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Bonded Manufacturer

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Devsthali Vidyapeeth College of Pharmacy
Devsthali Vidyapeeth College of Pharmacy

There are two modes of manufacturing medical and toilet preparations containing alcohol: manufacturing in bond or non-bonded. Manufacturing in bond requires facilities like a spirit store, manufacturing rooms, storage rooms, and compliance with security measures. Alcohol is obtained from approved distilleries and stored in the bonded laboratory where it is measured and issued for production. Final products are stored and sampled before being issued, with duties paid based on alcohol content. Wastage is regulated and recovered alcohol can be reused or destroyed if unfit.

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MANUFACTURE IN BONDED LABORATORIES
There are two modes of manufacture of medical and toilet preparation containing alcohol:- a) Manufacture in Bond. b) Manufacture in out side bond or Non-bonded
The Bonded Manufactory or Bonded Laboratory Structures of the Bonded Manufactory  The license is issued from office of the Excise Commissioner of the State for alcohol. The application should include:- • A separate spirit store. • Room or rooms for manufacture of medicinal preparation. • One or more rooms for storage of finished medicinal preparation • The storage room for toilet preparation. • Every room in the bonded laboratory should bear a board indicating the name of the room and serial number. • The pipe and sink or wash basins in the laboratory should be connected with the general discharge of the laboratory. • The windows should be covered from inside with strong wire netting, the aperture of which should not exceed 25 mm in diameter. • All the gas regulators or switches should be securely locked and cut off at the end of days work.
• There should be only one entrance to the laboratory, only one door for each of its compartments. • Accommodation with necessary furniture for the office-in-charge of the bonded laboratory near its entrance. • The bonded laboratory should be opened and closed in presence of excise officer in charge and secured with excise ticket locks. • Every window in the bonded laboratory should be provided with iron rods not less than 19 mm in thickness set apart at a distance of not more than 102 mm. • The spirit should be obtained from the spirit warehouse approved by the Excise Commissioner • No wastage during transshipment is permissible and for any loss due to negligence of the manufacturer, excise duty has to be paid.
Manufacturing of Alcoholic preparation: 1. Obtaining of sprit from distillery or sprit warehouse: A distillery or sprit warehouse approved by the excise commissioner supplies the sprit for the manufacture of medical or toilet preparation. After receiving the indent the officer-in-charge of bonded laboratory or warehouse officer shall issue the sprit under the appropriate permit. No wastage of sprit during its transit from distillery to bonded lab is permitted. The manufacturer is liable to pay duty on any loss of amount of sprit, if some loss occurs due to negligence.
2. Verification and Storage of Alcohol/ Sprit on its arrival: On its arrival in bonded laboratory, alcohol is measured in volume and Strength. Entries are made in register and stored in spirit store room under excise lock with perfect coordination between excise officer in charge and officer of manufacturing unit.
3. Issue of sprit from sprit store for manufacture:- Calculated quantities of sprit can be obtained by the manufacturer on a requisition to the office-in-charge who shall issue the same from the sprit store. The sprit so issued has to be immediately mixed with other ingredients of the preparation in the presence of the officer-in-charge. The percolator or vessels should be labeled with: 1- Name and batch no. of the preparation. 2- Description and quantity of alcohol put in it. 3- Date of removal of preparation and the quantity of sprit such preparation removed.  As soon as the mfg of preparation has been completed it should be removed to the finished good store. Details of preparation should be entered in the register.
Sampling:-  On completion of medical or toilet preparation, the manufacturer may be permitted to take free sample of each quantity as the officer-in-charge consider necessary for analysis and determination of its alcoholic strength.  Any quantity left over after the analysis should be returned to finished goods store and mixed with the main bulk of the batch.  The excise officer-in-charge also withdraw 2 Samples from each batch, each not more than 150 ml.  One may be sent to chemical examiner and other kept under excise ticket- lock.  After the receipt of the report from the chemical examiner the duplicate sample should be returned to the finished goods store.  If the chemical examiner declares the strength more than 3° over proof the strength declared by the manufacturer or has been declared to be spurious.
5. Storage of Finished Product:  Finished medicinal or toilet preparations may be transferred from the finished store. The goods are arranged in such a way that they can be easily checked from the stock store.  All finished preparation should be stored in bulk in jars or bottles, each containing not less than 2.5 (80fl.oz) ltr. Of the preparation. Every container should be labeled with the:  Name of Preparation  Strength  Date of storage,  Actual content in bulk liters.  Ready for use preparation may be filled in bottles or containers of not less than 50ml. (2fl.oz) *fl.oz – US fluid ounce. *1fl.oz equal to 29.574ml.
Issue of Alcoholic Preparation from Bonded Laboratories:-  The manufacturer makes application to excise officer and pays excise duty or it can be adjusted against any advance duty payed by him. Only on payment of calculated duty, the goods containing alcohol and narcotic drugs are permitted to be taken out of bonded laboratory by the excise officer.  Dutiable goods cannot be delivered from the Bonded laboratory or a bonded warehouse before 6.00 a.m and after 6.00 p.m on all working days. No goods are taker out on Sunday or any other proceeding holidays.  The manufacturer should maintain up-to-date and proper account of his transaction of business in his laboratory and deliver them to proper officer by 5th of each month. Exemptions:  The preparations supplied to Government hospitals, dispensaries and charitable hospitals, and institutions which supply medicines to poor as certified by the district medical officer are exempted from payment of excise duties.
Important Facts:- 1- Wastage of Sprit during Manufacturing: a) The permissible percentage of wastage of alcohol during the manufacture of a particular medicine or toilet preparation is fixed the state Govt. from time to time. b) Any wastage exceeding the permissible limit and not properly accounted the manufacturer will be libel to pay the duty on the excess wastage along with any penalty prescribed by the excise commissioner. 2- Disposal of Sub-standard preparations:  A finished medicinal or toilet preparation which have deteriorated in quality may be destroyed by the manufacturer with the permission of the Excise Commissioner. He may allow a manufacturer to reprocess a sub-standard preparation.  If he get satisfied that the deterioration of the preparation was due to reason beyond the control of the manufacturer, he may exempt the excise duty on the preparation. 3-Dispoal of recovered alcohol:-  Alcohol which is recovered during the manufacture may be used manufacture of subsequent batches of some preparation. A separate account should be maintained for it.
 If recovered alcohol declared by the manufacturer to be unfit for consumption shall be destroyed by him in the presence of excise office-in-charge, on submission of written application. 4-Remission of duty in case of loss due to accident:  In cases of any accidental loss of alcohol in a bonded laboratory (other than theft) due to reason beyond the control of the manufacturer, the duty on the alcohol so lost shall be remitted with the approval of Excise Commissioner.
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  • 2. There are two modes of manufacture of medical and toilet preparation containing alcohol:- a) Manufacture in Bond. b) Manufacture in out side bond or Non-bonded
  • 3. The Bonded Manufactory or Bonded Laboratory Structures of the Bonded Manufactory  The license is issued from office of the Excise Commissioner of the State for alcohol. The application should include:- • A separate spirit store. • Room or rooms for manufacture of medicinal preparation. • One or more rooms for storage of finished medicinal preparation • The storage room for toilet preparation. • Every room in the bonded laboratory should bear a board indicating the name of the room and serial number. • The pipe and sink or wash basins in the laboratory should be connected with the general discharge of the laboratory. • The windows should be covered from inside with strong wire netting, the aperture of which should not exceed 25 mm in diameter. • All the gas regulators or switches should be securely locked and cut off at the end of days work.
  • 4. • There should be only one entrance to the laboratory, only one door for each of its compartments. • Accommodation with necessary furniture for the office-in-charge of the bonded laboratory near its entrance. • The bonded laboratory should be opened and closed in presence of excise officer in charge and secured with excise ticket locks. • Every window in the bonded laboratory should be provided with iron rods not less than 19 mm in thickness set apart at a distance of not more than 102 mm. • The spirit should be obtained from the spirit warehouse approved by the Excise Commissioner • No wastage during transshipment is permissible and for any loss due to negligence of the manufacturer, excise duty has to be paid.
  • 5. Manufacturing of Alcoholic preparation: 1. Obtaining of sprit from distillery or sprit warehouse: A distillery or sprit warehouse approved by the excise commissioner supplies the sprit for the manufacture of medical or toilet preparation. After receiving the indent the officer-in-charge of bonded laboratory or warehouse officer shall issue the sprit under the appropriate permit. No wastage of sprit during its transit from distillery to bonded lab is permitted. The manufacturer is liable to pay duty on any loss of amount of sprit, if some loss occurs due to negligence.
  • 6. 2. Verification and Storage of Alcohol/ Sprit on its arrival: On its arrival in bonded laboratory, alcohol is measured in volume and Strength. Entries are made in register and stored in spirit store room under excise lock with perfect coordination between excise officer in charge and officer of manufacturing unit.
  • 7. 3. Issue of sprit from sprit store for manufacture:- Calculated quantities of sprit can be obtained by the manufacturer on a requisition to the office-in-charge who shall issue the same from the sprit store. The sprit so issued has to be immediately mixed with other ingredients of the preparation in the presence of the officer-in-charge. The percolator or vessels should be labeled with: 1- Name and batch no. of the preparation. 2- Description and quantity of alcohol put in it. 3- Date of removal of preparation and the quantity of sprit such preparation removed.  As soon as the mfg of preparation has been completed it should be removed to the finished good store. Details of preparation should be entered in the register.
  • 8. Sampling:-  On completion of medical or toilet preparation, the manufacturer may be permitted to take free sample of each quantity as the officer-in-charge consider necessary for analysis and determination of its alcoholic strength.  Any quantity left over after the analysis should be returned to finished goods store and mixed with the main bulk of the batch.  The excise officer-in-charge also withdraw 2 Samples from each batch, each not more than 150 ml.  One may be sent to chemical examiner and other kept under excise ticket- lock.  After the receipt of the report from the chemical examiner the duplicate sample should be returned to the finished goods store.  If the chemical examiner declares the strength more than 3° over proof the strength declared by the manufacturer or has been declared to be spurious.
  • 9. 5. Storage of Finished Product:  Finished medicinal or toilet preparations may be transferred from the finished store. The goods are arranged in such a way that they can be easily checked from the stock store.  All finished preparation should be stored in bulk in jars or bottles, each containing not less than 2.5 (80fl.oz) ltr. Of the preparation. Every container should be labeled with the:  Name of Preparation  Strength  Date of storage,  Actual content in bulk liters.  Ready for use preparation may be filled in bottles or containers of not less than 50ml. (2fl.oz) *fl.oz – US fluid ounce. *1fl.oz equal to 29.574ml.
  • 10. Issue of Alcoholic Preparation from Bonded Laboratories:-  The manufacturer makes application to excise officer and pays excise duty or it can be adjusted against any advance duty payed by him. Only on payment of calculated duty, the goods containing alcohol and narcotic drugs are permitted to be taken out of bonded laboratory by the excise officer.  Dutiable goods cannot be delivered from the Bonded laboratory or a bonded warehouse before 6.00 a.m and after 6.00 p.m on all working days. No goods are taker out on Sunday or any other proceeding holidays.  The manufacturer should maintain up-to-date and proper account of his transaction of business in his laboratory and deliver them to proper officer by 5th of each month. Exemptions:  The preparations supplied to Government hospitals, dispensaries and charitable hospitals, and institutions which supply medicines to poor as certified by the district medical officer are exempted from payment of excise duties.
  • 11. Important Facts:- 1- Wastage of Sprit during Manufacturing: a) The permissible percentage of wastage of alcohol during the manufacture of a particular medicine or toilet preparation is fixed the state Govt. from time to time. b) Any wastage exceeding the permissible limit and not properly accounted the manufacturer will be libel to pay the duty on the excess wastage along with any penalty prescribed by the excise commissioner. 2- Disposal of Sub-standard preparations:  A finished medicinal or toilet preparation which have deteriorated in quality may be destroyed by the manufacturer with the permission of the Excise Commissioner. He may allow a manufacturer to reprocess a sub-standard preparation.  If he get satisfied that the deterioration of the preparation was due to reason beyond the control of the manufacturer, he may exempt the excise duty on the preparation. 3-Dispoal of recovered alcohol:-  Alcohol which is recovered during the manufacture may be used manufacture of subsequent batches of some preparation. A separate account should be maintained for it.
  • 12.  If recovered alcohol declared by the manufacturer to be unfit for consumption shall be destroyed by him in the presence of excise office-in-charge, on submission of written application. 4-Remission of duty in case of loss due to accident:  In cases of any accidental loss of alcohol in a bonded laboratory (other than theft) due to reason beyond the control of the manufacturer, the duty on the alcohol so lost shall be remitted with the approval of Excise Commissioner.