Lok Sabha Question No. 1806 (UNSTARRED), answered on 2022-12-16
Subject: Implementation of AOGUSY
Ministry: AYURVEDA,YOGA & NATUROPATHY,UNANI,SIDDHA AND HOMEOPATHY (AYUSH)
Asked by: Amar Singh

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO.1806 TO BE ANSWERED ON 16 TH  DECEMBER, 2022

## IMPLEMENTATION OF AOGUSY

## 1806.  DR. AMAR SINGH:

Will the Minister of AYUSH be pleased to state?

- a) Whether the government has taken cognizance that the effective implementation of Central Sector Scheme ' Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana' (AOGUSY) would help in strengthening the Central and States Regulatory  Framework of Quality Control along with the Pharmacopeia Commission of Indian Medicine  & Homeopathy (PCIM&H) for making standards of AYUSH Drugs; and
- b) If so, the initiatives taken/to be taken by the Government in this regard?

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

- (a)  &  (b):  Yes  Sir.  Ministry  of  Ayush  has  implemented  Central  Sector  Scheme  AYUSH Oushadhi  Gunvatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY).  The  objectives  of  the Scheme are as under;
- i. To enhance India's manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat.
- ii. To facilitate adequate infrastructural & technological upgradation and institutional activities in public  and  private  sector  for  standardization,  quality  manufacturing  and  analytical  testing  of Ayush drugs & materials.
- iii. To strengthen regulatory frameworks at Central and State level for effective quality control, safety monitoring and surveillance of misleading advertisements of Ayush drugs.
- iv. To encourage building up synergies, collaborations and convergent approaches for promoting standards and quality of Ayush drugs & materials.

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.

AYUSH  Oushadhi  Gunvatta  Evam  Uttpadan  Samvardhan  Yojana  (AOGUSY)  was approved by Standing Finance Committee (SFC) on 16.03.2021. The total financial allocation to this scheme is Rs 122.00 crores for five years. The funds disbursed under the scheme AYUSH Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) are as follows:

2022-23

| Components of AOGUSY scheme                                                                                                                                   | During Financial Year 2021-22 (Rs. in Crores)                            | During Financial Year 2022-23 (Rs. in Crores)                       |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------|
| Strengthening and up-gradation of Ayush Pharmacies and Drug Testing laboratories to achieve higher standards.                                                 | 0.18 (Funds released to State Govt. of Mizoram)                          | -                                                                   |
| Pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements                                                                          | 2.72 (Funds released to All India Institute of Ayurveda, New Delhi)      | 4.30 (Funds released to All India Institute of Ayurveda, New Delhi) |
| Strengthening of Central and State regulatory frameworks including Human Resource Development & Capacity Building programs for quality control of Ayush drugs | 0.04 (Funds released to National Institute of Unani Medicine, Bengaluru) | -                                                                   |
| Total                                                                                                                                                         | 2.94                                                                     | 4.30                                                                |

The PCIM&H is already involved in this central sector scheme to the extent specified in the fourth component of the AOGUSY Scheme, i.e. "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."

Ministry of Ayush  has setup Pharmacopeia  Commission  of  Indian  Medicine  & Homoeopathy  (PCIM&H),  Ghaziabad  to  lay  down  Pharmacopoeial  Quality  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 and the standards mentioned therein are mandatory. Consequent upon decision of  Central  Government  (dated  3rd    June,  2020),  the  Government  of  India    has  re-established Pharmacopoeia Commission for Indian Medicines and  Homoeopathy (PCIM&H),  as a subordinate  office  under  Ministry  of  Ayush  by  merging  into  it,  the  two  central  laboratories namely  PLIM  and  HPL  (notified  vide  gazette  dated  6th    July,  2020).    PCIM&H  lays  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.

Under second component of AOGUSY  Scheme,  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. .

Under  third  component  of  AOGUSY  Scheme,  'Strengthening  of  Central  and  State regulatory frameworks including Technical Human Resource & Capacity Building programs for Ayush  drugs',  total  09  posts  i.e.  04  posts  of  Drug  Inspectors  (01  in  each  stream-  Ayurveda, Siddha, Unani and Homoeopathy); 04 posts of Assistant Drug Controller (01 each for Ayurveda, Siddha, Unani and Homoeopathy) and 01 post of Deputy Drug Controller (ASU&H) has been created for setting up of the Office of the Central AYUSH Drugs Controller in the Ministry of Ayush.  Ministry  of  Ayush  has    appointed  its  09  officers  for  the  additional  charge  of  above mentioned  09  posts  in  addition  to  their  normal  duties  in  the  Ministry  of  Ayush,  without  any additional remuneration vide gazette notification S.O. 4562(E) dated 27.09.2022.

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