February 2017: CDSCO Updates

February 2, 2017

In G.S.R.101 (E) – In D & C Act following changes has been made.

This G.S.R 101 (E) is related for Blood donation camps

  1. In rule 122 P, after item (xiii), the following has been inserted – “(xiv) The whole human blood and blood components may be transferred, under prescribed storage conditions, to another blood bank which have facilities to store and monitor blood distribution.” “(xv) The recipient blood bank shall not further transfer units obtained from another blood bank except to another blood storage center or a patient.”
  1. In Schedule F, in Part XII B under the heading “II. BLOOD DONATION CAMPS”, after item (c) this has been inserted “A licensed blood bank run by registered voluntary or charitable organization recognized by State or Union territory Blood Transfusion Council; or (e) a private hospital blood bank.”

In G.S.R 102 (E) – in D & C act following changes has been made.

  1. In rule 2, after clause (a), following clause has been inserted, In this clause classification of biopharmaceutical has been given, which is as follows; it is classified as category I- high solubility and high permeability, category II- low solubility and high permeability, category III- high solubility and low permeability, and category IV- low solubility and low permeability.
  2. In rule 74, after clause (p), the following clause has been inserted “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”
  3. In rule 74 B, after clause (7), the following clause has been inserted “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.
  4. In rule 76, after clause (9), the following clause has been inserted “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”
  5. In rule 78, after clause (q), the following clause has been inserted “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”
  6. In rule 78 A, after clause (8), the following clause has been inserted “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”

February 20, 2017

CDSCO has released a notice on 20 February 2017 for import of radiopharmaceutical products / Radio-immuno assay for (in vivo or in vitro) diagnostic use.

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