Lok Sabha Question No. 3677 (UNSTARRED), answered on 2018-03-16
Subject: Effectiveness of AYUSH Drugs
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: ANTO  ANTONY

## GOVERNMENT OF INDIA MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)

LOK  SABHA UNSTARRED  QUESTION NO. 3677 TO BE ANSWERED ON 16 TH MARCH, 2018

## EFFECTIVENESS OF AYU SH DRUGS

## 3677. SHRI ANTO ANTONY:

Will  the  Minister of AYURVEDA,  YOGA  AND  NATUROPATHY,  UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

- (a) whether it is a fact that the Government has received a number of queries under the Ri Information (RTI) Act and complaints also regarding effectiveness of AYUSH drugs such IME - 9;
- (b) if so, the details thereof, and the response of the Government there to; and
- (c)  the  steps  being  taken  by  the  Government  to  ensure  foolproof  clinical  trials  of medicines?

## ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY

## (SHRI SHRIPAD YESSO NAIK)

(a) &( b):      Yes ,the Government has received queries under the Right to Information (RTI) public complaints and grievances regarding effectiveness claims of AYUSH drugs including - 9. Such issues have been brought up to the notice of Ministry of AYUSH directly by t he consumers including public representatives and after registered in the GAMA (Grievances against M Advertisements) portal maintained by the Department of Consumer Affairs and monitored b Advertising  Standards  Council  of  India.  Since  enforce ment  of  the  legal  provisions  of  licensing quality  control  and  advertisements  of  Ayurvedic,  Siddha,  Unani  and  Homeopathic  (ASU medicines  is  vested  with  the  State  Governments,    the  Central  Government  in  the  Mini AYUSH has been providing relevant i nformation/clarification to the applicants or complainants forwarding the alleged matters to the concerned State Licensing Authorities for appropr under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder and Drugs and R emedies (Objectionable Advertisements), Act, 1954.  In order to address quality issues o medicines, it is mandatory for the manufacturers to comply with the Good Manufacturing P and  quality  standards  prescribed  in  the  respective  pharmacopoei a  including  permissible  limits  of heavy metals, pesticide residue, afla - toxins and microbial load.

Contd……….

(c):     The extant Rule 158 - B  of  the  Drugs  &  Cosmetics  Rules,  1945  prescribes  the  regulato requirement of submission of proof of safety a nd effectiveness inter alia based on pilot studies licensing of various categories of ASU medicines.  Enforcement of these provisions is purview of the Licensing Authorities appointed by the State Governments. Ministry of AYUSH has published 'Good Clinical Practice Guidelines for conduct of clinical trials in Ayurveda, Siddha and Unani  Medicine.  These  guidelines  are  for  voluntary  use  and  encompass  the  design,  c termination, audit, analysis, reporting and documentation of the systematic studies involving human subjects for determining the safety and efficacy of Ayurvedic, Siddha and Unani (ASU) m and to ensure that the studies are scientifically and ethically sound and the clinical p ASU medicines under investigati on are properly documented.

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