Abstract
Eleven anti-TB drugs were included in the Government of India's Schedule H1 drug regulations in 2014. The National Strategic Plan for TB Elimination in India 2017-2025 recognized the opportunity to strengthen the TB surveillance system and improve the quality of TB care by implementing the Schedule H1 regulation. However, there were no documented systematic large-scale efforts to use Schedule H1 regulation to support TB surveillance or improve the quality of care. We aimed to document the process of implementation of the Schedule H1 regulation to enhance the quality of TB care and strengthen the TB surveillance system in Kerala, India. We conducted 33 in-depth interviews of the drugs control department enforcement officers, chemist shop owners, private-sector doctors, leaders of professional medical associations, and program managers and key staff of the TB Elimination Program in Kerala. Major themes identified were the process of implementation of Schedule H1 and how the National TB Elimination Program used the information. Findings from the qualitative interviews were corroborated with the quantitative information from the annual program performance reports and anti-TB drug sales data. The TB Elimination Program of Kerala used the information from the Schedule H1 drug register to identify the missing TB cases and strengthen TB notification, identify providers for engagement and extend support to them for ensuring standards of TB care, and provide feedback to providers regarding prescription practices. Stakeholders felt that implementation of Schedule H1 surveillance has helped to improve TB patient notifications from the private sector, build better public-private partnerships, and improve the quality of TB diagnosis and treatment in Kerala. Pharmacy-based drug sales data collected either through regulatory or non-regulatory methods have immense potential to support TB elimination programs.
Highlights
Eleven anti-TB drugs were included in the Government of India’s Schedule H1 drug regulations in 2014
We conducted 33 in-depth interviews (IDI) of people who were closely associated with the implementation of Schedule H1 including drugs control department enforcement officers (7), chemist shop owners (5), chemists’ association leaders (3), National TB Elimination Program (NTEP) district-level program managers (3), NTEP subdistrict level staff (7), private sector doctors (5), and professional medical association leaders (3)
We have compiled the findings of the IDIs into 2 categories: implementation of Schedule H1 and ways the NTEP used the Schedule H1 information
Summary
Eleven anti-TB drugs were included in the Government of India’s Schedule H1 drug regulations in 2014. We aimed to document the process of implementation of the Schedule H1 regulation to enhance the quality of TB care and strengthen the TB surveillance system in Kerala, India. We aim to sistance to antimicrobial agents, in 2014, the document the Government of India established Schedule H1 noprocess of tification, which was an amendment to the Drugs implementation of and Cosmetics Rules of 1945—the legislation that the Schedule H1 regulates the import, production, sale, prescripsurveillance to tion, and use of medicines.[6] Schedule H1 notificaenhance the tion controls over-the-counter sales of certain quality of TB care drugs, such as third and fourth generation antibioand strengthen tics and psychotropic drugs, and includes 11 antithe TB surveillance TB drugs. The law mandates that Schedule H1 system in Kerala, drugs can be sold by pharmacists, known as
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
