The Drugs Controller General of India (DCGI) is considering a significant change in regulations for companies manufacturing disinfectants. The proposed move aims to make it easier for these companies to operate, reflecting the growing demand for disinfectants in the wake of the COVID-19 pandemic.
Currently, disinfectants are categorized under Schedule-O of the New Drugs and Import Registration rules, placing them on par with drugs and medicines. This means that companies seeking to manufacture disinfectants must comply with stringent regulatory requirements, including obtaining an import license and market authorization certificate.
To simplify the process, the DCGI is exploring the possibility of removing disinfectants from Schedule-O, thereby reducing the regulatory burden. As part of this plan, the DCGI intends to issue a comprehensive guidance note detailing specific requirements for obtaining licenses and registration certificates for disinfectants.
This proposed change stems from the exponential growth in the market for disinfectants, driven by increased hygiene awareness during the pandemic. The hand sanitizer market in India alone was valued at $150.63 million in 2024 and is projected to grow at a rate of 5.1% annually until 2030. Similarly, the surface disinfectant market reached a size of over $6.93 billion in 2023 and is expected to expand at a rate of 7.3% from 2024 to 2032.
The current regulatory protocol, which treats disinfectants as drugs, requires stringent compliance with the Drugs Rule 1945. This approach, while aiming for safety and efficacy, has been seen by some as unnecessarily burdensome for manufacturers. In contrast, many other countries delegate the regulation of disinfectants to agencies other than drug regulators.
The Drugs Consultative Committee, in a June meeting, discussed the proposal to remove disinfectants from Schedule-O and the need for a streamlined regulatory framework. The committee acknowledged the significant market growth and the potential for simplified regulations without compromising on public health. The proposed guidance note will provide clarity on specific requirements for obtaining import and registration certificates, as well as marketing authorization for disinfectants.
While the health ministry spokesperson has yet to respond to queries regarding the proposed changes, the move suggests a proactive approach by the DCGI to adapt to evolving market realities while ensuring consumer safety.
