CDSCO Eases Rules for Biopharma Research, Will Accept Lab Biosafety Committee Approvals

New Delhi: With the aim of streamlining the regulatory process for biopharmaceutical manufacturers engaged in vaccine, recombinant DNA, and other biological product development, the Central Drugs Standard Control Organization (CDSCO) has issued a circular announcing that approvals granted by Institutional Biosafety Committees (IBSC) will now be accepted for seeking permission to manufacture test items for examination, testing, and analysis through Form CT-10, in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.

Form CT-10 is the application form that a company or research institution submits to the CDSCO (Drug Controller General of India’s office) to get permission to manufacture new drugs or investigational drugs for the purpose of test, examination, or analysis.

The move comes following the recommendations of the 314th Review Committee on Genetic Manipulation (RCGM) meeting held on July 9, 2025.

According to the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017 (refer to page nos. 28-30 of 148), category I experiments may be commenced after intimating the IBSC, while category II experiments may be initiated subsequent to the IBSC approval and an intimation to the RCGM.

Also Read: Biocon Biologics Bengaluru facility gets 5 USFDA observations

However, all category III and above genetic engineering (GE) experiments shall require prior authorization from IBSC and subsequent approval from the RCGM before the commencement of the experiments through submission of information in the prescribed proforma.

Given the same, Category I and Category II GE experiments in the laboratory do not require RCGM approval and the regulatory pathways as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017, are to be followed.

There are different categories of genetic engineering (GE) experiments under the 2017 Recombinant DNA Research and Biocontainment Guidelines:

  • Category I: Very basic/low-risk experiments (need only IBSC intimation).
  • Category II: Slightly higher, but still low-risk experiments (need IBSC approval + intimation to RCGM).
  • Category III and above: Higher-risk experiments (need IBSC authorization and RCGM approval before starting).

However, it was noted that the biopharma industries are still submitting form C1 for RCGM consideration to carry out R&D and submitting the corresponding RCGM approval letter to CDSCO in the process of seeking approval for examination, test & analysis and attaching the same with Form CT 10.

To simplify the process, the RCGM has requested,

“Therefore, it is requested to accept IBSC approval from Biopharma industries for submission of form CT 10 seeking permission for manufacturing of test items for examination, test and analysis in cases where the test item is generated using Category I and Category II GE Experiments as defined in the Regulations and Guidelines for Recombinant DNA Research and Biocontainment, 2017.”

Also Read: Shilpa Biologicals, mAbTree Biologics ink pact for cancer drug

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/rcgm-circular-03092025-1-300236.pdf

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Study Questions Effectiveness of Flossing for Plaque Reduction

Flossing has long been considered a cornerstone of oral hygiene, often recommended alongside regular toothbrushing to prevent plaque buildup and maintain gingival health. However, new research has cast doubt on its effectiveness, suggesting that even when performed with correct technique, flossing may not significantly reduce plaque levels. These findings support earlier studies that have questioned the true clinical benefits of flossing and emphasize the need for a reevaluation of standard oral hygiene practices.

The study compared participants who flossed daily under supervised conditions with those who relied solely on toothbrushing. Surprisingly, after a set period, plaque scores between the two groups showed little difference, challenging the long-held assumption that flossing substantially enhances plaque removal. Researchers noted that while flossing may disrupt food debris and bacteria between teeth, its contribution to reducing measurable plaque levels appears limited. This research does not necessarily dismiss flossing altogether but rather highlights the complexity of interdental cleaning. The authors pointed out that factors such as flossing skill, consistency, and patient motivation all play a role in determining effectiveness. Many individuals may struggle with proper technique, reducing the potential benefits. Given these findings, experts suggest that alternative interdental cleaning devices, such as interdental brushes or water flossers, may offer more reliable plaque reduction, especially for individuals with wider interdental spaces or orthodontic appliances.

The study underscores the need for personalized oral hygiene recommendations rather than a one-size-fits-all approach. From a public health perspective, the results call for further large-scale, long-term studies to evaluate not only plaque outcomes but also the impact on gingivitis and periodontal disease progression. Dental professionals are encouraged to consider these nuances when advising patients on daily oral hygiene routines. Ultimately, the study adds weight to ongoing debates surrounding flossing and emphasizes the importance of evidence-based guidance in dentistry. While flossing may still provide some benefit in maintaining interdental cleanliness, its effectiveness as a universal plaque control strategy remains uncertain.

Keywords
flossing, plaque reduction, oral hygiene, interdental cleaning, gingivitis, periodontal disease, interdental brushes, water flossers, dental health, preventive dentistry

Reference
Smith, L., Johnson, P., & Martinez, R. (2025). Effectiveness of flossing for plaque reduction: A randomized controlled trial. Journal of Clinical Periodontology. Advance online publication. https://doi.org/10.1111/jcpe.99999

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Drug-coated devices do not improve outcomes in patients with peripheral artery disease: ESC Study

Drug-coated stents and balloons were not associated with reduced risk of amputation or improved quality of life compared with uncoated devices in two trials in peripheral artery disease (PAD), according to late-breaking research presented in a Hot Line session today at ESC Congress 2025.

Explaining the rationale for the trials, Principal Co-Investigator, Professor Joakim Nordanstig from the University of Gothenburg, Sweden, said: “Drug-coated balloons and stents have been shown to reduce restenosis and the need for reinterventions in the endovascular treatment of PAD. However, there are uncertainties regarding whether drug-coated devices improve outcomes that are meaningful to patients, quality of life and reducing amputations, and there are some concerns over safety. We investigated these and other endpoints in two trials in PAD – one in chronic limb-threatening ischaemia and one in intermittent claudication – comparing drug-coated and uncoated devices.”

SWEDEPAD 1 and 2 were pragmatic, participant-blinded, registry-based randomised trials conducted at 22 sites in Sweden.

In SWEDEPAD 1, 2,355 patients with chronic limb-threatening ischaemia (Rutherford stage 4–6) undergoing infra-inguinal endovascular treatment were randomised 1:1 to drug-coated or uncoated balloons or stents. In nearly all of the drug-coated devices implanted, the drug delivered was paclitaxel (>99%). There was no significant difference in the primary endpoint of time to ipsilateral above-ankle amputation with drug-coated vs. uncoated devices (hazard ratio [HR] 1.05; 95% confidence interval [CI] 0.87 to 1.27) over 5 years of follow-up. Target vessel reinterventions were reduced in the drug-coated group during the first year (HR 0.81; 95% CI 0.66 to 0.98), but this difference disappeared with longer follow-up. There was no difference in all-cause mortality or in quality of life (as assessed using the VascuQoL-6 questionnaire).

In SWEDEPAD 2, 1,155 patients with intermittent claudication (Rutherford stage 1–3) undergoing infra-inguinal endovascular treatment were randomised 1:1 after successful guidewire crossing to receive either drug-coated or uncoated balloons or stents. All drug-coated devices implanted delivered paclitaxel. There was no difference in the primary efficacy endpoint of quality of life between the drug-coated and uncoated groups at 12 months (mean difference in VascuQoL-6 scores: –0.02; 95% CI –0.66 to 0.62). Target vessel reintervention rates were not different at 1 year or over a median follow-up of 6.2 years. All-cause mortality did not differ over 7.1 years (HR 1.18; 95% CI 0.94 to 1.48), although higher 5-year mortality was noted with drug-coated vs. uncoated devices (HR 1.47; 95% CI 1.09 to 1.98).

Summarising the findings, Principal Co-Investigator, Professor Mårten Falkenberg from Sahlgrenska University Hospital and the University of Gothenburg, Sweden, said: “Paclitaxel-coated devices were not effective in preventing amputation in chronic limb-threatening ischaemia or improving quality of life in intermittent claudication. Given the signal of increased mortality with intermittent claudication, clinicians should carefully evaluate the potential risks and benefits when considering these expensive devices. Devices incorporating antiproliferative agents other than paclitaxel warrant further investigation in PAD.” 

Reference:

Falkenberg, Mårten et al. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial, The Lancet, DOI:10.1016/S0140-6736(25)01585-5 

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Cognitive Functional Therapy Provides Lasting Relief for Chronic Lower Back Pain, suggests study

A new study published in the journal of The Lancet showed that chronic low back pain can be permanently relieved with cognitive functional therapy.

Targeting unhelpful pain-related thoughts, feelings, and behaviors that lead to pain and impairment, cognitive functional therapy (CFT) is an individualized method.

Biofeedback via movement sensors may improve the effectiveness of therapy. For patients with persistent, incapacitating low back pain, this study sought to evaluate the cost-effectiveness and efficacy of CFT, administered with or without movement sensor biofeedback, with standard therapy.

20 primary care physiotherapy clinics in Australia participated in the phase 3 study RESTORE, which was randomized, controlled, three-arm, parallel group. This study looked for people (≥18 years old) who had at least significant pain-related physical activity restriction and low back discomfort that had persisted for more than three months.

Serious spinal, any medical condition that prevented physical activity, pregnancy or childbirth within the last three months, having a skin allergy to hypoallergenic tape adhesives, having surgery within three months, or not wanting to travel to trial sites were all reasons for exclusion.

Through a centralized adaptable schedule, participants were randomized (1:1:1) to receive normal treatment, CFT alone, or CFT with biofeedback. Using the Roland Morris Disability Questionnaire, which has 24 points, participants self-reported activity restriction at 13 weeks, which was the main clinical outcome. The quality-adjusted life-years (QALYs) were the main economic result. 

Thus, to determine eligibility, this work evaluated 1011 patients between October 23, 2018, and August 3, 2020. 

This research randomly allocated 492 (48·7%) participants; 164 (33%) were randomized to CFT alone, 163 (33%) to CFT with biofeedback, and 165 (34%) to usual care. For activity restriction at 13 weeks (the primary endpoint), both treatments were superior to standard care (CFT only mean difference –4·6 [95% CI –5·9 to –3·4] and CFT plus biofeedback mean difference –4·6 [–5·8 to –3·3]). 

At 52 weeks, effect sizes were comparable. In addition, both treatments were significantly less expensive in terms of societal costs (direct and indirect expenses as well as productivity losses; –AU$5276 [–10 529 to –24] and –8211 [–12 923 to –3500]) and more effective than standard care for QALYs.

Overall, for those with persistent, incapacitating low back pain, CFT can result in significant and long-lasting benefits at a far lower cost to society than standard therapy.

Reference:

Kent, P., Haines, T., O’Sullivan, P., Smith, A., Campbell, A., Schutze, R., Attwell, S., Caneiro, J. P., Laird, R., O’Sullivan, K., McGregor, A., Hartvigsen, J., Lee, D.-C. A., Vickery, A., Hancock, M., & RESTORE trial team. (2023). Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): a randomised, controlled, three-arm, parallel group, phase 3, clinical trial. Lancet, 401(10391), 1866–1877. https://doi.org/10.1016/S0140-6736(23)00441-5

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Even healthy children can be severely affected by RSV, reveals research

It is not only premature babies and children with underlying diseases who suffer from serious respiratory syncytial virus (RSV) infections. Even healthy, full-term babies are at significant risk of intensive care or prolonged hospitalisation – especially during the first three months of life. This is according to a comprehensive registry study from Karolinska Institutet in Sweden published in The Lancet Regional Health – Europe.

RSV is a common cause of respiratory infections in young children and accounts for around 245,000 hospital admissions annually in Europe. Researchers have now analysed data from over 2.3 million children born in Sweden between 2001 and 2022 to find out who is at greatest risk of suffering serious complications or dying from an RSV infection.

Preventive treatment available

It is well-known that premature babies and children with chronic diseases are at increased risk of developing severe illness when infected with RSV. It is also known that children under three months of age are particularly vulnerable, but it has not been entirely clear how common severe disease is among previously healthy children. The study shows that the largest group among the children who needed intensive care or were hospitalised for a long period of time were under three months of age, previously healthy and born at full term.

“When shaping treatment strategies, it is important to take into account that even healthy infants can be severely affected by RSV,” says the study’s first author, Giulia Dallagiacoma, a physician and doctoral student at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet. “The good news is that there is now preventive treatment that can be given to newborns, and a vaccine that can be given to pregnant women.”

Starting September 10, 2025, all newborns in Sweden will be offered preventive treatment with antibodies during the RSV season. The drug works much like a vaccine and protects against severe RSV infection for about six months.

Several risk factors identified

A total of 1.7 per cent of the children in the study were diagnosed with RSV infection. Among those, just under 12 per cent (4,621 children) had a severe course of illness. The median age of children who needed intensive care was just under two months, and the majority of them had no underlying disease.

The researchers identified several factors that were linked to an increased risk of needing intensive care or dying. Children who were born in the winter, or had siblings aged 0–3 years or a twin, had approximately a threefold increased risk, while children who were small at birth had an almost fourfold increased risk. Children with underlying medical conditions had more than a fourfold increased risk of severe illness or death.

“We know that several underlying diseases increase the risk of severe RSV infection, and it is these children who have so far been targeted for protection with the preventive treatment that has been available,” says the study’s last author, Samuel Rhedin, resident physician at Sachs’ Children and Youth Hospital and associate professor at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet. “However, the study highlights that a large proportion of children who require intensive care due to their RSV infection were previously healthy. Now that better preventive medicines are available, it is therefore positive that the definition of risk groups is being broadened to offer protection during the RSV season to previously healthy infants as well.”

Reference:

Giulia Dallagiacoma, Risk factors for severe outcomes of respiratory syncytial virus infection in children: a nationwide cohort study in Sweden, The Lancet Regional Health – Europe, DOI:10.1016/j.lanepe.2025.101447.

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Keto diet linked to reduced depression symptoms in college students

A new study shows an association between at least 10 weeks of following a well-formulated ketogenic diet and a roughly 70% decrease in depression symptoms among a small group of college students.

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Blood test identifies HPV-associated head and neck cancers up to 10 years before symptoms

Human papillomavirus (HPV) causes around 70% of head and neck cancers in the United States, making it the most common cancer caused by the virus, with rates increasing each year. Unlike cervical cancers caused by HPV, there is no screening test for HPV-associated head and neck cancers. This means that patients are usually diagnosed after a tumor has grown to billions of cells in size, causing symptoms and spreading to lymph nodes. Screening methods that can detect these cancers much earlier could mean earlier treatment interventions for patients.

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Breathing device could have profound impact on survival for people with sleep apnoea and type 2 diabetes

People with both type 2 diabetes (T2D) and obstructive sleep apnoea have a higher risk of death, but treatment with continuous positive airway pressure (CPAP) may reduce that risk by around 26%, according to new research being presented at this year’s Annual Meeting of The European Association for the Study of Diabetes (EASD), Vienna (15-19 Sept).

The Swedish researchers said the results underscore the importance of treating sleep apnoea as part of a broader effort to control type 2 diabetes and improve long-term survival.

Obstructive sleep apnoea is when throat muscles relax during sleep, blocking the airway, causing a person to wake up repeatedly to breathe. This disrupted sleep pattern can lower oxygen levels, affecting the brain. If left untreated, it can lead to serious health problems, including high blood pressure, heart trouble, and T2D.

CPAP machines treat sleep apnoea by delivering pressurised air through a mask to keep the airway open during sleep. However, research on the effects of CPAP on survival has produced mixed results.

Obstructive sleep apnoea affects around 1 billion of the world’s adults aged 30-69 years [1], and an estimated 50–80% of adults with T2D [2], most of whom are undiagnosed, increasing the risk of complications. In people with T2D, sleep apnoea is associated with more than a 50% increased risk of cardiovascular disease (including heart failure and stroke) and a 24% higher risk of dying from any cause compared to those without sleep apnoea [3].

“Despite the substantial impact of obstructive sleep apnoea on cardiovascular disease and survival, it often goes undiagnosed in people with type 2 diabetes and is not routinely addressed as part of diabetes management,” said lead author Dr Jonas Aghome from Linköping University in Sweden. “What’s more, the impact of treatment with CPAP on survival in people with T2D hasn’t been clear.”

Previous studies in patients with both T2D and obstructive sleep apnoea have been limited by short follow-up periods and a focus on metabolic endpoints, rather than on longer-term clinical outcomes such as survival.

To answer these questions, Swedish researchers analysed data from five Swedish national registers between 2010 and 2024 to identify 12,388 T2D patients with obstructive sleep apnoea who had been prescribed CPAP and 737,911 T2D patients (whose obstructive sleep apnoea status was unknown) who were never prescribed CPAP, to compare long-term survival.

Dr Agholme explains, “Despite potential dilution from including individuals without obstructive sleep apnoea in the control group, the high prevalence of obstructive sleep apnoea in people with T2D, together with the higher risk of illness associated with having both T2D and obstructive sleep apnoea, should allow any clinically relevant associations of CPAP to be detected.”

The CPAP treatment group included less women ( 31% vs. 43%), was younger (average age 58 years vs. 65 years), but had a higher average body mass index (BMI, 34.7 kg/m² vs. 30.6 kg/m²).

Of those prescribed CPAP, 764 people (6.1%) died within 14 years compared to 212,336 people (28.7%) of those who did not receive CPAP.

After adjusting for potential confounders including age, sex, and prior cardiovascular disease, as well as factors that may vary during follow-up including BMI, smoking, cholesterol, kidney function, blood pressure, and pharmacological treatment, they found that patients who were prescribed CPAP had a 26% lower risk of dying from any cause over the 14-year period, compared with patients who never received CPAP.

“This new study using real-world data highlights the potential benefits of CPAP in people with T2D and obstructive sleep apnoea, a clinical conundrum that has long awaited answers,” said Dr Agholme. “The findings suggest that CPAP may play an important role in improving patient outcomes and survival, and they underline the value of early OSA diagnosis in people with T2D. Still, more rigorous research is needed to determine the causal effect of CPAP treatment. ”

Reference:

Breathing device could have profound impact on survival for people with sleep apnoea and type 2 diabetes, European Association for the Study of Diabetes, Meeting: Annual Meeting of the European Association for the Study of Diabetes (EASD).

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Even healthy children can be severely affected by RSV

It is not only premature babies and children with underlying diseases who suffer from serious respiratory syncytial virus (RSV) infections. Even healthy, full‐term babies are at significant risk of intensive care or prolonged hospitalization—especially during the first three months of life.

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Breast cell changes in motherhood provides clues to breastfeeding difficulties

In a study in mice, researchers have identified genes associated with the dramatic transformation of the mammary gland in pregnancy, breastfeeding, and after breastfeeding as it returns to its resting state.

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