Page 5 - Guidance document for import of Drugs & Pharmaceuticals from India
P. 5
1. Handling of quality failure of drugs exported from India (reviewing of
complaints, responding to complaints, appropriate investigation of the
complaints, etc)
2. International Co-operation among Regulatory Agencies.
3. Exchange of information on product recalls, emergency notifications, not
of standard quality drugs, etc.
4. International collaborations including Memorandum of Understanding
(Mou), Joint Working Group (JWG), Statement of Intent (Sol)etc.
5. Preparing guidance document related to functions/responsibilities of
International Cell.
6. Coordinate the visits of Foreign FDA officials.
HOW EXPORTS TAKE PLACE IN INDIA
An Indian exporter dealing with Drugs & Pharmaceuticals follow the
procedures as below:
Import-Export Code
Every exporter is required to obtain Import-Export Code by registering with
DGFT office (Director General of Foreign Trade). An individual or a firm or a
company can apply for IE Code. One IE code is issued against one PAN
(Permanent Account Number) issued by Income Tax department
License to manufacture / trade:
Manufacturing License:
complaints, responding to complaints, appropriate investigation of the
complaints, etc)
2. International Co-operation among Regulatory Agencies.
3. Exchange of information on product recalls, emergency notifications, not
of standard quality drugs, etc.
4. International collaborations including Memorandum of Understanding
(Mou), Joint Working Group (JWG), Statement of Intent (Sol)etc.
5. Preparing guidance document related to functions/responsibilities of
International Cell.
6. Coordinate the visits of Foreign FDA officials.
HOW EXPORTS TAKE PLACE IN INDIA
An Indian exporter dealing with Drugs & Pharmaceuticals follow the
procedures as below:
Import-Export Code
Every exporter is required to obtain Import-Export Code by registering with
DGFT office (Director General of Foreign Trade). An individual or a firm or a
company can apply for IE Code. One IE code is issued against one PAN
(Permanent Account Number) issued by Income Tax department
License to manufacture / trade:
Manufacturing License:
