This document outlines the quality control and standardization requirements for the export of herbal drugs from India, specifying necessary documentation such as a no objection certificate, purchase order, manufacturing license, performa invoice, and registration certificate. It also details labeling rules and guidelines for compliance with the importing country's regulations, including batch identification and expiry dates. Additionally, it emphasizes the importance of quality control testing and the physical destruction of unexported quantities.

1. Quality Control & Standardization Of Herbals
Preparation Of Documents For Export Registration
By
Kaushal Kumar

2. Tabel Of Contents
01 02 03 04
Introduction Document Rule Guideline

3. A manufacturer holding valid license copy in Form-25 & 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 Drugs /
banned drug from India.
Purpose
Requirement for the common submission format for issuance of
No Objection Certificate for export of approved / unapproved
new drugs/banned drugs from India.
This document is made as per guidelines issued by the Ministry
of Health and Family Welfare for Export purpose and Rule 94 of
the Drugs and Cosmetic Act, 1940.
Introduction

4. Required Document
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:
⭧ Covering Letter
⭧ Purchase Order
⭧ Manufacturing License
⭧ Performa Invoice
⭧ Registration Certificate

5. Required Document
Covering Letter
The covering letter mentioning list of products to be exported indicating name of the drug,
dosage form, composition and strength, packet size along with quantity and country to be
exported duly signed and stamped by the authorized signatory, indicating the name and
designation of the authorized signatory along with the name and address of the firm.
Purchase Order
Order from the foreign buyer either in the name of manufacturer or in the name of trader
mentioning list of products to be exported clearly indicating name of the drug, dosage form,
composition and strength, packet size duly signed by the competent authority with specific
destination point of the importing country.
Manufacturing License
License issued by the State Licensing Authority should be enclosed along with each application
for the required location to manufacture the drug for export purpose.

6. Required Document
Performa Invoice
A copy of the Performa invoice from the importing country should accompany with the
application for import of unapproved Active Pharmaceutical Ingredients, used in the drug
formulation, it should be duly signed by the competent authority.
Registration Certificate
A copy of registration certificate from the specific importing country along with composition &
strength of the drug should accompany with the application.
Registration certificate should be provided in the name of the manufacturer.

7. Rule
 Rule 94 - Packing and labeling of drugs other than Homeopathic Medicines
 Rule 95: Prohibition of sale or distribution unless labelled
 Rule 96: Manner of Labeling
Rule 94
Packing and labeling of drugs other than Homeopathic Medicines
Labels on packages or containers of drugs for export should be adapted to meet the specific
requirements of the law of the country to which the drug is to be exported.
⭧ Name of the drug
⭧ Name & address of the manufacturer and the number of the license under which, the drug has
been manufactured
⭧ Batch or lot number
⭧ Date of expiry, if any.

8. Rule
Rule 95
Prohibition of sale or distribution unless labelled
Subject to the other provisions of these rules, no person should sell or distribute any drug
(including a patent or proprietary medicine) unless it is labelled.
Rule 96
Manner of labelling
Printed or written in indelible ink & should appear in a conspicuous manner on the label of the
inner most container of any drug and on every other covering in which, the container is packed,
namely-
⭧ Name of the drug
⭧ For drugs included in the Pharmacopoeias,
⭧ Schedule F or Schedule F (1), National Formulary of India.

9. Guideline For Export Of Drug
 Ensure the physical destruction of all un exported quantity of drugs.
 Manufacturing license issued to the applicant by the State Licensing Authority.
 Identify the premises where, the drug will be manufactured for export.
 Batch to be exported has undergone Quality control testing.
 Copy of valid export order & NOC will be issued on a case by case basis against each such
order.
 Inspection of the appropriate authorities

10. THANKS!
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