रजिस्ट्री सं॰ डी॰ एल॰-33004/99
REGD. NO. D. L.-33004/99 असाधरण
EXTRAORDINARY
भाग II—खण्ड 3—उप-खण्ड (i)
PART II—Section 3—Sub-section (i)
प्राध्किार से प्रकाशित
PUBLISHED BY AUTHORITY
सं. 725] नई दिल्ली, मंगलवार, नवम्बर 24, 2015/अग्रहायण 3, 1937
No. 725] NEW DELHI, TUESDAY, NOVEMBER 24, 2015/AGRAHAYANA 3, 1937
आयुव(cid:5)द, योग व (cid:11)ाकृ (cid:15)तक (cid:17)च(cid:19)क(cid:20)सा, यूनानी, (cid:25)स(cid:26) एवं हो(cid:30)योपैथी (आयुष) मं&ालय
अ(cid:17)धसूचना
नई (cid:4)द(cid:6)ल(cid:8), 24 नवंबर, 2015
सा.का.(cid:15)न. 897(अ).—औष(cid:22)ध और (cid:24)साधन साम(cid:28)ी (cid:30)नयम, 1945 का और संशोधन करने के %लए क(cid:30)तपय (cid:30)नयम) का (cid:30)न*न%ल+खत (cid:24)ा-प, िजसे क0 1(cid:8)य सरकार, औष(cid:22)ध और (cid:24)साधन साम(cid:28)ी अ(cid:22)ध(cid:30)नयम, 1940 (1940 का 23) क6 धारा 33 ढ 8वारा (cid:24)द9त शि:तय) का (cid:24)योग करते हुए, बनाना चाहती है, उ:त धाराओं क6 अपेBानुसार ऐसे सभी Eयि:तय) क6 जानकार(cid:8) के %लए िजनके उससे (cid:24)भाFवत होने क6 संभावना है (cid:24)का%शत Gकया जाता है और यह सूचना द(cid:8) जाती है Gक उ:त (cid:24)ा-प [(cid:30)नयम)] पर पणधाLरय) के आBेप) या सुझाव) पर उस तार(cid:8)ख से, पOताल(cid:8)स (cid:4)दन क6 अव(cid:22)ध समाPत होने के पQचात ् िजसको भारत के उस राजपS क6 (cid:24)(cid:30)तयां िजसम0 यह अ(cid:22)धसूचना (cid:24)का%शत क6 जाती है, जनता को उपलTध करा द(cid:8) जाती है; 8वारा Fवचार Gकया जाएगा।
ऐसे आBेप) या सुझाव) पर, जो उ:त (cid:24)ा-प (cid:30)नयम) क6 बाबत Gकसी Eयि:त से, इस (cid:24)कार Fव(cid:30)न(cid:4)दXYट अव(cid:22)ध के भीतर (cid:24)ाPत ह)गे, क0 1(cid:8)य सरकार 8वारा Fवचार Gकया जाएगा;
आBेप या सुझाव, य(cid:4)द कोई है, स(cid:22)चव, आयुव[द, योग व (cid:24)ाकृ (cid:30)तक (cid:22)चGक9सा, यूनानी, %स] एवं हो*योपैथी (आयुष) मंSालय, आयुष भवन, 'बी' Tलॉक, जीपीओ कॉ*पलै:स, आईएनए, नई (cid:4)द(cid:6)ल(cid:8)-110023 को भेजे जा सकते हO।
(cid:11)ा.प (cid:15)नयम
1. (1) इन (cid:30)नयम) का संdBPत नाम औष(cid:22)ध और (cid:24)साधन साम(cid:28)ी (सातवां संशोधन) (cid:30)नयम, 2015 है।
(2) ये अ(cid:22)धसूचना के राजपS म0 अं(cid:30)तम (cid:24)काशन क6 तार(cid:8)ख को (cid:24)वृ9त ह)गे।
2. औष(cid:22)ध और (cid:24)साधन साम(cid:28)ी (cid:30)नयमावल(cid:8), 1945 म0, (cid:30)नयम 161 - ख के fथान पर (cid:30)न*न%ल+खत (cid:30)नयम रखा जाएगा, अथाXत :-
4914 GI/2015
(1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] "161 ख औष(cid:17)ध क5 उपयोग अव(cid:17)ध या अवसान क5 तार8ख (1) आयुव[द, %स] और यूनानी (एएसयू) औषध के उपयोग करने क6 अव(cid:22)ध क6 तार(cid:8)ख यथािfथ(cid:30)त आयुव[द, %स] और यूनानी औष(cid:22)ध के पाS या पैके ज पर साफ-साफ %लखी जाएगी और उ:त समापन अव(cid:22)ध के बाद Gकसी भी औष(cid:22)ध का Fवपणन, Fवjय, Fवतरण या खपत नह(cid:8)ं Gकया जाएगा:
परंतु यह उप-(cid:30)नयम उन आयुव[द(cid:8)य, %स] और यूनानी औष(cid:22)धय) पर लागू ह)गे िजनके Fव(cid:30)नमाXण के %लए इन (cid:30)नयम) क6 अ(cid:22)धसूचना क6 तार(cid:8)ख के बाद अनुkिPत लेने या अनुkिPत के नवीकरण क6 आवQयकता पड़ेगी।
(2) इस अ(cid:22)ध(cid:30)नयम क6 धारा 3 के खंड (ज) के अधीन पLरभाFषत आयुव[द, %स] या यूनानी औष(cid:22)धय) के Fव(cid:30)नमाXण हेतु अनुkिPत लेने या अनुkिPत नवीकरण कराने के %लए आवेदन करने वाला (cid:24)9येक Eयि:त आयुव[द(cid:8)य, %स] या यूनानी भेजषजसं(cid:4)हता म0 (cid:30)नधाXLरत मागXदशXक %स]ांत (cid:30)नद[श) के अनुसार औष(cid:22)धय) के अnययन के आधार पर औष(cid:22)धय) क6 वैkा(cid:30)नक आंकड़) पर आधाLरत उपयोग अव(cid:22)ध या समापन तार(cid:8)ख राज ्य अनुkापन (cid:24)ा(cid:22)धकार(cid:8) को (cid:24)fतुत करेगा।
परंतु यह उप-(cid:30)नयम इन (cid:30)नयम) क6 अ(cid:22)धसूचना क6 तार(cid:8)ख से तीन वषX बाद लागू होगा;
(3) राoय अनुkापन (cid:24)ा(cid:22)धकार(cid:8), Gकसी समय आयुव[द(cid:8)य, %स] या यूनानी ओष(cid:22)ध के %लए अनुkिPत देने या अनुkिPत नवीकरण से पूवX, Fव(cid:30)नमाXता 8वारा उस औष(cid:22)ध क6 दावाकृ त उपयोग अव(cid:22)ध के समथXन म0 (cid:24)fतुत Gकए गए आंकड़) क6 Fव(cid:22)धमाpय सु(cid:30)निQचत करेगा।
(4) राoय अनुkिPत (cid:24)ा(cid:22)धकार(cid:8) Fव(cid:30)नमाXता को Gकसी भी समय औष(cid:22)ध के नमूने देने और अpय कोई संबं(cid:22)धत सूचना देने के %लए (cid:30)नदेश दे सकता है और उसे Fवश ्लेषण या fवतंS Fव(cid:22)धमाpयकरण हेतु भारतीय (cid:22)चGक9सा भेषजसं(cid:4)हता (cid:24)योगशाला, गािजयाबाद के साथ साझा कर सकता है।
(5) जहां Fव(cid:30)नमाXता उप-(cid:30)नयम (4) के अधीन राoय अनुkिPत (cid:24)ा(cid:22)धकार(cid:8) के (cid:30)नदेश का अनुपालन करने म0 असफल हो जाता है वहां Fव(cid:30)नमाXता को सुनवाई का उपयु:त अवसर (cid:24)दान करने के पQचात, उस औष(cid:22)ध के Fव(cid:30)नमाXण का उसका अनुkिPत (cid:30)नलंबन Gकया जा सकता है।
(क) इस अ(cid:22)ध(cid:30)नयम क6 धारा 3 के खंड (क) म0 यथापाLरभाFषत Gकसी आयुव[द, %स] या यूनानी औष(cid:22)ध क6 उपयोग अव(cid:22)ध या समापन तार(cid:8)ख, य(cid:4)द वैkा(cid:30)नक आंकड़) के आधार पर अpयथा (cid:30)नधाXLरत न क6 गई हो, तो (cid:30)न*नानुसार होगी :-
(ख) आयुव(cid:5)द8य औष(cid:17)ध
| jc c | M = [ )!6,=!!-( | F XK !6 ', $ @( #; !6 2 (!6', |
| (i) | 2!X | X |
| (ii) | M 2LYZ | X |
| (iii) | 2 $<,, ड,(!,;=ड | 4 X |
| (iv) | >HKX !R ^>HKX $(>HKX, ' /3>HKX5 | X |
| (v) | H( | X |
| (vi) | 1 !, K,B | X |
| (vii) | q\' | X |
| (viii) | ; r;= = | X |
| (ix) | ; =Z! | |
| 3I5s@(sDfs;=r;=3$(;=Z!q Z<'5!$ ^!Yt =:';=Z! Z | X | |
| (II) !$ !Yt 3$( ;=Z! q Z <'5 =:';=Z! Z | 4 X | |
| 3III5!$ s@(sDf =:';=Z!s Z | X | |
| (x) | $5 !KXsu =3!,!0ड/$ H | X |
| (xi) | ! H ( (: | X |
| (xii) | < | 4 X |
| (xiii) | डH bv< | X |
| (xiv) | ;Df, ;Df'wDf | X |
| (xv) | 5 $Su =3M ,0ड/$ H | X |
| (xvi) | ((XZ | X |
| (xvii) | F(YZDf | X |
| (xviii) | <: ^3 B <'!75 | 4 X |
| (xix) | #; | |
| (I) ! $ s@(sDf =:' #; | X | |
| (II) !YtA!$ ^s@(sDf =:' #; | X | |
| (xx) | ÙÙÙÙ 3 (()$P'5 | X |
| (xxi) | "!X | 4 X |
| (xxii) | Q $'((XZ | X |
| (xxiii) | 'ै | 4 X |
| (xxiv) | 'x | X |
(ख) (cid:25)स(cid:26) औष(cid:17)धयां:-
| jc c | %] )!6,=!!-( | F XK !6 ', $ @( #; !6 2 (!6', |
| (i) | >HKX | X |
| ! >HKX Rs2 >HKX Rs! > >HKX Rs@9! >HKX Rs = Z F(yH (#yK G!N >HKX Rs(#ड ^%^X >HKX Rs(#ड s(S= >HKX Rs >HKX RsAS'>HKX Rs $^=>HKX Rs(=;ै>HKX Rs!>HKX Rs^= ै>HKX R | ||
| (ii) | ै' ैs '! | X |
| (I) !$ H;ै2 ) =:'3!= ड >HKX Rै' ै<'5 32^X' $*H!= Z ै' ै5 | ||
| (II) ^^=(#z9!s/ (#z9!s((s0'=s!= {K3!= Z >HKX Rै' ै<'5!$ ^H;ै2 ) =:' | X | |
| (III) !$ ^^=(#z9!s((s0'=s!= Ks!yHs! != =:' | X | |
| (iii) | b(-p^=;3D #;($ =:' | |
| (I) ^^=(#z9!s((s0'=s!= Ks!yHs! != !$ ^=;ै 2 )2 'F XYZ | 4 X | |
| (II) ! $ ^^=(#z9!s((s0'=s!= Ks!yH s! != 2 'F XYZ | X | |
| (iv) | ((s0'= | |
| (I) ! ; % ((5 $ H;ै2 )2 'F XYZ32^X'!= | X | |
| (II) ! $ ^^=(#z9!s((s0'=s!= Ks!yH s ! != !$ ^ H;ै2 )2 'F XYZ32^X'M 0'=5 | X | |
| (III) / (#z9!!$ H;ै2 )<'32^X' ;=((5 X | ||
| (v) | !zP(= | |
| (I) ! $ H;ै2 ) =:'32^X' ==9'!5 | X | |
| (II) ^^=(#z9!!$ ^H;ै2 ) =:' 32^X'% 2',^;!zP(=5 | X | |
| (III) / (#z' R!!$ ^H;ै2 ) =:'32^X'!f'= !zP(=,(y=!zP(=5 | X | |
| (vi) | (' ! | |
| (I) H;ैML'(' !32^X' (' !5 | X | |
| (II) ML'(' !32^X'0'=5 | X | |
| (vii) | ! = (= Gj (ML' | |
| (I) 2ैP(=!= (=32^X'2; ' != (=5 | X | |
| (II) WLP(=!= (=32^X'!= .9'!= (=5 | 4 X | |
| (viii) | $=!= | |
| Gj (ML' (I) 2ैP(=$=!= 32^X'% ;$=!= 5 | X | |
| Gj (ML' (II) W|डP(=$=!= 32^X'; $=!= sW ' $=!= 5 | 4 X | |
| !}> (ML' (III) H;ै$=!= 32^X'ै!= ड$=!= 5 | 4 X | |
| (ix) | !( | |
| !}> (ML' (I) H;ै!(32^X'!ै!(, 'L(!(5 | X | |
| !}> (ML' ;/!(5 (II) H;ै^^=!(32^X'M \ | X | |
| Gj (ML' (III) 2ैP(=!(32^X'Wz$!(5 | 4 X | |
| (x) | 9'= | |
| (I) H;ै$P'9'=32^X' '9'=5 | X | |
| (II) ^^=(#z9!$P'9'=32^X'M 9'=, 9'=, ^=z=9'=5 | X | |
| (III) / (#z9!$P'9'=32^X'(HKX;, %;= $P'0=9'=5 | X | |
| (xi) | W!s$; sW!$ Ks | 4 X |
| (xii) | !.:!ss!% =s s $p | X |
| (xiii) | !3!H5 | X |
| (xiv) | !yH3 =:'(y 5s ैs 'xs ' | X |
| (xv) | !yHs! != s!= K | X |
| (xvi) | ! = Z sG! N3 dB )<'5 | 4 X |
| (xvii) | KP(!= s(; | 4 X |
| (xviii) | % '=s!'=s$F '= | X |
| (xix) | sq\'s!ड= ;= | X |
| (xx) | @^s%;(Ks^H(:!= | X |
| (xxi) | (:!= ,^$p# | X |
| (xxii) | ( ड ैP(= | X |
| (xxiii) | ( >= | X |
| (xxiv) | =.9';ै | X |
| (xxv) | 'ैs&pैs(H>= | 4 X |
| (xxvi) | ' | X |
| (xxvii) | ' !3^^=(#z9!$P'5 | X |
(ग) यूनानी औष(cid:17)धयां:-
| j. . | )!6,=!!-( H | F XK !6 ', $ @( #; !6 2 (!6', |
| (i) | 2!X 3% 2!X b&b2/ 5 | X |
| (ii) | 2!X b&b2/ | X |
| (iii) | 2 L/s=Hs/=-s~ | X |
| (iv) | =-s=Xs!#<s%" i | X |
| (v) | 4 X | |
| (vi) | < | 4 X |
| (vii) | WS i | 4 X |
| (viii) | /v<s/ < | X |
| (ix) | / L" | X |
| (x) | , | 4 X |
| xi) | ! = Q' | X |
| (xii) | H | 4 X |
| (xiii) | ! | 4 X |
| (xiv) | /Hs | 4 X |
| (xv) | X | |
| (xvi) | =i$ X< | 4 X |
| (xvii) | =T | X |
| (xviii) | | X |
| (xix) | ! = X3Z$ै5 | 4 X |
| (xx) | !'H | X |
| (xxi) | #; 's ' | 4 X |
| (xxii) | "X's%! / | 4 X |
| (xxiii) | (I) =iH i3!<'5 | X |
| (II) =iH i3!2 'F XYZ5 | X | |
| (xxiv) | ' X! | 4 X |
[सं. के . 11024/5/2013-डीसीसी(आयुष)]
िजत01 शमाX, संयु:त स(cid:22)चव
<ट>पण: - मूल (cid:30)नयम भारत के राजपS म0 अ(cid:22)धसूचना सं. एफ.28-10/45एच(1), तार(cid:8)ख 21 (cid:4)दसंबर, 1945 8वारा (cid:24)का%शत Gकए गए थे और अ(cid:22)धसूचना सा.का.(cid:30)न. 826 (अ) तार(cid:8)ख 30.10.2015 8वारा अं(cid:30)तम संशोधन Gकया गया था।
MINISTRY OF AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(AYUSH)
NOTIFICATION
New Delhi, the 24th November, 2015.
G.S.R. 897(E).—The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required by the said section, for the information of all persons likely to be affected thereby; and notice is hereby given that the objections or suggestions of the stakeholders on the said draft rules will be taken into consideration after the expiry of a period of forty five days from the date on which copies of the Official Gazette in which this notification is published, are made available to the public;
Any objection or suggestion, which may be received from any person with respect to the said draft rules within the period specified above, will be taken into consideration by the Central Government;
Objections or suggestions, if any, may be addressed to the Secretary, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), AYUSH Bhawan, 'B' Block, GPO Complex, INA, New Delhi-110023.
DRAFT RULES
1. (1) These rules may be called the Drugs and Cosmetics (Seventh Amendment) Rules, 2015.
(2) They shall come into force from the date of their final publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, for rule 161-B the following rule shall be substituted, namely:-
"161B. Shelf life or date of expiry of medicines.- (1) The date of expiry of Ayurveda, Siddha or Unani medicines shall be conspicuously displayed on the label of container or package of Ayurvedic, Siddha or Unani medicine, as the case may be, and after the said date of expiry, no medicine shall be marketed, sold, distributed or consumable;
[भाग II—खण्ड 3 (i)] भारत का राजपत्रा : असाधरण 7Provided that this sub-rule shall apply to Ayurvedic, Siddha and Unani medicines seeking licence or renewal of licence for manufacturing after the date of notification of the rules.
(2) Every person applying for licence or renewal of licence for the manufacturing of Ayurveda, Siddha or Unani medicines defined under clause (h) of section 3 of the Act shall submit to the State Licensing Authority scientific data based shelf life or date of expiry of the medicine based on the studies of medicines in accordance with the guidelines prescribed in the Ayurvedic, Siddha and Unani Pharmacopoeia.
Provided that this sub-rule shall be applicable after three years from the date of notification of the rules.
(3) The State Licensing Authority shall, before granting license or renewal of license for an Ayurvedic, Siddha or Unani medicine, ensure validity of the data submitted by the manufacturer in support of the claimed shelf-life of that medicine.
(4) The State Licensing Authority may at any time direct the manufacturer to provide the samples of the medicine and any other related information; and may share it with the Pharmacopoeial Laboratory for Indian Medicine, Ghaziabad for analysis or independent validation.
(5) Where the manufacturer fails to comply with direction of the State Licensing Authority under sub-rule (4), the license for the manufacturing of the medicine shall be liable for suspension after giving a reasonable opportunity of being heard.
(a) The shelf life or date of expiry of an Ayurveda, Siddha or Unani medicine defined under clause (a) of section 3 of the Act shall, unless otherwise determined on the basis of scientific data, be as follows:-
(b) Ayurvedic medicines:
| S. No. | Dosage form of Ayurvedic medicines | Shelf life or date of expiry with effect from the date of manufacture |
| (i) | Arka | 1 year |
| (ii) | Asava Arista | 10 years |
| (iii) | Avaleha, Khanda, Paka, Guda | 3 years |
| (iv) | Churna, Kwatha Churna, Lapa Churna, Dant Manjan (Churna) | 2 years |
| (v) | Dhoopan | 2 years |
| (vi) | Dravaka, Lavana, Kshara | 5 years |
| (vii) | Ghrita | 2 years |
| (viii) | Guggulu | 5 years |
| (ix) | Gutika | |
| (I) Gutika or Vati containing Kasth Aushadhi along with Rasa / Uprasa/ Bhasma/ Guggulu (including Lepa Gutika and Ghan Vati) | 5 years | |
| (II) Gutika or Vati containing only Kasth Aushadhi (including Lepa Gutika and Ghan Vati) | 3 years | |
| (III) Gutika / Vati containing only Ras / Uprasa / Bhasma | 10 years | |
| (x) | Karna/ Nasa bindu (Ear/Nasal drop) | 2 years |
| (xi) | Kupipakva Rasayana | 10 years |
| (xii) | Malahar | 3 years |
| (xiii) | Mandura-Lauha | 10 years |
| (xiv) | Naga Bhasma, Vanga Bhasma and Tamra Bhasma | 5 years |
| (xv) | Netra bindu (Eye drop) | 1 year |
| (xvi) | Parpati | 10 years |
| (xvii) | Pisti and Bhasma | 10 years |
| (xviii) | Pravahi Kwatha (Decoction with preservative) | 3 years |
| (xix) | Rasayoga | |
| (I) Rasayoga Containing only Rasa / Uprasa / Bhasma | 10 years | |
| (II) Rasayoga Containing Rasa / Uprasa/ Bhasma along with Kasth Aushadhi/Guggulu | 5 years | |
| (xx) | Sattva (derived from medicinal plant) | 2 years |
| (xxi) | Sharkar | 3 years |
| (xxii) | Shveta parpati | 2 years |
| (xxiii) | Taila | 3 years |
| (xxiv) | Varti | 2 years |
(b) Siddha medicines:-
| S. No. | Dosage form of Siddha medicines | Shelf life or date of expiry with effect from the date of manufacture |
| (i) | Curanam | |
| Kutinir Curanam/Adai Curanam/Kanchi Curanam/Utkali Curanam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ Pattru Curanam/ Pottanam or Kizhi Curanam/ Ottratam Curanam/ Vethu Curanam/ Pugai Curanam/Kali Curanam /Thuvalai Curanam | 2 years | |
| (ii) | Mattirai/ Vatakam | |
| (I) Containing only Mooligai ingredients (including Kudineer Curanam Mattirai) (eg. Nilavembu kutinir Mattirai) | 2 years | |
| (II) Containing Mooligai ingredients along with Thathu Porutkal/ Jeeva Porutkal /Parpam/ Centuram /Cunnam. (including kutinir Curanam Mattirai ) | 5 years | |
| (III) Containing only Thathu Porutkal /Parpam/ Centuram / Cunnam/ Kattu/Kalanku. | 10 years | |
| (iii) | Rasa-Paadana Marunthugal ( All Mercurial Preparation) | |
| (I) Containing Mooligai ingredients along with Thathu Porutkal/ Parpam/ Centuram/ Cunnam /Kattu /Kalanku | 3 years | |
| (II) Containing only Thathu Porutkal / Parpam/ Centuram / Cunnam Kattu/Kalanku | 10 years | |
| (iv) | Parpam / Centuram | |
| (I) Containing only Mooligai ingredients (eg. Kungiliya Parpam) | 4 years | |
| (II) Containing Mooligai ingredients with Thathu Porutkal / Parpam/ Centuram / Cunnam/ Kattu/Kalanku (eg. Aya Centuram) | 10 years | |
| (III) Containing Mooligai ingredients with Jeeva Porutkal (e.g. Sangu Parpam ) | 10 years | |
| (v) | Karuppu | |
| (I) Containing only Mooligai ingredients (eg. Vasambu Sutta Kari) | 2 years | |
| (II) Containing Mooligai ingredients with Thathu Porutkal (e.g. Sivanar Amirtham, Thalaga Karuppu) | 5 years | |
| (III) Containing Mooligai ingredients with Jeeva Porutkal (e.g. Kasthuri Karuppu, Pattu Karuppu) | 5 years | |
| (vi) | Patankam | |
| (I) Mooligai based Patankam (eg. Sambirani Patankam) | 5 years | |
| (II) Rasa based Patankam (eg. Rasa Centuram) | 10 years | |
| (vii) | Kulampu Based on process- | |
| (I) Araippu Kulampu (eg. Agathiyar Kulampu) | 5 years | |
| (II) Erippu Kulampu (eg. Kumatti Kulampu) | 3 years | |
| (viii) | Meluku | |
| Based on process- (I) Araippu Meluku (eg. Linga Meluku) | 5 years | |
| Based on Process- (II) Idippu Meluku (eg. Rasa Gandhi Meluku / Idi Vallthi Meluku) | 3 years | |
| Based on raw materials- (III) Mooligai Meluku (eg. Malaikudara Meluku) | 3 years | |
| (ix) | Karpam | |
| Based on raw materials- (I) Mooligai Karpam (eg. Karisalai Karpam , Thiripala Karpam) | 2 years | |
| Based on raw materials- (II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) | 5 years | |
| Based on process- (III) Araippu Karpam (eg. Irunelli Karpam) | 3 years | |
| (x) | Satthu | |
| (I) Satthu derived from Mooligai (eg. Seenthil Satthu) | 2 years | |
| (II) Satthu derived from Thathu Porutkal (eg. Aya Satthu, Eya Satthu,Thurusu Satthu) | 10 ears | |
| (III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthu derived from Poonagam, Mayiliragu) | 5 years | |
| (xi) | Ilakam / Legiyam/ Iracayanaam | 3 years |
| (xii) | Kallikkam/ Mai/ Kalimbu/ Neer/ Venney | 1 year |
| (xiii) | Karam (Karanool) | 2 years |
| (xiv) | Kattu (Medicated bandage cloth)/Seelai/Varthy/ Thiri | 1 year |
| (xv) | Kattu / Kalanku/ Cunnam | 10 years |
| (xvi) | Kutinir / Kiyazham(with preservatives) | 3 years |
| (xvii) | Manappaku/ Panagam | 3 years |
| (xviii) | Nasiya thuli/Kan thuli /Sevi thuli | 1 year |
| (xix) | Ney / Ghirutham/Kadugu | 2 years |
| (xx) | Oothal/Nasigaparanam/ Thoopa sarakku | 1 year |
| (xxi) | Pakkuvam , Thennoral | 1 year |
| (xxii) | Panda Vaippu | 10 years |
| (xxiii) | Peechu | 2 years |
| (xxiv) | Sutigai | 2 years |
| (xxv) | Tailam / Ennai/ Poochu | 3 years |
| (xxvi) | Tinir | 1 year |
| (xxvii) | Tiravakam (derived from Thathu Porutkal ) | 5 years |
(c ) Unani medicines
| S. No. | Dosage form of Unani medicines | Shelf life or date of expiry with effect from the date of manufacture |
| (i) | Arq (except Arq-e-Ajeeb) | 1 year |
| (ii) | Arq -e-Ajeeb | 5 years |
| (iii) | Ayarij / Sunoon/ Zuroor/Ghazah | 2 years |
| (iv) | Burood / Surma / Kohal/shiyaf | 5 years |
| (v) | Habb (Pills) | 3 years |
| (vi) | Halwa | 3 years |
| (vii) | Itrifal | 3 years |
| (viii) | Jauhar/ Jawahir | 5 years |
| (ix) | Jawarish | 4 years |
| (x) | Khamira | 3 years |
| (xi) | Kushta | 10 years |
| (xii) | Laboob | 3 years |
| (xiii) | Laooq | 3 years |
| (xiv) | Majoon / Dawa | 3 years |
| (xv) | Marham / Zimad / Qairooti | 2 years |
| (xvi) | Mufarreh | 3 years |
| (xvii) | Murabba | 1 year |
| (xviii) | Nabeez | 10 years |
| (xix) | Qurs (Tablets) | 3 years |
| (xx) | Qutoor | 1 year |
| (xxi) | Raughaniyat/ Tila | 3 years |
| (xxii) | Sharbat/ Sikajabeen | 3 years |
| (xxiii) | (I) Sufoof (Without Salt) | 2 years |
| 2 Sufoof (Containing salt) | 1 year | |
| (xxiv) | Tiryaq | 3 years" : |
[F. No. K.11024/5/2013-DCC (AYUSH)]
JITENDRA SHARMA, Jt. Secy.
Note.—The principal rules were published in the Gazette of India vide notification No. F.28-10/45H(I), dated 21st December, 1945 and were last amended vide notification G.S.R.826 (E), dated 30.10.2015.
Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.