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MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family \lUelfare)
NOTIFICATION
New Delhi, the 30th August, 2013
GS.R.588(E)--Whereas certain draft rules further to amend the Drugs and Cosrlnetics
Rules, 1945, weid'Tublished, as required by sections 12 and 33 of the Drugs and Cosntetics
Act, 1940 (23 of 1940), without consulting the Drugs TechnicalAdvisory Board vide notifi(ation
of the Government of lndia, Ministry of Health and Family Welfare (Department of Healtth anO
Family Welfare), number G.S.R. 228(E), dated the 20th March, 2012, published in the Gdzette
of lndia, Extraordinary, Part ll, Section 3, Sub-section (i), dated the 20th March, 2012, inMiting
objections and suggestions from all .persons likely to be'affected thereby before the expir| of a
period of forty-five days from the date on which the cdpies of the Official Gazette cont{ining
the said notification were made available to the public;

And whereas the copies of the Gazette in which the said notification was publlished
were made available to the public on the 20th March ,2012i

And whereas, the Drugs TechnicalAdvisory Board has been consulted in the,rnattgr,

And whereas, objections and suggestions received in respect of the said draft rules
have been considered by the Central Government;
 I fi it qU-s 3(i)l
llKf, 6l-{fstn : qglgRrrl
Now' therefore, in exercise of the powers
conferred by sections 12'and 38 of the
Drugs
Bij"l?'J;*:,1*,,1:lg,(::-,"tJl1gi,i[:il'i#i*iou","n,.nent, after consurtation with the
l;;n;":ffjil$ffl1,:?n,_r1"#*ff l+,i.r*in-ilffi ilJ';,"d,;ffi ::lJ:ilHf l,,:H":!:
1' (1) These
ry]es may be called the Drugs -..'- cosmetics (Fourth Amendment)
v- and
Rules, 2013.
(2) They shall come into force after six months
of their publication in the official
Gazette.
2' ln the Drugs and cosmetics Rules, 1945 (hereinafter
referred to as said rules),-
(i) in rule 65,-
(a) in condition (3), in clause (1),_
(A) in sub-crause (0 and in item (ii)
of the third proviso to sub_crause (g),
for the words and retter,schedure
H,, the words and retters ,,schedure
H
and schedure H1",sharr respectivery
be substituted;
(B) after crause (g) and the provisos
thereof, the foilowing shal be
inserted, namely:-
"(h) the supply of a drug
specified in schedure H1 shall be recorded
in a
separate register at the time of
the suppry 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 (g), in crauses (a) and (b),
for the words and retter ,schedure
H', the words and retters ,,schedure H and
schedure H1" sha*
respectively be substituted;
(c) in condition (11), for the words and
retter,schedure H,, the words and
letters "schedure H and schedure. H1"
shafl be substituted;
(d) in condition (11A), for the words
and retter ,schedure H,, the words and
letters "schedule H and Schedule H1,,shall
be substituted;
(ii)'in rure 97, in sub rure (1), after crause (d),
the foilowing shail be inserted,
namely,-
'(e) if it contains a drug substance specified
in schedure Hl, the drug
formulation shall be labelled with the
symbol Rx which shall be in red and
conspicuously displayed on the left top corner
of the label, and shall also
be labelled with the following words,in a box with
i7 dz <4 ts-2 a red border:
 TFIE CAZEI'TE OF INDIA EX'I-RAORDJNARY
{P,rr<r Il- Sr,r.. J(i)J

..SCHEDULE
H1 DRUG _WARNING.
-lt is dangerous to take this preparation \
except ini
accordance with the medical advice.
-Not to be sord by retail without the prescription
of ar
Registered Medical practitioner, "';

3. ln the said rules, in Schedule H, the following entries shall be omitted,

namely:-
"1, Alprazolam

2. Cefdinir
3. Cefepime Hydrochloride
4. Cefetamet pivoxil
5. Cefpirome
6. Cefpodoxime poxetil
7. Ceftazidime pentahydrate
B. Ceftizoxime Sodium
9. Chlordiazepoxide
10. Clofazimine
11. Codeine

12. Diazepam

13. Diphenoxylate and its salts

1 4. Ethambutol Hyd rochloride

1S. Ethionamide

16. Levofloxacin
17. Meropenam

18. Midazolam

19. Moxifloxacin

20. Nitrazepam
2l.Penlazocine
22.Pyrazinamide
23. Sparfloxacin
24.Thiacetazone
25. Tramadol hydrochloride

, 26.Zolpidem',;
lwT rr-_qu-s j(i)l gr{f, ?S',t TrFl-f . slffgr{ur

4' ln the said rules, after schedule H, the following

$chedule shill be inserted,
nameily:-

. "Schedule Hl
(See rules 65 and g7)
1. Alprazolam
2. Balofloxacin
3. Buprenorphine
4, Capreomycin
5. Cefdinir
6. Cefditoren
7. Cefepime
8. Cefetamet
9. Cefixime
10. Cefopeiazone
11. Cefotaxime
l2.Cefpirome
13. Cefpodoxime
14. Ceftazidime
15. Ceftibuten
16. Ceftizoxime
17, Ceftriaxone
18. Chlordiazepoxide
19. Clofazimine
20. Codeine
21. Cycloserine
22.Diazepam
23. Diphenoxylate
24. Doripenem
25. Ertapenem
26. Ethambutol Hydrochloride
27. Ethionarnide
28. Feropenem

29. Gemifloxacin
 THE GAZETTE OF INDIA: EXTRAORDINARY [P,u<r ll Sr,r. 3(i)]

30.lmipenem
:. 31. tsoniazid
32. Levofloxacin
33. Meropenem
34. Midazolam

35. Moxifloxacin
36. Nitrazepam
3T.Pentazocine
38. Prulifloxacin
39. Pyrazinamide
40. Rifabutin
41. Rifampicin
42. Sodium Para-aminosalicylate
43. Sparfloxacin
44.Thiacetazone
45.Tramadol
46.Zolpidem
Note.- Preparations containing the above drug substances and their salts
excluding those intended for topical or enernal use (except ophthatmic and ear
or nose preparations) containing above substances are also covered by this
Schedule.",

[F. No. X-1 1 014/6/201 0-DFQCI

ARUN K. PANDA, Jt SecY

:
Foot note The principal rules were published in the Official Gazette vide
notificali-.ion No. F.28-10/45-H (1), dated 21"t December, 194s and last amended
vide notification number G.s.R. z2 (E), dated the gth February, 2013.

l)nntcd i)!'tlre )\'[anagcr, (;overrrrncnt of ]ttdia Press, Rrng Road, Mayapuri, Nctv l)elhi-ll{)06"1
and Puhlishcd br the Controller of Publications. Dclhi-l 10054.