Parl panel’s concerns about AOGUSY need to be acted upon

A Parliamentary panel recently expressed its concern over the slow progress of the Union Ayush Ministry’s Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) scheme. It was launched to promote and project quality, acceptability and visibility of Ayush products so as to gain people's confidence and to improve trade. The department-related Parliamentary Standing Committee on Health and Family Welfare, in its recent report on the Demand for Grants of the Ministry of Ayush for the year 2023-24 expressed its concern over the physical and financial progress of AOGUSY. This was in the wake of the findings that the targets set in strengthening and up-gradation of Ayush pharmacies and drug testing laboratories to achieve higher standards and pharmaco-vigilance of ayurveda, siddha, unani and homoeopathy drugs including surveillance of misleading advertisements suffered a lot and remains a far flung mission.

The panel’s concern is genuine as it has observed that the approved total allocation to the scheme is Rs. 122 crore for five years and the scheme is currently valid up to March 31, 2026. The total outlay for the five years was Rs 22.50 crore for the first year, Rs 23.50 crore for the second and third year, Rs 25 crore for the fourth year and Rs 27.50 crore for the final year.

For the financial year 2021-22, the budget estimate was nil and the revised estimate allocated Rs 10 crore for the scheme, out of which the actual utilisation was Rs 1.77 crore. An amount to the tune of Rs. 23.50 crore was allocated in BE 2022-23 but the same was reduced to Rs 20 crore at the RE stage. The Ministry stated that the variation was because of less allocation from the Ministry of Finance and less engagement of the programme management unit.

The launch of the AOGUSY scheme was of great significance as at present India has approximately more than 8000 licensed ayurvedic, siddha, unani and homoeopathy drug manufacturers. Most of them are small and medium scale entrepreneurs with inadequate capacities and avenues for growth. Regulatory requirements and emerging demand for quality Ayush products need adequate investment towards infrastructural facilities and quality control systems for production of Ayush products in the domestic and international markets.

Considering the range and scope of Ayush products in the national and international markets and the strategic steps needed for their mainstreaming, it is envisaged to support the manufacturers in their efforts for adopting quality production technology, in-house quality control facilities, quality certification of products, strengthening and rationalizing the drug regulatory system, promotion of research and development in the pharmaceutical sector and building synergy and evolving a convergent approach with related sectors.

In this backdrop the scheme marks a good step as it is intended to provide support for manufacture of quality drugs.

Commercial production of ASU&H drugs without license is not permitted. Compliance to Good Manufacturing Practices (GMP) is mandatory for obtaining manufacturing license. Requirement of in-house testing laboratories is prescribed under the Drugs and Cosmetics Rules, 1945, Schedule T for the GMP of ASU manufacturing units and Schedule M1 for Homoeopathy drugs manufacturing units.

The units which do not have such facilities are allowed to get their drugs tested from approved laboratories. Also, as per rule 161B of Drugs and Cosmetics Rules, 1945, stability study data has been made mandatory for obtaining license since 2019. Quality standards of identity, purity and strength of drugs and compliance for permissible limits of heavy metals, pesticide residue, and microbial load as prescribed in the respective pharmacopoeias of ASU&H system are also mandatory.

Drug inspectors, technical committees and drug testing laboratories are provided to licensing authorities to take considered and objective decisions in licensing and quality control matters.

Yhe Ayush Ministry initiated the Central Sector Scheme for augmenting quality of drugs during the 15th Finance Cycle (2021-22 to 2025-26) by merging the existing Central Sector Schemes of Pharmaco-vigilance initiative, Central Drug Controller of Ayush and Quality Control of ASU&H drugs and inclusion of certain new elements to facilitate standardization, effective enforcement of rules and regulations, technology up-gradation for manufacturing and analytical testing, certification and accreditation, training and capacity building activities intended towards quality assurance of Ayush drugs.

This is today known as AOGUSY.

The growth and development of traditional Indian and homoeopathic medicines in the interest of public health is expected within the objective of making accessible, safe, effective and quality medicines to the people. Emerging global developments in the area of drug regulatory compliance are incorporated for ASU&H medicines in accordance with the national health circumstances and regulatory needs of standardization & quality control, research & development of drugs.

The Parliamentary panel’s concerns are genuine and the government should pay heed to it as the scheme will enhance India's manufacturing capabilities and exports of traditional medicines and health promotion products under the initiative of Atmanirbhar Bharat. Besides, it will also facilitate adequate infrastructural and technological upgrading and institutional activities in public and private sector for standardization, quality manufacturing and analytical testing of Ayush drugs and materials.

(The author is freelance journalist with varied experience in different fields)