Section 161B(2) in The Drugs and Cosmetics Rules, 1945
(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.
