[ad_1]
New Delhi: India plans to remove the power of the state drug regulators to approve antibiotics because the country faces the world’s worst public health threat from the anticoagiosity resisted by excessive use and abuse of drugs. .
Anti -antimicrobial drugs that treat infections from pathogens, including bacteria, viruses and fungi – will now be classified “new drug” under new drugs and clinical testing rules, 2019, according to two officials, of development Will know about. The only authority, the only authority to allow the manufacture of new antibiotics in the country, said on the condition of anonymity as the details are not yet out.
The World Health Organization has termed the antimicrobial resistance (AMR) as one of the top 10 global public health hazards. India has the worst burden of drug resistant pathogens in India. Last year, the central government said that due to drug-resistant infections, about 600,000 people lost their lives every year.
Increased increase in use of antibiotics is inspired by misuse of infection, overgrowth, self-medication, and livestock, Dr. According to Sandeep Dewan, Senior Director and Department-Monitoring Care, Fortis Memorial Care, Fortis Memorial Research Institute. “Poor hygiene, antimicrobial resistance, and lack of awareness spoiled the issue. Irregular access and insufficient diagnosis further contributes, making it important to promote responsible antibiotic use and strengthen infection control measures globally. ,
Also read India is tightening fake medicines – retailers, wholesaler can pay the price
How is the center planning to take control
The first of the first two officers quoted told how the approval of the manufacture of antibiotics currently works:
If the first time any new antibiotic is to be introduced in India, it is called a ‘new medicine’ and the manufacturer requires a certificate and compulsory approval without any objection from the Central Drugs Standard Control Organization (CDSCO) . Subsequently, the company may contact the State Licensing Officers (Slas).
A special antibiotic remains a ‘new drug’ for four years, allowing the central regulator to monitor data during this period. After that, Slas is allowed to give a license to any manufacturer to develop the same formulation.
Under the proposed provision, antibiotics will remain ‘new medicine’ even after that, the officer said. “The license for the manufacture of antibiotics will be issued by CDSCO, not by the state, even after four years.”
Under the definition of a ‘new drug’ under the definition of new drugs and clinical testing rules, the proposal to include all antimicrobials, Drug Consultative Meeting (DCCCCCCCC ) It was presented before.
Also read Parameters to gag to states for drug enforce
When antibiotics live under the category of ‘new drugs’, this will ensure a similar process for manufacturing approval, the other person first quoted. “This will prevent unnecessary approval on their related parameters by the State Licensing Authority,” the official said.
A spokesman for the Health Ministry said in a reply that the matter was first discussed on the matter of 91st Drugs Technical Advisory Board (DTAB) on 14 August 2024 and then in the 65th DCC. MintQuestions of. DCC recommended that appropriate provisions could be made in the rules for regulatory inspection by CDSCO, the spokesperson said, saying that it would be discussed in DTAB “” for appropriate decision/ intermittent “.
Mirror global approach
A drug falling under the definition of ‘new drugs’ is under the near monitoring of the central government for construction and license and other relevant data.
Government of India moves the European Union’s stringent regulatory approach to combat antimicrobial resistance (AMR), Raj Prakash Vyas, President Corporate Affairs, Cadila Pharmaceuticals Limited, “This is an important step, because this is an important step, because furious in India Antibiotic abolition, unlike the decentralized manufacturing approval.
First, Mint The top drug regulator directed the state governments to monitor the availability of unpublished antibiotics being sold in the market and intimate CDSCOs to ban such drugs.
Dr. of Fortis Health “Excessive use of counter availability of antibiotics is a major reason for excessive use of antibiotics.” , And proper diagnosis can further reduce unnecessary antibiotic consumption and effectively combat resistance, he said.
Also read The pharmaceutical industry has its own deep moment
However, Pharmacy Lobby AIOCD General Secretary Rajiv Singhal said, “We have made our chemist sensitive to customers without selling any medicine without a doctor’s legitimate prescription.”
He said, “Most times, customers come to us citing fever or cold for 2-3 days and insist on giving us medicines.” There are no other drugs such as schedule H and H1 drugs (including azithromycin or anti-TB drugs, which are under strict government control and cannot be sold without a doctor’s prescription). ,
According to pharmotrac data shared by All India Organization of Chemists and Drugists (AIOCD), India’s anti-infective pharmaceutical market, including anti-bacterial, anti-fungal and anti-viral, had values of values, values were valued. 26,094 crore in fiscal ended March 2024.
Also read The Center asks the small drug manufacturer to submit a plan to meet quality criteria in 3 months
The government’s decision to centralize approval will increase regulatory monitoring, improve monitoring, and encourage the development of new antibiotics, protect public health, Arushi Jain, Director, Acres Drugs and Acresy Drugs and Pharmaceuticals Limited said, “This Steps will harmonize India’s regulatory structure with international practices. To promote global cooperation in combating AMR. ,
[ad_2]
