Lok Sabha Question No. 900 (UNSTARRED), answered on 2021-07-23
Subject: Immunity Booster
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: K. Muraleedharan, Faizal P.P. Mohammed, Amar Singh, Gaurav Gogoi, Kumbakudi Sudhakaran, Adoor Prakash

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

## LOK SABHA UNSTARRED  QUESTION NO. 900 TO BE ANSWERED ON 23 RD JULY , 2021 IMMUNITY BOOSTER

## 900. SHRI K. MURALEEDHARAN:

SHRI MOHAMMED FAIZAL P.P.:

DR. AMAR SINGH:

SHRI GAURAV GOGOI:

SHRI KUMBAKUDI SUDHAKARAN:

ADV. ADOOR PRAKASH:

Will the Minister of AYUSH be pleased to state:

- (a) whether the Government has upgraded the license for Patanjali Ayurved's Coronil from an 'immunity booster' to a 'supporting measure' in treating COVID - 19;
- (b) if so, the details thereof alongwith the data/ studies based on which such an upgrade was approvedand the limitations of such data/studies, if any;
- (c) the details of the decision - making process in granting such approval;
- (d) the laws/rules/policies/guidelines under which such approval was granted; and
- (e)  the  definitions  of  'immunity  booster'  and 'supporting  measure'  under  the  applicable laws/rules/ policies/guidelines, and the procedure and conditions subject to which such license is granted?

## ANSWER

## THE MINISTER OF STATE OF THE MINISTRY OF AYURVEDA, YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (DR. MUNJPARA MAHEND RABHAI)

- (a)to (c) : Application titled, 'updating theAYUSH license forDivya Coroniltablet from 'Immunity booster' to 'Medicine for COVID -19'' submitted by Patanjali Research Foundation Trust, Haridwar, Uttarakhand to this Ministry, was placed before the Interdisciplinary Technical Review Comm ittee (ITRC) setup by Ministry ofAYUSH on 28.10.2020 for examination of the applications/claims on patent & propriety (P&P) ASU&H medicineswith new indications or repurposing of licensed P&P, ASU&H medicines for COVID- 19. ITRC reviewed the study and itwas suggested  that  it  may  be  used  as  supporting  measure  in  COVID.  The  State  Licensi Authority  was  also  informed  that Coronil tablet  may  be  used  as  supporting  measure in the management of COVID-19 without claiming cure.
- (d) & (e): The regulatory provisio n  for granting license and approval of Ayurvedic, Siddha, Unani and Homoeopathy drugs are prescribed under Drugs and Cosmetics Act,1940 and  Rules  1945.  Section  3(a)  and  Section  3(h)  defines  all  Ayurvedic,  Siddha,  Unani medicines intended for internal or e xternal use for or in the diagnosis, treatment, mitigation or  prevention  of  diseases  or  disorder  in  human  beings  or  animals, and manufactured exclusively  in  accordance  with  the  formulae  described  in, the authoritative  books  of Ayurvedic, Siddha and Unani T ibb systems of medicine, specified in the First Schedule.

The State Licensing Authority Uttarakhand has granted license of drug 'Coronil' after  examination  of  the  application  submitted  by  the  applicant.  The StateLicensing Authority Ayurveda government of Uttarakhand was informed that 'Coronil' Tablet may be used as supporting measure in the management of COVID - 19 withoutclaming cure.

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