Lok Sabha Question No. 1318 (UNSTARRED), answered on 2024-02-09
Subject: Production and Distribution of AYUSH Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Nishikant  Dubey, Poonamben Hematbhai Maadam, Khagen Murmu, Harish Dwivedi, Kirit Premjibhai Solanki, Pradeep Kumar Singh, Sandhya Ray, Ratansinh Magansinh Rathod, P. C. Mohan, (Dr.) Ram Shankar Katheria

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1318 TO BE ANSWERED ON 09 th  February, 2024

'Production and Distribution of AYUSH Medicines'

## 1318.   DR. NISHIKANT DUBEY:

SHRIMATI POONAMBEN MAADAM:

SHRI KHAGEN MURMU:

SHRI HARISH DWIVEDI:

DR. (PROF.) KIRIT PREMJIBHAI SOLANKI:

SHRI PRADEEP KUMAR SINGH:

SHRIMATI SANDHYA RAY:

SHRI RATANSINH MAGANSINH RATHOD:

SHRI P.C. MOHAN:

DR. RAM SHANKAR KATHERIA:

- (a)  whether  the  Government  has  taken  steps  for  the  qualitative  production  and  distribution  of AYUSH medicines;
- (b) if so, the details thereof;
- (c) whether the Government proposes to widen and deepen the research into AYUSH medicines; and
- (d) if so, the details thereof?

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

- (a)  and  (b)  Yes.  Government  has  taken  following  steps  for  the  qualitative  production  and distribution of AYUSH medicines:
- i. As  prescribed  in  Drugs  and  Cosmetics  Act  1940  and  Rules  1945  made  thereunder, enforcement  of  the  legal  provisions  pertaining  to  Quality  Control  and  issuance  of  drug license of Ayurveda, Siddha, Unani and Homoeopathy drugs, is vested with the State Drug

Controllers/ State Licensing Authorities appointed by the concerned State/ Union Territory Government. Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I) in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathy medicines. It is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units &  medicines  including proof of safety &  effectiveness,  compliance  with  the  Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs and Cosmetics Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

- ii. In  2021,  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  AYUSH  Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The total financial allocation to this scheme is Rs. 122.00 crores for five years. The components of AOGUSY scheme are as follows -
- A.  Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards.
- B.  Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements.
- C.  Strengthening  of  Central  and  State  regulatory  frameworks  including  Technical  Human Resource & Capacity Building programs for Ayush drugs.
- D.  Support for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centres.

Detailed guidelines of this scheme are available at https://ayush.gov.in/images/Schemes/aoushdhi.pdf

- iii. Government  of  India  has  established  Pharmacopoeia  Commission  for  Indian  Medicine  & Homoeopathy  (PCIM&H),  as  its  subordinate  office.  PCIM&H  on  behalf  of  Ministry  of Ayush lays down the formulary specifications and Pharmacopoeial Standards for Ayurveda, Siddha,  Unani  and  Homoeopathy  (ASU&H)  drugs/  medicines,  which  serve  as  official compendia for ascertaining the quality control (identity, purity and strength) of the ASU&H drugs, included herein, as per Drugs & Cosmetics Act, 1940 and Rules 1945, thereunder and compliance  to  these  quality  standards  are  mandatory  for  the  production  of  ASU&H  drug

being manufactured in India. Implementation of these pharmacopoeial standards ensures that the medicines reaching to masses conform to optimum quality standards in terms of identity, purity and strength. So far, 2259 quality standards on raw materials (single drugs of plant/ animal/ Mineral/ metal/ chemical origin) used in ASU&H has been published. Further, 405 quality  standards  and  2666  formulary  specifications  of  Ayurveda,  Siddha,  Unani  (ASU) formulations have also been published in respective pharmacopoeia.

In addition to above, supporting documents in the form of Macro-Microscopic & TLC Atlas on 351 single drugs incorporated in Ayurvedic Pharmacopoeia of India (API) has also  been  published.    PCIM&H  act  as  an  appellate  drug  testing  laboratory  and  receives samples  from  Government  agencies  as  per  Drugs  &  Cosmetics  Act,  1940  &  Rules  there under for ascertaining their quality. PCIM&H on behalf of Ministry of Ayush, also imparts training to the Drug  Regulatory  Authorities,  State  Drug  Testing  Laboratories  (Drug Analysts), etc. on laboratory techniques and methods used to maintain the quality of ASU&H drugs.

- iv. Government has established Indian Medicines Pharmaceutical Corporation Limited (IMPCL) in the year 1978 which is manufacturing and supplying Ayurveda and Unani medicines in the country.
- v. Rule 160 A to J of the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for approval of Drug Testing Laboratory 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. As on date, 34 State Drug Testing Laboratories have been supported for strengthening their infrastructural  and  functional  capacity.    Further,  106  laboratories  are  approved  or  licensed under the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials. Details of the State Drug Testing Laboratories and Private Drug testing laboratories licensed   under the provisions of Drugs and Cosmetics Rules, 1945 are available at https://ayush.gov.in/images/domains/quality\_standards/StateDrugTestingLaboratoryASUHE ng. and https://ayush.gov.in/images/domains/quality\_standards/ListofAyurvedaSiddhaUnani.pdf.
- vi. In  2009, Quality Control of India (QCI), at the behest of the then Department of AYUSH (Now Ministry of Ayush), launched a voluntary certification scheme for Ayush Products

having two levels - AYUSH Standard Mark and AYUSH Premium Mark. Currently there are  5435  products  carrying  AYUSH  Mark.    Details  of  the  schemes  are  available  at https://padd.qci.org.in/voluntary-certification-scheme-for-ayush-products/.

- vii. Central Drugs Standard Control Organization (CDSCO)  issues the Certificate of Pharmaceutical Product (COPP) of Ayurvedic products for export purpose based on joint inspection  by  representatives  from  CDSCO,  Ministry  of  Ayush  and  respective  State Licensing Authority. Details are available at https://cdsco.gov.in/opencms/opencms/en/Aayush/.

(c)  and  (d)  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 Homeopathy (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, Drug Standardization, Pharmacological Research, Clinical Research, Literary  Research  &  Documentation  and  Tribal  Health  Care  Research  Programme.  Research activities  are  carried  out  through  its  peripheral  Institutes/  Units located  across  the  country  and also in collaboration with various Universities, Hospitals and Institutes.

To  widen  and  deepen  the  research  into  Ayush  medicines,  Institute  of  Teaching  and Research in Ayurveda (ITRA), Jamnagar has recently made a MoU with Gujarat Biotechnology Research Center (GBRC), Gandhinagar and IIT, Gandhinagar.

National Institute of Homoeopathy (NIH) has taken initiative to collaborate with National Institute of Pharmaceutical Education & Research (NIPER) at Kolkata and the title of the project is 'Evaluation of Homoeopathic Preparation and its potency as potential therapy for Inflammatory Bowel Disease'.

National  Commission  for  Homoeopathy  is  constituted  on  5 th July  2021  to  standardize homoeopathy education and homoeopathy practice in India. Various steps taken by Homoeopathy  Education Board of National Commission  for Homoeopathy  to promote education, research and innovation are at Annexure-I.

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Steps  taken  by  Homoeopathy  Education  Board  of  National  Commission  for  Homoeopathy  to promote education, research and innovation are as follows -

-  National Commission for Homoeopathy encourages Homoeopathy Medical professionals to adopt latest medical research in their work and contribute to research in Homoeopathy.
-  National Commission for Homoeopathy has notified the Homoeopathy Graduate Degree Course-B.H.M.S  regulation  on  07.12.22  wherein  Research  Methodology  subject  is introduced at undergraduate level to promote young researchers.
-  For each department in Homoeopathy Medical College, methodology for supplementing modern  advancement,  research  and  technology  in  homoeopathy  (SMART-Hom)  is included in regulation.
-  It  has been recommended to have research journals subscription and research library in Homoeopathy  medical  colleges  to  motivate  the  faculty  and  students  for  conducting research.
-  Homoeopathy medical colleges are guided to maintain systematic documentation of cases being treated at attached hospitals for proper analysis and for undertaking future research.
-  Regulation for Research in Homoeopathy Gazette notified on 04.12.2023.
-  Total  03  stakeholders  meet  are  conducted  by  NCH  during  2022-23  wherein  education matter and research were discussed at length.
-  Online training  program  was  conducted  to  encourage  &  enlighten  the  clinical  research methods knowledge of the postgraduate students in view of synopsis and dissertation.
-  Training  conducted  with  participation  of  about  2300  PG  students  and  approx.  600  PG faculties from 60 PG colleges all over India.