Drug Controller definition

Drug Controller means the Head of the Drug Regulatory Authority appointed by the Government under Section 11.1 of this Act.
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Examples of Drug Controller in a sentence

  • Eleventh Drug Licenses issued by Central / State Drug Controller.

  • Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards, including manufacturing standards promulgated by the Drug Controller General of India (DCGI) (“Minimum Quality Standards”); and (ii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.

  • SPONSOR hereby agrees and undertakes to abide by the new rule “122-DAB” point (6) of Drugs & Cosmetics Rules, 1945, India, which states as follows: Further, SPONSOR understands and agrees that in accordance with the above rule, SPONSOR thereby authorizes the CRO to apply for the permission from the Licensing Authority and give the undertaking to the Drug Controller General of India for and on behalf of the SPONSOR.

  • SponsorSPONSOR hereby agrees and undertakes to abide by the new rule “122-DAB” point (6) of Drugs & Cosmetics Rules, 1945, India, which states as follows: Further, SponsorSPONSOR understands and agrees that in accordance with the above rule, SponsorSPONSOR thereby authorizes the CRO to apply for the permission from the Licensing Authority and give the undertaking to the Drug Controller General of India for and on behalf of the SponsorSPONSOR.

  • The second-largest company in the world for the manufacturing of generic and specialty pharmaceuticals, Mylan N.V received the permission of the Drug Controller General of India (DCGI) for the launch of its generic version of Gilead Sciences Remdesivir drug for the treatment of COVID-19 positive patients in India.

  • Valid Schedule 'M' Certificate clearly indicating the products (Items) which should not have been issued more than five years ago, issued by Centre / State Drug Controller, need to be submitted.

  • Licensee agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards, including manufacturing standards promulgated by the Drug Controller General of Africa, Central America, South America and Caribbean (DCGI) (“Minimum Quality Standards”); and (ii) on a country-by-country basis, any applicable national, regional or local standards as may be required by the specific country where Product is sold.

  • Manufacturing firm must enclose certificate issued by Chartered Accountant/ concerned State Drug Controller indicating actual production detail of a particular molecule, batch-wise, for items quoted.

Related to Drug Controller

  • Data Controller means an entity that determines the purposes and means of the processing of Personal Data.

  • Joint Controller with the other Party;

  • Controller means the natural or legal person, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State law;

  • Joint Controllers means where two or more Controllers jointly determine the purposes and means of processing;

  • Chief Pretrial Services Officer (i.e., CPSO) means the individual appointed by the court to supervise the work of the court’s pretrial services staff. For the purpose of the contract, the “Chief Probation Officer” acts as the contract administrator on behalf of the Director of the Administrative Office of the United States Courts.