Lok Sabha Question No. 4741 (UNSTARRED), answered on 2025-03-28
Subject: Fake Ayurvedic Medicines and Unrecognized Practitioners
Ministry: AYUSH
Asked by: Shri Gurmeet Singh Meet Hayer

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4741

## TO BE ANSWERED ON 28 th  MARCH, 2025

## 'Fake Ayurvedic Medicines and Unrecognized Practitioners'

## 4741. Shri Gurmeet Singh Meet Hayer:

Will the Minister of AYUSH be pleased to state:

(a) whether it is true that there is large-scale sale of fake Ayurvedic medicines and the presence of  unrecognized Ayurvedic practitioners and medicine shops across the  country  and if so, the details thereof;

(b) the steps being taken/proposed to be taken by the Government to monitor and regulate the manufacturing, distribution and sale of Ayurvedic medicines to ensure quality and safety;

(c) whether there is any mechanism to verify the credentials of Ayurvedic doctors and medicine shops and if so, the details thereof;

(d) whether the Government has any data or study on ill-effects of fake ayurvedic medicines and if so, the details thereof;

(e)  whether  the  Government  plans  to  introduce  stricter  licensing  norms  and  penalties  for unauthorized practitioners and sellers and if so, the details thereof; and

(f)  the  measures  being  taken  by  the  Government  to  increase  public  awareness  about  the  risks associated with fake Ayurvedic medicines and unqualified practitioners?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH

## (SHRI PRATAPRAO JADHAV)

(a) No such information is available in this Ministry.

(b) The steps being taken/proposed to be taken by the Government to monitor and regulate the manufacturing, distribution and sale of Ayurvedic medicines to ensure quality and safety are as follows:

1. The  Drugs  &  Cosmetics  Act,  1940  and  Drugs  Rules,  1945  have  exclusive  regulatory provisions  for  Ayurvedic,  Siddha,  Unani,  and  Homoeopathy  drugs.  Provisions  relating  to Ayurveda, Siddha and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and in Rules 151 to 169, Schedules E(I), T & TA of the

Drugs  Rules,  1945.  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 of Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

2. As on date, 34 State Drug Testing Laboratories and 106 Private Drug Testing laboratories are approved for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.

(c)  Credentials  of  Ayurvedic  doctors  can  be  verified  through  the  State  Indian  System  of Medicine Council.

(d) and (f) The Pharmacovigilance Program for Ayurvedic, Siddha, Unani and Homoeopathy (ASU  &  H)  Drugs  has  been  implemented  under  Central  Sector  Scheme  Ayush  Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which work through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance  Centers  (IPvCs)  and  99  Peripheral  Pharmacovigilance  Centers  (PPvCs) established  across  the  country.  The  program  is  regularly  reporting  Suspected  Adverse  Drug Reactions for ASU &H drugs. The scheme mainly focuses on augmenting quality of Ayush drugs. The Pharmacovigilance Program contributes towards developing awareness on safe use of Ayush drugs and informs about the risks associated with the use of fake medicines.

Ministry of Ayush has issued a public notice on 08.10.2024, informing the general public about the facts regarding ASU&H drugs/medicines and urging them to avoid patronizing misleading advertisements, which was published in 100 leading newspapers across India in Hindi, English, and several regional languages.

(e ) Ministry of Ayush vide gazette notification issued on 21.09.2020 under the provision of NCISM  Act  2020  has  established  National  Commission  for  Indian  System  of  Medicine (NCISM) to improve the quality of Ayurveda education. Specific penalties for the practitioners have been defined in the NCISM Act (2020), which is mentioned under the Section 34 of the Act.

*****