Lok Sabha Question No. 1028 (UNSTARRED), answered on 2017-07-21
Subject: Research Activities in Ayurveda
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: JANARDAN SINGH SIGRIWAL

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

LOK  SABHA UNSTARRED  QUESTION NO. 1028 TO BE ANSWERED ON 21 ST JULY, 2017

## RESEARCH ACTIVITIES IN AYURVEDA

## 1028. SHRI JANARDAN SINGH SIGRIWAL:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a) the details of the study and research activities in Ayurveda including literary and study, clinical and therapeutic research an d drug development research during the last three years and the current year;
- (b)  whether  toxicity  has  been  reported  in  Ayurvedic  products  which  lead  to  health  pro among  the  users  and  if  so,  the  details  thereof  along  with  preventive  measures  taken y  the Government in this regard;
- (c) whether storage conditions can also alter the bioavailability of herbal medicines, w lead to loss of activity, fungal or bacterial contamination resulting into batch to batc and
- (d)  if so,  the  measure  taken  to  deliver  consistent  marketed  formulation  and  check  quali ayurvedic products?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOM OEOPATHY (SHRI SHRIPAD YESSO NAIK)

- (a): Ministry of AYUSH has set - up  Central  Council  for  Research  in  Ayurvedic  Sciences (CCRAS) as apex body for formulation and development of Ayurvedic medicines for variou diseases.

Year wise details of the study and research activities in Ayurveda including liter conceptual study, clinical and therapeutic research and drug development research underta CCRAS during the last three years and the current year are as under : -

## 2014- 2015

- i. Eight Clinical Research completed.
- ii. A total 18 drugs were studied pharmacognostically.

Contd…….

- iii. Under Drug Standardization, 25 singles drugs have been carried out.
- iv. Toxicological  study  of  three  coded  drugs  completed.  Biological  activity  of  one completed.
- v. Eight books have been published.
- vi. Five Intra Mural Literary Research projects completed.

## 2015- 2016

- i. 10 Clinical Research completed.
- ii. Three Intra Mural Medicinal Plant Research projects completed.
- iii. Under Drug Standardization, 54 singles drugs and 28 compound formulations have bee carried out.
- iv. Five Intra Mural Pharmacological Research Projects completed.
- v. Eight  books  published.  Besides  this,  three  Intra  Mural  Lit erary  Research  projects completed.

## 2016- 2017

- i. Ten Clinical Research completed.
- ii. Five Intra Mural Medicinal Plant Research projects completed.
- iii. Under Drug Standardization, 88 singles drugs and 33 compound formulations have bee carried out.
- iv. Three Intra Mural Drug Standardization Research projects completed.
- v. One Intra Mural Pharmacological Research Project completed.
- vi. Nine  books  have  been  published.  Besides  this,  three  Intra  Mural  Literary  Resea projects completed.

## 2017- 2018 (upto June)

- i. 20 Clinical Research completed.
- ii. Under Clinical Research, One Intra Mural Research project completed.
- iii. Under Drug Standardization Programme, five IMR projects competed. Under Medicinal Plant Research, one project completed.
4. (b): CCRAS has informed t hat toxicity has not been reported in the clinical trials condu by them.

Rule  158 - B  of  the  Drugs  &  Cosmetics  Rules,  1945  seeks  proof  of  safety  and effectiveness for the purpose of licensing of various categories of Ayurvedic, Siddha an drugs. E nforcement of these provisions is under the purview of the State Licensing Author appointed by the State Governments.

Contd………

Such  Ayurvedic,  Siddha  and  Unani drugs  containing  any  of  the  potentially  hazardous ingredients of plant, animal or mineral origin as specified in the Schedule E(1), Rule the Drugs and Cosmetics Rules, 1945, are required to be taken under medical supervision. regard  an  A dvisory  has  been  issued  on  1st  February,  2016  for  Manufacturers  of  Ayurvedi Siddha and Unani drugs for ensuring to imprint 'Caution: to be taken under medical supervision' both in English and Hindi on the labels of all such Ayurvedic, Siddha and Unani dr ugs which contain potentially hazardous ingredients of plant, animal or mineral origin as specifi Schedule E(1) of the Drugs and Cosmetics Rules, 1945.

There  is  a  specific  category  of  herbo  mineral  or  metallic  Ayurvedic  medicines  c Rasaushad ies or Rasa yoga. Many of such medicines make use of heavy metals like  Mercur Arsenic  and Lead as ingredients after subjecting them to a series of processes called Marana, Amritkaram etc. to render them safe and  therapeutically effective. Sep arate GMP of Rasaaushadhies have been made mandatory under the provision of Drugs & Cosmetics Rules.

(c)& (d): Herbal Medicines are not covered in the provisions of Drugs and Cosmetics Ac 1940  and  Rules  there  under,  and  hence  are  not  recognized  as a  class  of  medicines  in  India. However, It is a scientific fact that the quality, efficacy, potency, shelf life and ba consistency of plant material based products are affected by storage conditions.

Pharmacopoeial Standards of ayurvedic drugs are prescribed in the Ayurvedic Pharmacopoea along with permissible limit of heavy metals, aflatoxins, pesticide residu microbial load. For manufacturing  of ayurvedic products of assured quality in accordanc these standards

Shelf  life  of  variou s  categories  of  ayurvedic  drugs  is  also  notified  under  Drugs  an Cosmetics  Rule,  1945  and  it  is  mandatory  for  the  manufacturer  to  comply  with  Goo Manufacturing Practices for obtaining manufacturing license.

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