Preamble - DRUGS AND COSMETICS (5TH AMENDMENT) RULES, 2016
DRUGS AND COSMETICS (5TH AMENDMENT) RULES, 2016
PREAMBLE
Whereas the draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published as required by sub-section (1) of section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940) in Part II, Section 3, Sub-section (i) of the Gazette of India, Extraordinary, vide number G.S.R 897(E), dated the 24th November, 2015 inviting objections and suggestions from persons likely to be affected thereby before the expiry of a period of forty five 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 was made available to the public on the 24th November, 2015;
And whereas, objections or 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 sub-section (1) of section 33-N read with clause (e) of sub-section (2) of the said section of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely:-
Rule 1 - RULE 1
(1) These Rules may be called the Drugs and Cosmetics (5th Amendment) Rules, 2016.
(2) They shall come into force on the date of their publication in the Official Gazette.
Rule 2 - RULE 2
In the Drugs and Cosmetics Rules, 1945, for rule 161-B the following rule shall be substituted, namely:-
"161-B. Shelf life or date of expiry of medicines.-
(1) The date of expiry of Ayurvedic, 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 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.
Provided also that this rule shall not be applicable to the Ayurvedic, Siddha or Unani medicines manufactured and marketed prior to the date of this notification.
(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 Real time stability studies of medicines in accordance with the guidelines prescribed in the Ayurvedic Pharmacopoeia of India.
Provided that this sub-rule shall be applicable after three years from the date of notification of the rules.
(3) The guidelines regarding stability studies as prescribed in the Ayurvedic Pharmacopoeia of India, Part-I, Volume-VIII shall be applicable to all the medicines of Ayurvedic, Siddha and Unani.
(4) 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.
(5) 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.
(6) Where the manufacturer fails to comply with direction of the State Licensing Authority under sub-rule (5), the license for the manufacturing of the medicine shall be liable for suspension after giving a reasonable opportunity of being heard.
(7) Any person aggrieved by an order passed by the State Licensing Authority under sub-rule (6), may within sixty days of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as is considered necessary, pass such order in relation thereto as it deems fit. The decision of the Central Government shall be final and binding.
(8) 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:-
(Ayurvedic medicines)
S. No.
Dosage form
Shelf life or date of
expiry with effect from
the date of
manufacture
(1)
(2)
(3)
(i)
Anjana
a) Anjana made from Kasthaushadhi
1 year
b) Anjana made from Kasthaushadhi along with Rasa/Uprasa/Bhasma
