New Delhi: India plans to take away the power of state drug regulators to grant approvals to manufacture antibiotics as the country faces the world’s worst public health threat from antimicrobial resistance developed by overuse and abuse of medicines.
Antimicrobial medicines used to treat infections from pathogens—including bacteria, viruses and fungi—will now be categorized “new drug” under the New Drugs and Clinical Trial Rules, 2019, according to two officials aware of the development. That would make the central government the sole authority to allow manufacture of new antibiotics in the country, the officials said on the condition of anonymity as details are not out yet.
The World Health Organization has called antimicrobial resistance (AMR) as one of the top 10 global public health threats. India has the worst burden of drug-resistant pathogens. Last year, the central government said that around 600,000 lives lost in India each year due to drug-resistant infections.
The rise in antibiotic use is driven by increased infections, overprescription, self-medication, and misuse in livestock, according to Dr Sandeep Dewan, senior director and head of department-critical care, Fortis Memorial Research Institute. “Poor hygiene, antimicrobial resistance, and lack of awareness worsen the issue. Unregulated access and inadequate diagnostics further contribute, making it crucial to promote responsible antibiotic use and strengthen infection control measures globally.”
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How Centre plans to take control
The first of the two officials quoted earlier explained how the approval to manufacture antibiotics works at present:
If any new antibiotic has to be introduced in India for the first time, it’s termed a ‘new drug’ and the manufacturer needs a no-objection certificate and mandatory approval from the Central Drugs Standard Control Organization (CDSCO). Thereafter, the company can approach the state licensing authorities (SLAs).
A particular antibiotic remains a ‘new drug’ for four years, allowing the central regulator to monitor data during this period. After that, the SLAs are allowed to grant a licence to any manufacturer wishing to develop the same formulation.
Under the proposed provision, the antibiotic will remain ‘new drug’ even after that, said the official. “The licence for manufacturing antibiotics will be issued by the CDSCO, not by the state, even after four years.”
The proposal to include all antimicrobials under the definition of a ‘new drug’ under New Drugs and Clinical Trial Rules, 2019 was first presented before the Drugs Consultative Meeting (DCC) headed by the Drugs Controller General of India (DCGI) in December 2024.
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When antibiotics stay in the category of ‘new drugs’, that will ensure a uniform procedure for manufacturing approval, said the second person quoted earlier. “This will stop unnecessary approvals by the state licensing authority on their respective parameters,” the official said.
The matter was first discussed in the 91st Drugs Technical Advisory Board (DTAB) meeting on 14 August 2024 and thereafter in the 65th DCC held on 20 December 2024, a health ministry spokesperson said in response to Mint‘s queries. The DCC recommended that suitable provisions may be made in the rules for the regulatory oversight by CDSCO, the spokesperson said, adding that it will be further discussed in the DTAB “for appropriate decision/ finalization”.
Mirrors global approach
A medicine falling under the definition of the ‘new drugs’ is under the close surveillance of the central government for manufacturing and licences and other relevant data.
The Indian government’s move mirrors the EU’s stringent regulatory approach to combat antimicrobial resistance (AMR), according to said Raj Prakash Vyas, president corporate affairs, Cadila Pharmaceuticals Ltd. “This is a critical step, as India grapples with rampant antibiotic misuse, a problem exacerbated by decentralized manufacturing approvals. Unlike the previous fragmented system, this centralized control empowers the government to enforce stricter guidelines, aligning with global best practices.”
Earlier, Mint reported that the apex drug regulator directed the state governments to monitor the availability of unapproved antibiotic combinations being sold in the market and intimate the CDSCO to ban such medicines.
“Over the counter availability of antibiotics is a major reason for excessive use of antibiotics,” Dr Dewan of Fortis Health said. “To curb this, stricter regulations, public awareness, prescription audits, and antimicrobial stewardship programs are essential. Promoting hygiene, vaccination, and proper diagnosis can further reduce unnecessary antibiotic consumption and combat resistance effectively, he said.
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However, Rajiv Singhal, general secretary of pharmacy lobby AIOCD, said, “We have sensitized our chemists not to sell any medicine to the customers without the valid prescription of a doctor.”
“Most of the times, customers come to us citing fever or cold for 2-3 days and insist us to give medicines,” he said. “In that case, we may give OTC (over-the-counter) drugs like paracetamol but not other drugs like Schedule H and H1 medicines (including azithromycin or anti-TB drugs, which are under strict government control and can’t be sold without a physician’s prescription).”
According to Pharmatrac data shared by All India Organization of Chemists and Druggists (AIOCD), India’s anti-infective pharmaceutical market, including anti-bacterials, anti-fungals and anti-virals, was worth ₹26,094 crore in the fiscal ended March 2024.
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The government’s decision to centralize approvals will enhance regulatory oversight, improve surveillance, and stimulate the development of new antibiotics, safeguarding public health, said Arushi Jain, Director, Akums Drugs & Pharmaceuticals Ltd. “This move would harmonize India’s regulatory framework with international practices, fostering global collaboration in combating AMR.”
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