Lok Sabha Question No. 108 (UNSTARRED), answered on 2024-02-02
Subject: Traditional Systems of medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Gowdar Mallikarjunappa Siddeshwara

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 108 TO BE ANSWERED ON 02/02/2024

'Traditional Systems of medicines'

## 108. SHRI G.M. SIDDESHWAR:

Will the Minister of AYUSH be pleased to state: (a)  whether  the  advertisements  of  health  products  are  shown  on  television  by resorting to various traditional systems of medicine like Ayurveda, etc.; (b) if  so, whether these products also have any approval from the Drug Controller General of India; (c)  whether it is true that the use of such products lead to health hazard issues as they have a direct effect on the liver/kidneys, since most of the products do not have the certification of benefits and safety for human body and if so, the details thereof; (d) whether the Government is planning to frame rules/laws to ban such products; and (e) if so, the time by which such rules/laws come into force and if not, the reasons

- therefor?

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

- (a) Yes  Sir.  Such  advertisements  are  frequently  noticed  on  television  regarding various traditional systems of medicine.
- (b) Ministry of Ayush does not accord any approval/ permission for manufacturing and  sale  of  Ayurvedic,  Siddha,  or  Unani  medicinal  products.  Further,  as

enforcement of the regulations prescribed in Drugs and Cosmetics Rules, 1945 is vested with the State Licensing Authority.

Provisions regarding manufacture for sale of Ayurvedic (including Siddha) or Unani  drugs  have  been  prescribed  from  Rule  151  to  Rule  169,  of  Drugs  & Cosmetics Rules, 1945 and enforcement of these regulations are vested with the State Licensing Authorities.

Further, as per existing regulatory framework, all advertisements telecast on private  satellite  TV  channels  are  required  to  adhere  to  the  Advertising  Code prescribed  under  the  Cable  Television  Networks  (Regulation)  Act,  1995  and rules framed thereunder. Rule 7(5) of the Advertising Code inter alia provides that  'No  advertisement  shall  contain  references  which  are  likely  to  lead  the public  to  infer  that  the  product  advertised  or  any  of  its  ingredients  has  some special or miraculous or super-natural property or quality, which is difficult of being proved.

- (c) to (e) In India, CDSCO is the National Regulatory Authority (NRA), accordingly, DCG(I)  grants  WHO-GMP/CoPP  Certificate  for  ASU  Drugs.  Additionally, support for development of standards and accreditation/ certification of Ayush products  &  materials  in  collaboration  with  QCI  and  other  relevant  scientific institutions and industrial R&D centres.

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 & Rules thereunder.

Additionally,  pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Sector 'Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana Scheme' (AOGUSY 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.

Appropriate action is also taken by Ministry of Information & Broadcasting (MOIB) against the private TV channels when violation of any provisions of the Advertising Code is found. Ministry also issues advisories from time to time to broadcasters for ensuring compliance to the Advertising Code.

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