AOGUSYSUAPTL

The scheme-component aims to strengthen and upgrade ASU&H pharmacies and drug testing laboratories to improve quality control and manufacturing standards of Ayush drugs.

The scheme-component "Strengthening and Up-Gradation of Ayush Pharmacies and Drug Testing Laboratories to Achieve Higher Standards" under the "Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana" implemented by the Ministry of Ayush, Government of India, focuses on enhancing the quality and regulatory compliance of ASU&H pharmacies and drug testing laboratories. It provides financial assistance for infrastructure development, technology modernization, and stability testing facilities to meet GMP and NABL requirements. The scheme also supports the establishment and strengthening of in-house testing laboratories, particularly for micro and small Ayush manufacturing units, to ensure consistent quality, safety, and efficacy of Ayush drugs.

> For State Government/Union Territory ASU&H Pharmacies/ State Government ASU&H Cooperatives/ State Government ASU&H Public Sector Undertakings (PSUs):

• The pharmacy must be licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945 and should be GMP certified.
• Government Pharmacies that received partial funding earlier will be considered for additional funds up to the prescribed cap.
• Pharmacies that availed grants under previous schemes are eligible for additional funding, subject to full utilization of earlier grants and submission of work completion certificates with photographs.
• Existing pharmacies must provide details of medicines manufactured during the last three years, including batch capacity and number of batches produced annually.
• Applicant pharmacies must propose rational machinery, technology, and infrastructure upgrades aligned with existing facilities.
• Note:

• Pharmacies without GMP certification can obtain certification through support under this scheme.
• Priority will be given to Government Pharmacies that did not receive funding under earlier schemes due to fund constraints or technical reasons.
• Application will be as per Format A1.

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

• The Drug Testing Laboratory must be licensed under the Drugs and Cosmetics Act, 1940 and Rules, 1945.
• ASU&H Drug Testing Laboratories that availed grants under earlier schemes will be eligible for additional funds under the revised scheme, subject to full utilization of previous grants and submission of work completion certificates with photographs.
• Existing ASU&H Drug Testing Laboratories must provide details of ASU&H drug samples tested during the last three years, including the number of samples passed and failed.
• The laboratory must have a Scientific Officer from the Ayush stream and a notified Government Analyst.
• Funding will be provided only to Drug Testing Laboratories located in States/UTs with functional ASU&H Pharmacies.
• Applicant laboratories must propose rational equipment and infrastructure aligned with existing facilities for strengthening and NABL accreditation.
• Applications must include a Detailed Project Report (DPR), land records, and a commitment from the State Government for creation of regular posts to run the establishment.

• Note:

• Priority will be given to Government Drug Testing Laboratories that were not granted funds under earlier schemes due to non-availability of funds or technical reasons, and such laboratories must apply afresh.
• Laboratories that received partial funding under earlier schemes will be considered for additional funding up to the prescribed cap.
• Equipment and instruments must be selected from the approved list (Annexure 2).
• Applications must be submitted in the prescribed Format A2.

> For Private ASU&H Pharmacies:

• The Pharmacy should be licensed under Drugs and Cosmetics Act, 1940 and Rules, 1945 and holding valid manufacturing license and GMP certificates for last ten years.
• The firm should have total turnover of minimum ten crores from the date of their inception to the date of application.
• The premises and the available machinery and equipment and utility bills should be in the name of the applicant/firm.

• Note:

• Pharmacies having other ASU&H Pharmacies within the vicinity or at arm’s length will be given preference under this scheme.
• Application will be as per Format A3.

> For Private ASU&H Drug Testing Laboratories/in house Quality Control Lab of GMP certified ASU&H Manufacturing Units:

• The Laboratory having valid ASU&H drug testing license for last five years and not holding NABL.
• The premises and the available machinery and equipments and utility bills should be in the name of the applicant/firm.
• The laboratory should have an ASU&H stream scientific officer appointed on regular basis.

• Existing ASU&H DTLs are required to provide number of ASU&H drug samples tested during last three years with number of samples passed/failed reports.
• DTLs of only that State/UT will be funded where there is functional ASU&H Pharmacy.
• Applicant Laboratories should demand rationale equipment and infrastructure which matches with their existing infrastructures to upgrade for NABL accreditation.
• Note:

• The equipment/instruments are allowed as per the list to purchase annexed as Annexure 2.

• Application will be as per FormatA4.

> For State Government/Union Territory ASU&H Pharmacies/ State Government ASU&H Cooperatives/ State Government ASU&H Public Sector Undertakings (PSUs):

• Funding Support: Up to ₹6,00,00,000/- per unit.

1. Non-Recurring Expenditure (70% of Project Cost – ₹4,20,00,000/-):

• Funds are provided for infrastructure and technology upgradation and released in 30:40:30 instalments over five years, subject to submission of utilization certificates.

2. Recurring Expenditure (30% of Project Cost – ₹1,80,00,000/-):

• Released over 5 years with an annual ceiling of ₹36,00,000/-.
• Recurring funds are released only after completion of infrastructure and upgradation works.

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

• Funding Support: Up to ₹3,00,00,000/- per unit.

1. Non-Recurring Expenditure (70% of Project Cost – ₹2,10,00,000/-):

• Funds are provided for Addition of section in the existing building/renovation and Equipments for achieving higher standards/upgradation of technology.

2. Recurring Expenditure (30% of Project Cost – ₹90,00,000/-):

• Released over 5 years with an annual ceiling of ₹18,00,000/-.
• Recurring funds to units also availing non recurring fund under the present scheme will be eligible only on completion of infrastructure or up gradation related works.

> For Private ASU&H Pharmacies:

• Funding Support: Private manufacturing units will be supported with 50% of the project cost limited to ₹3,00,00,000/- for equipment, machinery and scientific instruments to achieve higher standards of GMP (like WHO-GMP, cGMP, EU-GMP).

> Private ASU&H Drug Testing Laboratories/in house Quality Control Lab of GMP certified ASU&H Manufacturing Units:

• Funding Support: Private ASU&H Laboratories will be supported with50% of the project cost limited to ₹1,50,00,000/- for acquiring scientific equipment and instruments for NABL accreditation. - Grants would be for Capital Expenditure for purchase of instruments and equipment only and not towards other laboratory infrastructure including furniture and fixtures.