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Union of India - Section

Section 158B in The Drugs and Cosmetics Rules, 1945

158B. [ Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs. [Inserted by Notification No. G.S.R. 663 (E) dated 10.8.2010 (w.e.f. 21.12.1945)]

- I.(A) Ayurveda, Siddha Unani Medicines under section 3(a):-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;
(B)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 Scheduled, 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 mentioned in 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.
II.(A) For issue of license 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 asreferred 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 Unanidrugs as described in section 3(a) of the Drugs and CosmeticsAct, 1940 As per text As per text Not Required Required Not Required
3. (C) Ayurveda, Siddha and Unani drugs referred in 3(a) to beused for new indication As per text New Not Required IF Required Required
II.(B) 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 or Proprietary medicine As per text Textual rationale Not Required Of Ingredients *Pilot study as per relevant protocol for Ayurveda, Siddhaand Unani drugs.
2. Ayurveda, Siddha, Unani drug with any of the ingredients ofSchedule E(1) of The Drugs and Cosmetics Act, 1940. As per text Existing Required Required Required
(III)For issue of license with respect to Balya and Poshak 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.
(IV)For issue of license with respect to Saundarya Prasadak (Husane afza/Azhagu Sodhan) the person who applied for license is require 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.
(V)For issue of license with respect to medicine Aushadh Ghana extract of medicinal plant (dry or wet).
SI.no. 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. (A1) Aqueous As per Text New indication 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/Hydro-Alcohol As specified As specified Required Acute, Chronic, Mutagenicity and Teratogenicity If required Required
* The standard protocol will also include concept of Anupan, Prakriti & Tridosh etc. published by Central Research Councils Ayurveda, Siddha, Unani and other Government/Research Bodies.** New indication means which is other than mentioned in 1st schedule books of Drugs & Cosmetics Act, 1940.]