Lok Sabha Question No. 256 (STARRED), answered on 2021-03-12
Subject: Quality of Ayurvedic Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Ajay Bhatt

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

## LOK SABHA STARRED QUESTION NO. 256 TO BE ANSWERED ON 12 TH MARCH , 2021

## QUALITY OF AYURVEDIC MEDICINES

## †*256. SHRI AJAY BHA TT:

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

- (a)  whether  the  Government  proposes  to  formulate  guidelines  on  Goo Manufacturing  Practice  (GMP)  and  Good  Laboratory  Practice  (GLP)  for compliance  by  units  manufacturing  Ayurvedic  medicines,  on  the  lines Allopathy;
- (b) if so, the details thereof;
- (c )  the  steps  taken  by  the  Government  to  check  the  use of  heavy  metals other harmful ingredients in Ayurvedic medicines; and
- (d)  the  other  steps  taken  including  the  mechanism  set  up  to  improve efficacy/quality of Ayurvedic medicines?

## ANSWER

THE MINISTER OF STATE(IC) OF THE MINISTRY OF YOUTH AFFAIRS AND SPORTS AND ADDITIONAL CHARGE OF MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

(SHRI KIR EN RIJIJU)

(a) to( d):  A statement i s laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 256 * FOR 12 TH MARCH , 2021

(a) & (b) As per the provisions of Rule 157(1) of Drugs and Cosmetics Rule 1945, the manufacture of Ayurvedic (Including Siddha) or Unani drugs are to carried out in such premises and such hygienic conditions as are specif Schedule - T (Good Manufacturing Practices). It is mandatory for th manufacturers to comply with GMP for obtai ning license of Ayurveda, Siddha and Unani (ASU) drug manufacturing.

There are no separate guidelines of Good Laboratory Practice ( GLP) for Ayurvedic Medicines. However under Rule 160 A to J of Drug & Cosmetics Rules 1945 ,there are provisions for approva l of laboratories for carrying out tests on Ayurvedic drugs and raw materials.

(c) As  per  Drugs  &  Cosmetics  Act  1940  and  Rules  made  thereunder,  it  i mandatory for all Ayurvedic medicines to comply with the standards prescr under  Ayurvedic  Pharmacopeia of  India  (API),  published  by  Ministry  of AYUSH, Government of India from time to time, which includes pharmacopoeial  standards  for  heavy  metals  content,  microbiological  lim aflatoxins etc. and products are tested against the set standards.  Howeve eavy metals  are  in  built  ingredients  of  certain  ASU  drugs  and  mentioned  u Schedule  E - 1  of  the Drugs  &  Cosmetics  Rules,  1945.  For  such  substances , 'Caution: to be taken under medical supervision' is to be conspicuously labeled on the container.

An advis ory has been issued on 14 th October, 2005 by this Ministry which prescribes limit and testing of heavy metals mandatory for export purpos respect of every batch of purely herbal ASU drugs by every licensee.

(d) Ministry of AYUSH has a Central Sector Scheme of Pharmacovigilance of Ayurveda, Siddha Unani & Homeopathy Drugs already functional since June 2018  for  inculcating  the  culture  of  Adverse  Drug  Events  (ADE)  reporti documentation  and  analysis  for  further regulatory  action.  The  Scheme  has  an est ablished  three  tier  network.  All  India  Institute  of  Ayurveda  (AIIA), Delhi , has  been  designated  as  the National  Pharmacovigilance  Coordination Centre (NPvCC), 5 Intermediary Pharmacovigilance Centres (IPvC's) and 74 Peripheral Pharmacovigilance Centre s (PPvC's).

Rule 158B in the Drugs & Cosmetics Act Rules, 1945 ,has mandatory provision relating to safety study and the experience or effectiveness for issuing license to ASU drugs.

evidenc

The Government has established Pharmacopoeia Commission f or Indian Medicine and Homoeopathy under the Ministry of AYUSH. The prime mandate of the Commission is to publish and revise Ayurvedic Pharmacopoeia of In (API),  Siddha  Pharmacopoeia  of  India  (SPI),  Unani  Pharmacopoeia  of  Indi (UPI) and Homoeopathic Ph armacopoeia of India (HPI). The Pharmacopoeial standards are basic need to ensure quality, safety and efficacy of Ayur Siddha, Unani and Homoeopathic medicines.

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