Lok Sabha Question No. 3988 (UNSTARRED), answered on 2016-12-09
Subject: Quality of Herbal Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: ASHWINI KUMAR CHOUBEY

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

## LOK  SABHA UNSTARRED QUESTION NO.3988 TO BE ANSWERED ON 9 TH DECEMBER, 2016

## QUALITY OF HERBAL ME DICINES

## 3988. SHRI ASHWINI KUMAR CHOUBEY:

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

- (a) the details of research activities in Ayurveda which includes literary and conceptu clinical and therapeutic research, drug devel opment including drug standardization during the last three years and the current year;
- (b) whether the use of ayurvedic HMPs (Herbal Medicinal Products), can cause lead toxicit cause conditions like epilepticus, encephalopathy, sensory neural deafn ess etc., if so, the details thereof along with the preventive steps taken by the Government in this regard;
- (c) whether storage conditions can also affect the quality of herbal medicines, which may loss of activity, fungal or bacterial contamina tion resulting into batch to batch variation;
- (d)  if  so,  the  steps  taken  by  the  Government  to  ensure  the  delivery  of  the  same  ma formulation of ayurvedic HMPs; and
- (e) whether the Government has any mechanism to keep a check on adulteration of the ayurvedi products, if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (SHRI SHRIPAD YESSO N AIK)

- (a): The  Ministry  of  AYUSH,  Govt.  of  India  has  set  up  Central  Council  for  Research Ayurvedic Sciences (CCRAS) for undertaking coordinating, developing and promoting researc on scientific lines in Ayurveda. The activities are carried out throug h 30 institute/Centres/Units located all over India. The Council also conduct research through collaborative studies with various  universities,  hospitals  and  institutes.  The  research  activities  of  the  counc medicinal plant research (Medico - ethn   botanical survey, pharmacognosy and tissue culture), Drug  Standardization  Pharmacological  Research,  Clinical  Research,  Literary  Research Documentation, and other outreach activities.

Contd…….

The details of activities by CCRAS related to the research during last three years and year are at Annexure.

(b)  to  (d): There  is  a  specific  category  of  herbo - min al  or  metallic  Ayurvedic  medicines called Rasaushadies or Rasa yoga. Many of such medicines make use of heavy metals like Mercury, Arsenic and Lead as ingredients after subjecting them to a series of processes ca Shodana, Marana, Amritkaram etc. to render them safe and th rapeutically effective . Heavy metals in Ayurvedic formulations are not present in free elemental forms but incomplex compounds. It  is the synergy of various ingredients and  use of  purification  and detoxification techniques  that  makes  the  formulation  com patible  to  the  body system  for therapeutic action with judicious consumption. Permissible limits of heavy metals are defined in the Ayurvedic Pharmacopoeia and are not applicable to Rasaushadhies.

No observations regarding storage conditions have been recorded by the CCRAS.

The  Government  has  issued  directions  to  the  States  and  Central  Government  Health Scheme (CGHS) to accept supply of Ayurveda, Siddha, Unani And Homoeopathy (ASU&H) medicines  with  batch  wise  quality  analysis  from  an  approved  la boratory/NABL  accredited Laboratory.

Good Manufacturing Practices for Ayurveda, Siddha and Unani (ASU) drugs has been made mandatory for license of ASU drugs to ensure storage conditions should be free fr fungal or bacterial contamination. In - h use qua lity control section is also made mandatory for batch wise testing facility of ASU products.

(e): The Government of India has defined adulterated drugs under section 33 EE(Chapter IV-A) of the Drugs & Cosmetics Act, 1940.

Under  Section  33 -I,  p enalties  have  been  prescribed,  for  manufacture,  sale  etc.  of Ayurvedic,  Siddha  or  Unani  drug  in  contravention  of  the  Act. State  Drug  Licensing Authorities are empowered to take action accordingly.

………

## Annexure

## Details of activities of CCRAS during last three years

## Collaborative Clinical Research

Under the Collaborative Clinical Research, one study on coded Ayurvedic drugs on Improvem in quality of life of Breast cancer patients has been concluded.

## Drug Research Programme

## Medicinal Plant Research

Medico- ethno - botanical  survey  conducted  58  tours  in  selected  areas  of  5  states.  During survey 83 museum samples, 1421.57 Kg raw drug collected and documented 677 folk claims.  4 new medicinal plants int roduced in demonstrative gardens of Institutes. 3 Intra Mural Medicin Plant Research projects have been completed

## Drug Standardization

Under Drug Standardization, 92 singles drugs and 28 compound formulations have been carr out .

## Pharmacological Resea rch

Under this programme, 5 Intra Mural Pharmacological Research Projects have been completed.

## Literary Research Programme

24  books  have  been  published.  Further  3  Intra  Mural  Lterary  Research  projects  have completed.

AYUSH  Research  Portal -A  web  bas ed  portal  for  Research  publication  in A YUSH  is successfully continued and the information being updated periodically. Till date 21839 sc publications have been uploaded.

## Outreach Activities

- Tribal Health Care Research Programme

Under tribal health care research programme, the Council has covered a population o 2,27,546. 450 folk claims/local health traditions (LHTs) have been documented.

- Ayurvedic Mobile Health Care Research Programme under Scheduled Castes Sub Plan (SCSP)

A total 51001 Scheduled Castes population surveyed, 105 villages/colonies covered.

- Swasthya Rakshan Programme

A total of 96 villages/colonies covered for providing medical aids to 24308 patient

- Integration of AYUSH (Ayurveda) with National Programme for Prevention and control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) started in 3 distr Surendra Nagar (Gujarat), Bhilwara (Rajasthan) &Gaya (Bihar).

## Patent and Commercialization

CCRAS  has  developed  an  anti - d abetic  drug  A YUSH - 82  and  the  License  has  been  granted through National Research Development Corporation (NRDC), New Delhi for its commercial production.