1. 1Labelling & Pack Size of Drugs under Drugs Act, 1940 & Rules 1945 A Presentation by Lalit Kumar Goel ASDC Haryana Contact no. 7056702999 17.12.2022 (Raipur) LKG
2. 2All Drugs should be labelled in the Prescribed Manner.Provisions for labelling and Packing of Drugs are mentioned in Part-IX (94 to Rule 106 B) of the Drugs Rules.LKG
3. Unlabelled Drugs No Drug can be sold without proper label, if so it contravenes Rule 95 of the Drug Rules. 3LKG
4. Contravention of Drug ActMisbranded DrugSection 17 (c) 4LKG
5. Export of Drugs (Rule 94) For export of drugs, certain exemptions from the labelling are given to meet the requirements of importing country. 5LKG
6. Rule 96 Labelling on the outer and innermost container of any Drug should be same. 6LKG
7. Rule 96 GSR 222 (E) dated 13.03.2018 effective from 01 April 2019 ‘Proper name’ should be larger than the ‘Brand name’ and Brand name should be mentioned below the Proper name. 7LKG
8. Example: Paracetamol Tablets I.P. Crocin Tablets OKCrocin Paracetamol Tablets IP Not OK8LKG
9. Proper name (Generic name) of Drugs Should always suffix with pharmacopeia abbreviations (if pharmacopoeia) Example : Ibuprofen Tablets I.P. OK Ibuprofen Tablets Not Ok 9LKG
10. Brand names are not pharmacopeial Example : Brufen Tablets Ok Brufen Tablets I.P Not Ok10LKG
11. Generic name of the Drug should be suffixed with dosage form Example :Ofloxacin Tablets I.P. OK Ofloxacin I.P. Tablet Not Ok 11LKG
12. If any Drug formulation is official in I.P. then it should be sold in India with word ‘I.P.’ on the label.12LKG
13. Example : For Sale in India Paracetamol Tablet I.P. - OK Paracetamol Tablets B.P. - Wrong If the product is not in I.P. then it can be labeled as B.P., U.S.P. & In house specifications.13LKG
14. Labelling Provisions for loan licensed firms or Loanee firms: Example : Suppose Drugs are manufactured by M/s Cubic Pharma, 8 ,HSIDC, Karnal, Haryana i.e. Host firm and Minto Pharma, Jalandhar is its loanee firm, then labelling manufacturers address will be as under:14LKG
15. Labelling of Drugs Under Loan License for Manufacturing Address With Example Name of Loanee firm: Glaxo Pharma.Address of Host firm: Syntex Ltd. Address Industrial Area Phase-I, Baddi, Himachal Pradesh. Address: Glaxo Pharma, Industrial Area Phase-I, Baddi Himachal Pradesh.15LKG
16. Dose of Active Ingredients Liquid Oral : Each 5ml ________mg.If dose is below 5ml then it can be each ml.If dose is above 5ml then it should be approved by Licensing Authority as minimum single dose.16LKG
17. Dry Syrups It is mandatory to mentioned weight of Granules in Dry Syrups.17LKG
18. Labeling of Tablets Each Uncoated.Film coated.Sugar coated.Enteric coated.Sustained Release.Bi-layer Tablet.Chewable Tablet.Sub-Lingual Tablet.18LKG
19. Name of Manufacturers with Address where the Drug has been manufactured If the Drug is in 01 ml only the name of the manufacturer and the principal place of the manufacturer is to be mentioned. 19LKG
20. Batch number can be written on the label in following ways: Batch No.B.No.BatchLot No.Lot20LKG
21. Manufacturing License Number can be written as under in following ways:Manufacturing License NumberMfg. Lic. No.ML21LKG
22. Drugs containing Alcohol If a Drug formulation contains Alcohol more than 3 % then volume of Alcohol should be mentioned on the label of that Drug.22LKG
23. Ointments/ Lotions . ‘For External use only.’Veterinary Drugs. ‘Not for human use for animal treatment only.’If the Drug is official in I.P. as Veterinary then labeling should be I.P. vet.23LKG
24. Rule 104-A No alteration on the label of a drug can be done without permission of Licensing Authority.24LKG
25. Packaging of Drugs-Rule 105 Tablets & Capsules if less then ten in number then it can be packed as one to ten.If pack size is above ten then it should be packed as multiple of five.25LKG
26. Packaging of Drugs-Rule 105 Oral preparation. 30 ml for paediatric use only.60 ml/ 100 ml/ 200ml/450 ml.26LKG
27. Paediatric oral drops 5 ml.10 ml.15 ml.Eye, Ears & Nasal Drops.3 ml.5 ml.10 ml.27LKG
28. Eye Ointments 3 gms.5 gms.10 gms.28LKG
29. Pack size of Injectables No such packing rules are available for injectables.Licensing Authority can ask for justification of pack size.SVP upto 99ml.LVP from 100ml and above.So the manufacturer cannot claim 100ml veterinary use as SVP.29LKG
30. Pack size is not applicable to the following:Imported Formulations.Veterinary Drugs.Drugs for export.Vitamin Preparation.Cough Syrups.Antacids.Laxatives.Sale to hospitals-Hospital Supply.Large Volume Drugs.Physician Samples Drugs.30LKG
31. Exemption for Pack Size There are 23 Drugs under Schedule P-1 with fix pack sizes.Examples:Cotrimoxazole Suspension = 50ml.Atenolol Tablets= 14 Tablets.Aspirin Tablets= 14 tablets.Piperazine Syrup= 30 ml.Vitamin A oral Drops= 7.5 ML. 31LKG
32. Combipack of Drugs Examples 1. Nandrolone Inj. + Syringe On the outer Carton of the above Combipack Drug complete details of syringe must be given i.e – exp. Date, Batch No., Mfg. Lic. No., Mfd. By etc. 32LKG
33. 33Storage of drugs as given in Drug Act (schedule P)Cool place 10 to 25 degree CCold place upto 8 degree C Room Temp: If storage temperature is not mentioned on the drug then it should be kept at room temperature. Cold place …. Refrigerator Cool place ….. AC
34. Colour in the DrugsName of the Colour should be labeled on the label of the Drugs (if added). List of Permitted colours is given under Rule 127 of the Drugs Act.34LKG
35. Colour in the CapsulesAs per G.S.R. 186(E) dated 07.12.2018.Colour used in capsule need not to be mentioned on the label. Only approved or permitted colour shall be mentioned used. 35LKG
36. License No.Biological or Non Biological. Biological preparations :- 1. Parenterals . 2. Vitamins. 3. Antibiotics.Non biological preparations :- Paracetamol, Nimesulide, Ciprofloxacin. 36LKG
37. How to label Ciprofloxacin tablet?37LKG
38. 1. Ciprofloxacin tablet IP.2. Tablet Ciprofloxacin IP.3. Ciprofloxacin IP tablet.4. Ciprofloxacin BP tablet.38LKG
39. Correct :Ciprofloxacin Tablet IP.39LKG
40. Labeling of this Drug under which license?40LKG
41. This drug comes under license Form-25.41LKG
42. You have to label only 01 license number on 01 product. 42LKG
43. Example: Combination Drug:Ofloxacin + Ornidazole Tablet IP. 43LKG
44. If the firm has taken permission to manufacture a drug/ formulation without any Pharmacopoeia status and same has been included in I.P. then firm should have to obtain fresh permission from the SLA for that formulations. 44LKG
45. Anhydrous Wherever pharmacopoeia Status of API in anhydrous form, it is mandatory to labeled word anhydrous. Examples :- 1. Cephalexin (anhydrous) I.P. 2. Caffeine (anhydrous) I.P.45LKG
46. 46Schedule G DrugsIts warning should be printed on a box There are approximately 50 drugs which are covered under Schedule G DrugsNo Rx on these Drugs.ExamplesChlorpheniramine. Cyproheptadine.Diphenhydramine.Pheniramine.Promethazine.
47. 47In case of a Pharmacopoeial drug if strength is not given in the Pharmacopoeia then what will be the labelling status of that Drug
48. 48Example:-If SLA has given permission for manufacturing of Prednisolone tablet 20 mg but usual strength is not given in I.P. then this tablet should be labelled as I.P. only.
49. 49Ciprofloxacin Eye / Ear Drops U.S.P.Ciprofloxacin Ophthalmic solution U.S.P is official and correct.
50. 50Status of Drug Paracetamol tablet & syrup:This drug is not covered under any schedule.Hence, can be sold without prescription.
51. 51Labeling of Paracetamol with other Drugs:Paracetamol with Non-steroidal anti-inflamatory drug.The strength should be upto 325mg or should not be exceed from 325 mg. E.g. Paracetamol- 325mg Nimesulide-100mgInstruction as per DCGI letter dated 04.04.2012.Box warning about the ‘lever toxicity’ must be given on the label of above mentioned combination.
52. 52Enteric Coated Drugs:If the Drugs are Enteric coated it should be mentioned as Enteric coated.Pantoprazole.Rabeprazole.Esomeprazole.Diclofenac.Domperidone. Pancreatin.Trypsin Chymotrypsin.Aspirin.Sodium Valproate.
53. 53Expiry Date Example – Analgin Tablets expiry date March 2007 It means its expiry is 31-3-2007Last day of the month.
54. Labelling of Medical Devices Rule 44:The label of a medical device shall bear expiry date of the product.The word ‘shelf life’ can also be used on the label of Medical Device.Shelf life of the Medical Device shall not exceed 60 months. 54LKG
55. Repacking of Medical Devices:There is no provision f0r repacking of medical devices under MDR, 2017.55LKG
56. MetrologyDrugs are exempted. Medical Devices are not exempted.As per Rule 26 C, all the schedule drugs and non schedule drugs are exempted from this Act but not medical devices are not exempted under these Rules. 56LKG
57. Psychotropic SubstancesWord NRx is required to be labeled on such formulations. (On Top left Corner)Examples are:PentazocineAlprazolamChlordiazepoxideDiazepamNitrazepamBuprenorphine57LKG
58. Date of Manufacturing = Mfg. DateDate of Expiry = Expiry DatePhysician’s Sample = ‘Physician’s sample-Not to be sold’58LKG
59. Now, there is no needNo need to put red line on Schedule DrugsVide Notification No. GSR 408 dated 26.04.2018.59LKG
60. Adrenaline InjectionAs per notification number GSR 174 (2) dated 16 March 2005 storage condition of this drug has been changed from ‘cold place to protection from light’. Expiry date of this product is one year from manufacturing date only.60LKG
61. Atropine InjectionNo storage condition and expiry date has been mentioned in Schedule P. So, the manufacturer can fix the expiry date as per the stability study performed by the firm and storage condition manufacturer can be at room temperature. 61LKG
62. Paracetamol Paediatric oral suspension IPIf manufacturer is labelling as ‘Paracetamol Suspension I.P. ’ then this labelling is wrong.Paracetamol Suspension IP.62LKG
63. Labelling of Albendazole Tablet I.P.For this drug/ tablet, IP mentions ‘that this tablet should be chewed before swallowing.’So, this chewable condition should be mentioned on the label of the drug.63LKG
64. Example:Labelling of Linseed oilThis drug was official in IP 1966. This drug was deleted in IP 2010.Now, this drug is official in BP.So, manufacturer can label this drug as linseed oil BP only.Labelling of linseed oil as IP (1966) is wrong. 64LKG
65. Labelling of Phenobarbitone TabletsThis drug was excluded from Schedule X in the year 1993. This drug is a Psychotropic drug so manufacturer should mention NRx on the label as per provisions. 65LKG
66. Notification GSR 219 (E) dated 26.03.2022 Hydroxychloroquine Drug comes under Schedule H1 through Section 26 B of the Act. 66LKG
67. Notification under NDPS ActDrug Etizolam has been notified as Psychotropic Drug vide (S.O. – 1276 (E) dated 23.03.2021), so should be labelled with ‘NRx’ as per the provisions.Drug Tramadol has been notified as Psychotropic Drug vide notification no. S.O. 1761 (E) dated 26.04.2018. So should be labelled with NRx as per the provisions. 67LKG
68. Status of Ketamine DrugIt is covered under NDPS Act.It is a Psychotropic Drug. (S.O. No. 1430 (E) dated 21.06.2011).It is also a Schedule X Drug included on 07.11.2013 in Schedule X. 68LKG
69. Notification 558 (E) dated 17 July 2015Diclofenac Injection for Human use shall be sold in single dose pack only. 69LKG
70. Notification 28 (E) dated 17 January 2012For Veterinary Drugs under Rule 97, ‘withdrawal period of the drugs for the species on which it is intended to be used’ should be labelled/ mentioned. 70LKG
71. Penalty under Drugs ActSection 27 (d) Punishable with imprisonment for a term which shall not be less than one year but which may extended to 2 years & with fine.71LKG
72. THE END Thank You !!!72LKG
