Drug and Cosmetics (Sixth Amendment) Rules, 2009

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy)
NOTIFICATION New Delhi, the 15th October, 2009 G.S.R. 764(E). WHEREAS the draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published, vide notification of the Government of India in the Ministry of Health and Family Welfare, number G.S.R. 691(E), dated the 26th November, 2005 in the Gazette of India, Extraordinary, dated the 26th November, 2005, inviting objections and suggestions from persons likely to be affected thereby and notice was given that the said draft rules shall be taken into consideration after the expiry of a period of thirty days from the date on which copies of the Official Gazette containing the said notification were made available to the public;
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AND WHEREAS, the said Gazette Notification was made available to the public on the 26th November, 2005; AND WHEREAS, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; NOW, THEREFORE, in exercise of the powers conferred by section 33-N of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely :1. (1) (2) 2. These rules may be called the Drug and Cosmetics (Sixth Amendment) Rules, 2009. They shall come into force w.e.f. 1st April, 2010 after the publication in the Official Gazette.

In the Drugs and Cosmetics Rules, 1945, after rule 161A, the following rule shall be inserted, namely :-

161B. 1. The date of expiry of Ayurveda, Siddha and Unani medicines shall be conspicuously displayed on the label of container or package of an Ayurvedic, Siddhas and Unani medicines, and after the said date of expiry, these medicines shall not be in circulation. 2. The Shelf-life i.e. for Ayurveda, Siddha and Unani medicines shall be as follows:(i) Shelf life or date of expiry for Ayurvedic medicines. Name of the Group of Ayurvedic Medicine. Shelf life and date of expiry with effect from the date of manufacture 2 years 3 years 3 years 5 years No expiry date1 No expiry date1 3 years 5 years 10 years 2 years

Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9.
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Churna, Kwatha Churna Gutika (Vati-Gutti, Pills, Tablets except Gutika with Rasa) (i) Gutika Tablet containing Kasth aushadhi (ii) Gutika, Tablet containing Kasth aushadi and Rasa, Uprasa, Metallic Bhasmas, and Guggulu. Rasaushadhies Asava Arista Avaleha Guggulu Mandura Lauha Ghrita

Published in the Gazette of India (extraordinary) Part-II, section 3, sub-section (i), vide G.S.R. 764(E), dated 15th/20th October, 2009.

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10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. Note 1. Taila Arka Dravaka, Lavana, Ksara Lepa Churna Dant Manjan Powder Dunt Manjan Paste Lepa Guti Lepa Malahar (Ointment)/Liniment/Gels/lotions/creams Varti Ghana Vati Kupipakva Rasayan Parpati Sveta parpati Pisti and Bhasma Svarna, Rajata, Lauha, Mandura, Abhraka bhasma, Godanti, Shankha Bhasma, etc. Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 Capsules made of soft gelatin (depending upon the content material) for Kashtha aushadhi Capsules of hard gelatin (depending upon the content material) containing Kasth aushdhi with Rasa, Bhasma, Parad Gandhak Syrup/liquid oral (Karna/Nasa Bindu) Ear/Nasal drops Eye drops Khand/Granule/Pak Dhoopans-Inhalers Pravahi Kwatha (with preservatives) 3 years 1 year 5 years 3 years 2 years 2 years 3 years 3years 2 years (one time use) 3 years No expiry date1 No expiry date1 2 years No expiry date1 No expiry date1 5 years2 3 years 5 years2 3 2 1 3 2 3 years years year years years years

Item at Sr. No.4,5,19,20,22,23 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items. Bhasmas at Sr. No. 23, start solidifying after five years and they need one or two Puta again before using in the dosage form.

Note 2.

(ii) Shelf life or date of expiry for Siddha Medicines Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Name of the Group of Medicine. Shelf Life or date of expiry with effect from the date of manufacture No expiry date* 5 years No expiry date* No expiry date* No expiry date* No expiry date* No expiry date* 5 years 5 years 5 years 2 years 2 years 3 years 3 years

Karpam Cunnam Kalanku Kattu Parpam Centuram Karuppu Patankam Kulampu Meluku Tinir Tiravakam Mattirai Tailam

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15. 16. 17. 18. 19. 20. 21. 22. Note. * Ilakam Iracayanaam Ney Manappaku Venney Vatakam Curanam Pura Maruntukal 3 3 2 3 3 3 2 5 years years years years years years years years

Items at Sr. No.1,3,4,5,6,22 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items.

(iii) Shelf life or date of expiry for Unani System of Medicines Sl. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. Name of the Group of Medicine Shelf Life or date of expiry with effect from the date of manufacture 3 years 3 years 3 years 3 years 3 years 3 years 2 years 2 years 2 years 2 years 3 years 5 years 3 years 3 years 2 years 1 year 3 years 3 years 3 years 1 year 1 year 5 years 1 year 2 years [No. K. 11020/3/2000-DCC (AYUSH)] B. ANAND, Jt. Secy. Note : The principal rules were published in the Gazette of India, vide notification number F. 29-10/45-11 dated the 21st December, 1945 and last amended vide number G.S.R. 651 (E), dated the 9th September, 2009. --------------------------------

Habb (Pills) Qurs (Tablets) Majoon/Dawa Khamira Itrifal Tiryaq Laooq Laboob Halwa Mufarreh/Yaqooti Burood/Surma/Kohal Kushta Raughaniyat Marham/Zimad/Qairooti Ayarij/Sufoof Safoof (Namak wala/containing salt) Sharbat/Sikanjabeen Jawarish Capsule Arq Qutoor Nabeez Murabba Tila