Lok Sabha Question No. 358 (STARRED), answered on 2023-03-24
Subject: Cosmetic Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Rajendra Dhedya  Gavit

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

## LOK SABHA STARRED QUESTION NO. 358 TO BE ANSWERED ON THE 24 TH  MARCH, 2023

## COSMETIC PRODUCTS

## *358. SHRI RAJENDRA DHEDYA GAVIT:

Will the Minister of AYUSH be pleased to state:

- (a)  whether  the  Government is aware that  authoritative  Ayurvedic texts  are  replete with references on cosmetic combinations which are supposed to have no side effects in comparison to chemical based cosmetic products available in the market;
- (b) if so, whether scientific studies followed by clinical trials have been conducted in this regard by the Government controlled or aided scientific research institutions of the country; and
- (c) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY(AYUSH)

(SHRI SARBANANDA SONOWAL)

- (a) to (c) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 358* FOR 24 TH  MARCH, 2023

(a) to (c)  Yes Sir. Authoritative books of Ayurvedic system of medicines prescribed under first schedule of Drugs & Cosmetics Act, 1940 are replete with references on cosmetic combinations which may be used for cosmetic purposes. Some references from Ayurvedic Formulary of India (AFI), having indications of cosmetic purpose are as follows -

|   S.no. | Name of the Ayurvedic formulation   | Reference                                  |
|---------|-------------------------------------|--------------------------------------------|
|       1 | Kunkumadi taila                     | AFI, Part-I, Second edition, page no. 131  |
|       2 | Nilikadya taila                     | AFI, Part-I, Second edition, page no. 139  |
|       3 | Nilibhrngadi taila                  | AFI, Part-I, Second edition, page no. 139  |
|       4 | Kimsukadi taila                     | AFI, Part-III, First edition, page no. 184 |

Ayurveda drug is defined under section 3(a) and 3  (h)  (i)  of  Drugs  & Cosmetics Act, 1940.  Classical ayurvedic drug 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 system  of  medicine,  as  specified  in  the  First  Schedule  of  Drugs  &  Cosmetics  Act, 1940. As per section 3 (h) (i) of Drugs & Cosmetics Act, 1940, Patent or proprietary medicine means, in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine of  all  formulations  containing  only  such  ingredients  mentioned  in  the  formulae described in  the  authoritative  books  of  Ayurveda,  Siddha  or  UnaniTibb systems  of medicine 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 under section 3 (a).  Schedule I A of the Drugs & Cosmetics Act, 1940 comprises of 59 authoritative text books of Ayurvedic system of medicine.

As prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder,  enforcement  of  the  legal  provisions  pertaining  to  Quality  Control  and issuance  of  drug  license  of  Ayurveda,  Siddha,  Unani  and  Homoeopathic  drugs,  is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government.

Rule  158-B  in  the  Drugs  and  Cosmetics  Rules,  1945  provides  the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines    with  respect  to Saundarya  Prasadak i.e.  cosmetics.  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 Ist  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).

| Sl. no.   | Category                       | Ingredie n t (S)   | Indication (s)    | Safety study                                             | Experience/Evidence of Effectiveness   | Experience/Evidence of Effectiveness   |
|-----------|--------------------------------|--------------------|-------------------|----------------------------------------------------------|----------------------------------------|----------------------------------------|
| (1)       | (2)                            | (3)                | (4)               | (5)                                                      | (6)                                    | (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        | New Indication* * | Not Required                                             | Not Required                           | Required                               |
| 3         | (B) HydroAlcohol               | As per text        | As per text       | Not Required                                             | If Required                            | Not Required                           |
| 4         | (B1) HydroAlcoho               | As specified       | New Indication* * | Required                                                 | If Required                            | Required                               |
| 5         | Other than Hydro/ HydroAlcohol | As specified       | As specified      | Required Acute, Chronic, mutagenicity and teratogenicity | If Required                            | Required                               |

Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Scheme of Ministry of Ayush are mandated to monitor and report the misleading advertisements to the respective State Regulatory Authorities. A three tier structure comprising of a National Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs)  is  established.  All  India  Institute  of  Ayurveda  (AIIA),  New  Delhi  under Ministry of Ayush is the National Pharmacovigilance Co-ordination Centre (NPvCC) for  the  implementation  of  the  National  Pharmacovigilance  program  for  Ayurveda, Siddha,  Unani  &  Homoeopathy  drugs.    Objectionable  advertisements  are  being reported to the respective State Licensing Authorities by PPvC at regular intervals. The identified centers under this program report instances of misleading advertisements to the respective state licensing authorities for suitable action against the defaulters.

Department of Saundarya Ayurveda in National Institute of Ayurveda (NIA), Jaipur  under  Ministry  of  Ayush  is  running  M.Sc.  and  short  term  regular  course  for awareness concept in Cosmetology. Till date, 93 academic research works with respect to Cosmetology (skin, hair, nail etc.) has been done in various departments of NIA.

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