The antibiotic resistance crisis of India leads to a drastic measure: state rulers to lose license power | Mint

New Delhi: India is planning to remove the power of drug controllers to provide approvals to produce antibiotics, since the country is confronted with the world's worst threat of public health by antimicrobial resistance developed through excessive use and abuse of medication.

Antimicrobial drugs used to treat infections of pathogens – including bacteria, viruses and fungi – will now be categorized “new drug” among the new drugs and clinical trial rules, 2019, according to two officials who are aware of development. That would make the central government the only authority to allow the production of new antibiotics in the country, the officials said about the condition of anonymity because details are not yet out.

The World Health Organization has mentioned Antimicrobial Resistance (AMR) as one of the top 10 worldwide threats on public health. India has the worst trouble with drug -resistant pathogens. Last year the central government said that every year about 600,000 lives lost in India due to drug -resistant infections.

The increase in antibiotic use is driven by increased infections, over -presentation, self -medication and abuse in cattle, according to Dr. Sandep Dewan, senior director and head of department critical care, Fortis Memorial Research Institute. “Poor hygiene, antimicrobial resistance and lack of consciousness worsen the problem. Non -regulated access and insufficient diagnostics further contribute, making it crucial to promote responsible antibiotic use and to strengthen the measures of combating infection worldwide. “

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How the center is planning to take control

The first of the two cited officials explained how the approval for the production of antibiotics currently works:

If a new antibiotic must be introduced in India for the first time, this is called a 'new medicine' and the manufacturer needs a no-object certificate and mandatory approval from the Central Drugs Standard Control Organization (CDSCO). The company can then approach the State Licensing Authorities (SLAs).

A certain antibiotic will remain a 'new medicine' for four years, so that the central regulator can check data during this period. After that, the SLAs may grant a license to any manufacturer who wants to develop the same formulation.

Under the proposed provision, the antibiotic 'new medicine' will even remain afterwards, the official said. “The license for the production of antibiotics will be issued by the CDSCO, not by the state, even after four years.”

The proposal to include all antimicrobial resources under the definition of a 'new medicine' under new medicines and rules for clinical test, 2019 was first presented before the Drugs Consultative Meeting (DCC) led by the Medicines Controller General of India ( DCGI) in December 2024.

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If antibiotics remain in the 'new medicines' category, it will ensure a uniform procedure for approval of production, said the second person previously quoted. “This stops unnecessary approvals from the State Licensing Authority on their respective parameters,” said the civil servant.

The case was first discussed in the 91st Drugs Technical Advisory Board (DTAB) meeting on August 14, 2024 and then in the 65th DCC on December 20, 2024, said a spokesperson for the Ministry of Health in response to response Mintask. The DCC has recommended that suitable provisions can be affected in the rules for the supervision of the regulations by CDSCO, the spokesperson said, adding that it will be further discussed in the DTAB “for appropriate decision/ completion”.

Reflects the global approach

A medicine that falls under the definition of the 'new medicines' is under the close supervision of the central government for production and licenses and other relevant data.

The movement of the Indian government reflects the stringent EU regulatory approach to combating Antimicrobial Resistance (AMR), according to the aforementioned RAJ Prakash Vyas, President Corporate Affairs, Cadila Pharmaceuticals Ltd. “This is a critical step, because India calls with unbridled antibiotic abuse, a problem worsened by decentralized production approvals. In contrast to the previous fragmented system, this centralized control enables the government to enforce stricter guidelines, in accordance with global best practices. “

Earlier, Mint Reported that the APEX drug regulator ordered the state governments to check the availability of non -well -approved antibiotic combinations on the market and intim the CDSCO to ban such medicines.

“About the counter, the availability of antibiotics is an important reason for excessive use of antibiotics,” said Dr Dewan of Fortis Health. “To curb this, stricter regulations, public awareness, audits for prescription and antimicrobial stewardship programs essential. Promotion of hygiene, vaccination, and the correct diagnosis can effectively reduce unnecessary antibiotic consumption and combat resistance, he said.

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Rajiv Singhal, general secretary of pharmacy lobby AIOCD, said: “We made our chemists sensitive not to sell medicines to the customers without the valid recipe of a doctor.”

“Usually customers come to us who quoted fever or a cold for 2-3 days and allows us to give medication,” he said. “In that case we can give OTC (freely available) medicines such as paracetamol, but no other medicines such as H1 schedule without the recipe of a doctor). “

According to Pharmatrac data that are shared by the All India Organization of Chemists and Druggists (AIOCD), the anti-infectious pharmaceutical market of India, including antibacteria, anti-bungals and antivirals, was worthy £26,094 Crore in the tax ended March 2024.

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The government's decision to centralize approvals will improve the supervision of regulations, improve supervision and stimulate the development of new antibiotics, secure public health, said Arushi Jain, director of Akums Drugs & Pharmaceuticals Ltd. Promoting global cooperation in combating AMR. “