Drug Testing Costs to Rise Annually: Health Ministry Notifies New Fee Structure Under Drugs Rules
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New Delhi: In a major regulatory update aimed at modernising and rationalising laboratory testing charges under the Drugs and Cosmetics framework, the Ministry of Health and Family Welfare (MoHFW) has notified revised fee structures for drug testing and analysis conducted by Central Drugs Laboratories (CDLs), State Drugs Laboratories (SDLs), and the Pharmacopoeial Laboratory for Indian Medicine (PLIM).
The amendment also introduces an automatic 5 per cent annual increase in prescribed testing and analysis charges under Schedule B and Schedule B(1).
The amendments have been notified through the Drugs (Third Amendment) Rules, 2026, published in the Official Gazette on May 22, 2026. The revised provisions replace the existing Schedule B and Schedule B(1) of the Drugs Rules, 1945, which prescribe the fees payable for testing and analysis of drugs, vaccines, sera, herbal medicines, homeopathic products, and traditional medicines.
The notification comes after the publication of draft rules vide G.S.R. 52(E) dated January 22, 2026. Copies of the draft notification were made available to the public on January 27, 2026, inviting objections and suggestions for a period of thirty days. The Central Government stated that no objections or suggestions were received from stakeholders during the consultation period.
Accordingly, the government has finalised the amendments after consultation with the Drugs Technical Advisory Board (DTAB). The new rules will come into force three months from the date of their publication in the Official Gazette.
Under the revised Schedule B, the government has comprehensively updated testing charges for a wide range of pharmaceutical analyses conducted by Central and State Drug Laboratories. The fee structure now covers animal-based assays, microbiological tests, identification tests, physical evaluations, analytical assays, and miscellaneous laboratory examinations.
Among the notable revisions, fees have been specified for specialised biological and animal-based tests such as insulin potency testing, glucagon assay, pyrogen testing, toxicity testing, and determination of lethal doses (LD10 and LD50). Charges for microbiological evaluations including sterility testing, microbial limit tests, bacterial endotoxin testing, and molecular biological identification methods such as PCR and RFLP have also been standardised.
The revised schedule further details charges for sophisticated analytical techniques including High-Performance Liquid Chromatography (HPLC), High-Performance Thin Layer Chromatography (HPTLC), Gas Liquid Chromatography (GLC), Infrared (IR) Spectroscopy, Ultraviolet (UV) Spectroscopy, Atomic Absorption Spectroscopy (AAS), and Inductively Coupled Plasma (ICP) analysis.
A separate Part-B of Schedule B prescribes testing charges for sera, vaccines, antitoxins, monoclonal antibodies, and immunological products. The schedule includes fees for potency, identity, stability, biochemical testing, virus inactivation studies, endotoxin testing, and protocol scrutiny for various vaccines including measles, rubella, mumps, hepatitis, influenza, rabies, Japanese encephalitis, HPV, typhoid, pneumococcal, meningococcal, cholera, rotavirus, varicella, and DTP group vaccines.
The amendment also introduces revised testing charges for homeopathic and herbal medicines under Part-C, covering identification of botanical and chemical raw materials, assay procedures, mother tincture testing, and chromatographic analyses.
Significantly, the notification provides that where any test is not specifically listed in the Schedule, the applicable fee will be determined by the Director or Government Analyst of the concerned laboratory or institute.
Another key feature of the amendment is the introduction of an automatic annual fee escalation mechanism. The notification specifies that all prescribed testing and analysis charges under Schedule B shall increase by 5 per cent every year.
In addition, Schedule B(1), relating to testing and analysis carried out by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Government Analysts for AYUSH medicines, has also been revised. The updated schedule prescribes charges for sterility testing, toxicity testing, chromatographic analyses, pesticide residue testing, aflatoxin testing, heavy metal analysis, microscopic examination, and various quality control parameters applicable to traditional medicines.
The revised Schedule B(1) also authorises the Director of the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) or the concerned Government Analyst to determine or revise testing charges in consultation with the Ministry of AYUSH. Similar to Schedule B, testing fees under Schedule B(1) will also automatically increase by 5 per cent annually.
The Gazette notification stated:
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: ─
“SCHEDULE B (See rules 7 and 48) FEES FOR TEST OR ANALYSIS BY THE CENTRAL DRUGS LABORATORIES OR STATE DRUGS LABORATORIES
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 | ||
(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 | |
(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 | |
(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 Limit test for impurities with impurity standard | 500 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 | |
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 |
(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 |
(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
(b) Sugar coated
| 100 200 150 |
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 (TLC) without reference standard or TLC with reference standard | 500 each 3000 each |
17 | HPLC Pressure liquid Chromatography | 4000 each |
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.”.
