January 2017: CDSCO Updates

January 16, 2017

In G.S.R 36 (E), Drugs and Cosmetic Rules in Schedule A in form 44 paragraph 1, relating to ‘Particulars of new drug’ item 8 and all the entries relating to that has been omitted.

January 17, 2017

FIRST UPDATE

In G. S.R 41 (E), for drug import through sea into India quite a few ports have been substituted like Vishakhapatnam and Krishnapatnam port in Andhra Pradesh along with Hazira port and Inland container depot Khohdiyar and Gandhinagar in Gujarat.

SECOND UPDATE

In G.S.R 43 (E), Drug and cosmetics rule number 24, sub rule 1 following sentence has been omitted “And by an undertaking in form 9 duly signed by or on behalf of manufacturer”.

THIRD UPDATE

G. S.R 44 (E) has newly added to the D & C Act. In the Drugs and Cosmetics Rules, in rule 3A, in sub-rule (8), in clause (b), after item (5):

Enzymes and Hormones such as –

  • Streptokinase which is Natural and Recombinant.
  • Human Chorionic Gonadotrophin (hCG)
  • Human Menopausal Gonadotrophin (hCG)
  • Bacterial vaccines such as Bacillus Calmette – Guerin (BCG)

Viral vaccines such as-
(a) Live attenuated Measles vaccine;
(b) Live attenuated Rubella vaccine;
(c) Cell culture Rabies vaccine

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