Good regulatory practice in import and export of drugs (documentation, license, renewal, e-governance)

2. Good regulatory practice in import of drug includes; documentation, licenses,
renewal and e-governance are explained below.
Authorizing letter: issued by Director/Company Secretary/Partner of Indian
agent firm revealing the name and designation of the person authorized to sign
form 40 and Power of Attorney.
Power of Attorney: The authorization by a manufacture to his agent in India.

3. Wholesale license: issue to manufacture or it's agent by the state licensing
authority in India.
Undertaking signed and stamped by manufacture /Authorized agent.
Schedule D (2) requirement Standard of Drug: Imported drug complied as
IP, USP, BP, EP.
Label Submission: True copy of label as per respective official book.
Testing of drug: Method of analysis, COA tested in their laboratory, impurity
standard , marker compound, reference standard along with its COA where ever
applicable.
Free Sale Certificate (FSC): FSC should state that the proposed drug is freely
sold in Country of Origin.

4. Certificate of Pharmaceutical Products (COPP): The valid copy of GMP
certificate or COPP as per WHO scheme for each drug issued by the National
Drug Regulatory Authority of the Country of origin.
Manufacturing License: The valid copy of the Manufacturing license or Market
Authorization certificate issued by National Drug Regulatory Authority of
Country of origin.
Product registration Certificate: The valid copy of registration certificate
wherever applicable in respect of foregin manufacturing site.
Recall register
Record of sales of drug for the import of which a license is required, showing
particular of drug and of person to whom it is sold.

5. Separate register for sale or distribution of schedule X drug:
a) Name of drug
b) Batch Number
c) Name and address of manufacture
d) Date of transaction
e) Opening stock on the business day
f) Quantity of drug received, if any, and source from which received
g) Name of purchaser, his address and license number
h) Balance quantity of drug at the end of business day
i) Signature of the person under whose supervision the drug have been supplied.

6.  Form 10 for the import of drug other than schedule X
 Form 10A for the import of drug specified in schedule X
 The CDSCO issue licenses to medicine that are imported India.
 Filing application, submission of document, verification, payment of fee through
GRAS system, grant and renewal of manufacturing, import lincense are
processed through online only.
 SUGAM is e-governance system to discharge various function performer by
CDSCO under Drug and Cosmetic Act 1940.

7.  It is online web portal where applicant can apply for NOCs, licenses,
registration certificate, permission and approval.
 It also enable CDSCO official to process the application online and
generate the permission online and generate MIS(Management
Information System) report.

8.  Export means to send (goods or service) to another Country for sale.
 Export are product and service that are produced domestically, but then
sold to customers residing in other countries.
 Good regulatory practice export of drug including documentation,
licenses, renewal, and e-governance.

9.  Copy of company Incorporation Certificate
 Copy of Valid Export order and NOC issued on a case to case basis against
each such order.
 NOC for manufacture of new (Unapproved) drug solely export from DCGI.
 Details of premices where the drug is to be manufactured for export.
 Record of quality control of the batch to be exported
 Record showing that no part of drug to be exported is divided for domestic
sale in India.
 Information regarding each consignment dispatched, remaining stock of drug
and related row material and intermediate in hand.

10.  Record to ensure physical destruction of all unexported quality of drug.
 Each consignment of export shall be accompanied with requisite import license
from importing country.
 WHO GMP certification.
 Dossier contains following detail,
a) Product detail
b) Approved generic names
c) Strengh per dosage
d) Dosage form
e) Visual description
f) Details regarding the packing
k) Efficacy and safety

11. g) List of contries in which product has been approved, rejected and withdrawn
h) List of active pharmaceutical ingredients with their property.
i) Site of manifacturing and method of synthesis.
j) Stability testing.
 The state licensing authority shall issue the manufacturing licenses for these
formulation on each export order on basis of a No Objection Certificate from
Drug Controller, India.
 There is no drug licenses required in India when the drug is being exported
from India.

12.  However, the licenses is needed from country to which the drug is to be
exported.
 Secondly, the import and export code by the Directorate General of Foregin
Trade(DGFT) is required to exporters and importers of India.
• Licensing authority of state has presented the guidelines manual for the easy
understanding of processing of various applications through online system. It
is made completely paperless.
• Document can be maintained electronically to have easy traceability.
• Information Education and Communication (IEC) can be obtained by
applying on line on Director General of Foregin Trade portal.(DGFT).