Lok Sabha Question No. 4336 (UNSTARRED), answered on 2024-12-20
Subject: Complaints against AYUSH Products
Ministry: AYUSH
Asked by: Dr. Kirsan Namdeo

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4336 TO BE ANSWERED ON 20 th December 2024

## 'Complaints against AYUSH products'

## 4336. Dr. Kirsan Namdeo:

Will the Minister of Ayush be pleased to state:

- (a) the total number of complaints received against misleading claims made about any herbal and AYUSH products through advertisements given in any electronic/print media during the last  three years, year wise;
- (b) whether  any  complaints  have  been  received  against  sale  of  these  herbal  and  AYUSH products in the market without any authentic clinical trial and if so, the details thereof;
- (c) whether the Government has issued any directives to the States  for  appointing  Gazetted Officers  to  monitor  advertisements  of  such  medicines,  in  order  to  check  the  veracity  of AYUSHg products and if so, the details thereof; and
- (d)  the  extent  to  which  the  Government has succeeded in checking these advertisements and misleading claims in the country?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAP RAO JADHAV)

(a)  and  (d)  Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Scheme of Ministry of Ayush are mandated to monitor and report the misleading advertisements to the respective

State Regulatory Authorities. A three tier structure comprising of a National Pharmacovigilance Co-ordination  Centre  (NPvCC),  Five  Intermediary  Pharmacovigilance  Centres  (IPvCs)  and Ninety-nine Peripheral Pharmacovigilance Centres (PPvCs) is established across the country. All  India  Institute  of  Ayurveda  (AIIA),  New  Delhi  under  Ministry  of  Ayush  is  the  National Pharmacovigilance  Co-ordination  Centre  (NPvCC)  for  the  implementation  of  the  National Pharmacovigilance program for Ayurveda, Siddha, Unani & Homoeopathy drugs.

Under  the  pharmacovigilance  program,  objectionable  advertisements  are  regularly reported to the respective State Licensing Authorities for initiating action against the defaulters. Till date approximately 378 brands of Ayush system have been issued the notice for exploiting various regulations.

Under the Pharmacovigilance program till date a total of 42951 misleading advertisements  related  to  Ayush  drugs  has  been  reported,  details  of  last  three  years  are  as below:

| Year                | Misleading Advertisements   |
|---------------------|-----------------------------|
| 2022                | 7367 + 4 (COVID)            |
| 2023                | 7771                        |
| 2024(Till Nov 2024) | 9032                        |
| Total               | 24174                       |

(b)  Ministry  of  Ayush  has  issued  a  clarification  on  the  request  of  State  regulators  and  drug manufacturers about the provisions of Rule 158-B of the Drugs & Cosmetics Rules, 1945 in respect of pilot studies that are required as proof of safety and effectiveness for grant of license to manufacture for sale certain types of Ayureveda, Siddha & Unani (ASU) drugs. The term ''clinical  trial''  as  such  is  not  mentioned  in  the  context  of  ASU  drugs-related  regulatory provisions  under  Drugs  &  Cosmetics  Rules,  1945.  However,  in  accordance  with  the  extant legal provisions, proof of effectiveness in the form of pilot study may be required for issuing license  to  an  intended  ASU  drug,  if  the  textual  rationale,  published  literature  and  textual (authoritative  book-based)  indications  are  not  furnished  to  support  the  claim  of  use  or indication of that drug.

(c) Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances including AYUSH medicines, which appear in the print and electronic media and Government  has taken note thereof. State/UT Governments  are empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements)  Act,  1954  and  Rules  there  under  and  Gazetted  officers  have  been  notified under section (8) of Drugs  & Magic Remedies (Objectionable Advertisements) Act, 1954 to enter, search any premises or examine or seize any record related to the alleged misleading or improper advertisements and initiate action against the cases of default.

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