Lok Sabha Question No. 976 (UNSTARRED), answered on 2022-07-22
Subject: Permission from Drug Controller of India
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: K. Muraleedharan

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.976 TO BE ANSWERED ON 22 ND  JULY, 2022

## 'PERMISSION FROM DRUG CONTROLLER OF INDIA'

## 976. SHRI K. MURALEEDHARAN:

Will the Minister of AYUSH be pleased to state:

- (a) whether  the  Government  of  India  has  mandated  that  the  manufacturers  of  Ayurvedic medicines  should  seek  permission  from  Drugs  Controller  of  India  before  placing  any advertisements and that there should be a designated monitoring cell involving officials for the purpose: and
- (b) if so, the details thereof ?

## ANSWER THE MINISTER OF AYUSH (SHRI SARBANANDA SONOWAL)

(a) & (b) Sir, as prescribed in Drugs and Cosmetics Act 1940 and Rules 1945 made thereunder, enforcement of the legal provisions pertaining to regulation and Quality  Control of Ayurveda, Siddha, and Unani drugs, is vested with the State drug Controllers/ State Licensing Authorities appointed by the concerned State Government/ Union Territory.

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.  Central Government has notified insertion of Rule 170 in the Drugs & Cosmetics Rules, 1945 on 24 th December, 2018 specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines.

State/UT  Governments  are  empowered  to  enforce  the  provisions  of  Drugs  &  Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under and Rule 170 of the Drugs &  Cosmetics Rules, 1945 pertaining to control and prohibition of misleading advertisements and exaggerated claims of drugs. Accordingly, directives have been issued to the States/UTs for appointing Officers 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.

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), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) is established. 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.  Objectionable advertisements are being reported to the respective State Licensing Authorities by PPvC at regular intervals.

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