33. Import of drugs for examination, test or analysis.
- Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:-(a)no drug shall be imported for such purpose except under a license in Form 11;(b)the licensee shall use the substances imported under the license exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the license, or in such other places as the licensing authority may from time to time authorize;(c)the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;(d)the licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation, and the name of the manufacturer;(e)the licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice.[33-A. Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. [Inserted by G.S.R. 604(E), dated 24.8.2001 (w.e.f. 1.1.2003).]- Small quantities of a new drug, as defined in rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:-(a)no new drug shall be imported for the said purpose except under a license in Form 11-A, and the said drug has been approved for marketing in the country of origin;(b)the licensee shall use the substances or drugs imported under the license exclusively 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, under the supervision of its own Medical Officers at the place, specified in the license or at such other places, as the licensing authority, may from time to time authorize;(c)the licensee shall allow an Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof;(d)the licensee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the license, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease;(e)the licensee shall comply with such other requirements, if any, applicable to the holders of import licenses for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice;(f)the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist;(g)the quantity of any single drug so imported shall not exceed 100 average dosages per patient:Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug in larger quantity.]
