Lok Sabha Question No. 4866 (UNSTARRED), answered on 2022-04-01
Subject: Safety and Quality of Ayurveda, Unani and Homeopathy Medicines
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Bheemrao Baswanthrao Patil, Jayant Sinha

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 4866 TO BE ANSWERED ON 1 st  April, 2022

## SAFETY AND QUALITY OF AYURVEDA, UNANI AND HOMEOPATHY MEDICINES

## 4866. SHRI B.B.PATIL: SHRI JAYANT SINHA:

Will the Minister of AYUSH be pleased to state:

- (a) the efforts being made by the Government to win the trust of the global community about the safety and quality of Ayurveda, Unani and Homeopathy medicines;
- (b) the roadmap prepared/being prepared by the Government to increase the productivity of Ayurveda and other Indian medicinal products and herbs across all States in the country;
- (c)  the  details  of  the  productivity  (high  and  low)  of  the  said  medicines,  State/UT-wise including Telangana;
- (d) whether any action was taken in 2021-22 against misleading advertisements for treatment and drugs under AYUSH and if so, the details thereof;
- (e)  the  number  of  registered  manufacturing  units  of  AYUSH  drugs,  State-wise,  and  yearwise; and
- (f) whether any subsidies or incentives are being given for manufacturing AYUSH drugs and if so, the details thereof?

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

- (a) To assure safety and quality of Ayurveda, Siddha, Unani and Homeopathy medicines, the manufacturing of these medicines has been brought under the scope of Drugs and Cosmetics Act,  1940  and  rules  made  thereunder.  As  per  the  provisions  of  the  Drugs  rules,  1945, manufacturing  license  is  granted  by  the  concerned  State  Licensing  Authority  only  after ensuring  that  the  requirements  specified  under  Schedule  T  for  Ayurveda,  Siddha,  Unani medicines and Schedule M1 for Homoeopathy medicines.

The Ministry of Ayush has also implemented a Central Sector Scheme of Pharmacovigilance of Ayurveda, Siddha Unani& Homeopathy drugs since June 2018 for inculcating the culture of Adverse Drug Events (ADE) reporting, documentation and analysis for further regulatory action.  The  Scheme  has  an  established  three  tier  network.  All  India  Institute  of  Ayurveda (AIIA),  New  Delhi  has  been  designated  as  the  National  Pharmacovigilance  Coordination Centre (NPvCC). At present, there are 5 Intermediary Pharmacovigilance Centres (IPvC's) and 74 Peripheral Pharmacovigilance Centres (PPvC's).

International standards for AYUSH products are governed by WHO-GMP, EU-GMP or any other  standards  that  are  laid  down  by  the  importing  countries  and  to  comply  with  other requirements  of  importing  countries.  The  WHO  certification  scheme,  which  is  a scheme of Certificate of Pharmaceutical Product (COPP) is issued by National Regulatory Authority (NRA) for the purpose of international commerce i.e. for registration of products in foreign countries.  Central  Drugs  Standard  Control  Organisation  (CDSCO)  issues  Certification  of Pharmaceutical Product (COPP) to Ayurvedic, Siddha or Unani products after examination of such applications in consultation with the Ministry of Ayush.

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

(i)  Certification  of  Pharmaceutical  Products  (CoPP)  as  per  WHO  Guidelines  for herbal products.

(ii) 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.

Further,  on  25 th March,  2022  a  Host  Country  agreement  has  been  signed  between  the Government of India and the World Health Organization (WHO) at Geneva for establishment of the WHO Global Centre for Traditional Medicine (WHO GCTM) in Jamnagar, Gujarat. This  would  be  the  first  and  only  global  outposted  Centre  (office)  for  traditional  medicine across the globe. It shows the support offered by Government of India to this cause and its recognition globally.

- (b) Ayush  Ministry  has  taken  various  steps  to  increase  the  productivity  of  Ayurveda  and other Indian medicinal products and herbs at different levels:

i.  Ease  out  licensing  process:  This  Ministry  has  issued  Gazette  notification  no.  GSR 716 E for Amendment in the Drugs Rules, 1945 related to licensing process of ASU drugs  on  1.10.2021.  The  amendments  have  been  done  with  a  view  to  reduce  the compliance burden and facilitate ease of doing business. The process to grant license to manufacture  Ayurveda,  Siddha  and  Unani  (ASU)  drugs  swift,  paperless  and  more transparent the license application system has been made online through eaushadhi.gov.in  portal.  The  license  of  the  ASU  drugs  have  been  made  perpetual  i.e. with one time registration fee the license of the product will be valid lifetime with no further retention or renewal fees thereafter.The maximum time in granting the license to manufacture ASU drugs has been reduced from three months to two months.

## ii. Promotion of Ayush products for Covid-19:

-  In the wake of COVID-19 outbreak, the Ministry of Ayush has issued direction to  All  State  Government/UT's  to  give  permission  for  issue  of  license  to  the Ayurvedic  drug  manufactures  to  manufacture  and  sell  in  Generic  name  as 'AyushKwath' in accordance with the provisions of Drugs and Cosmetics Rules 1945.
-  The medicines which emerged out to be useful and mentioned in the National Guidelines issued by the Ministry of Ayush, are being manufactured by most of the Ayurvedic drugs manufacturers.
-  Research and Transfer of technology: During the second wave of this pandemic, the  scientists  of  reputed  research  institutions  of  the  country  have  found  that AYUSH 64,  a  poly  herbal  formulation  developed  by  the  Central  Council  for Research  in Ayurvedic  Sciences  (CCRAS)  is  useful  in  the  treatment of asymptomatic, mild and moderate COVID-19 infection as an adjunct to standard care.  In  order  to  provide  maximum  benefit  of  Ayush  systems  of  medicine,  a Nation-wide  campaign  for  distribution  of  AYUSH-64  and  KabasuraKudineer (Siddha  Medicine)  was  taken  up  across  the  country.  CCRAS  has  transferred AYUSH-64 manufacturing technology through National Research Development Corporation (NRDC) to 46 manufacturing units for manufacturing of AYUSH64.
-  During COVID-19/Omicron surge the Ministry promoted the use of Ayuraksha Kit, BalRaksha Kit and Ayur care Kit for the health promotion of the masses. In

this regard all the State licensing authorities were informed that requirement of separate  Licence  for  making  kits  with  the  specified  components  of  Ayuraksha Kit, BalRaksha Kit and Ayur care Kit for the manufacturers having valid license of the individual component of the kit is not required.

iii.  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.  Also,  under  medicinal  plants component  of  NAM,  financial  assistance  has  been  provided  in  the  form  of  subsidy  to encourage  the  farmers  for  cultivation  of  medicinal  plants  throughout  the  country.  At present, Central Sector Scheme for AyushOushadhiGunavattaevamUttpadanSamvardhanYojana (AOGUSY ) has been implemented for the year 2021-2026. One of the components of the scheme is Strengthening and up-gradation of Ayush Pharmacies to achieve higher standards.

iv.  In  order  to  provide  a  platform  for  trade  of  Medicinal  Plants  &  to  provide  easy  market access,  National  Medicinal  Plants  Board  (NMPB),  Ministry  of  Ayush  has  launched  'eCHARAK' mobile application  as  well  as  web  portal  for  the  promotion  and  marketing  of medicinal plants/herbs. 'e-CHARAK' is a platform to enable information exchange between various  stakeholders  mainly  farmers  involved  in  the  medicinal  plants  sector  across  the country.  The  'e-CHARAK'  application  supports  different  local  languages  and  it  also provides  fortnightly  market  price  of  100  Medicinal  Plants  from  25  herbal  markets  across India.

- (c)  State-wise  details  of  the  productivity  (high  and  low)  of  the  said  medicines  is  not maintained by the Ministry of Ayush.
- (d)  The  Drugs  and  Magic  Remedies  (Objectionable  Advertisements)  Act,  1954  and  Rules thereunder  encompass  the  provisions  for  prohibition  of  misleading  advertisements  and exaggerated  claims  of  drugs  and  medicinal  substances  including  Ayush  medicines.  The State/UT Governments are empowered to enforce the legal provisions under this Act.

339  such  misleading  advertisements  of  Ayush  products  and  services  registered  on  the Grievance Against Misleading Advertisement (GAMA) portal of Department of Consumer Affairs  in  the  F.Y.  2021-22  and  8144  misleading  advertisements  of  Ayush  products  and

services reported by the Pharmacovigilance centres in 2021 (Jan-Dec) were forwarded to the respective State Licensing Authorities for taking appropriate action as per extant rules.

(e) Thenumber of registered manufacturing units of AYUSH drugs, State-wise, and year-wise is at Annexure.

(f)  In  order  to  support  the  pharmacies,  the  Ministry  of  Ayush  is  implementing  a  Central Sector  Scheme  for  AyushOushadhiGunavattaevamUttpadanSamvardhanYojana  (AOGUSY) for  the  year  2021-2026.  One  of  the  components  of  the  scheme  is  Strengthening  and  upgradation  of  Ayush  Pharmacies  to  achieve  higher  standards,  wherein  financial  support  is provided to both private and public sector manufacturing units.

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Annexure Number of registered manufacturing units of AYUSH drugs, State-wise, and year-wise

| Sl. No.   | State/UT                  |   2019 |   2020 |   2021 |
|-----------|---------------------------|--------|--------|--------|
| 1         | A&N Island                |      0 |      0 |      0 |
| 2         | Andhra Pradesh            |    304 |    261 |    261 |
| 3         | Arunachal Pradesh         |      1 |      1 |      1 |
| 4         | Assam                     |     40 |     40 |     44 |
| 5         | Bihar                     |    252 |    155 |    286 |
| 6         | Chandigarh                |      1 |      1 |      2 |
| 7         | Chhattisgarh              |     32 |     30 |     30 |
| 8         | D&N Haveli &Daman and Diu |     17 |     23 |     23 |
| 9         | Delhi                     |    103 |    120 |    125 |
| 10        | Goa                       |      6 |      9 |     11 |
| 11        | Gujarat                   |    587 |    751 |    797 |
| 12        | Haryana                   |    518 |    613 |    447 |
| 13        | Himachal Pradesh          |    138 |    144 |    161 |
| 14        | Jammu &Kashmir            |     15 |     21 |     22 |
| 15        | Jharkhand                 |     27 |     28 |     34 |
| 16        | Karnataka                 |    222 |    358 |    226 |
| 17        | Kerala                    |    905 |    814 |    753 |
| 18        | Ladakh                    |      0 |      0 |      0 |
| 19        | Lakshadweep               |      0 |      0 |      0 |
| 20        | Madhya Pradesh            |    584 |    679 |    699 |
| 21        | Maharashtra               |    725 |    882 |    834 |
| 22        | Manipur                   |      0 |      0 |      0 |
| 23        | Meghalaya                 |      0 |      0 |      0 |
| 24        | Mizoram                   |      0 |      0 |      0 |
| 25        | Nagaland                  |      0 |      0 |      0 |
| 26        | Odisha                    |     90 |     92 |     91 |
| 27        | Puducherry                |     40 |     60 |     55 |
| 28        | Punjab                    |    232 |    293 |    352 |
| 29        | Rajasthan                 |    350 |    355 |    317 |
| 30        | Sikkim                    |      3 |      5 |      5 |
| 31        | Tamil Nadu                |    305 |    343 |    313 |
| 32        | Telangana                 |    634 |    774 |   1162 |
| 33        | Tripura                   |      0 |      0 |      0 |
| 34        | Uttar Pradesh             |   1755 |   1784 |   1835 |
| 35        | Uttarakhand               |    196 |    270 |    324 |
| 36        | West Bengal               |    325 |    373 |    218 |
|           | TOTAL                     |   8407 |   9279 |   9428 |