Regulation/Guidelines

Fourth Amendment in Drugs & Cosmetics Rules, 2013

  • 14th July, 2016

G.S.R. 588(E) – whereas certain draft rules further to amend the Drugs & cosmetics Rules, 1945, were published, as required by sections 12 and 33 of the drugs & cosmetics act, 1940 (23 of 1940), without consulting the Drugs Technical Advisory Board vide notification of the Government of India, Ministry of Health And Family Welfare (Department of health and family welfare) number GSR 228 (E), dated the 20th March, 2012 published in the Gazette of India, Extraordinary, Part II, Section 3, sub-section(i), dated he 29th March 2012, inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of forty-five days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

Following are the rules to amend the Drugs & Cosmetics Rules, 1945, namely

  1. (1) These rules may be called the Drugs & cosmetics (Fourth Amendment) Rules, 2013

(2) They shall come into force after six months of their publication in the Official Gazette.

2. In the Drugs & Cosmetics Rules, 1945 (herein after referred to as said rules)-

(i) in rule 65,-

a) In condition (3), in clause (1)-

(A) In sub-clause (f) and in item(ii) of the third proviso to sub clause (g), for the words and letter ‘Schedule H’ the words and letters “Schedule H and Schedule H1” shall respectively be substituted;

(B) after clause (g) and the provisos thereof , the following shall be inserted, namely:-

“(h) the supply of the drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.

b) In condition (9), in clauses (a) and (b) for the words and letter ‘Schedule H’ the words and letters Schedule H and Schedule H1” shall respectively be substituted;

c) In condition (11), in clauses (a) and (b) for the words and letter ‘Schedule H’ the words and letters “Schedule H and Schedule H1” shall respectively be substituted;

d) in condition (11A), in clauses (a) and (b) for the words and letter ‘Schedule H’ the words and letters “Schedule H and Schedule H1” shall respectively be substituted;

(ii) in rule 97, in sub rule (1), after clause (d) the following shall be inserted,-

e) if it contains a drug substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labeled with the following words in a box with a red border:

“SCHEDULE H1 DRUG- WARNING-It is dangerous to take this preparation except in accordance with the medical advice

– Not to be sold by retail without the prescription of a Registered Medical Practitioner

3. In the said rules, in Schedule H, the following entries shall be omitted, namely:-

“1. Alprazolam

2. Cefdinir

3. CefepimeHydrochloride

4. CefetametPivoxil

5. Cefpirome

6. CefpodoximePoxetil

7. CeftazidimePentahydrate

8. Ceftizoxime Sodium

9. Chlordiazepoxide

10. Clofazimine

11. Codeine

12. Diazepam

13. Diphenoxylate and Its Salts

14. Ethambutol Hydrochloride

15. Ethionamide

16. Levofloxacin

17. Meropenam

18. Midazolam

19. Moxifloxacin

20. Nitrazepam

21. Pentazocine

22. Pyrazinamide

23. Sparfloxacin

24. Thiacetazone

25. Tramadol hydrochloride

26.Zolpidem”

4. In the said rules, after Schedule H, the following Schedule shall be inserted, namely:-

“Schedule H1

(See rules 65 and 97)

  1. Alprazolam
  2. Balofloxacin
  3. Buprenorphine
  4. Capreomycin
  5. Cefdinir
  6. Cefdioren
  7. Cefepime
  8. Cefetamet
  9. Cefixime
  10. Cefoperazone
  11. Cefotaxime
  12. Cefpirome
  13. Cefpodoxime
  14. Ceftazidime
  15. Ceftibuten
  16. Ceftizoxime
  17. Ceftrizoxine
  18. Chlordiazepoxide
  19. Clofazimine
  20. Codeine
  21. Cycloserine
  22. Diazepam
  23. Diphenoxylate
  24. Doripenem
  25. Ertapenem
  26. Ethambutol Hydrochloride
  27. Ethionamide
  28. Feropenem
  29. Gemifloxacin
  30. Imipenem
  31. Isoniazid
  32. Levofloxacin
  33. Meropenem
  34. Midazolam
  35. Moxifloxacin
  36. Nitrazepam
  37. Pentazocine
  38. Prulifloxacin
  39. Pyrazinamide
  40. Rifabutin
  41. Rifampicin
  42. Sodium Para-aminosalicylate
  43. Sparfloxacin
  44. Thiacetazone
  45. Tramadol
  46. Zolpidem

Note – Preparation containing the above drug substances and theur salts excluding those intended for topical or external use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule”.