Regulatory Overview for the Import of Sorbitol for Use in Pharma

Import of Sorbitol for Use in Pharma
Bangladesh - August 2023

This section provides a regulatory assessment for the import of Sorbitol to be used in Pharmaceuticals in Bangladesh.

1. Authorities in Charge, Enforcement Mechanism

In Bangladesh, the regulatory requirements for excipients in pharmaceutical products are governed by the “Directorate General of Drug Administration (DGDA)” - which works under the Ministry of Health & Family Welfare of the Government of the People’s Republic of Bangladesh. DGDA was established in 1976 as an attached department under the Ministry of Health and Population Control. On 17 January 2010, DGDA was upgraded to a separate division. 

DGDA supervises and implements drug regulations as well as regulates activities related to import, export, procurement of raw and packing material, and sale and pricing of all kinds of medicine including Allopathic, Ayurvedic, Unani, Herbal & homeopathic drugs. DGDA also works as Licensing Authority of drugs for the purpose of issuing licenses to manufacture, store, sell, import, and export drugs and medicines. 

The activities of DGDA are guided by the following Laws:

1. The Drug Act of 1940
2. The Drug Rules 1945 and their amendments 
3. The Drug Rules 1946 and their amendments 
4. The Drug (Control) Ordinance 1982 and its amendments 
5. The Drug (Control) Ordinance Amendment Act 2006 
6. National Drug Policy 2016

2. Product Classification and Definitions

The Bangladesh Custom Tariff is based on the HS (Harmonized System) standards and the classification of goods should follow the nomenclature system as described under the Harmonised System (HS) of coding known as H.S. Code. [1]

H.S. Code is an internationally recognized system for classifying products traded across borders. In Bangladesh, the HS Code is used for customs purposes to classify imported and exported goods. The HS Code in Bangladesh consists of eight digits, with the first six digits being the same as the global HS Code and the last two digits representing country-specific subheadings.

It's important to note that each product has a unique HS Code based on its characteristics, composition, and intended use. Therefore, it's advisable to consult the official customs tariff or seek guidance from a qualified professional or customs agent when determining the correct HS Code for your specific product in Bangladesh.

To determine the specific HS Codes for different products in Bangladesh, please refer to the Bangladesh Customs Tariff published by the National Board of Revenue (NBR). This document provides a comprehensive list of goods along with their corresponding HS Codes. [2]

In Bangladesh, Sorbitol is classified as an organic chemical under Chapter 29 of the Customs Tariffs. [2]

Table 2  HS CODE Sorbitol

Sorbitol is a permitted excipient for use in pharmaceutical products in Bangladesh. It is commonly used as a sweetening agent, humectant, and thickening agent in various pharmaceutical formulations.

However, it's important to note that the regulatory requirements for excipients in pharmaceutical products can vary depending on the country and the specific product. It's always best to consult with a regulatory expert or the regulatory authority in Bangladesh for the most up-to-date information and requirements regarding the use of Sorbitol or any other excipient in pharmaceutical products.

3. Compositional Aspects

The raw materials used in medicines produced in Bangladesh or overseas should be of quality as per the specifications mentioned in the relevant pharmacopeias [3] and shall meet the standards established by the Bangladesh Pharmacopoeia (BP) or other recognized pharmacopeias such as British pharmacopeia or US Pharmacopoeia.

Excipients should be used at a level that is safe and appropriate for the intended use of the product. For Sorbitol, there is no maximum limit specified as a food additive or for use as raw material in the manufacture of medicines. 

Raw materials should comply with the current Good Manufacturing Practices (cGMP) guidelines of the World Health Organization (WHO). [3]

It's important to note that the regulatory requirements for excipients in pharmaceutical products can vary depending on the specific product and the intended use. It's always best to consult with a regulatory expert or the DGDA directly for guidance on the specific requirements for your finished product.

4. GMP/Regulations for Raw materials Procured from Overseas

The overseas manufacturing facility shall comply with the current Good Manufacturing Practices (cGMP) guidelines of the World Health Organization (WHO). In this case, importers shall ensure GMP Compliance. [3]

In order to ensure that the imported raw materials are manufactured in accordance with GMP, the manufacturing establishment will be inspected by the National Medicines Regulatory Authority, if necessary, along with the provision of certification. In light of the GMP guidelines and the prepared checklist, the pharmaceutical factory of the exporting country will be validated.

5. Registration, License, and Other Mandatory Requirements

The licensee (importer) shall obtain prior approval of the licensing authority for procurement of materials/class of materials for the manufacture of drugs, indicating the name of the materials quantity, value, source and drugs to be manufactured with the raw materials so procured and further, if the licensing authority so directs, the licensee shall submit invoices, documents or list of materials for subsequent verification as to whether materials have been procured in accordance with the prior approval given by the licensing authority. [4]

In the case of the import of raw materials from the pharmaceutical industry [4], the condition of obtaining prior permission from any authority other than the approval of the Director General, Directorate of Medicines Administration (DGDA) is mentioned in drug rules 1946, the permission of the concerned authorities (Bangladesh Trade FDA (BFDA)) shall be obtained for the import of the said raw materials and a copy of the approved blocklist shall be sent to the Director General, as usual, to be supplied by the Directorate of Drug Administration to the Customs Authority and to the Office of the Chief Controller of Imports and Exports.

6. Importation Requirements

General conditions of import of goods to Bangladesh [5]:

1. Mandatory use of H.S. Code - Use of H.S. Code with at least eight digits corresponding to the classification of goods as given in the First Schedule of the Customs Act, 1969 (Act No. IV of 1969) based on the Harmonized Commodity Description and Coding System is mandatory. The HS Code helps to identify the custom tariffs.
2. The country of origin (COO) shall be clearly stated on the container.

6.1 Import of raw materials from overseas [6]

6.1.1 List of Documents Required:

1. Online application form for Import Permit (IP) issued by Bangladesh Economic Zone Authority (BEZA) 
2. Supporting Documents for obtaining Import Permit 
   1. Proforma Invoice
   2. Commercial Invoice
   3. Packing List
   4. Bill of Lading(B/L)
   5. Letter of Credit (L/C) (if necessary) 
   6. Certificate of Origin (if necessary) 
3. Bill of Entry (BOE) with the signature of Customs at the Port

• No. 1-2 are submitted to Bangladesh Economic Zones Authority (BEZA) online for Import Permit.
• No. 1-3 are submitted to Customs in Economic Zones (EZ) for entering the good into EZ. 
• Other documents might be required in accordance with the type of cargo.

Table 4 - Custom Tariffs Bangladesh (Sorbitol)

8. Labeling Requirements [4,8,9]

As per the guidelines or regulations issued by DGDA, Sorbitol as a pharmaceutical excipient in Bangladesh may include the following labeling instructions on the container:

1. Proper identification and declaration of Sorbitol as an excipient on the product label.
2. Accurate quantity or concentration of Sorbitol used in the formulation.
3. Clear instructions or indications regarding its use, if applicable.
4. Compliance with any specific formatting or language requirements specified by DGDA.
5. Pharmacopoeial reference, if any.
6. Batch no
7. Mfg date
8. Exp date

The above list includes general requirements for Sorbitol as raw material. However, to ensure compliance with the current regulations pertaining to labeling requirements for Sorbitol, specifically as a pharmaceutical excipient in Bangladesh for use in the production of specific medicine related to pharmaceuticals formulations such as tablets, syrups, or capsules, it is advisable to consult with DGDA or seek guidance from a qualified professional.

9. Claims

Not applicable for Pharmaceutical excipients. The Raw material to be used in pharmaceuticals should meet the functions/uses listed under relevant Pharmacopoeia such as British Pharmacopoeia and US Pharmacopoeia. 

Application for any new claims/indication that is currently not listed under food additives or for pharmaceutical use should be submitted to BSFA/DGDA supported with sufficient scientific evidence supporting the safety and efficacy of the proposed claim or indication.

Under the Use of Food Additives Regulation of Bangladesh (2017), Sorbitol is listed as an approved additive. [10]

Table 5 - Use of Sorbitol as Additive

10. Difference between Drug and Pharma Excipient Regulatory Requirements

Both Pharmaceutical excipients and Drugs, should comply with and meet the requirements listed in:

1. The Drug Act of 1940 [9]
2. The Drug Rules 1945 and their amendments [8]
3. The Drug Rules 1946 and their amendments [4]
4. The Drug (Control) Ordinance 1982 and its amendments [11]
5. The Drug (Control) Ordinance Amendment Act 2006 [12]
6. National Drug Policy 2016 [3]

Excipients used in the pharmaceutical formulation should be of pharmaceutical grade and should be of quality as per the specifications mentioned in the relevant pharmacopeias and shall meet the standards established by the Bangladesh Pharmacopoeia (BP) or other recognized pharmacopeias such as British pharmacopeia or US Pharmacopoeia.

11. Any Other Product Compliance (e.g. data reporting, etc. to regulator)

Not applicable.

12. References