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This scheme component aims to upgrade Ayush pharmacies and drug testing labs, improving the quality and manufacturing  Read More... standards of Ayush medicines in India. Read less

Details

The Indian government, through the Ministry of Ayush, is actively working to ensure the highest quality and safety standards for Ayush medicines. Under the 'Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana' (AOGUSY), a specific component focuses on strengthening and upgrading Ayush Pharmacies and Drug Testing Laboratories. This initiative provides crucial financial support to enhance infrastructure, adopt modern technologies, and improve testing facilities to meet national and international quality benchmarks like GMP and NABL.

What Is This Scheme?

This particular part of the AOGUSY scheme is designed to help both government and private entities involved in Ayush medicine production and testing. It offers financial assistance to upgrade existing facilities, install new equipment, and develop robust quality control systems. The goal is to ensure that all Ayush drugs available in the market are consistently high in quality, safe to use, and effective.

Who Can Benefit From This Scheme?

The scheme is open to a wide range of applicants, including:

  • State Government and Union Territory Ayush Pharmacies.
  • State Government Ayush Cooperatives.
  • State Government Ayush Public Sector Undertakings (PSUs).
  • State/UT Government Ayush Drug Testing Laboratories and Government Research Council Laboratories.
  • Private Ayush Manufacturing Units (Pharmacies).
  • Private Ayush Drug Testing Laboratories and in-house Quality Control Labs of GMP-certified Ayush Manufacturing Units.

Why This Scheme Is Important

By investing in the upgrading of Ayush pharmacies and drug testing laboratories, the government aims to build greater trust in Ayush medicines. Enhanced quality control means safer products for consumers and a stronger reputation for the Indian Ayush industry globally. This initiative supports manufacturers, especially small and medium-sized ones, in meeting stringent quality requirements, thereby promoting the growth and development of the Ayush sector.

Objective

This scheme component aims to upgrade Ayush pharmacies and drug testing labs, improving the quality and manufacturing standards of Ayush medicines in India.

Benefits

Under this scheme, the dependents of the deceased receive financial assistance of ₹4,00,000/- as an ex-gratia grant.

Sources and references

Eligibility Criteria

For State Government/Union Territory ASU&H Pharmacies, Cooperatives, and PSUs:

  1. Must hold a valid license under the Drugs and Cosmetics Act, 1940 and Rules, 1945, and possess GMP certification.
  2. Existing government pharmacies that received partial funding previously can receive additional funds up to the set limit.
  3. Pharmacies that previously received grants must have fully utilized them and submitted work completion certificates with photos to be eligible for more funding.
  4. Must provide details of medicines manufactured in the last three years, including batch capacity and annual production volume.
  5. Proposals must include plans for rational machinery, technology, and infrastructure upgrades that match existing facilities.
  6. Pharmacies not yet GMP certified can obtain certification with support from this scheme.
  7. Priority will be given to government pharmacies that did not receive funding in earlier schemes due to budget or technical issues.
  8. Applications should be submitted as per Format A1.

For State/U.T. Govt ASU&H Drug Testing Laboratories and Government Research Councils:

  1. Must be licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
  2. Laboratories that received grants under earlier schemes can get additional funds if previous grants were fully utilized and work completion certificates with photos are submitted.
  3. Must provide data on ASU&H drug samples tested in the last three years, including pass/fail rates.
  4. Must have a qualified Scientific Officer from the Ayush stream and a notified Government Analyst.
  5. Funding is available only for laboratories located in States/UTs that have functional ASU&H Pharmacies.
  6. Proposals must focus on rational equipment and infrastructure upgrades aligned with existing facilities for strengthening and NABL accreditation.
  7. Applications need a Detailed Project Report (DPR), land records, and a commitment from the State Government for creating regular posts to operate the facility.
  8. Priority will be given to government laboratories that didn't receive funds earlier due to reasons like fund unavailability or technical difficulties; these must apply afresh.
  9. Laboratories that received partial funding previously can be considered for additional funding up to the prescribed limit.
  10. Equipment and instruments must be chosen from the approved list (Annexure 2).
  11. Applications must be submitted in Format A2.

For Private ASU&H Pharmacies:

  1. Must hold a valid manufacturing license and GMP certificate for the last ten years, issued under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
  2. The firm must have a total turnover of at least ₹10 crores from its inception until the application date.
  3. The premises, machinery, equipment, and utility bills must be in the name of the applicant or the firm.
  4. Preference will be given to pharmacies located near other ASU&H pharmacies.
  5. Applications should be submitted as per Format A3 available at Format A3.

For Private ASU&H Drug Testing Laboratories / In-house Quality Control Labs of GMP Certified Units:

  1. Must have held a valid ASU&H drug testing license for the last five years and should not currently hold NABL accreditation.
  2. The premises, machinery, equipment, and utility bills must be in the name of the applicant or the firm.
  3. Must have an ASU&H stream Scientific Officer appointed on a regular basis.
  4. Existing DTLs must provide data on ASU&H drug samples tested in the last three years, including pass/fail numbers.
  5. Funding is available for DTLs only in States/UTs with functional ASU&H Pharmacies.
  6. Applicant labs must propose equipment and infrastructure upgrades that align with their existing facilities to achieve NABL accreditation.
  7. The equipment/instruments must be selected from the list provided in Annexure 2.
  8. Applications should be submitted as per Format A4 available at Format A4.

How To Apply

Applications are invited twice a year, in January and July, through advertisements in national daily newspapers. Applicants need to submit their proposals in both hard and soft copies.

  1. Prepare your proposal according to the specific format required for your entity type (Format A1, A2, A3, or A4).
  2. Ensure all required documents are attached.
  3. Submit the hard copy of the application to the designated address.
  4. Send the soft copy (in PDF/Word format) via email to the Drug Policy Section, Ministry of Ayush, at: [email protected].

Documents Required

The specific documents needed depend on the type of applicant. Here's a general list:

For State Government/Union Territory ASU&H Pharmacies, Cooperatives, and PSUs:

  • Attested Copy of License.

For State/U.T. Govt ASU&H Drug Testing Laboratories and Government Research Councils:

  • Attested Copy of License.

For Private ASU&H Pharmacies:

  • Concept paper of the proposal.
  • Audited statements of Income & Expenditure for the last three years.
  • Non-conviction certificate in original from the State Licensing Authority/Drug Controller, issued within 15 days of the application date.
  • An undertaking stating that financial assistance for the same purpose has not been availed or is not being availed from any other Central or State Government source.
  • Attested copy of the Manufacturing License.
  • Attested copy of the GMP Certificate.
  • Utility Bills in the name of the applicant/firm.
  • Self-certified Undertaking for abiding by the Terms & Conditions as specified in the format at Annexure 3.

For Private ASU&H Drug Testing Laboratories / In-house Quality Control Labs of GMP Certified Units:

  • Concept paper of the proposal.
  • Audited statements of Income & Expenditure for the last three years.
  • Non-conviction certificate in original from the State Licensing Authority/Drug Controller, issued within 15 days of the application date.
  • An undertaking stating that financial assistance for the same purpose has not been availed or is not being availed from any other Central or State Government source.
  • Attested copy of the License.
  • Attested copy of any accreditation already held by the laboratory.
  • Self-certified Undertaking for abiding by the Terms & Conditions as specified in the format at Annexure 3.

Official Sources

For detailed formats and annexures, please refer to the official notification and guidelines:

FAQ’s

What is the main goal of this Ayush scheme?

The primary goal is to boost the quality and production standards of Ayush medicines by upgrading Ayush pharmacies and drug testing laboratories. This involves enhancing infrastructure and modernizing technology to meet higher quality benchmarks.

Who can apply for funding from this scheme?

The scheme is open to various entities, including state government Ayush pharmacies, cooperatives, PSUs, drug testing labs, research councils, and private Ayush manufacturing units and laboratories.

How much financial aid can government pharmacies receive?

State Government and UT Ayush pharmacies can get up to ₹6 crore per unit. This includes funds for non-recurring costs like infrastructure (70% of project cost) and recurring costs like operational expenses (30% of project cost) over five years.

When are applications accepted for this scheme?

The Ministry of Ayush invites applications twice a year. Advertisements are typically released in January and July, published in major national newspapers.

What kind of support is offered to private Ayush drug testing labs?

Private Ayush drug testing laboratories or in-house quality control labs can receive 50% of their project cost, capped at ₹1.5 crore. This funding is specifically for purchasing scientific equipment and instruments needed to achieve NABL accreditation.

What are the eligibility requirements for private Ayush pharmacies?

Private pharmacies must have held a valid manufacturing license and GMP certificate for at least ten years. They also need a minimum total turnover of ₹10 crore since their inception, and all premises, machinery, and utility bills should be in the firm’s name.

How is the money for non-recurring expenses provided to government pharmacies?

The non-recurring funds, which make up 70% of the project cost, are disbursed in three instalments: 30%, 40%, and then 30% over a period of five years. This release is contingent upon the submission of utilization certificates.

Are there any specific conditions for recurring expenditure support?

Yes, recurring expenditure funds are released over five years with an annual ceiling. Importantly, these funds are only disbursed after the initial infrastructure and upgradation works have been fully completed.

What are the conditions for government drug testing labs to be eligible?

Eligible government drug testing labs must be licensed, have a qualified Ayush Scientific Officer and a notified Government Analyst. They also need to provide data on samples tested over the last three years and submit a Detailed Project Report (DPR) along with land records and a State Government commitment for staff posts.

What kind of financial aid can private manufacturing units get?

Private Ayush manufacturing units can receive financial support covering 50% of their project cost, up to a maximum of ₹3 crore. This aid is intended for purchasing equipment and machinery to meet higher GMP standards like WHO-GMP.

How should I submit my application online?

You need to email the soft copy of your application in PDF or Word format to the Drug Policy Section, Ministry of Ayush, at [email protected]. Ensure you also submit the hard copy of the application.

What if a lab already has some accreditation?

For private drug testing labs applying for NABL accreditation support, an attested copy of any existing accreditation they hold must be submitted as part of the application.

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