Lok Sabha Question No. 4735 (UNSTARRED), answered on 2025-03-28
Subject: AYUSH Medicines
Ministry: AYUSH
Asked by: Adv. Chandra Shekhar

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.4735 TO BE ANSWERED ON 28 th  March 2025

## 'AYUSH Medicines'

## 4735. Adv. Chandra Shekhar:

Will the Minister of Ayush be pleased to state: (a)  whether the  Government is aware of the high metal content in AYUSH medicines that have been highlighted, posing serious health risks to consumers and if so, the details thereof; (b)  the  current  actions  the  Government  have  undertaken  to  the  enhance  quality  control measures and ensure compliance with safety standards; and (c) the manner in which the Government plan to implement post-marketing surveillance and harmonize  AYUSH  medicine  standards  with  international  norms  to  protect  public  health effectively?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAOJADHAV)

(a) and (b) As per the information received from various States/UTs, no instances of high metal content in Ayush medicines have been reported. Further the Ministry of Ayush has taken following initiatives to enhance the quality control measures and ensure compliance with safety standards;

1. As  prescribed  in  Drugs  and  Cosmetics  Act,  1940  and  Rules  made  thereunder, enforcement of the legal  provisions  pertaining  to  Quality  Control  and  issuance  of drug license of Ayurveda, Siddha, Unani and Homoeopathy 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 Rules, 1945 provides the  regulatory  guidelines  for  issue  of  license  to  manufacture  Ayurvedic,  Siddha, Unani  medicines  and  Rule  85  (A  to  I)  in  the  Drugs  Rules,  1945  provides  the regulatory guidelines for issue of license to manufacture Homoeopathy medicines. It

is  mandatory  for  the  manufacturers  to  adhere  to  the  prescribed  requirements  for licensing of manufacturing units &  medicines including proof of safety  & effectiveness,  compliance  with  the  Good  Manufacturing  Practices  (GMP)  as  per Schedule T & Schedule M-I for Ayurveda, Siddha, Unani drugs and Homoeopathy drugs respectively of the Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

2. Drug  Inspectors  collect  medicine  samples  regularly  from  manufacturing  firms  or sale  shops  with  in  their  jurisdiction  and  sent  it  to  Drug  Testing  Laboratory  under Drug Control department for quality testing and if any sample found to be Not of Standard  Quality,  appropriate  action  initiates  such  as  preventing  the  sale  of  the products from the market and appropriate legal actions as per Drugs and Cosmetics Act 1940 and Rules made thereunder.

(c)  Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H) Drugs  set  up  in  different  parts  of  the  country  under  the  Central  Sector  Scheme  -Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana(AOGUSY) are mandated to report adverse  drug  reaction  through  a  three-tier  network  of  a  National  Pharmacovigilance  Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs) and 99 Peripheral Pharmacovigilance Centres (PPvCs).

The quality parameters included in the Pharmacopoeias and Formularies of Ayurveda, Siddha, Unani & Homoeopathic (ASU&H) drugs prescribing mandatory regulatory standards have been identified to align the parameters prescribed by WHO/other major pharmacopoeias prevalent worldwide.

The Central Drugs Standard Control Organization (CDSCO) provides Certification of Pharmaceutical Product (COPP) as per World Health Organization (WHO) guidelines, which is extended to Ayurveda, Siddha and Unani (ASU) medicines.

The Central Sector Scheme- Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana(AOGUSY),  under  the  component  of  Strengthening  and  up-gradation  of  Ayush Pharmacies  and  Drug  Testing  Laboratories  to  achieve  higher  standards  supports  Ayurveda, Siddha,  Unani  and  Homoeopathy(ASU&H)  Pharmacies  for  upgrading  to  World  Health Organisation(WHO)- Good Manufacturing Practices(GMP) standards.

*****