India’s Battle Against Antibiotic Crisis: Centralizing Manufacturing Approvals
As India grapples with the alarming rise of antimicrobial resistance (AMR), the country is set to make a significant shift in its approach to regulating the manufacturing of antibiotics. State drug regulators will soon lose the authority to grant approvals for manufacturing antibiotics, a move aimed at combating the overuse and abuse of these crucial medicines that poses a severe threat to public health.
The World Health Organization has identified AMR as a top 10 global public health threat, with India carrying the heaviest burden of drug-resistant pathogens. Recent data from the central government revealed a staggering toll of around 600,000 lives lost annually in India due to drug-resistant infections, underscoring the urgent need for effective measures to address this crisis.
Dr. Sandeep Dewan, a senior director and critical care specialist at Fortis Memorial Research Institute, highlighted the factors driving the surge in antibiotic use. These include increased infections, overprescription, self-medication, and misuse in livestock. He emphasized the role of poor hygiene, lack of awareness, and inadequate diagnostics in exacerbating the problem, stressing the importance of promoting responsible antibiotic use and strengthening infection control measures globally.
### Centralizing Manufacturing Approvals: A New Strategy for India’s Antibiotic Crisis
The proposed changes in the approval process for manufacturing antibiotics aim to streamline regulatory oversight and ensure uniform standards across the country. Currently, if a new antibiotic is introduced in India, the manufacturer requires approval from the Central Drugs Standard Control Organization (CDSCO) and subsequent licensing from state authorities. However, under the new rules, all antimicrobials will be categorized as ‘new drugs,’ with the CDSCO becoming the sole authority for granting manufacturing licenses even after the initial four-year monitoring period.
The move to centralize manufacturing approvals mirrors global best practices and aligns with the European Union’s stringent regulatory approach to combat AMR. Raj Prakash Vyas, president of corporate affairs at Cadila Pharmaceuticals Ltd., hailed the decision as a critical step towards curbing antibiotic misuse in India, emphasizing the need for stricter guidelines and centralized control to effectively address the issue.
Dr. Dewan reiterated the importance of stringent regulations, public awareness campaigns, prescription audits, and antimicrobial stewardship programs to combat antibiotic resistance effectively. He emphasized the role of promoting hygiene, vaccination, and proper diagnosis in reducing unnecessary antibiotic consumption and safeguarding public health.
### Impact on Public Health and Regulatory Framework
The government’s decision to centralize manufacturing approvals is expected to enhance regulatory oversight, improve surveillance, and foster the development of new antibiotics. Arushi Jain, Director at Akums Drugs & Pharmaceuticals Ltd., lauded the move as a step towards harmonizing India’s regulatory framework with international standards, facilitating global collaboration in the fight against AMR.
Amid concerns about over-the-counter availability of antibiotics, pharmacy lobby AIOCD has taken steps to educate chemists on the importance of dispensing medicines only with a valid prescription. With strict government controls on certain antibiotics, including Schedule H and H1 medicines, efforts to regulate sales and promote responsible antibiotic use are crucial in combating resistance effectively.
As India continues to grapple with the challenges posed by antimicrobial resistance, the centralization of manufacturing approvals marks a significant step towards safeguarding public health and promoting sustainable antibiotic use. By aligning with global best practices and fostering collaboration, India aims to tackle the antibiotic crisis head-on, ensuring a safer and healthier future for its citizens.
