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This initiative by the Ministry of Ayush aims to upgrade Ayush pharmacies and drug testing labs, boosting Read More... the quality and standards of Ayush medicines. Read less
Details
The Ministry of Ayush, Government of India, runs a scheme called 'Ayush Oushadhi Gunvatta evam Utpadan Samvardhan Yojana' (AOGUSY). A key part of this is strengthening and upgrading Ayush pharmacies and drug testing laboratories. The goal is to make sure Ayush medicines are of the highest quality and meet all regulations.
What Is This Scheme?
This scheme component focuses on improving the infrastructure and technology of Ayush drug manufacturing units (pharmacies) and the laboratories that test these drugs. It helps them adopt better manufacturing practices (GMP) and get accredited (like NABL), ensuring that the medicines produced are safe, effective, and consistently high-quality.
Who Can Benefit From This Scheme?
The scheme is designed to help various types of institutions involved in Ayush drug production and quality control. This includes government-run Ayush pharmacies, cooperatives, and public sector undertakings. It also supports government drug testing laboratories and research councils. Additionally, private Ayush manufacturing companies and their in-house quality control labs, as well as private drug testing labs, can apply.
Why This Scheme Is Important
By supporting the upgrade of these facilities, the scheme plays a crucial role in building trust in Ayush medicines. It helps manufacturers meet international quality standards, making Indian Ayush products more competitive globally. For consumers, it ensures access to reliable and safe traditional medicines.
Objective
Benefits
Sources and references
Eligibility Criteria
Eligibility varies based on the applicant type:
- For Government ASU&H Pharmacies/ Cooperatives/ PSUs:
- Must hold a valid license under the Drugs and Cosmetics Act, 1940 and Rules, 1945, and be GMP certified.
- Existing pharmacies that received partial funding earlier can get additional funds up to the prescribed limit.
- Those who have availed grants under previous schemes are eligible if previous grants were fully utilized and work completion certificates with photos are submitted.
- Must submit details of medicines manufactured over the last three years, including batch capacity and annual production numbers.
- Proposals should include rational upgrades for machinery, technology, and infrastructure that align with existing facilities.
- Pharmacies without GMP certification can get support to obtain it.
- Priority will be given to government pharmacies that didn't receive funding previously due to fund constraints or technical issues.
- Applications should be submitted as per Format A1.
- For Government ASU&H Drug Testing Laboratories/Research Councils Laboratories:
- Must be licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
- Laboratories that availed grants under earlier schemes can get additional funds if previous grants were fully utilized and work completion certificates with photos are submitted.
- Must provide details of ASU&H drug samples tested in the last three years, including pass/fail rates.
- Must have a Scientific Officer from the Ayush stream and a notified Government Analyst.
- Funding is only for Drug Testing Laboratories located in States/UTs that have functional ASU&H Pharmacies.
- Proposals should include rational equipment and infrastructure plans that align with existing facilities for strengthening and NABL accreditation.
- Applications need a Detailed Project Report (DPR), land records, and a state government commitment to create permanent posts for operation.
- Priority will be given to government drug testing labs that did not receive funds earlier due to non-availability or technical reasons, and they must re-apply.
- Labs that received partial funding earlier can get additional funds up to the limit.
- Equipment and instruments must be selected from the approved list (Annexure 2).
- Applications must be in the prescribed Format A2.
- For Private ASU&H Pharmacies:
- Must hold a valid manufacturing license and GMP certificate for the last ten years.
- Total turnover from the inception of the firm to the application date must be at least ₹10 crores.
- Premises, machinery, and utility bills must be in the name of the applicant/firm.
- Preference will be given to pharmacies located near other ASU&H pharmacies.
- Applications should be submitted as per Format A3.
- For Private ASU&H Drug Testing Laboratories/In-house Quality Control Labs:
- Must have a valid ASU&H drug testing license for the last five years and not currently hold NABL accreditation.
- Premises, machinery, and utility bills must be in the name of the applicant/firm.
- Must have an ASU&H stream Scientific Officer appointed on a regular basis.
- Existing DTLs must provide the number of ASU&H drug samples tested over the last three years with pass/fail rates.
- DTLs in States/UTs will only be funded if there is a functional ASU&H Pharmacy in that region.
- Applicant labs should propose equipment and infrastructure plans that match their existing facilities to upgrade for NABL accreditation.
- Equipment/instruments must be chosen from the list provided in Annexure 2.
- Applications should be submitted as per Format A4.
How To Apply
The Ministry of Ayush invites applications for proposals twice a year, typically in January and July, through advertisements in national daily newspapers. Applicants must submit their proposals in both hard and soft copies. The soft copy (in PDF or Word format) should be emailed to the designated Email ID of the Drug Policy Section, Ministry of Ayush, at: [email protected].
Specific application formats (Format A1, A2, A3, A4) are required depending on the applicant type, as indicated in the eligibility criteria.
Documents Required
The documents needed vary depending on the applicant:
- For State Government/Union Territory ASU&H Pharmacies/ Cooperatives/ PSUs:
- Attested Copy of License.
- For State/U.T. Govt ASU&H Drug Testing Laboratories/ Government and Research Councils Laboratories:
- Attested Copy of License.
- For Private ASU&H Pharmacies:
- Concept paper of the proposal.
- Audited statements of Income & Expenditure for the last three years.
- Original Non-conviction certificate from the State Licensing Authority/Drug Controller, issued within 15 days of application.
- Undertaking confirming 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 to the Terms & Conditions as specified in the format at Annexure 3.
- For Private ASU&H Drug Testing Laboratories/ In-house Quality Control Lab of GMP Certified ASU&H Manufacturing Units:
- Concept paper of the proposal.
- Audited statements of Income & Expenditure for the last three years.
- Original Non-conviction certificate from the State Licensing Authority/Drug Controller, issued within 15 days of application.
- Undertaking confirming 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 existing accreditation of the laboratory.
- Self-certified Undertaking for abiding to the Terms & Conditions as specified in the format at Annexure 3.
FAQ’s
How often does the Ministry of Ayush accept applications for this scheme?
The Ministry of Ayush announces opportunities to apply for this scheme twice a year. Advertisements are typically published in national daily newspapers, once in January and again in July.
Can a private pharmacy that already has a GMP certificate apply for this upgrade scheme?
Yes, private ASU&H pharmacies that have held valid manufacturing licenses and GMP certificates for the last ten years, and meet the turnover criteria, are eligible to apply. The scheme supports them in acquiring equipment and machinery to achieve even higher GMP standards.
What is the maximum financial aid a State Government ASU&H pharmacy can receive for upgrades?
State Government or Union Territory ASU&H Pharmacies can receive financial support of up to ₹6,00,00,000/- per unit. This amount is split between non-recurring (infrastructure, technology) and recurring (operational) expenses.
Is there any financial support for recurring expenses under this scheme?
Yes, recurring expenditure is supported. For government pharmacies, it's 30% of the project cost (up to ₹1,80,00,000/- over 5 years), and for government drug testing labs, it's 30% (up to ₹90,00,000/- over 5 years). For private entities, the focus is primarily on capital expenditure for equipment.
What is the main goal of the Ayush Oushadhi Gunvatta evam Utpadan Samvardhan Yojana component?
The primary goal is to significantly improve the quality, safety, and regulatory compliance of Ayush medicines by strengthening and upgrading both Ayush pharmacies and drug testing laboratories across India.
What kind of support do private drug testing labs get?
Private ASU&H Drug Testing Laboratories, or in-house Quality Control Labs of GMP-certified manufacturers, can receive 50% of their project cost, up to ₹1,50,00,000, for purchasing scientific equipment and instruments to gain NABL accreditation.
What conditions must a private pharmacy meet to be eligible?
A private pharmacy must have held a valid manufacturing license and GMP certificate for at least ten years. Additionally, the firm must have achieved a total turnover of at least ₹10 crores since its inception until the application date. The premises and utility bills should also be in the firm's name.
How is the funding for infrastructure upgrades for government pharmacies disbursed?
The non-recurring expenditure, which covers infrastructure and technology upgrades for government pharmacies, is released in three instalments: 30%, 40%, and 30% over a period of five years. This release is contingent upon the submission of utilization certificates.
Can a government drug testing lab that received partial funding before apply again?
Yes, laboratories that received partial funding under earlier schemes are eligible for additional funds under the revised scheme. They must, however, ensure that the previous grants were fully utilized and submit work completion certificates with photographs.
What specific type of expenditure is covered for private ASU&H drug testing laboratories?
The grants for private ASU&H Drug Testing Laboratories are exclusively for capital expenditure, meaning they can be used to purchase scientific equipment and instruments required for NABL accreditation. Other laboratory infrastructure costs, such as furniture, are not covered.
Where can I find the application formats for this scheme?
The application formats (Format A1, A2, A3, A4) are specified within the scheme guidelines. For private pharmacies and private drug testing labs, Format A3 and Format A4 respectively are linked from the eligibility criteria section. You can find these at https://ayush.gov.in/resources/pdf/schemes/aoushdhi.pdf.
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