Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-27012026-269590
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 52]
NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947
490 GI/2026
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 22nd January, 2026
G.S.R. 52(E).—The following draft of certain rules, which the Central Government proposes to make, in
exercise of the powers conferred by sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940),
after consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to
be affected thereby, and notice is hereby given that the said draft rules will be taken into consideration on or after the
expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules
are made available to the public.
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001
or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (1) These rules may be called the Drugs (......Amendment) Rules, 2026.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, for Schedule B, the following 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
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 | 3000 |
| | oxytocin activity | |
| (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)| Antigencity 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 |
+-----+------------------------------------------------------------------+----------+
| | 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 |
| с. | Surgical Dressings | 1000 |
| d. | Ophthalmic ointment | 1000 |
| e. | Syringes & needles | 1000 |
| f. | Transfusion and infusion sets or assemblies, other sterile | 2000 |
| | devices | |
| 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 |
+-----+----------------------------------------------------------------+------------+
| | 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 |
+-----+----------------------------------------------------------------+------------+
| | Physical tests--- | |
+-----+----------------------------------------------------------------+------------+
| (1) | Optical rotation, Specific gravity, Refractive index, weight per | 200 each |
| | ml, Fluorescence etc. | |
| (2) | Viscosity | 200 |
| (3) | pH, Solubility, Loss on drying, Net content, Ash, Sulphated | 100 each |
| | ash, Description etc. | |
| (4) | Uniformity of dispersion | 150 |
| (5) | Minimum fill | 150 |
| (6) | Absorbency, Weight per unit area (Surgical), Foreign matter, | 150 each |
| | Extractive value, Threads count, Length & Width (Surgical), | |
| | Surface active substances, Acidity or alkalinity, Neps, Setting| |
| | time etc. | |
+-----+----------------------------------------------------------------+------------+
| (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, | 500 each |
| | Acetyl value, Methoxy value | |
+-----+--------------------------------------------------------------------+--------------------------+
| (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 |
| с. | 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)| Wt. 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 |
| с. | 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 |
+-----+--------------------------------------------------------------------+--------------------------+
| | Assays-- | |
+-----+--------------------------------------------------------------------+--------------------------+
| (1) | Chemical methods (Visual Titration) | 300 each |
| (2) | Chemical methods (Instrumental) | 600 each |
+-----+--------------------------------------------------------------------+--------------------------+
| (3) | Chromatography | |
+-----+--------------------------------------------------------------------+--------------------------+
| i. | T.L.C. | 500 |
| ii. | H.P.T.L.C. | 1500. each |
| iii.| G.L.C. | 1200 |
| iv. | 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 |
+-----+--------------------------------------------------------------------+--------------------------+
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)| Virus 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 Polio 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 Botulinum 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 Haemophilus 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 | 3000 |
| | polysaccharide Vaccine | |
| (61)| Biochemical testing of Typhoid polysaccharide Vaccine | 4800 |
| (62)| O- acetyl Content/ Vi Polysaccharide content for Typhoid | 3000 |
| | polysaccharide Conjugate Vaccine | |
| (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 | 10000 |
| | Vaccine | |
| (68)| Identity test for Pneumococcal Polysaccharide conjugate Vaccine | 3000 |
| (69)| Identity test for D, T and P components in DTP group of | 500 |
| | vaccines | |
| (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, | 10000 |
| | Pentavalent Vaccine and Hexavalent Vaccines | |
| (82)| Free PRP for Hib component in Tetravalent vaccine, | 10000 |
| | Pentavalent Vaccine and Hexavalent Vaccines | |
| (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 | 250 |
| | than assay of constituents) | |
| (2) | Identification test for raw material of chemical origin (other | 200 |
| | than assay of constituents) | |
| (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 | 400 |
| | equivalent | |
| (7) | U.V. or I.R. or H.P.L.C or H.P.T.L.C determination | 500 |
+--------+------------------------------------------------------------------+----------+
Notes.-
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. The above prescribed testing/analysis fees shall automatically increase by 5% annually.
3. In the Drugs Rules, 1945, for Schedule B(1), the following 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 /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 | |
| (1) | Uncoated or film coated | 100 |
| (2) | Sugar coated | 200 |
| (3) | Capsule | 150 |
| 11. | Tests other than assay (limit tests for impurities, ash | 500 each |
| | content, total solids, acid value, iodine value, | |
| | Saponification value, loss on drying, extract value etc.)| |
| | for each test | |
| 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 |
| 18. | Gas liquid chromatography | 1500 each |
| 19. | H.P.T.L.C restricted to single drugs qualitative | 2000 each |
| 20. | A.A.S./I.C.P. for Hg, Pb, As, Cd etc. | 2000 each |
| 21. | Identification test for raw material or plant origin | 1000 |
| | (other than assay of constituents) | |
| 22. | Identification test for raw material of chemical origin | 500 |
| | (other than assay) | |
| 23. | Limit test for drugs of chemical origin | 500 |
| 24. | Test for pesticide residue (Organochlorine pesticide, | 6000 |
| | Organophosphorus Pesticide, pyrethroids pesticide) | |
| 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]
HARSH MANGLA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F.28-10/45-H (1), dated
21st December 1945 and last amended vide notification number G.S.R. ...... (E), dated..........