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Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY): Strengthening of Central and State Regulatory Frameworks Including Technical Human Resource and Capacity Building Programs for Ayush Drugs

Ministry Of Ayush

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Overview

The scheme component aims to strengthen the regulatory framework for Ayush drugs at the Central and State/UT levels by enhancing technical manpower, capacity building, quality control systems, and regulatory infrastructure.

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Details

Description
The scheme-component "Strengthening of Central and State Regulatory Frameworks Including Technical Human Resource and Capacity Building Programs for Ayush Drugs" under the "Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana" implemented by the Ministry of Ayush, Government of India, focuses on improving regulatory oversight of Ayurveda, Siddha, Unani and Homoeopathy ASU&H drugs. At the Central level, the scheme supports the Ayush vertical under the Central Drugs Standard Control Organization CDSCO for professional services, training programs, documentation, dissemination of quality control materials, and upgradation of drug regulatory portals and websites. At the State/UT level, the scheme strengthens Ayush Drug Control systems by supporting regulatory and quality control activities, training of technical staff, testing of statutory and survey samples, portal maintenance, and awareness programs.

Exclusions
• <br>

Benefits
• Training Support: Training programs for capacity building are supported with a financial cap of ₹5,00,000/- per program.
• Training Support Limit: A maximum of three training programs can be supported under this component.
• Support for Regulatory and Quality Control Activities: Financial assistance up to ₹15,00,000/- per year per State/UT for regulatory and quality control activities.
• Reimbursable Expenditure Includes:
• Maintenance and development of online regulatory portals of Ayush Drug Controller/Licensing Authority,
• Collection and testing of statutory and survey drug samples,
• Training of technical staff at PCIM&H / NABL as per approved norms,
• Awareness and IEC activities related to Ayush drug regulation.

Eligibility Criteria
1. > **For Ayush vertical in CDSCO:**
2. - The Ayush vertical under the Central Drugs Standard Control Organization (CDSCO) is eligible for financial assistance under this component.
3. > **For State Ayush Directorate / State Drug Controller of Ayush drugs:**
4. - State Ayush Directorate / State Drug Controller of Ayush drugs are eligible.
5. - The state should have a functional Drug Testing Laboratory and a separate functional Enforcement Mechanism for ASU&amp;H drugs.
6. > **Note:** Preference is given to States/UTs maintaining a database of manufacturing units and products, implementing dossier-based licensing, and conducting regular inspections as per the [Drugs and Cosmetics Act, 1940](https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf) and Rules, 1945.
7. <br>

Application Process
Step 1: The grantee institute/Central/State Govt. may apply in the FORMAT –C1 for seeking a grant-in-aid under the component.
Offline

The grantee institute/Central/State Govt. may apply in the FORMAT –C1 for seeking a grant-in-aid under the component.

Step 2: Step 1: Visit the Ayush NGO Portal.
Online
Step 1: Visit the Ayush NGO Portal.

Step 3: Step 2: Fill in all the mandatory details and upload the relevant documents.
Online
Step 2: Fill in all the mandatory details and upload the relevant documents.

Step 4: Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.
Online
Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.

Step 5: Step 1: Visit the Ayush NGO Portal.
Online
Step 1: Visit the Ayush NGO Portal.

Step 6: Step 2: Enter the registered email id, password.
Online
Step 2: Enter the registered email id, password.

Step 7: Step 3: Type the captcha and click on "Login".
Online
User Manual: Click here.
Contact Us: Click here.

Required Documents
• Recommendation letter of the Director, Department of Ayush, State Govt./ UT’s or the Controlling Officer of the Organization.
• Any other documents as required.

Frequently Asked Questions
Q: What is the objective of this scheme-component?
A: The objective of this component is to strengthen the regulatory framework for Ayush drugs by enhancing technical capacity, quality control systems, and regulatory infrastructure at the Central and State/UT levels.
<br>

Q: Who is eligible to receive funding at the Central level?
A: The Ayush vertical under the Central Drugs Standard Control Organization (CDSCO) is eligible to receive funding for strengthening the Central regulatory framework.
<br>

Q: Who is eligible to receive funding at the State/UT level?
A: State Ayush Directorates or State Drug Controllers responsible for ASU&amp;H drugs are eligible for funding under this component, subject to fulfillment of prescribed conditions.
<br>

Q: What activities are supported under the Central regulatory framework funding?
A: The funding supports professional charges, capacity building and training programs, documentation and dissemination of quality control materials, and upgradation of drug regulatory portals and websites.
<br>

Q: What is the funding limit for training programs?
A: Training programs are supported with a financial cap of ₹5.00 lakh per program, with a maximum of three training programs.
<br>

Q: What is the funding limit for State/UT regulatory and quality control activities?
A: Funding for State/UT regulatory and quality control activities is limited to ₹15,00,000/- per year per State/UT.
<br>

Q: What types of expenditures are reimbursable for States/UTs?
A: Reimbursable expenditures include online portal development and maintenance, collection and testing of statutory and survey samples, training of technical staff, and awareness and IEC activities.
<br>

Q: Are all States and Union Territories eligible for funding?
A: Only those States and Union Territories with a functional Drug Testing Laboratory and a separate enforcement mechanism for ASU&amp;H drugs are eligible for funding.
<br>

Q: What preference criteria are considered for States/UTs?
A: Preference is given to States/UTs that maintain a database of manufacturing units and products, implement dossier-based licensing systems, and conduct regular inspections as per the Drugs and Cosmetics Act, 1940 and Rules, 1945.
<br>

Q: How should applications be submitted for this component?
A: Applications must be submitted in the prescribed [Format C1](https://ayush.gov.in/resources/pdf/schemes/aoushdhi.pdf) along with required organizational, infrastructure, and regulatory details and recommendations from the State Ayush Department or controlling authority.
<br>

Q: What is dossier-based licensing for ASU&H medicines?
A: Dossier-based licensing is a regulatory system in which detailed technical and scientific information on medicines is submitted for evaluation before licensing.
<br>

Q: Why is strengthening the regulatory framework for Ayush drugs important?
A: Strengthening the regulatory framework is important to ensure the safety, quality, and efficacy of Ayush drugs and to protect public health through effective enforcement and quality control mechanisms.
<br>

Eligibility Criteria

1

> **For Ayush vertical in CDSCO:**

2

- The Ayush vertical under the Central Drugs Standard Control Organization (CDSCO) is eligible for financial assistance under this component.

3

> **For State Ayush Directorate / State Drug Controller of Ayush drugs:**

4

- State Ayush Directorate / State Drug Controller of Ayush drugs are eligible.

5

- The state should have a functional Drug Testing Laboratory and a separate functional Enforcement Mechanism for ASU&amp;H drugs.

6

> **Note:** Preference is given to States/UTs maintaining a database of manufacturing units and products, implementing dossier-based licensing, and conducting regular inspections as per the [Drugs and Cosmetics Act, 1940](https://www.indiacode.nic.in/bitstream/123456789/15278/1/drug_cosmeticsa1940-23.pdf) and Rules, 1945.

7

<br>

Benefits

Training Support: Training programs for capacity building are supported with a financial cap of ₹5,00,000/- per program.

Training Support Limit: A maximum of three training programs can be supported under this component.

Support for Regulatory and Quality Control Activities: Financial assistance up to ₹15,00,000/- per year per State/UT for regulatory and quality control activities.

Reimbursable Expenditure Includes:

Maintenance and development of online regulatory portals of Ayush Drug Controller/Licensing Authority,

Collection and testing of statutory and survey drug samples,

Training of technical staff at PCIM&H / NABL as per approved norms,

Awareness and IEC activities related to Ayush drug regulation.

Required Documents

# Document
1 Recommendation letter of the Director, Department of Ayush, State Govt./ UT’s or the Controlling Officer of the Organization.
2 Any other documents as required.

How to Apply

1

The grantee institute/Central/State Govt. may apply in the FORMAT –C1 for seeking a grant-in-aid under the component.

Offline The grantee institute/Central/State Govt. may apply in the FORMAT –C1 for seeking a grant-in-aid under the component.

2

Step 1: Visit the Ayush NGO Portal.

Online Step 1: Visit the Ayush NGO Portal.

3

Step 2: Fill in all the mandatory details and upload the relevant documents.

Online Step 2: Fill in all the mandatory details and upload the relevant documents.

4

Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.

Online Step 3: Verify the captcha and click on "Register". If required, click "Cancel" to discard changes.

5

Step 1: Visit the Ayush NGO Portal.

Online Step 1: Visit the Ayush NGO Portal.

6

Step 2: Enter the registered email id, password.

Online Step 2: Enter the registered email id, password.

7

Step 3: Type the captcha and click on "Login".

Online User Manual: Click here. Contact Us: Click here.

Frequently Asked Questions

The objective of this component is to strengthen the regulatory framework for Ayush drugs by enhancing technical capacity, quality control systems, and regulatory infrastructure at the Central and State/UT levels. <br>

Sources and references

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