Govt may mandate QR codes on vaccines, key drugs to curb counterfeits
Vaccines
, antimicrobials, narcotic drugs and psychotropic substances, and additional
cancer drugs
would have to mandatorily print or affix bar codes or quick response (QR) codes on their labels. This follows the government mulling the possibility of bringing them under Schedule H2 of Drug Rules to track their movement to curb counterfeiting.
Additionally, the government is considering inclusion of details of excipients on every medicine strip for 300 drug formulations that are under Schedule H2. Currently, the labels declare only those active substances added in the formulation.
An excipient is a constituent of a medicine other than the active substances, added in the formulation for a specific purpose. While most excipients are considered inactive, some can have a known action or effect in certain circumstances.
"The
Drug Controller General of India
(DCGI) will hold a meeting this week to deliberate on both the issues," people in the know told ET.
Earlier the drug regulatory authority had included a few cancer drugs to help validate the authenticity of medicines following incidents of refilling of expensive anti-cancer drugs with
counterfeit drugs
. It came to light that criminals in collusion with hospital pharmacies were found refilling empty vials of expensive anti-cancer medicines with counterfeit drugs. These fake drugs were then mixed with genuine stocks and sold to unsuspecting cancer patients, putting their lives at risk.
Live Events
In a bid to weed out spurious drugs, the regulator had made it mandatory for companies to have a barcode on the top 300 brands, so that information such as manufacturing licence and batch number can be accessed upon scanning. These drugs included widely-used analgesics, pain relievers, anti-platelet, vitamin supplements, blood-sugar lowering medicines and contraceptive tablets.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Economic Times
2 days ago
- Economic Times
India clears Roche's 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition
Synopsis Roche has received clearance to import and market Atezolizumab injection (Tecentriq) for subcutaneous administration in India, potentially reducing cancer treatment time and costs. The approval, granted by a technical committee, requires Roche to conduct a Phase IV clinical trial in India. This new route offers a faster, more convenient option for patients, with administration possible outside of hospitals. Roche Gets Approval to Import Key Cancer Injection for Domestic Mkt New Delhi: The technical committee constituted for supervising clinical trials on new chemical entities has cleared Swiss drug major Roche to import and market cancer drug Atezolizumab injection (Tecentriq) through subcutaneous (SC) route-under the skin injection for Indian decisions is expected to provide relief to patients in the contry as the new subcutaneous injections will cut treatment time to nearly seven minutes from the 30-60 minutes in the standard intravenous (IV) infusion, besides saving on costs. The panel's permission has been given with a condition that the company would conduct a Phase IV clinical trial in India. "Switching from intravenous (IV) to subcutaneous (SC) administration of Atezolizumab can potentially reduce costs due to decreased healthcare professional time and improved patient convenience," a government official told ET. "Tecentriq may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home," he added. Atezolizumab is an immunotherapy called an immune checkpoint inhibitor, which blocks the immune system's natural brakes to help immune cells fight technical committee under the Director General of Health Services (DGHS) was formed in 2013 following the directions of the Supreme a recent meeting, Roche presented the proposal for grant of permission to import and market the drug product Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for subcutaneous administration for the following indications with the request of local Phase III clinical trial waiver and commitment to conduct a Phase IV trial in is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. It is a monotherapy for the first line treatment of patients of metastatic committee noted the pharmacokinetic-pharmacodynamic or PK/PD results of Asian & non-Asian population from the global clinical study for the ethnic differences in the PK parameters in the study. The committee further noted that firm has received the USFDA approval for the SC route on committee also asked the company to submit Phase IV clinical trial protocol to CDSCO within three months of grant of marketing authorisation.
Time of India
2 days ago
- Time of India
India clears Roche's 7-minute cancer injection Tecentriq for patients, with Phase IV trial condition
New Delhi: The technical committee constituted for supervising clinical trials on new chemical entities has cleared Swiss drug major Roche to import and market cancer drug Atezolizumab injection ( Tecentriq ) through subcutaneous (SC) route-under the skin injection for Indian patients. The decisions is expected to provide relief to patients in the contry as the new subcutaneous injections will cut treatment time to nearly seven minutes from the 30-60 minutes in the standard intravenous (IV) infusion, besides saving on costs. The panel's permission has been given with a condition that the company would conduct a Phase IV clinical trial in India. "Switching from intravenous (IV) to subcutaneous (SC) administration of Atezolizumab can potentially reduce costs due to decreased healthcare professional time and improved patient convenience," a government official told ET. "Tecentriq may be administered by a healthcare professional outside of the hospital, in a community care setting or at a patient's home," he added. Atezolizumab is an immunotherapy called an immune checkpoint inhibitor, which blocks the immune system's natural brakes to help immune cells fight cancer. The technical committee under the Director General of Health Services (DGHS) was formed in 2013 following the directions of the Supreme Court. In a recent meeting, Roche presented the proposal for grant of permission to import and market the drug product Atezolizumab injection (Tecentriq®) 1875 mg/15 mL vial for subcutaneous administration for the following indications with the request of local Phase III clinical trial waiver and commitment to conduct a Phase IV trial in India. Atezolizumab is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. It is a monotherapy for the first line treatment of patients of metastatic NSCLC. The committee noted the pharmacokinetic-pharmacodynamic or PK/PD results of Asian & non-Asian population from the global clinical study for the ethnic differences in the PK parameters in the study. The committee further noted that firm has received the USFDA approval for the SC route on 12.09.2024. The committee also asked the company to submit Phase IV clinical trial protocol to CDSCO within three months of grant of marketing authorisation.
Time of India
3 days ago
- Time of India
Anti-aging and stem cell research gains momentum in India's healthcare sector
The landscape of health and longevity in India is witnessing a quiet but profound transformation, driven by advancements in regenerative medicine, particularly stem cell research. What was once considered a speculative area of science is now demonstrating tangible results, fostering a new perspective on aging not merely as an inevitable decline but as a process amenable to management and enhancement. This evolving narrative is being shaped by both personal anecdotes and rigorous clinical exploration, signaling a pivotal moment in the nation's healthcare trajectory. The deeply personal experience of a wealthy industrialist's family has, for instance, illuminated the potential of these advanced therapies. Following the untimely demise of his 71-year-old brother due to a cardiac event, the younger sibling, then 65, embarked on a deliberate quest for healthy aging. This journey led him to embrace cellular therapy as an annual regimen, often necessitating travel abroad for access to these specialized treatments. At 75, he not only maintains a remarkably active lifestyle but has also strategically invested in numerous biotechnology and stem cell research ventures, underscoring his conviction in their potential. His personal narrative has become a catalyst for broader discussions on how advanced therapies can contribute not just to extended lifespans but crucially, to an enhanced quality of life in later years. Echoing these individual successes, India itself is beginning to generate its own compelling case studies. A notable example is that of Mr. Pathak, a resident of Kanpur, who had grappled with uncontrolled diabetes for many years. Enrolled in a clinical program at GSVM Medical College, Pathak underwent a transplant utilizing adipose-derived stem cells adipose derived cellular concentrate. The outcome proved remarkable, exceeding even his own expectations. His HbA1c, a vital marker for long-term blood sugar control, saw a significant reduction from 9.5 to 6.5, achieved without substantial alterations to his existing medication regimen. This particular procedure was meticulously guided by Dr. B.S. Rajput , a visiting professor at GSVM Medical College and a distinguished consultant in orthopedic and cellular transplants. Dr. Rajput elucidated the methodology, stating, 'We carried out this cellular therapy using an Australian patented ultrasonic cavitation technology. This approach holds approval from the Drug Controller General of India for the management of pain in arthritis-affected knees.' He further emphasized a critical, often underestimated, aspect of healthy aging: 'When people can move without pain, their overall health outcomes improve significantly. Mobility is one of the most underrated factors in healthy aging. ' This highlights the intricate connection between pain management, mobility, and overall well-being in the aging process. The broader wellness and regenerative medicine industry in India is keenly observing these developments. Rajiv Chaturvedi, Vice President of Umbicell Pvt Ltd, a Mumbai-based healthcare firm, affirmed the accelerating awareness surrounding healthy aging. 'The next decade unequivocally belongs to wellness and longevity science. We are witnessing a greater societal acceptance of stem cell enhancers and joint health supplements, integrating them into everyday healthcare practices,' Chaturvedi commented. This indicates a growing consumer appetite and market readiness for innovative solutions in this domain. Beyond its foundational role in pain management, stem cell therapy's applications are progressively expanding. Researchers and clinicians are now exploring its efficacy for conditions once deemed intractable, including severe spinal cord injuries, debilitating muscular dystrophies, and even cerebral palsy in children. Dr. Rajput elaborated on these burgeoning areas: 'We are witnessing positive outcomes in cases once thought to have limited treatment options. While these remain closely monitored and clinically guided, the results offer substantive hope for a significantly improved quality of life for patients,' This expansion into complex neurological and musculoskeletal disorders underscores the transformative potential of regenerative approaches. Concurrently, research interest is branching into related, yet equally vital, areas such as gut health, which is increasingly recognized for its profound links to immunity and metabolic function. Varun Singh, Director of Scigenomics Pvt Ltd, a Navi Mumbai-based genomics and stem cell research laboratory, highlighted this symbiotic relationship. 'Gut wellness is emerging as a cornerstone of comprehensive anti-aging strategies. Our extensive microbiome testing work across Southeast Asia is instrumental in identifying precisely how gut bacteria influence not only digestion but also broader patterns of overall health and aging.' Singh stated. This interdisciplinary approach, integrating genomics and gut microbiome analysis, represents a holistic strategy toward understanding and mitigating the effects of aging. Globally, the anti-aging industry is projected to exceed USD 90 billion by the year 2030. India is poised to be a significant contributor to this substantial growth, propelled by its expanding middle class, increasing disposable incomes, and the continuous evolution of its healthcare infrastructure. While present challenges such as the high cost of therapies and limited accessibility remain pertinent, experts anticipate that wider adoption will naturally lead to reduced costs as research scales up and the underlying technologies mature, fostering greater affordability and reach. For the present, success stories like Pathak's remarkable improvement in diabetic control and the businessman's sustained vitality and activity well into his seventies are instrumental in reshaping public perception of longevity in India. These individual triumphs, synergistically combined with the rapid advancements in regenerative medicine, are fueling a more expansive public discourse. This conversation centers on aging not as an inevitable slide into infirmity but as a dynamic process that, with scientific intervention and responsible choices, can be actively managed for a better future. Dr. Rajput distilled the emerging philosophy succinctly. He commented, 'The science is ready, and awareness is unequivocally growing. If individuals approach these treatments responsibly, integrating prevention alongside therapy, then the goal of living longer, healthier, and more fulfilling lives can indeed become a realistic and attainable objective.' This forward-looking perspective underscores a shift from merely extending lifespan to fundamentally enhancing the quality of those additional years through informed and proactive health management. The above is non-editorial content and TIL does not guarantee, vouch or endorse any of it. Please take all steps necessary to ascertain that any information and content provided is correct, updated, and verified.
