Quality control for AYUSH drugs

With AYUSH industry currently being regulated under the Drugs and Cosmetics Act that regulates the modern pharmacy industry, the AYUSH Task Force has recommended a separate regulator for the industry for providing quality products.

It is observed that the regulator is focused more on modern medicine than on AYUSH products. “This may be owing to the size of the pharma industry and the many pressing issues facing it.”

The task force said in its report, “The AYUSH industry regulation gets neglected with many States not even having qualified manpower for AYUSH regulation and hence, on the ground the consumer does not get access to quality products as intended under the regulation.”

It said, “There is poor inflow of samples to AYUSH laboratories for testing quality, and laboratories set up by investing considerable funds by the Ministry of AYUSH function poorly.”

The manufacturer should have an in-house drug testing laboratory which should be approved by the AYUSH Ministry and have the National Accreditation Board for Testing and Calibration Laboratories accreditation, the report said.

While international standards for good manufacturing practices (GMP) have been prescribed by the WHO for herbal medicines, AYUSH regulation was still short of international standards such as the GMP. Therefore, “AYUSH products are not globally competitive,” the task force said.

As per the data in Traditional Knowledge Digital Librarythere are about 2,00,000 herbal formulations in ayurveda, Siddha, and Unani texts. However, about 500 formulations are manufactured for contemporary practice, the report said.

There was a need for a scheme to encourage establishment of semi-processing industries for supply of quality raw/semi-processed material, including those managed by community-based enterprises.

Uniform syllabus, uniform duration of courses, uniform evaluation, and better faculty and infrastructure are the need of the hour to ensure quality education in yoga and naturopathy.

Prashant Shetty, principal and chief medical officer, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada

Key recommendations

AYUSH manufacturer should have an in-house drug testing laboratory

Set up more labs in non-governmental and private sectors

Promote excellence through voluntary certifications

Encourage establishment of semi-processing industries for supply of quality raw/semi-processed material

‘Establish links with other departments’

Instead of functioning in isolation, the AYUSH Task Force has recommended that the Department of AYUSH develop an effective interface with other departments such as Commerce, Ministry of External Affairs, Tourism, Science and Technology, Biotechnology, Tribal Development, Women and Child Development, and Council of Scientific and Industrial Research.

It has recommended promoting AYUSH schemes in Union government programmes such as NRHM and NHM. It said a budget of Rs. 50 crore a year could to be created for “inter-departmental cooperation”.

At least 10 well-designed pilot projects, implemented by reputed NGOs/colleges/universities, should be supported by the National AYUSH Mission, for demonstrating effective models for integrative healthcare in selected rural taluks.