rule 34A
Offences by Government Departments.
The Drugs and Cosmetics Act and RulesChapter V Chapter V
(1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be. (2) The licensing authority may require such further particulars to be supplied, as he may consider necessary. (3) Every application in Form 12-AA shall be accompanied by a fee of Rs. 100 for a single drug and an additional fee of Rs. 50 for each additional drug. (4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.
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