This scheme component is designed to bolster the quality and production standards of Ayush medicines by improving Read More... regulatory systems and building technical expertise at both central and state levels in India. Read less
Details
Ensuring the quality and safety of medicines is paramount. For traditional Indian systems like Ayurveda, Siddha, Unani, and Homeopathy (ASU&H), robust regulatory oversight is crucial. The Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) has a key component dedicated to exactly this: strengthening the regulatory framework for Ayush drugs.
This specific part of the AOGUSY, managed by the Ministry of Ayush, focuses on upgrading the systems that oversee Ayush drugs. It aims to improve how these drugs are regulated and to enhance the skills of the people involved in this process.
The benefits of this component extend to key government bodies responsible for drug regulation. At the national level, the Ayush section within the Central Drugs Standard Control Organization (CDSCO) receives support. Similarly, Ayush Directorates and Drug Controllers in various States and Union Territories are key beneficiaries, helping them maintain high standards for Ayush medicines across the country.
The effectiveness of Ayush medicine relies heavily on ensuring its quality and proper manufacturing. This scheme is vital because it directly supports the infrastructure and human resources needed for stringent quality checks and regulation. By boosting these capabilities, it helps build public trust in Ayush products and promotes their safe and widespread use.
Objective
Benefits
Under this scheme, farmers will be provided with free irrigation facilities. The following projects are constructed for collective irrigation in Scheduled Tribe-dominated areas:
Sources and references
To be considered for support under this scheme component, the following conditions must be met:
Applications for this scheme component need to be submitted through the prescribed process:
What is the main goal of this scheme's component?
The primary aim is to enhance the regulatory system for Ayush medicines. This involves boosting technical skills, improving quality control measures, and strengthening the overall regulatory infrastructure at both the central and state levels in India.
Which central government bodies can get funding?
At the central level, the Ayush vertical operating under the Central Drugs Standard Control Organization (CDSCO) is eligible to receive funds to improve its regulatory functions.
Which state-level bodies are eligible for this support?
State Ayush Directorates and State Drug Controllers that oversee Ayush drugs are eligible. However, they must meet certain conditions, including having a functional Drug Testing Laboratory and a dedicated enforcement mechanism for ASU&H drugs.
What kind of activities are funded for the central regulatory body?
Funding is provided for professional services, training programs for staff development, creating and sharing quality control materials, and upgrading the online portals and websites used for drug regulation.
What is the maximum funding for a training program?
Each training program can be supported up to ₹5,00,000. This initiative allows for a maximum of three such training programs.
What is the annual financial limit for states and UTs?
States and Union Territories can receive financial assistance of up to ₹15,00,000 per year for their ongoing regulatory and quality control activities related to Ayush drugs.
What expenses are covered for states and UTs?
The funding can be used for several purposes, including the development and upkeep of online licensing portals, testing drug samples, training technical staff, and conducting public awareness campaigns about Ayush drug regulations.
Are all states automatically eligible for funding?
No, eligibility for states and UTs is conditional. They must possess a functional Drug Testing Laboratory and a well-established enforcement system specifically for ASU&H drugs.
What makes a state or UT stand out for preference?
States and UTs are preferred if they actively maintain databases of manufacturers and products, use a dossier-based approach for licensing, and conduct regular inspections as mandated by the Drugs and Cosmetics Act, 1940, and its Rules.
How do I submit an application for this scheme component?
You need to fill out the application in the official Format C1, including all organizational and regulatory details. A recommendation letter from your State Ayush Department or controlling authority is also required.
What does 'dossier-based licensing' mean for Ayush medicines?
Dossier-based licensing means that before a license is granted, a comprehensive file (dossier) containing detailed scientific and technical information about the medicine must be submitted and approved by the regulatory authority.
Why is improving the Ayush drug regulatory system so important?
Strengthening the regulatory framework is crucial for ensuring that Ayush drugs are safe, effective, and of high quality. This protects public health and builds confidence in the Ayush system.