Lok Sabha Question No. 159 (STARRED), answered on 2022-12-16
Subject: Promotion of AYUSH Products
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Ramya  Haridas

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

## LOK SABHA STARRED QUESTION NO. 159 TO BE ANSWERED ON THE 16 TH  DECEMBER, 2022

## PROMOTION OF AYUSH PRODUCTS

## *159. MS. RAMYA HARIDAS:

Will the Minister of AYUSH be pleased to state:

- (a)  whether  the  Ministry  proposes  to  promote  better  quality  AYUSH  products  on  a larger scale for maximum benefit of the consumers;
- (b) if so, the challenges being faced by the Ministry in promoting such products for their wider use by the consumers;
- (c) whether any cases of malpractice in manufacturing of different AYUSH medicines have been detected; and
- (d) if so, the preventive measures taken in this regard?

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

(SHRI SARBANANDA SONOWAL)

- (a) to (d) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 159* FOR 16 TH  DECEMBER, 2022

(a) to (d) Yes Madam, Ministry of Ayush has taken following steps to promote better quality AYUSH products in the country:

i.  Schemes  to  support  Ayurvedic  medicines  production:  Under  National  Ayush Mission  (NAM)  from  2014-2021,  apart  from  other  services  Grant-in-aid  were  also provided  for  Strengthening  of  State  Government  ASU&H  Pharmacies.  At  present, Central Sector Scheme for Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented for the year 2021-2026. The components of the AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) Scheme are as under;

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.

ii. Ministry of Ayush has setup Pharmacopoeia Commission for Indian Medicines and Homoeopathy  (PCIM&H),  as  a  subordinate  office  under  Ministry  of  Ayush  to  lay down Pharmacopoeial Standards and Formulary specifications for Ayurveda, Siddha, Unani  &  Homoeopathy  (ASU&H)  drugs,  which  serve  as  official  compendia  for ascertaining the identity, purity and strength of the drugs included therein.

iii.  In  addition  to  the  above,  for  facilitating  exports,  Ministry  of  Ayush  encourages following certifications of AYUSH products as per details below:-

-  Certification  of  Pharmaceutical  Products  (CoPP)  as  per  WHO  Guidelines  for herbal products.
-  Quality  Certifications  Scheme  implemented  by  the  Quality  Council  of  India (QCI)  for  grant  of  AYUSH  Premium  mark  to  Ayurvedic,  Siddha  and  Unani products on the basis of third party evaluation of quality in accordance with the status of compliance to international standards.

iv.  27  State  Drug  Testing  Laboratories  have  been  supported  for  strengthening  their infrastructural  and  functional  capacity.    As  on  date  81  laboratories  are  approved  or licensed under Rule -160 A to J of the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.

v.  Pharmacovigilance  Centres  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy (ASU&H) Drugs set up in different parts of the country under the Central Scheme of Ministry of Ayush are mandated to monitor and report the misleading advertisements to the respective State Regulatory Authorities. A three tier structure comprising of a National Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs)  is  established.  All  India  Institute  of  Ayurveda  (AIIA),  New  Delhi  under Ministry of Ayush is the National Pharmacovigilance Co-ordination Centre (NPvCC) for  the  implementation  of  the  National  Pharmacovigilance  program  for  Ayurveda, Siddha,  Unani  &  Homoeopathy  drugs.    Objectionable  advertisements  are  being reported to the respective State Licensing Authorities by PPvC at regular intervals.

v.  Ministry  of  Ayush  has  organized  a  three  day  Global  Ayush  Investment  and Innovation Summit (GAIIS) from 20 -22 April, 2022 at Mahatma Mandir, Gandhinagar, Gujarat. The Global Ayush investment and Innovation Summit, 2022 was a distinctive effort by the Government of India to attract the world's attention to India's  ancient  wisdom  and  traditional  knowledge,  and  capitalize  on  it  to  pave  the way  for  a  sustainable  future.  The  Summit  was  organized  in  line  with  Sustainable Development Goal Number 3 of promoting 'Good Health and Well-being.' A total of five  plenary  sessions,  eight  roundtables,  six  workshops,  and  two  symposiums  were organized and 90 eminent speakers and 100 exhibitors participated during GAIIS.

vii.  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  for  Promotion  of Information, Education and Communication (IEC) in AYUSH  to take up initiatives for propagation and promotion of Ayush systems of medicines. The objectives of this scheme are as follows -

-  Pursue  activities  in  the  areas  of  Information,  Education  and  Communication  to fulfill the mandate of 'propagation' of AYUSH' Systems of Healthcare, assigned to the Ministry in the Government of India (Allocation of Business) Rules 1961. Creation  of  awareness  amongst  the  citizens  about  the  efficacy  of  the  Ayush systems, their cost effectiveness and the availability of ASU&H drugs services and other  solutions.  Utilizing  various  communication  channels  for  this  purpose,  and produce  IEC  material  including  digital  and  audio-video  publicity  material  to achieve the objective of health for all;
-  Dissemination  of  information  on  proven  results  of  Research  and  Development work  conducted  in  Ayush  Systems  at  National/  State  level  through Fairs, Exhibitions, Seminars, Workshops, Symposiums  and educational platforms. Planning and organizing the observation of important Days;
-  Providing  information  and  communication  forums  where  horizontal  and  vertical interaction among stakeholders of Ayush Systems can take place through digital events,  conferences,  seminars  and  fairs/  melas  at  State  and  National  levels  and encourage stakeholders to participate in them.
-  Organising  events  for  the  propagation  and  promotion  of  Ayush  Systems,  like Seminars, Conferences, Symposiums and Workshops (including in digital mode) on AYUSH Systems and providing information to shareholders relating to recent development in AYUSH sector.

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  Homoeopathic  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  Homoeopathic  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.

As per the information received from various States/ UTs, cases of malpractice detected in manufacturing of different AYUSH medicines are as follows -

|   S.no. | Name of the State/UTs   | No. cases of malpractice detected in manufacturing of different AYUSH medicines and preventive measures taken                       |
|---------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
|       1 | Andhra Pradesh          | 04 license cancelled &Unit seized , 03 license suspended and 01 case filed in Court of law and convicted                            |
|       2 | Assam                   | 52 drug samples were found were non-compliant to Drugs and Cosmetics Act, 1940 from 2020 to 2021                                    |
|       3 | Chhattisgarh            | NIL                                                                                                                                 |
|       4 | Gujarat                 | 02 product permission has been cancelled, 01 court case launched and 03 Ayush products are under investigation during 2019 to 2022. |

|   5. | Karnataka      | NIL                                                                                                                                                                 |
|------|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|    6 | Kerala         | 113 samples of Ayurvedic medicines were found as Not of Standard Quality (NSQ)                                                                                      |
|    7 | Manipur        | NIL                                                                                                                                                                 |
|    8 | Mizoram        | 04 drugs (02 Ayurvedic) drugs were found to be non-compliant to Drugs and Cosmetics Act, 1940.                                                                      |
|    9 | Maharashtra    | 21 samples of Ayurvedic medicines were found as Not of Standard Quality (NSQ) during 01.04.2021 to 31.10.2022.                                                      |
|   10 | Nagaland       | NIL                                                                                                                                                                 |
|   11 | Odisha         | NIL                                                                                                                                                                 |
|   12 | Punjab         | NIL                                                                                                                                                                 |
|   13 | Rajasthan      | License of 02 firms suspended for one year, 02 license of the sub-standard drug was cancelled and license of 09 sub-standard medicines was suspended for 06 months. |
|   14 | Sikkim         | NIL                                                                                                                                                                 |
|   15 | Tamil Nadu     | 01 Ayush product has been suspended for one month                                                                                                                   |
|   16 | Uttar Pradesh  | NIL                                                                                                                                                                 |
|   17 | Madhya Pradesh | NIL                                                                                                                                                                 |
|   18 | Uttarakhand    | NIL                                                                                                                                                                 |
|   19 | Delhi          | 01 manufacturing license has been suspended and orders has been issued to 02 manufacturers to stop manufacture and distribution                                     |
|   20 | Lakshadweep    | NIL                                                                                                                                                                 |
|   21 | Puducherry     | NIL                                                                                                                                                                 |
|   22 | Chandigarh     | NIL                                                                                                                                                                 |

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