New Delhi: The approval of the country’s apex drug regulator—the Central Drugs Standard Control Organisation (CDSCO)—will be mandatory to launch any antibiotics in the country, including the ones with approved active pharmaceutical ingredients (API). This comes amid growing concern over antimicrobial resistance (AMR) globally and in India.
The Drug Consultative Committee (DCC), an advisory panel of the CDSCO, in its last meeting in December 2024, recommended the inclusion of all antimicrobials in the definition of “new drug” under the New Drugs and Clinical Trials (NDCT) rules, 2019, ThePrint has learnt.
“Following the DCC meeting, the CDSCO has initiated the move to tweak the NDCT rules,” a senior official in the regulatory agency said. “Once the amendment is notified, all drug manufacturers will be required to seek the central nod before launching any new antibiotics, including the generic ones.”
It was not immediately clear when this would happen.
This will ensure that the CDSCO analyses the rationale for the launch of the antibiotics before allowing the manufacturing and marketing of any new drug, the official added.
Currently, under the NDCT, 2019, the CDSCO is required to grant manufacturing and marketing licenses to medicines classified as “new drugs”. These may either contain new molecules that have not been introduced in the country before or a new dosage strength and formulation of molecules already permitted.
However, for generic or me-too versions of these medicines, drugmakers need not apply to the CDSCO and can get manufacturing licenses from the state drug administration before starting production.
The DCC noted that this issue had been discussed by the Drug Technical Advisory Board (DTAB) of the CDSCO prior to the deliberation by the panel.
“After detailed deliberation, the DCC recommended that suitable provisions may be made in the rules for regulatory oversight by CDSCO for approving antimicrobials in the country to ensure uniformity of implementation and compliance with the rules,” the panel said. ThePrint has seen a copy of the minute of the DCC meeting.
With the rise of drug-resistant pathogens, mainly in hospital settings, AMR has emerged as a major public health challenge and a big cause of death.
For instance, in 2019, Bacterial AMR, a condition in which pathogenic bacteria no longer respond to existing antibiotics, killed between 3 lakh and 10.4 lakh people in India, according to a report published in The Lancet last year.
Also Read: Why a govt-appointed panel has recommended a complete ban on popular painkiller nimesulide
Misuse and overuse of antibiotics rampant in India
In India, the overuse and misuse of antibiotics have been identified as major contributors to the development of AMR, eroding the effectiveness of the drugs, said a scientist with the Indian Council of Medical Research (ICMR)’s AMR division, who did not wish to be named.
Since 2017, the World Health Organisation (WHO) has been publishing its AWaRe classification of drugs to, among other things, help countries monitor their antibiotic use.
It puts individual antibiotics under the Access (to be widely available and affordable), Watch (to be used only for specific indications because their use increases the potential for the emergence of antimicrobial resistance), and Reserve (for situations when all other alternatives have failed) categories.
In India, the Watch and Reserve group antibiotics are particularly abused, leading to an exacerbation of the AMR crisis, say experts.
Another issue, they say, is the wide array of antibiotic fixed-dose combinations (FDCs), which are of unknown effectiveness.
FDCs comprise two or more drugs combined in a fixed ratio of doses and available as a single dosage.
India has the highest number of FDC antibiotics marketed in the world, the CDSCO official quoted above said.
According to a 2022 WHO bulletin, in 2020, 12.1 billion standard units of systemic antibiotics were sold in India. There were 78 single antibiotics and 112 FDC antibiotics on the market, accounting for 62.7 percent and 37.3 percent of total antibiotic sales, respectively.
It further said that FDCs on the WHO not-recommended list were marketed in 229 formulations, with 114 formulations (49.8 percent) having no record of formal approval or no-objection certificate in India.
While there were no not-recommended fixed-dose combinations on the national list of essential medicines, 13 of the top-20 selling antibiotic fixed-dose combinations were WHO not-recommended, the report noted.
(Edited by Sanya Mathur)
Also Read: 2nd ‘living drug’ against blood cancer gets regulatory nod. All about Qartemi, made in India