Lok Sabha Question No. 1086 (UNSTARRED), answered on 2025-07-25
Subject: Production and Distribution of AYUSH Medicines
Ministry: AYUSH
Asked by: Shri Biplab Kumar Deb

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1086 TO BE ANSWERED ON 25 TH  JULY, 2025

' Production and Distribution of AYUSH Medicines '

## 1086. Shri Biplab Kumar Deb:

Will the Minister of Ayush be pleased to state:

- (a) the  steps  taken  by  the  Government  for  the  qualitative  production  and  distribution  of AYUSH medicines; and
- (b) the  steps  proposed  to  be  taken  by  the  Government  for  broader  and  deep  research  in AYUSH medicines?

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH

## A NSWER (SHRI PRATAPRAO JADHAV)

(a) The  Government  has  taken  following  steps  for  the  qualitative  production  of  Ayush medicines:

1. The Drugs and Cosmetics Act, 1940 & rules made thereunder have exclusive regulatory provisions  regarding  manufacture  for  sale  or  for  distribution  of  Ayurvedic,  Siddha,  SowaRigpa, Unani, and Homoeopathy drugs.

2. Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval of  Drug  Testing  Laboratories  for  carrying  out  such  tests  of  identity,  purity,  quality  and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs.

3. Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) on behalf of Ministry of Ayush lays down the Formulary specifications and Pharmacopoeial Standards for Ayurveda, Siddha, Unani and Homoeopathic drugs, which serves as an official compendia for ascertaining the Quality Control (identity, purity and strength) of Ayush drugs, as per the Drugs  &  Cosmetics  Act,  1940  &  rules  made  thereunder.  Compliance  to  these  quality standards are mandatory for Ayush drugs being manufactured in India.

4. Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathic drugs set up in different parts of the country under the Central Sector Scheme of Ministry of Ayush are mandated to report adverse drug reactions to the respective State Regulatory Authorities.

5. Central Sector Scheme, Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented for the year 2021-2026. One of the components of this Scheme is to strengthen and up-grade Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.

6.  An  Ayush vertical  has  been  created  in  Central  Drugs  Standard  Control  Organization (CDSCO)  to  strengthen  regulatory  measures  ensuring  safety  and  quality  of  Ayush  drugs. Further, CDSCO issues WHO Certificate of Pharmaceutical Product (WHO-CoPP) to Ayush drugs having compliance to such standards.

(b) The Ministry of Ayush is implementing the Central Sector Scheme namely AYURGYAN Scheme  from  FY  2021-22.  The  Scheme  has  03  components  viz.  (i)  Capacity  Building  & Continuing Medical Education (CME) in Ayush (ii) Research &  Innovation in Ayush and (iii) Ayurveda Biology Integrated Health Research added under the scheme from FY 202324. Under the Research & Innovation in Ayush component, financial assistance is provided to the eligible Organizations/Institutions across the county as per the provision contained in the scheme  guidelines  to  support  clinical,  fundamental,  pharmaceutical,  literary  and  medicinal plant research in Extra Mural mode.

Government  of  India  has  established  Central  Council  for  Research  in  Ayurvedic Sciences  (CCRAS),  Central  Council  for  Research  in  Unani  Medicine  (CCRUM),  Central Council  for  Research  in  Homoeopathy  (CCRH),  Central  Council  for  Research  in  Siddha (CCRS)  and  Central  Council  for  Research  in  Yoga  &  Naturopathy  (CCRYN)  under  the Ministry of Ayush  as apex organizations for undertaking, coordinating, formulating, developing  and  promoting  research  in  Ayush  system  on  scientific  lines.  Core  research activities comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey), Pharmacognosy and in-vitro propagation techniques, Drug Standardization, Pharmacological Research,  Clinical  Research,  Literary  Research  and  Documentation  and  Tribal  Health  Care Research Programme.

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