Government Notifications

Govt. Notification

Government of India has recently issued a gazette notification regarding shelf life or date of expiry for ASU medicines. This notification clearly says that the date of expiry of Ayurveda, Siddha and Unani medicines shall be conspicuously displayed on the label of a container or package of an ASU medicine. It further says that medicine should not come in to circulation after the said date of Expiry.

The Gazette of India

Ministry of Health and Family Welfare (Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy)

NOTIFICATION

Where as 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;

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. These rules may be called the Drug and Cosmetics (Sixth Amendment) Rules, 2009.
  2. They shall come into force w.e.f. 1st April, 2010 after the publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, after rule 161A, the following rule shall be inserted, namely:- 376S GI / 09-2 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:
Sr.No. Name of the Group of Ayurvedic Medicine. Shelf life and date of expiry with effect from the date of manufacture
1. Churna, Kwatha Churna 2 years
2. Gutika (Vati-Gutti, Pills, Tablets except Gutika with Rasa) 3 years
3. (i) Gutika Tablet containing Kasth aushadhi 3 years
4. Rasaushadhies No expiry date1
5. Asava Arista No expiry date1
6. Avaleha 3 years
7. Guggulu 5 years
8. Mandura - Lauha 10 years
9. Ghrita 2 years
10. Taila 3 years
11. Arka 1 year
12. Dravaka, Lavana, Ksara 5 years
13. Lepa Churna 3 years
14. Dant Manjan Powder 2 years
15. Dunt Manjan Paste 2 years
16. Lepa Guti 3 years
17. Lepa Malahar (Ointment)/Liniment/Gels/lotions/creams 3 years
18. Varti 2 years (one time use)
19. Ghana Vati 3 years
20. Kupipakva Rasayan No expiry date1
21. Parpati No expiry date1
22. Sveta parpati 2 years
23. Pisti and Bhasma No expiry date1
24. Svarna, Rajata, Lauha, Mandura, Abhraka bhasma, Godanti, Shankha Bhasma, etc. No expiry date1
25. Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 5 years
26. Capsules made of soft gelatin (depending upon the content material) for Kashtha aushadhi 3 years
27. Capsules of hard gelatin (depending upon the content material) - containing Kasth aushdhi with Rasa, Bhasma, Parad-Gandhak 5 years
28. Syrup/liquid oral 3 years
29. Karna / Nasa bindu (Ear / Nasal drops)
Eye drops		 2 years
1 year
30. Khand/Granule/Pak 3 years
31. Dhoopans-Inhalers 2 years
32. Pravahi Kwatha (with preservatives) 3 years
Note 1. 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.
Note 2. Bhasmas at Sr. No. 23, start solidifying after five years and they need one or two 'Puta' again before using in the dosage form.
(ii) Shelf life or date of expiry for Siddha Medicines
Sl. No. Name of the Group of Ayurvedic Medicine Shelf life and date of expiry with effect from the date of manufacture
1. Karpam No expiry date*
2. Cunnam 5 years
3. Kalanku No expiry date*
4. Kattu No expiry date*
5. Parpam No expiry date*
6. Centuram No expiry date*
7. Karuppu No expiry date*
8. Patankam 5 years
9. Kulampu 5 years
10. Meluku 5 years
11. Tinir 2 years
12. Tiravakam 2 years
13. Mattirai 3 years
14. Tailam 3 years
15. Ilakam 3 years
16. Iracayanaam 3 years
17. Ney 2 years
18. Manappaku 3 years
19. Venney 3 years
20. Vatakam 3 years
21. Curanam 2 years
22. Pura Maruntukal 5 years
Note. * 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 of Unani System of medicines
Sl.No. Name of the Group of Ayurvedic Medicine Shelf life and date of expiry with
effect from the date of manufacture
1. Habb (Pills) 3 years
2. Qurs (Tablets) 3 years
3. Majoon/Dawa 3 years
4. Khamira 3 years
5. Itrifal 3 years
6. Tiryaq 3 years
7. Laooq 2 years
8. Laboob 2 years
9. Halwa 2 years
10. Mufarreh/Yaqooti 2 years
11. Burood/Surma/Kohal 3 years
12. Kushta 5 years
13. Raughaniyat 3 years
14. Marham/Zimad/Qairooti 3 years
15. Ayarij/Sufoof 2 years
16. Safoof (Namak wala/containing salt) 1 year
17. Sharbat/Sikanjabeen 3 years
18. Jawarish 3 years
19. Capsule 3 years
20. Arq 1 year
21. Qutoor 1 year
22. Nabeez 5 years
23. Murabba 1 year
24. Tila 2 years
Note : The principal rules were published in the Gazette of India, vide notification number F.29-10/45-II dated the 21st December, 1945 and last amended vide number G.S.R. 651(E), dated the 9th September, 2009.