Lok Sabha Question No. 1099 (UNSTARRED), answered on 2020-09-18
Subject: Illegal Immunity Drugs and Medicinal Formulas for COVID-19
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Asaduddin Owaisi, Imtiaz Jaleel Syed

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

## LOK SABHA UNSTARRED QUESTION NO. 1099 TO BE ANSWERED ON 18 th SEPTEMBER, 2020

## ILLEGAL IMMUNITY DRU GS AND MEDICINAL FOR MULAS FOR COVID - 19

## 1099. SHRI ASADUDDIN OWAISI: SHRI SYED IMTIAZ JALEEL:

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

- (a)  whether  it  is  a  fact  that  there  is  a  flood  of immunity  drugs/medicinal  formulas  after COVID - 19 cases across the country, if so, the details thereof;
- (b) whether these drugs and medicinal formulae are being sold without due approval of the Ministry, if so, the reasons therefor;
- (c) whether it is a fact that many people have been adversely affected due to consumption of immunitydrugs, if so, the details thereof; and
- (d) the further steps taken by the Government including the various corrective measures to check the sale/procurement and consumption of the said immunity drugs?

## ANSWER

## THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a): Yes, a number of medicinal products for immunity and health promotion have come in the market after Ministry of AYUSH issued public advisories of Ayush - based healthcare during COVID- 19 ou tbreak and promulgated a generic formulation called Ayush Kwath/Ayush Kudineer/Ayush Joshanda comprising of Tulsi (Ocimum sanctum) leaves: 4 parts,  Dalchini (Cinnamomum zeylanicum) stem bark: 2 parts, Sunthi ( Zingiber offici rhizome: 2 parts and Krishna Marich (Piper nigrum) fruits:1 part.  State Licensing Authorit have started granting license or approval for commercial manufacturing of such formula under the provisions of Drugs and Cosmetics Rules, 1945 as applicable to Ayurvedic, Si a and Unani (ASU) drugs.
- (b): As  per  the  provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rules  there  under approval of Ministry of AYUSH is not required to manufacture for sale of Ayurvedic, Si and Unani drugs and such medicinal formulations. Powers of regulation and quality control of  these  drugs  and  formulations  are  vested  with  the  State  Governments,  for  which Licensing Authorities/Drug Controllers are appointed.

( c) &( d) : Instances of adverse effects due to consumption of above - mentioned i mmunity boosting  drugs  are  not  reported  from  the  States/UTs.  But, the  incidences  of  COVID - 19 related exaggerated claims and misleading advertisements of ASU drugs have been repor by Pharmacovigilance centres and forwarded to  the concerned State Licensi ng Authorities / Drug Controllers and individual advertisers/manufacturers for corrective action. Mini AYUSH has received 154 misleading advertisements related to Ayush claims for COVID 19 from different parts of the country till August 2020. In thi s regard, Ministry of AYUSH has issued directives to the State/UT authorities to initiate necessary action against the and alleged manufacturers/ advertisers acting in contravention of the provisions of Dr Cosmetics Act, 1940 & Rules ther e under and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules there under and to send the details of the clinica of Ayush medicines claimed for the prevention or treatment of Covid 19 for verifica Ministry of  AYUSH h as also issued public advisories and guidelines for the practitio about the use of Ayush remedies to meet the challenge of Covid - 19 , details are available in the Ministry's website www.ayush.gov.in