Manufacture of Ayurveda Preparations under M and TP act 

Ayurveda Preparations containing alcohol may be of 2 types:

  1. Those containing self-generated alcohol. E.g., Asavas 
  2. Those in which alcohol is added in any stage of manufacture. 
Duty shall not be applied on preparation containing self-generated alcohol in which the alcohol content is less than 2 %

In case of preparation in which the alcohol is more than 2% and if it can be taken as alcoholic beverages, the duty shall be paid. 

Registered Ayurvedic Practitioner are allowed to manufacture and dispense preparations free of duty- 
  • They must take a license 
  • Use that products for only patients not for general people. 
  • They should allow Excise officer to draw sample in order to check the sample contains only self generated alcohol. 
  • They should maintain a record of the preparations along with the name and address of the patients. 
  • Can be manufactured with bond or without bond. 

Comments

Post a Comment

Popular posts from this blog

Image
Manufacture of New Drugs:  As per the Rule: A new drug can be a new substance of chemical or biological origin; in bulk or prepared dosage from; used for prevention, or treatment of disease in human or animal which is not used in the country except the clinical Trial  If the ratio of ingredients is in an already marketed combination must be changed with certain factors like- Indications  Dosage from  Route of Administration  All vaccines are new drugs unless certified by the licensing authority.  A drug is said to be a new drug for about 4 years from the date of tits approval.  Loan License:  It is issued by a licensing Authority to a person who do not have any manufacturing license.  A separate license may be issued for the sale of drug more than 1 place.  Before the grant of license the license authority must satisfy the conditions for the grant of license like the manufacturing unit must have enough staff and components for manufacture.  For the manufacture of drugs more than 10 ite
Read more
General Labelling Requirements The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed: 1. Drug name: the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any. 2. Net content: weight, volume, in metric system or units. 3. Content of Active ingredients: Oral liquids: Contents per single dose, i.e. 5 ml or multiple thereof. If dose is below 5 ml, then per ml. Liquid parenterals: Contents per ml or in percentage or per dose. Solid parenterals: Contents per mg or per gm or in terms of units. Tablets, capsules and pills: Contents per tablet, capsule, pill. For other preparations: Contents in terms of percentage by w/w or w/v or units per gm or ml. 4. Name and address of manufacturer. 5. Manufacturing license number: Mfg. Lic. No. or ML No. 6. Batch number: Batc
Read more
Conditions of license for the manufacture of Schedule C, C1 and X drugs  Following are the general conditions for the manufacture of schedule C, C1 and X drugs; License Must - 01 Provide and maintain staff, premises and equipments as per schedule M and M3 02 Test raw materials and final products of each batch by licensing authority. 03 Maintain records of Manufacturing and Testing of each batch. 04 Allow drug inspector to enter to inspect the premises and conduct the essential tests. 05 Allow drug inspector to check the registers and records. 06 Time to time report to the licensing authority about the (i)               Changes in staff (ii)             Alterations in material (iii)           Samples of Drugs 07 Not sell any batch until the licensing authority gives permission 08
Read more