DCGI plans to make it easier to manufacture disinfectants, a growing sector

New Delhi: The Drugs Controller General of India (DCGI) may make it easier for companies to manufacture disinfectants, whose market has grown exponentially since the covid-19 pandemic. 

DCGI may exclude disinfectants from Schedule-O of the New Drugs and Import Registration rules, which puts them at par with drugs and medicines. 

As a part of the plan, India’s apex drug regulator is also planning to issue a guidance note highlighting specific requirements for obtaining a licence for such items.

Currently, a company seeking to obtain a licence for disinfectants has to apply for an import licence, along with the market authorization certificate as per the Drugs Rule 1945. All drug manufacturers have to get an import licence, even if they do not have to import.

This calls for very strict regulatory compliance.

The matter was discussed in a Drugs Consultative Committee meeting held back in June.

Also read | DCGI inspection brings curtains down on 36% of 400 pharma units; plans for new digital projects

As per Drugs Rule, disinfectants are covered under the definition of drugs. Whenever any drug is imported into the country, the applicant has to obtain an import licence together which registration certificate. If any drug attracts the definition of New Drugs, an approval is also required to be obtained as per New Drugs Clinical Trials (NDCT) Rules, 2019.

Market size

The increased use of hand sanitizers and floor cleaners during covid-19 pandemic has led to a significant rise in the market size due to increased awareness of hygiene. In 2024, the hand sanitizer market in India was valued at $150.63 million and is expected to grow at 5.1% through 2030.

Also read | DCGI mandates adherence to BIS standards for medical devices, strengthening of testing protocols

Similarly, the surface disinfectants market size was over $6.93 billion in 2023 and is expected to grow 7.3% from 2024 to 2032. Practicing food infection control measures can significantly reduce the incidence of hospital-acquired infections (HAIs), thus reducing morbidity and mortality in the hospitals.

Stringent regulatory protocol applicable just like drugs

“As per, Drugs Rule 1945, disinfectants fall under the category of drugs. Stringent regulatory enforcement is applicable to the manufacturers just like drugs. In many countries, the regulation of disinfectants is looked after by some other agency, not the drug regulator. The committee deliberated the proposal to exclude disinfectants from schedule-O of the drugs and cosmetic act,” said an official aware of the matter.

“The plan is also to prepare and issue a guidance note for specific requirements for obtaining import and registration certificates and new drug permission (marketing authorization) for disinfectants,” said an official added.

Queries sent to the health ministry spokesperson remained unanswered till press time.

And read | DCGI calls for strict reporting of side-effects related to medical devices