
(21) | Potency/ Identity Oral Vaccine (OPV) | 20000
(22) | Biochemical testing of Inactivated Polo Vaccine | 10000
(23) | Potency/ Stability testing of Yellow Fever Vaccine | 10000
(24) | Potency for Rabies Antiserum | 7500
(25) | Biochemical Testing for Rabies Antiserum | 7500
(26) | Biochemical Testing for anti snake venom serum | 7500
(27) | Biochemical Testing for Tetanus antitoxin | 7500
(28) | Biochemical Testing for Diphtheria antitoxin | 7500
(29) | Biochemical Testing for Rabies Antiserum | 7500
(30) | Potency for anti snake venom serum | 30000
(31) | Potency for Tetanus antitoxin | 10000
(32) | Potency for Diphtheria antitoxin | 5000
[PART II-खण्ड 3(i)] | THE GAZETTE OF INDIA : EXTRAORDINARY
(33) | Biochemical testing of Mixed Gas Gangrene Antiserum | 7500
(34) | Biochemical Testing for Rabies Monoclonal antibodies | 5500
(35) | Biochemical testing for Botulinm toxin | 5000
(36) | Potency for tetanus Vaccine | 45000
(37) | Specific Toxicity test for DTP group of vaccine | 6000
(38) | Biochemical Testing for tetanus vaccine | 5000
(39) | Potency testing of Diphtheria component | 45000
(40) | Mouse Weight Gain test for pertussis Component | 6000
(41) | Potency for pertussis Component | 36000
(42) | Biochemical testing for DTP group of Vaccine | 5000
(43) | Potency test for Hib Component (Anti Hib Antibodies) | 9000
(44) | Identity test for BCG Vaccine | 800
(45) | Stability for BCG Vaccine | 10000
(46) | Test for Skin Reactivity for BCG Vaccine | 3000
(47) | Test for absence of Virulent Mycobacteria | 2000
(48) | Total PRP for Haemophiolus influenzae type B Vaccine | 3000
(49) | Free PRP for Haemophilus influenzae type B Vaccine | 3000
(50) | Identity test for Haemophilus influenzae type B Vaccine | 3000
(51) | Biochemical testing for Meningococcal A Conjugated Vaccine | 4000
(52) | Identity testing for Meningococcal A Conjugated Vaccine | 3000
(53) | Molecular Size testing for Meningococcal A Conjugated Vaccine | 3600
(54) | Biochemical testing for Meningococcal A+C Conjugated Vaccine | 4000
(55) | Identity testing for Meningococcal A+C Conjugated Vaccine | 3000
(56) | Molecular Size testing for Meningococcal A+C Conjugated Vaccine | 3600
(57) | Biochemical testing for Meningococcal A,C,Y, W Vaccine | 4000
(58) | Identity testing for Meningococcal A,C,Y, W Vaccine | 3000
(59) | Molecular Size testing for Meningococcal A,C,Y, W Vaccine | 3600
(60) | O- acetyl Content/ Vi Polysaccharide content for Typhoid polysaccharide Vaccine | 3000
(61) | Biochemical testing of Typhoid polysaccharide Vaccine | 4800
(62) | O- acetyl Content/ Vi Polysaccharide content for Typhoid polysaccharide Conjugate Vaccine | 3000
(63) | Biochemical testing of Typhoid polysaccharide Conjugate Vaccine | 4800
(64) | Biochemical testing for Oral Cholera Vaccine | 3000
(65) | Biochemical Testing for Pneumococcal Polysaccharide Vaccine | 3000
(66) | Identity test for Pneumococcal Polysaccharide Vaccine | 3000
(67) | Biochemical Testing for Pneumococcal Polysaccharide conjugate Vaccine | 10000
(68) | Identity test for Pneumococcal Polysaccharide conjugate Vaccine | 3000
18 | THE GAZETTE OF INDIA: EXTRAORDINARY | [PART II-SEC. 3(i)]
(69) | Identity test for D, T and P components in DTP group of vaccines | 500
(70) | Potency Varicella Vaccine | 10000
(71) | Potency Hepatitis A component | 12000
(72) | Potency Influenza vaccine | 20000
(73) | Potency Rotavirus | 20000
(74) | Potency test for J.E Vaccine inactivated | 20000
(75) | Potency test for J.E Vaccine Live | 20000
(76) | Biochemical testing for J.E. vaccine Live | 1500
(77) | Potency test for inactivated Polio Vaccine | 20000
(78) | Potency for Scorpion Venom Antiserum | 7500
(79) | Potency test for Mixed Gas Gangrene Antiserum | 7500
(80) | Potency test for Rabies Monoclonal Antibodies | 10000
(81) | Total PRP for Hib component in Tetravalent vaccine, Pentavlent Vaccine and Hexavalent Vaccines | 10000
(82) | Free PRP for Hib component in Tetravalent vaccine, Pentavlent Vaccine and Hexavalent Vaccines | 10000
(83) | Potency testing for Meningococcal A Conjugated Vaccine | 10000
(84) | Potency testing for Meningococcal A + C Conjugated Vaccine | 15000
(85) | Potency testing for Meningococcal A,C,Y, W Vaccine | 25000
(86) | Adsorption Test for D component in D.P.T vaccine | 1500
(87) | Adsorption Test for T component in D.P.T vaccine | 1500
(88) | Adsorption Test for Hepatitis B component in D.P.T vaccine | 1500
(89) | Protocol Scrutiny | 2500
PART-C
Sr.No. | Tests | Rupees
(1) | (2) | (3)
1. | Homeopathic/Herbal Medicines
(1) | Identification test for raw material of botanical origin (other than assay of constituents) | 250
(2) | Identification test for raw material of chemical origin (other than assay of constituents) | 200
(3) | Limit test for drugs of chemical origin | 450
(4) | Assay of total alkaloids or of drugs of chemical origin | 300
(5) | Identification test for drugs of animal origin or microbiological | 500
(6) | Fees for testing of mother tincture, lower potencies upto3x or equivalent | 400
(7) | U.V. or I.R. or H.P.L.C or H.P.T.L.C determination | 500
Note.-
(1) | For tests not listed in the Schedule, charges will be determined by the Director or the Government Analyst of the Laboratory or institute as the case may be.
(2) | The above prescribed testing or analysis fees shall automatically increase by 5% annually.";
(ii) | for Schedule B(1), the following schedule shall be substituted, namely:—
"SCHEDULE B(1)
(See rule 163 F)
FEES FOR THE TEST OR ANALYSIS BY THE PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINE (PLIM) OR THE GOVERNMENT ANALYST
Sr.No. | Type of testing or analysis | Cost of testing or analysis in Rupees
(1) | (2) | (3)
1 | Test for Sterility | 1000
2 | Abnormal toxicity or undue toxicity or safety test | 25,000
3 | Determination of lethal doses LD 50 to 10 on mice | 25,000
4 | Chemical test for each ingredient (Qualitative) | 1500
5 | Disinfectants | 2000
6 | Microbiological assay | 1000
7 | Microscopic examination of single drugs for identification | 500
8 | Microscopic examination of raw material of compound drugs | 2000
9 | Uniformity of weight of Tablets/Capsules/Vati/Gutika | 150
10 | Disintegration test
(a) | Uncoated or film coated | 100
(b) | Sugar coated | 200
(c) | Capsule | 150
11 | Tests other than assay (limit tests for impurities, ash content, total solids, acid value, iodine value, Saponification value, loss on drying, extract value etc.) for each test | 500 each
12 | Optical rotation | 250
13 | Refractive Index | 250
14 | Arsenic testing | 300
15 | Paper Chromatography | 500
16 | Thin layer chromatography | 500 each
| (TLC) without reference standard or |
| TLC with reference standard | 3000 each
17 | HPLC Pressure liquid Chromatography | 4000 each
20 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II-SEC. 3(i)]
18 | Gas liquid chromatography | 1500 each
19 | H.P.T.L.C restricted to single drugs qualitative | 2000 each
20 | A.A.S. or I.C.P. for Hg, Pb, As, Cd etc. | 2000 each
21 | Identification test for raw material or plant origin (other than assay of constituents) | 1000
22 | Identification test for raw material of chemical origin (other than assay) | 500
23 | Limit test for drugs of chemical origin | 500
24 | Test for pesticide residue (Organochlorine pesticide, Organophosphorus Pesticide, pyrethroids pesticide) | 6000
25 | Test for Aflatoxins (B1, B2, G1, G2) | 2000
Note.-
(1) | Sample testing charges will be determined or revised by the Director, Pharmacopoeia Commission for Indian Medicine and Homoeopathy or Government Analyst of its Central Laboratory, as the case may be, in consultation with the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH).
(2) | The prescribed cost of the test/analysis shall automatically increase by 5% annually.".
[F. No. X.11014/14/2025-DR-Part(2)]
HARSH MANGLA, Jt. Secy.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.
KUMER | Digitally signed by
CHAND | KUMER CHAND MEENA
Date: 2026.05.30
MEENA | 11:38:53 +05'30'
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