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[Section 161B]
[Entire Act]
Union of India - Subsection
Section 161B(8) in The Drugs and Cosmetics Rules, 1945
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Anjana | |
| a) Anjana made from Kasthaushadhi | 1 year | |
| b) Anjana made from Kasthaushadhi along withRasa/Uprasa/Bhasma | 2 years | |
| c) Anjana made only from Rasa/Uprasa/Bhasma | 3 years | |
| (ii) | Arka | 1 year |
| (iii) | Asava Arista | 10 years |
| (iv) | Avaleha, Khanda, Paka, Guda | 3 years |
| (v) | Churna, Kwatha Churna, Lepa Churna, Danta Manjan (Churna) | 2 years |
| (vi) | Dhoopan | 2 years |
| (vii) | Dravaka, Lavana, Kshara | 5 years |
| (viii) | Ghrita | 2 years |
| (ix) | Guggulu | 5 years |
| (x) | Gutika/Vati | |
| (I) Gutika or Vati containing Kasthaushadhi along with Rasa/Uprasa/ Bhasma/ Guggulu (including Lepa Gutika and GhanVati) | 5 years | |
| (II) Gutika or Vati containing only Kasthaushadhi (includingLepa Gutika and Ghan Vati) | 3 years | |
| (III) Gutika/ Vati containing only Ras/ Uprasa/ Bhasma exceptNaga, Vanga and Tamra Bhasma | 10 years | |
| (xi) | Karna/ Nasabindu | 2 years |
| (xii) | Kupipakva Rasayana | 10 years |
| (xiii) | Malahar | 3 years |
| (xiv) | Mandura-Lauha | 10 years |
| (xv) | Naga Bhasma, Vanga Bhasma and Tamra Bhasma | 5 years |
| (xvi) | Netrabindu | 1 year |
| (xvii) | Parpati | 10 years |
| (xviii) | Pishti and Bhasma except Naga, Vanga and Tamra Bhasma | 10 years |
| (xix) | PravahiKwatha | 3 years |
| (xx) | Rasayoga | |
| (I) Rasayoga Containing only Rasa/ Uprasa/ Bhasma except Naga,Vanga and Tamra Bhasma | 10 years | |
| (II) Rasayoga Containing Rasa/ Uprasa/ Bhasma along withKasthaushadhi/ Guggulu | 5 years | |
| (xxi) | Sattva (derived from medicinal plant) | 2 years |
| (xxii) | Sharkar/ Panak/ Sharbat | 3 years |
| (xxiii) | Shveta parpati | 2 years |
| (xxiv) | Taila | 3 years |
| (xxv) | Varti | 2 years |
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Curanam | |
| Kutinir Curanam/Adai Curanam/Kanchi Curanam/UtkaliCuranam/Pittu Curanam/ Podithimirthal Curanam/ Podi/ PattruCuranam/ Pottanam or Kizhi Curanam/ Ottratam Curanam/ VethuCuranam/ Pugai Curanam/Kali Curanam/ Thuvalai Curanam | 2 years | |
| (ii) | Mattirai/ Vatakam | |
| (I) Containing only Mooligai ingredients (including KudineerCuranam Mattirai) (eg. Nilavembu kutinir Mattirai) | 2 years | |
| (II) Containing Mooligai ingredients along with ThathuPorutkal/ Jeeva Porutkal/ Parpam/ Centuram/ Cunnam. (includingkutinir 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 ThathuPorutkal/Parpam/ Centuram/Cunnam /Kattu/Kalanku | 2 years | |
| (II) Containing only Thathu Porutkal/ Parpam/Centuram/CunnamKattu/ Kalanku | 10 years | |
| (iv) | Parpam/ Centuram | |
| (I) Containing only Mooligai ingredients (eg. KungiliyaParpam) | 2 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 SuttaKari) | 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 VallthiMeluku) | 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- | 5 years | |
| (II) Mooligai Thathu Karpam (eg. Aya Bringaraja Karpam) | ||
| Based on process- | 3 years | |
| (III) Araippu Karpam (eg. Irunelli Karpam) | ||
| (x) | Satthu | |
| (I) Satthu derived from Mooligai (eg. Seenthil Satthu) | 2 years | |
| (II) Satthu derived from Thathu Porutkal (eg. Aya Satthu, EyaSatthu,Thurusu Satthu) | 10 years | |
| (III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthuderived 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) | Nasiyathuli/ Kanthuli/ Sevithuli | 1 year |
| (xix) | Ney/ Ghirutham/Kadugu | 2 years |
| (xx) | Oothal/Nasigaparanam/ Thoopasarakku | 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 ThathuPorutkal) | 2 years |
| S. No. | Dosage form | Shelf life or date of expiry with effect fromthe date of manufacture |
| (1) | (2) | (3) |
| (i) | Arq (except Arq-e-Ajeeb) | 1 year |
| (ii) | Arq-e-Ajeeb | 5 years |
| (iii) | Ayarij/ Sunoon/ Zuroor/ Ghazah | 2 years |
| (iv) | Burood | 1 year |
| (v) | Shiyaf | 2 years |
| (vi) | Surma/ Kohal | 3 years |
| (vii) | Habb | 3 years |
| (viii) | Halwa | 3 years |
| (ix) | Itrifal | 3 years |
| (x) | Jauhar/ Jawahir | 5 years |
| (xi) | Jawarish | 4 years |
| (xii) | Khamira | 3 years |
| (xiii) | Kushta | 10 years |
| (xiv) | Laboob | 3 years |
| (xv) | Laooq | 3 years |
| (xvi) | Majoon/ Dawa | 3 years |
| (xvii) | Marham/ Zimad/ Qairooti | 2 years |
| (xviii) | Mufarreh | 3 years |
| (xix) | Murabba | 1 year |
| (xx) | Nabeez | 10 years |
| (xxi) | Qurs | 3 years |
| (xxii) | Qutoor | 1 year |
| (xxiii) | Raughaniyat/ Tila | 3 years |
| (xxiv) | Sharbat/ Sikajabeen | 3 years |
| (xxv) | (I) Sufoof (Without Salt) | 2 years |
| (II) Sufoof (Containing salt) | 1 year | |
| (xxvi) | Tiryaq | 3 years] |
| 161B. [ Shelf life or date of expiry of medicines. [Substituted by Notification G.S.R. 897(E), dated 24.11.2015 (w.e.f. 21.12.1945).]- (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;Provided that this sub-rule shall apply to Ayurvedic, Siddha and Unani medicines seeking license or renewal of license for manufacturing after the date of notification of the rules.(2) Every person applying for license or renewal of license 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:-(a) Ayurvedic medicines:{| | ||
| S. No. | Dosage form of Ayurvedic medicines | Shelf life or date of expiry with effect from thedate 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 LepaGutika 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 KasthAushadhi/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 |
| S. No. | Dosage form of Siddha medicines | Shelf life or date of expiry with effect from thedate 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/ PugaiCuranam/ Kali Curanam/ Thuvalai Curanam | 2 years | |
| (ii) | Mattirai/ Vatakam | |
| (I) Containing only Mooligai ingredients (including KudineerCuranam Mattirai) (eg. Nilavembu kutinir Mattirai) | 2 years | |
| (II) Containing Mooligai ingredients along with ThathuPorutkal/ Jeeva Porutkal/ Parpam/ Centuram/ Cunnam. (includingkutinir 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 ThathuPorutkal/ Parpam/ Centuram/ Cunnam/ Kattu/ Kalanku | 3 years | |
| (II) Containing only Thathu Porutkal/ Parpam/ Centuram/ CunnamKattu/Kalanku | 10 years | |
| (iv) | Parpam/ Centuram | |
| (I) Containing only Mooligai ingredients (eg. KungiliyaParpam) | 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 SuttaKari) | 2 years | |
| (II) Containing Mooligaiingredients with Thathu Porutkal(e.g. Sivanar Amirtham, Thalaga Karuppu) | 5 years | |
| (III) Containing Mooligaiingredients 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) | KulampuBased 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 VallthiMeluku) | 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, EyaSatthu, Thurusu Satthu) | 10 years | |
| (III) Satthu derived from Jeeva Porutkal (eg. Sembu Satthuderived 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 |
| S. No. | Dosage form of Unani medicines | Shelf life or date of expiry with effect fromthe 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) | (1) Sufoof (Without Salt) | 2 years |
| (2) Sufoof (Containing salt) | 1 year | |
| (xxiv) | Tiryaq | 3 years] |