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Introduction
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Form Sample
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Application for permission to import New Drug
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Central Drug Standard Control Organization
Any type of life saving drugs and medicine except for those which is otherwise restricted for import can be imported free of any custom duty. An individual or importer is also not required for any import license and the item can be imported registered courier as well.
Customs Notification No. 21/2002-, dated 1.3.2002 exempt specified life saving drugs, medicines including their salts and easters and specified diagnostic test kits from the whole of basic customs and additional customs duties subject to certain conditions. Other life saving drugs or medicines can be imported free of whole of the basic customs and additional customs duties provided.
Its is certified in the Form below, by the Director General or Deputy Director General or Assistant Director General., Health Services, New Delhi, Director of Health Services of the State Government or the District Medical Officer/Civil Surgeon of the district, in each individual case, that the goods are life saving drugs or medicines.
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Certificate No. ------------ Of ----------------- (years)
Certified that the drug/medicine--------------------------------(name of the drug/medicine)
being imported by ------------------------------- is a life saving drugs/medicine and exemption fro the payment of customs duty is recommended.
Signature with date of Director General/Deputy Director General/Assistant
Director General, Health Services,
New Delhi or
Director of Health Services or
District Medical Officer/Civil Surgeon
The importer produces the said certificate to the Deputy Commissioner of Customs or the Assistant Commissioner of Customs, as the case may be, at the time of clearance, or gives an undertaking as acceptable to furnish the said certificate within such period as specified by the Deputy Commissioner or the Assistant Commissioner, failing which to pay duty livable thereon.
Application for permission to import New Drug
No new drug shall be imported, except under, and in accordance with, the permission granted by the Licensing Authority, accompanied by a fee of fifty thousand rupees. The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission.
Central Drug Standard Control Organization
CDSCO is the leading organisation in India responsible for quality control of the drugs and medicine imported in India. Central Drug Standard Control Organization is also the licensing authority for the approval of new drugs proposed to be imported as well as the amount of drugs to be imported. The CDSCO functions from 4 zonal offices, 3 sub-zonal offices besides 7 port offices. The four Central Drug Laboratories carry out tests of samples of specific classes of drugs.