USFDA issues 1 observation for Granules Pharma USA facility

Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation after a Pre-Approval Inspection (PAI) for a first to
file controlled substance ANDA at the facility of Granules Pharmaceuticals, Inc., a wholly-owned
foreign subsidiary of the Company located in Chantilly, Virginia, USA.

The facility was inspected from 23rd June 2025 to
27th June 2025.

“Granules Pharmaceuticals, Inc. addressed and resolved
the observation during the inspection,” the Company stated in a BSE filing.

Read also: Granules India Bonthapally API facility gets 1 USFDA observation

Granules products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US, and UK. The Company has 10 manufacturing facilities out of which 8 are in India and 2 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC, and HALAL.

Read also: Granules India successfully closes acquisition of Swiss based CDMO Senn Chemicals

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Tamil Nadu to Launch Siddha-Based Fertility Clinic

Chennai: In a move to integrate traditional and modern healthcare, the Tamil Nadu Health Department will soon launch fertility clinics based on Siddha medicine on a pilot basis at the Government Siddha Hospital in Chennai. The initiative was announced by Health Minister Ma Subramanian during an event commemorating International Yoga Day. 

The announcement comes in the wake of rising infertility rates and the growing demand for affordable, holistic, and accessible fertility care. Tamil Nadu has already established three allopathic fertility clinics in Chennai, Coimbatore, and Salem to address this public health challenge.

Also Read: Infertility clinic to be set up at Dr Ram Manohar Hospital

Speaking to TOI, he said, “I read an article by a doctor from this institution who said textbooks of siddha medicine, written centuries ago, prescribe drugs to solve infertility. We will soon start a siddha clinic for fertility on this campus.”

In addition to the fertility clinic initiative, the government is also reviving its efforts to establish a dedicated Siddha medical university. Although the Tamil Nadu Siddha Medical University Bill, 2022, was previously tabled in the legislative assembly, it was later withdrawn. The government has now announced plans to introduce fresh legislation aligned with the provisions of the National Commission for Indian System of Medicine Act.

In 2021–2022, the state government announced plans to create a separate university for Siddha medicine. A bill to this effect was passed by the Tamil Nadu Legislative Assembly on April 28, 2022, and sent to the Governor for assent. However, the Raj Bhavan forwarded the bill to the President of India.

Also Read: Infertility Clinics Set Up at Nanded Government Hospitals

According to TOI, the Centre said certain provisions of the Tamil Nadu Siddha Medical University Bill, 2022, are not in accordance with the National Commission for Indian System of Medicine Act, 2020. “We will place the new bill in the coming assembly session,” Subramanian said.

Tamil Nadu is currently the only state in India with government-run colleges for all five streams of Indian medicine and homoeopathy. The state government has also announced plans to fill existing doctor vacancies in these streams.

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Haryana CM announces Free Treatment at District Hospitals from August 15

Kurukshetra: In a move to strengthen the public healthcare system, Haryana Chief Minister Nayab Singh Saini announced that beginning August 15, free treatment for all diseases will be made available at one government hospital in each district headquarters across the state. 

Speaking during a visit to the villages of Kishanpura and Girdarpur, CM Saini said these designated hospitals will be modernised and fully equipped, and will also offer services under the Ayushman Bharat scheme. He also visited Ban, Behlolpur, and Jalkheri villages, interacting with local residents.

To streamline patient referrals, the government will establish committees at these hospitals to evaluate cases requiring transfer to higher medical centres such as PGI Chandigarh or other tertiary care institutions.

During his interactions at the community centre in Kishanpura and the Gurdwara hall in Girdarpur, CM Saini listened to local grievances and instructed relevant departments to take immediate action. He also participated in a tree plantation drive with villagers and announced a grant of Rs 21 lakh each for development works in both villages.

Also Read: 1090 Medical Officers get appointment letters in Haryana

According to TOI, responding to demands submitted by the sarpanch of Kishanpura and Girdarpur, Saini assured that all requests would be fulfilled through relevant departments. He emphasised his deep connection with the Ladwa constituency, saying, “It is because of the people of Ladwa that I am the chief minister. Today, Ladwa holds a special place in Haryana’s development vision.”

He highlighted that over ₹110 crore worth of development projects are underway in the constituency and praised district officials for their responsiveness to public issues.

CM Saini invited people to freely submit their grievances in writing to DC Neha Singh, other local officials, or the CM’s office. He added that in case of an emergency, people are welcome to come and meet him in Chandigarh.

Also Read: 700-bed Civil hospital coming up in Gurugram, Health Minister reviews progress

The event was attended by key officials, including CM Office In-Charge Kailash Saini, Kurukshetra Deputy Commissioner Neha Singh, Superintendent of Police Nitish Aggarwal, local sarpanches, and other community leaders.

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Mifepristone Significantly Lowers HbA1c in Type 2 Diabetes with Hypercortisolism: Study

Researchers have discovered in a randomized placebo-controlled trial that mifepristone (Korlym) led to a significant reduction in HbA1c levels in patients with poorly controlled type 2 diabetes and hypercortisolism. The findings of the study were presented at the ADA annual meeting. The study was published in Diabetes Care by Ralph A. and colleagues.

Hypercortisolism, a frequently underappreciated cause of inadequate glycemic control, occurred in most patients in spite of being on several diabetes medications. Aiming to intervene on the glucocorticoid receptor, investigators sought to determine whether controlling cortisol action could enhance diabetic outcomes in cases where conventional treatment has not succeeded.

The study enrolled 136 participants aged 18 or older with established type 2 diabetes (HbA1c between 7.5% and 11.5%, equivalent to 58–102 mmol/mol) who were already on multiple glucose-lowering medications but had inadequate glycemic control. All participants demonstrated biochemical evidence of hypercortisolism based on dexamethasone suppression testing. Subjects were randomized in a 2:1 ratio to receive either mifepristone (91 participants) or placebo (45 participants) once daily for 24 weeks. Stratification was according to whether or not participants had an abnormality on adrenal imaging.

Key Findings

 • At baseline, mean HbA1c in the total cohort was 8.55% (69.9 mmol/mol). At 24 weeks of treatment:

• The mifepristone arm had a placebo-adjusted decrease in HbA1c of −1.32% (95% CI: −1.81 to −0.83; P < 0.001), indicating substantial glycemic improvement.

• Patients who were given mifepristone lost a mean of 5.12 kg (95% CI: −8.20 to −2.03) body weight and 5.1 cm waist circumference (95% CI: −8.23 to −1.99).

• In the users of mifepristone, 46% stopped therapy, primarily because of adverse effects, as was 18% in the placebo group.

• Nineteen participants had an adverse event.

• Common side effects occurring in over 10% of participants on mifepristone were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea, and dizziness.

• There were also increases in blood pressure among some participants, which is in agreement with the established pharmacological profile of the drug.

Among patients with poorly controlled type 2 diabetes and biochemical hypercortisolism, mifepristone treatment for 24 weeks substantially decreased HbA1c, body weight, and waist size. In spite of a significant frequency of therapy discontinuation because of side effects, the tolerability profile was as expected for the drug.

Reference:

Ralph A. DeFronzo, Vivian Fonseca, Vanita R. Aroda, Richard J. Auchus, Timothy Bailey, Irina Bancos, Robert S. Busch, John B. Buse, Elena A. Christofides, Bradley Eilerman, James W. Findling, Yehuda Handelsman, Steven E. Kahn, Harold J. Miller, Jonathan G. Ownby, John C. Parker, Athena Philis-Tsimikas, Richard Pratley, Julio Rosenstock, Michael H. Shanik, Lance A. Sloan, Guillermo Umpierrez, Samir Shambharkar, Iulia Cristina Tudor, Tina K. Schlafly, Daniel Einhorn, CATALYST Investigators; Inadequately Controlled Type 2 Diabetes and Hypercortisolism: Improved Glycemia With Mifepristone Treatment. Diabetes Care 2025; dc251055. https://doi.org/10.2337/dc25-1055

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Both Fenofibrate and Curcumin Improve Lipid and Inflammatory Markers in Type 2 Diabetes: Study

A new study published in the journal of BMC Pharmacology and Toxicology showed that both fenofibrate and curcumin effectively reduce lipid levels and improve inflammation in type 2 diabetes patients. However fenofibrate may offer additional benefits by more significantly reducing waist circumference, lowering fetuin-A levels, and increasing sirtuin levels.

One known risk factor for the onset of cardiovascular disease is type 2 diabetes. It was discovered that fenofibrate and curcumin were useful in reducing hyperlipidemia in diabetic individuals. This study compared the effects of adding fenofibrate against curcumin on weight, lipid profile, glycemic status, fetuin-A, high-sensitivity C-reactive protein (hs-CRP), and sirtuin 1, in patients with type 2 diabetes receiving glimepiride,.

3 groups of 60 individuals with type 2 diabetes mellitus were randomly assigned in this trial, where Group I received a placebo, Group II received 1100 mg of curcumin, and Group III received 160 mg of fenofibrate, all taken orally once daily. Glimepiride 4 mg was given orally once daily for three months.

The patients between the ages of 35 and 70, those with uncontrolled type 2 diabetes, those with hyperlipidemia, and those receiving glimepiride 4 mg were all eligible to participate. Other forms of diabetes, pregnancy, bad liver or kidney function tests, taking other anti-diabetic drugs, and non-adherence to treatment were among the exclusion criteria.

Anthropometric measures were taken at baseline and three months into the intervention, and blood samples were taken for biochemical examination of lipid profile, fetuin-A, sirtuin 1, glycated hemoglobin (HbA1c), blood glucose, hs-CRP, and fetuin. The body mass index, weight, two-hour postprandial glucose (2 h-PPG), fasting blood glucose, and HbA1c did not significantly differ among the three groups when compared 3 months after the intervention (p > 0.05).

The fenofibrate (p < 0.001) and curcumin (p < 0.05) groups showed significant reductions in triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), coronary risk index (CRI), atherogenic index (AI), and hs-CRP, while also increasing sirtuin 1.

The group that received fenofibrate had considerably greater levels of HDL-C than the group that received a placebo (p < 0.001). Also, fenofibrate significantly decreased waist circumferences and fetuin-A and elevated sirtuin 1 (p < 0.05) in comparison to curcumin.

Overall, in individuals with type II diabetes receiving glimepiride, the current trial demonstrated the significant advantages of adding fenofibrate as opposed to curcumin. When combined with glimepiride treatment, both medications improved the lipid profile, inflammatory markers, and glycemic picture.

Source:

Nada, E. M., El-Gharbawy, N. M., Abbas, H., & Werida, R. H. (2025). Effect of adding fenofibrate versus curcumin to glimepiride in patients with type 2 diabetes: a randomized controlled trial. BMC Pharmacology and Toxicology, 26(1), 119. https://doi.org/10.1186/s40360-025-00950-y

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Higher Hb levels with RBC transfusion does not offer benefits in patients with MI and anemia: JAMA

A new study published in the Journal of American Medical Association found that in patients with myocardial infarction (MI) and anemia, higher hemoglobin levels maintained by RBC transfusion could not significantly improve overall quality of life.

Anemia and MI both negatively impact health-related quality of life (QOL). By reducing symptoms and/or enhancing functional ability, red blood cell (RBC) transfusion may enhance quality of life following MI. This study was set to determine if patients with MI and anemia’s quality of life is impacted by a liberal transfusion approach as opposed to a more limited transfusion strategy.

The participants from 144 locations across 6 countries participated in the Myocardial Ischemia and Transfusion (MINT) experiment, a randomized clinical trial comparing a liberal vs. limited RBC transfusion approach, and QOL was analyzed as a predetermined secondary endpoint. Hospitalized individuals with anemia (hemoglobin [Hb] <10 g/dL) with acute MI.

This study includes patients who had QOL data gathered and those who passed away prior to the 30-day follow-up period, out of the 3504 patients who were randomized in the MINT experiment. Between April 2017 and April 2023, data were gathered, and between February 2024 and January 2025, they were examined. Patients in the MINT study were randomly assigned to either a liberal (Hb of less than 10 g/dL) or restrictive (Hb of 7 to 8 g/dL) RBC transfusion approach.

The mean (SD) age of the 2844 included patients was 71.9 (11.5 years), with 1551 (54.5%) being male. 319 (11.2%) of the 2525 individuals with QOL data passed away before to the 30-day follow-up. At 30 days after randomization, the mean and median scores for all EQ-5D-5L QOL outcomes did not differ amongst the allocated transfusion techniques.

Despite the fact that a greater proportion of patients in the liberal transfusion group than the restrictive group reported no problems at all in the domains of self-care (858 of 1271 [67.5%] vs 803 of 1254 [64.0%]), mobility (474 of 1270 [37.3%] vs 460 of 1254 [36.7%]), and usual activities (506 of 1268 [39.9%] vs 473 of 1247 [37.9%]), none of these differences were statistically significant.

There was no correlation between mean differences in any QOL outcome and the assigned transfusion technique, according to adjusted mixed-effects linear regressions. A liberal transfusion approach was linked to higher QOL scores in functional capacity domains, according to adjusted regressions in a number of predefined subgroups.

However, the effects were only statistically significant in patients who had previously experienced heart failure (Health Today rating: β, 2.06 [95% CI, −0.23 to 4.35] vs −1.44 [95% CI, −3.81 to 0.92]; P =.04). Overall, based on this study, individuals with MI and anemia may not have a discernible improvement in their overall quality of life from increased Hb levels maintained by RBC transfusion.

Source:

Prochaska, M. T., Portela, G. T., Brooks, M. M., Fergusson, D. A., Hébert, P. C., Polonsky, T. S., Caixeta, A., Cooper, H. A., Crozier, I., Daneault, B., Kim, S., Bainey, K. R., de Barros E Silva, P., Goldfarb, M., Gupta, R., Rao, S. V., Fonteles Ritt, L. E., Simon, T., & Carson, J. L. (2025). Transfusion strategy effect on quality of life in patients with myocardial infarction and anemia: A secondary analysis of the MINT randomized clinical trial. JAMA Internal Medicine. https://doi.org/10.1001/jamainternmed.2025.0654

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Leafy greens could be good for the heart, suggests study

A cup and a half of leafy green vegetables could go a long way to addressing atherosclerotic vascular diseases (ASVD’s), new research from Edith Cowan University (ECU), the University of Western Australia and the Danish Cancer Institute has found.

ASVDs are a subgroup of cardiovascular disease, which are current leading causes of death world-wide, primarily due to heart attacks and strokes. ECU PhD student Ms Montana Dupuy noted that in Australia, cardiovascular diseases claim the life of one person every 12 minutes.

Research led by Ms Dupuy has found that the higher dietary intake of Vitamin K1 could reduce the risk of ASVD.

“Leafy green and cruciferous vegetables, like spinach, kale and broccoli, contain Vitamin K1 which may assist in preventing vascular calcification processes that characterise cardiovascular disease. The great news is that these vegetables can be easily incorporated into your daily meals” she said.

In addition to its’ potential role in vascular calcification inhibition, Vitamin K may also be beneficial for musculoskeletal health, through its impact on bone strength.

ECU Senior Research Fellow Dr Marc Sim noted that a cup and a half of such vegetables is an easy way to increase our daily vitamin K intake and may lower our risk for cardiovascular disease”.

“This research found women who consumed approximately 30% higher intakes of Vitamin K1 than currently recommended in the Australian Dietary Guidelines had lower long-term risk of ASVD,” he said.

“Of importance, when we examined the blood vessels in the neck, those with a higher Vitamin K1 intake also had less thickening of these blood vessels, a marker of atherosclerosis.”

The work led by Ms Dupuy and Dr Sim on the impact of Vitamin K to vascular health, as well as musculoskeletal health, will now help to inform future research at ECU’s Future Foods and Digital Gastronomy Lab and to deliver specialised meals as part of clinical trials to improve population health.

“This research has provided key evidence to support our future studies. We are now creating new foods which pack more leafy greens that are rich in Vitamin K1. These novel foods can be used in communities with special nutritional and dietary requirements, such as aged care residents,” said ECU Post Doctoral Research Fellow Dr Liezhou Zhong.

“We are consolidating all our epidemiological data and converting that into a tangible product that would benefit the community,” he added.

Reference:

Dupuy, M., Zhong, L., Radavelli-Bagatini, S. et al. Higher vitamin K1 intakes are associated with lower subclinical atherosclerosis and lower risk for atherosclerotic vascular disease-related outcomes in older women. Eur J Nutr 64, 171 (2025). https://doi.org/10.1007/s00394-025-03686-x.

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Hyperbaric Oxygen Therapy Shows Lasting Relief for Radiation-Induced Cystitis: 5-Year RICH-ART Trial Results

Sweden: Researchers have revealed that hyperbaric oxygen therapy (HBO2) can offer sustained relief from symptoms of chronic radiation-induced cystitis for up to five years, according to a long-term follow-up of the RICH-ART trial published in eClinicalMedicine. The study, led by Dr. Nicklas Oscarsson from the University of Gothenburg, adds important new insights into the durability of the therapeutic effects of HBO₂.

Radiation-induced cystitis is a distressing complication that affects about 5–10% of patients who undergo pelvic radiotherapy for cancers such as prostate, bladder, or cervical cancer. Common symptoms include blood in the urine, urgency, frequency, and painful urination—all of which can severely impact a patient’s quality of life. While HBO₂ has been known to improve symptoms in the short term, evidence regarding its long-term efficacy has been limited.

The RICH-ART trial was a multicentre, open-label phase 2–3 study carried out across five Nordic hospitals in Sweden, Norway, Denmark, and Finland. It included patients aged between 18 and 80 years who had completed pelvic radiotherapy at least six months prior and had persistent bladder symptoms. Participants were randomly assigned to receive either HBO₂ therapy—30 to 40 daily sessions of 100% oxygen at high pressure—or standard care. Patients in the control group were later offered HBO₂.

The study led to the following findings:

  • The five-year follow-up included 70 patients who had received hyperbaric oxygen therapy (HBO₂).
  • Average urinary symptom scores improved by 18 points at six months post-treatment.
  • At five years, the improvement remained stable, with a 19.1-point increase from baseline.
  • Approximately 69% of patients (48 out of 70) experienced significant and sustained improvement, showing a mean increase of 22.9 points.
  • The remaining 31% (22 patients) showed little to no symptom improvement even after five years.
  • Only 12.8% of patients required repeat HBO₂ therapy due to the recurrence of symptoms.
  • Adverse events were documented only during the HBO₂ treatment period.
  • There were no new safety concerns during the long-term follow-up.

The findings not only reinforce the long-term efficacy of HBO₂ in managing chronic radiation cystitis but also underline the need for further research. “This is the first study to report five-year outcomes, offering vital data on the lasting impact of this therapy,” the authors stated. They suggest that HBO₂ could become a more widely adopted component of standard care, though further studies are needed to refine treatment protocols, assess economic viability, and identify predictors of treatment response.

The authors concluded, “The RICH-ART trial provides compelling evidence that HBO₂ can deliver durable symptom relief for patients suffering from radiation-induced bladder complications. As researchers continue to investigate optimal dosing and patient selection strategies, HBO₂ stands out as a promising and effective treatment option for improving long-term quality of life in this population.”

Reference: https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00146-4/fulltext

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15 Drugs Including Pomol-650, Glimiz-2 Banned in Karnataka, Check Full List

Bengaluru: In a move to protect public health, the Karnataka Government’s Drug Testing Laboratory has declared 15 drugs manufactured by 14 companies as “Not of Standard Quality”.

Authorities have issued an urgent directive to chemists, wholesalers, doctors, hospitals, and nursing homes, instructing them not to stock, sell, or use the listed drugs. Those already in possession of these products are required to intimate the concerned area Drugs Inspector or Assistant Drugs Controller. The public has also been strongly advised not to use these medicines.

Some of the notable substandard drugs include Compound Sodium Lactate Injection IP (Ringer-Lactate solution for injection) manufactured by Ultra Laboratories, Otsuka Pharmaceuticals India and Tam Bran Pharmaceuticals, Pomol-650 (Paracetamol Tablets IP 650 mg) by Aban Pharmaceuticals, and MITO Q7 Syrup by Bion Therapeutics India.

The list also includes Glimiz-2 (Glimepiride tablets IP 2mg) manufactured by Knm Pharma, Iron Sucrose Injection USP 100 mg (Irogain) manufactured by Regain Labs.

 

 

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Akums Gets CDSCO Panel Nod for BE Study of Rizatriptan-Meloxicam FDC, Told to Revise Phase III Protocol

New Delhi: In response to the proposal presented by the Akums Drugs & Pharmaceuticals along with BE and Phase III clinical trial protocol of the fixed dose combination (FDC) Rizatriptan Benzoate plus Meloxicam IP 20mg uncoated orally disintegrating Tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended for grant of permission to conduct the BE study of the proposed drug.

In addition, the committee opined that placebo should not be used as a comparator and patient with frequency of migraine attack more than 2 in a month should be included in inclusion criteria and above mentioned criteria for 6 months prior to starting study and patients on Prophylaxis medication should not be included in the study and same may be mentioned in the exclusion criteria.

Also, the committee recommended the firm to submit BE study report along with revised Phase III clinical trial protocol to CDSCO for further review by the committee.

This came after the firm presented the proposal along with BE & Phase III clinical trial protocol before the committee.

Meloxicam and rizatriptan combination is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches and is not used for cluster headaches. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID).

Rizatriptan is used to treat migraine headaches (severe, throbbing headaches that sometimes cause nausea and sensitivity to sound and light). Rizatriptan is in a class of medications called selective serotonin receptor agonists.

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis (juvenile rheumatoid arthritis, osteoarthritis, and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain.

At the recent SEC meeting for Neurology and Psychiatry held on 18th June 2025, the expert panel reviewed the proposal along with BE & Phase III clinical trial protocol before the committee.

After detailed deliberation, the committee recommended for grant of permission to conduct the BE study.

As regard to Phase III clinical trial protocol, the committee opined that:

1. Placebo should not be used as a comparator.

2. Patient with frequency of migraine attack more than 2 in a month should be included in inclusion criteria and above mentioned criteria for 6 months prior to starting study.

3. Patients on Prophylaxis medication should not be included in the study and same may be mentioned in the exclusion criteria.

“Accordingly, the firm should submit BE study report along with revised Phase III clinical trial protocol to CDSCO for further review by the committee,” the panel noted.

Also Read: Biocon Gets CDSCO Panel Nod to Market Trastuzumab PGS in India

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