Lok Sabha Question No. 2119 (UNSTARRED), answered on 2020-09-23
Subject: Monitoring of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Nayab Singh, Ravi Kishan Shukla, Gajendra Singh Patel, Ravindra Kushawaha, John Barla

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

## LOK SABHA UNSTARRED QUESTION NO. 2119 TO BE ANSWERED ON 23 RD SEPTEMBER, 2020

## MONITORING OF AYUSH MEDICINES

## 2119. SHRI NAYAB SINGH:

SHRI RAVI KISHAN:

SHRI GAJENDRA SINGH PATEL:

SHRI RAVINDRA KUSHWAHA:

SHRI JOHN BARLA:

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

- (a)  whether  the  Central  Scheme  started  by  the Government  hasstrengthened  the  safety vigilance monitoring mechanism for AYUSH medicines;
- (b) if so, the details thereof;
- (c) whether the mechanism is ensuring the safety and quality of AYUSH drugs; and
- (d)  if  so,  the  manner  in  which  it  is  assisting  in assessing  and evaluating  these  medicines including identification of the adverse effects of these medicines?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a)& (b): Ministry of AYUSH has implemented a Central Sector Scheme of Pharmacovigilance of Ayurvedic, Siddha, Unani and Homoeopathic (ASU&H) drugs since December, 2017.  Through this scheme, a network of National Pharmacovigilance Centre five Intermediary system - wise PharmacovigilanceCentres and sixty three Peripheral PharmacovigilanceCentr es has been established and made functional since August 2018 to inculcate  the  culture  of  reporting  Adverse  Drug  Events  and  misleading  advertisement ASU&H  drugs  for  regulatory  action.  Eleven  more  Peripheral  Centres  have  recently  be added to the netwo rk. All India Institute of Ayurveda (AIIA), New Delhi is designated as National  Pharmacovigilance  Coordination  Centre  (NPvCC)  with  five  National  AYUSH institutes  as  Intermediary  Pharmacovigilance  Centres  (IPvCs)  and  seventy  four  Perip Pharmacovigi lance  Centres  (PPvCs)  distributed  across  the  country.  Project  Apprai Committee and Project Sanctioning Committee are set up under the scheme to consider proposals related to pharmacovigilance activities and surveillance of misle advertisements. Signal  Detection  Committee  and  Causality  Assessment  Committee  are constituted  under  the  pharmacovigilance  scheme  to  analyze  the  adverse  effects  dat ASU&H  medicines  reported  from  different  centres  and  make  recommendations,  if  any regulatory action is r equired. The pharmacovigilance centres have reported ASU&H drugs related 8203 cases of misleading advertisements and 463 cases of suspected Adverse D Events (186 from Ayurveda drugs, 70 from Siddha drugs, 151 from  Unani drugs and 56 fro Homoeopathic d rugs)   up to August, 2020.
- ( c) &( d): Implementation of the pharmacovigilance scheme has facilitated safety and qu assessment  of  ASU&H  medicines  by  the  Expert  Committees  as  well  as  it  assisted  i identifying and detecting misrepresentation and poss ible adverse effects of these medicines for needed regulatory action by the Central and State authorities.