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:-

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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