Introduction: Chameli, scientifically known as Jasminum officinale, is a captivating and fragrant flowering plant that has enchanted people for centuries. Known by various names across different cultures, Chameli holds significant historical and contemporary importance. In this article, we will delve into the world of Chameli, exploring its remarkable characteristics, diverse uses, and cultivation techniques. Whether you are an avid gardener, a fragrance enthusiast, or simply curious about the wonders of nature, join us on this journey to discover the allure of Chameli and unravel its secrets. Description and Characteristics: Chameli, or Jasminum officinale, is a visually striking flowering plant with a graceful and elegant presence. It typically grows as a deciduous or semi-evergreen vine, though it can also be cultivated as a shrub. The size of Chameli varies depending on its growing conditions, but it can reach heights of 10 to 15 feet (3 to 4.5 meters) or even more in optimal
How to take approval of Ayurvedic Medicines (including Siddha and Unani Medicines) by Manufacturing Company?
There are two types of medicines generally manufactured
under ayurvedic medicine manufacturing license. One is Unbranded i.e. Classical Ayurvedic Medicines. Second is branded i.e. patent or proprietary medicines. For approval of ayurvedic medicines, a file is submitted to ayush department with detail of medicines to be manufactured in below format.
1. Ayurveda, Siddha Unani Medicines under section 3(a):- Classical and Sastrukta medicines:
Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;
For issue of licence to the medicine with respect to Ayurvedic, Siddha and Unani, the conditions relating to safety study and the experience or evidence of effectiveness shall be such as specified in columns (5) and (6) of The Table given below:-
1. Ayurveda, Siddha Unani Medicines under section 3(a):- Classical and Sastrukta medicines:
Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;
For issue of licence to the medicine with respect to Ayurvedic, Siddha and Unani, the conditions relating to safety study and the experience or evidence of effectiveness shall be such as specified in columns (5) and (6) of The Table given below:-
Serial number
|
Category
|
Ingredient (S)
|
Indication (s)
|
Safety study
|
Experience/Evidence of Effectiveness
|
|
1
|
2
|
3
|
4
|
5
|
6
|
|
Published Literature
|
Proof of Effectiveness
|
|||||
1
|
(A) Ayurveda, siddha and Unani drugs, given in 158 B as referred in
3(a)
|
As per text
|
As per text
|
Not Required
|
Required
|
Not Required
|
2.
|
(B) Any change in dosage form of Ayurveda, siddha and Unani drugs, as
described in section 3 (a) of the Drugs and Cosmetics Act 1940
|
As per text
|
As per text
|
Not Required
|
Required
|
Not Required
|
3.
|
(C) Ayurveda, siddha and Unani drugs, referred in 3(a) to be used for
new indication
|
As per text
|
New
|
Not Required
|
If required
|
Required
|
2. Patent or Proprietary medicine under section 3(h);
(i) In relation to Ayurvedic, Siddha and Unani Tibb system of medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);
(ii) Balya/Poshak/Muqawi/Unavuporutkal/positive health Promoter formulations having ingredients mentioned in books of First Schedule of the Drugs and Cosmetics Act and recommended for promotional and preventive health.
(iii) Saundarya Prasadak (Husane afza)/Azhagh-sadhan formulation having ingredients mentionedin Books of First Schedule of the Drugs and Cosmetics Act and recommended for oral, skin, hair and body care.
(iv) Aushadh Ghana (Medicinal plant extracts - dry/wet) extract obtained from plant mentioned in books of First Schedule of the Act including Aqueous or hydro-alcohol.
For issue of license with respect to Patent or Proprietary medicine. The condition relating to Safety studies and experience or evidence of effectiveness shall be specified as follows:-
Serial number
|
Category
|
Ingredient (S)
|
Indication (s)
|
Safety study
|
Experience/Evidence of Effectiveness
|
|
1
|
2
|
3
|
4
|
5
|
6
|
|
Published Literature
|
Proof of Effectiveness
|
|||||
1
|
Patent orPropri etary medicine
|
As per text
|
Textual Rationale
|
Not Required
|
Of Ingredients
|
Pilot study as per relevant protocol for Ayurveda, siddha and Unani
drugs
|
2.
|
Ayurveda, siddha and Unani drugswith any of the ingredients of
Schedule E(1) of the Drugs and Cosmetics Act, 1940
|
As per text
|
Existing
|
Required
|
Required
|
Required
|
3. For issue of license with respect to medicines the person who applied for license is required to submit the following:
(i) Photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;
(ii) Conduct safety studies in case the product contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda Siddha and Unani Drugs formulations;
(iii) For textual indications the safety and effectiveness study is not required.
4. For issue of license with respect to Saundarya Prasadak (Husane afza/Azhagu Sodhan) the person who applied for license is required to:-
(i) Submit photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;
(ii) Conduct safety studies, in case the formulation contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda, Siddha and Unani formulation;
(iii) For textual indications the safety and effectiveness study is not required.
5. For issue of license with respect to medicine Aushadh Ghana extract of medicinal plant (dry or wet):
Serial number
|
Category
|
Ingredient (S)
|
Indication (s)
|
Safety study
|
Experience/Evidence of Effectiveness
|
|
1
|
2
|
3
|
4
|
5
|
6
|
|
Published Literature
|
Proof of Effectiveness
|
|||||
1
|
(A) Aqueous
|
As per text
|
As per text
|
Not Required
|
Not Required
|
Not Required
|
2.
|
(Al). Aqueous
|
As per text
|
(Al). Aqueous
|
Not Required
|
Not Required
|
Required
|
3 .
|
(B) Hydro-
Alcohol
|
As per text
|
As per text
|
Not Required
|
If Required
|
Not Required
|
4.
|
(B1) Hydro-
Alcohol
|
As specified
|
New Indication
|
Required
|
If Required
|
Required
|
5.
|
Other than Hydro/ HydroAlcohol
|
As specified
|
As specified
|
Required Acute, Chronic, mutagenicityand teratogenicity
|
If Required
|
Required
|
Form of Free Sale
Certificate and Non-Conviction Certificate:
The State Drug Controller or Licensing Authority shall, on
request by the Ayurveda, Siddha and Unani Drugs manufacturer, issue, within 15
days; from the date of application, Free Sale Certificate in Form 26 E2-I for
original License holder or in Form 26 E2-II for loan license and Non Conviction
Certifacate for both original and loan license holder in Form 26 E3 or in the
format as specified by the importing country or tenderer respectively, after
fulfilment of all requisite formalities as required in the respective formats
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