Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organizations and providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.
A manufacturer holding valid license copy as per the Form-25 and Form-28 can obtain No Objection Certificate from Zonal/Sub Zonal offices of Central Drugs Standard Control Organization (CDSCO) for export purpose only for approved / unapproved new drug / banned drug in India.
The guidelines are issued by Ministry of Health and Family Welfare for Export purpose and Rule 94 of the Drugs and Cosmetic Act, 1940.
The application for Export NOC is filled as per checklist issued by the CDSCO.
The Following documents are required to be submitted in the following manner and order for issue of the No Objection Certificate for export of drugs from India
There are set rules related to export of drugs from India and set guidelines for the export of drug issued by Ministry of Health and Family Welfare which the manufacturer has to comply to.
Special Code and Neutral code are synonyms. Both are approved by CDSCO, when a manufacturer does not want to reflect name & address on the label. For export of finished formulation and bulk drugs, the manufacturer fill an application to get a special code for the finished formulation or bulk drugs with the required documents.
Special code is given by the manufacturer who is approved by the regulatory authority in the application to CDSCO.
Following documents required for the application for grant of permission to the use of Special Code for Export of Finished Formulation/Bulk Drug.