Ranchi: Jharkhand Chief Minister Hemant Soren on Thursday emphasized the need to create an integrated health circuit connecting all medical colleges, hospitals, and district health facilities across the state to enhance healthcare services.

According to the PTI report, the proposed circuit would help shift patients from one hospital to another as per the need and it would reduce the pressure of patients in one health facility, he said.

The chief minister, in a review meeting with health department officials, said that providing the best facilities to the people of the state was his government’s commitment.

Soren directed the officials that all government hospitals in the state should be functional 24×7 and take the initiative to ensure that better and modern facilities are provided at community health centres and district hospitals.

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“Complaints of mismanagement in hospitals are often received through various mediums. Patients coming to hospitals for treatment face many problems. Some of them are not able to get beds in hospitals, while others face inconvenience in getting tests done. There is a crowd of patients in the OPD,” the CM said.

He also asked hospital authorities to strengthen capacity and infrastructure so that patients can easily access all information related to treatment, news agency PTI reported.

Expressing concern over the rising number of cancer patients, Soren asked officials to prepare a complete database of such people in the state so that his government can move forward to provide better treatment.

Medical Dialogues had earlier reported that Jharkhand Chief Minister Hemant Soren laid the foundation for a 310-bed multi-speciality hospital in the Smart City area of Ranchi. The facility, set to be developed by Apollo Hospitals Enterprises Limited, will occupy 2.75 acres of land provided free of charge by the Ranchi Municipal Corporation (RMC).  

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New Delhi: IQVIA has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a phase III clinical study of the antipsychotic drug Lumateperone.

This came after clinical research organization IQVIA presented Phase III clinical study protocol no. ITI-007-421, Amendment 1 dated 15 Mar 2024 (India Amendment #1 dated 24 Oct 2024). This is a multicenter study of Lumateperone for the treatment of bipolar depression in pediatric patients.

Lumateperone is a novel 2nd-generation antipsychotic used to manage both positive and negative symptoms in patients with schizophrenia.

Lumateperone is unique among second-generation antipsychotics based on its target profile and dopamine D2 receptor occupancy. Unlike other antipsychotics, lumateperone has partial agonist activity at presynaptic dopamine (D2) receptors, resulting in reduced presynaptic release of dopamine, and antagonistic activity at postsynaptic dopamine (D2) receptors. These characteristics allow lumateperone to efficiently reduce dopamine signaling.

Lumateperone also targets dopamine (D1) receptors, and a useful secondary result of D1 activation is increased glutamatergic N-methyl-D-aspartate (NMDA) GluN2B receptor phosphorylation. This is significant since NMDA-mediated glutamate signaling appears to be impaired in patients with schizophrenia.

Finally, lumateperone is capable of modulating serotonin by inhibiting serotonin transporters (SERT) and by behaving as a 5-HT2A receptor antagonist.

At the recent SEC meeting for Neurology and Psychiatry held on 12th December 2024, the expert panel reviewed the Phase III clinical study protocol no. ITI-007-421, Amendment 1 dated 15 Mar 2024 (India Amendment #1 dated 24 Oct 2024).

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.

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New Delhi: Considering the request for bioequivalence (BE) and Phase III clinical trial (CT) waiver, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Exemed Pharmaceutical for manufacturing and marketing of the fixed dose combination (FDC) of Amlodipine besylate IPeq. to Amlodipine plus Bisoprolol Fumarate IP (2.5mg + 2.5mg, 2.5mg + 5mg).

However, this approval is subject to the condition to conduct the Phase IV clinical trial.

This came after Exemed Pharmaceutical presented their proposal along with justification for BE and phase III CT waiver before the committee.

The committee noted that the proposed FDC, i.e., S (-) Amlodipine besylate IP eq. to Amlodipine 2.5 mg plus Bisoprolol Fumarate USP 5 mg, is considered rational by the Prof. Kokate committee on 16.07.2015.

Furthermore, the expert panel noted that the FDC of S (-) Amlodipine Besilate Eq. to S (-) Amlodipine 2.5 mg/ 5 mg + HCTZ 12.5 mg / 12.5 mg tablet and Bisoprolol Fumarate 2.5 mg/ 5 mg + Hydrochlorthiazide 6.25 mg/ 6.25 mg tablet are already approved for the treatment of mild to moderate hypertension on 14.04.2004 and 13.05.1999, respectively.

Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure. Bisoprolol is a beta-1 adrenergic blocking agent used to prevent myocardial infarction and heart failure and to treat mild to moderate hypertension.

Though the mechanism of action of bisoprolol has not been fully elucidated in hypertension, it is thought that therapeutic effects are achieved through the antagonism of β-1adrenoceptors to result in lower cardiac output. Bisoprolol is a competitive, cardioselective β1-adrenergic antagonist. When β1-receptors (located mainly in the heart) are activated by adrenergic neurotransmitters such as epinephrine, both the blood pressure and heart rate increase, leading to greater cardiovascular work and increasing the demand for oxygen. Bisoprolol reduces cardiac workload by decreasing contractility and the need for oxygen through competitive inhibition of β1-adrenergic receptors

Amlodipine is a calcium channel blocker used to treat hypertension and angina. Amlodipine is considered a peripheral arterial vasodilator that exerts its action directly on vascular smooth muscle to lead to a reduction in peripheral vascular resistance, causing a decrease in blood pressure. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the influx of calcium ions into both vascular smooth muscle and cardiac muscle. Amlodipine blocks calcium ion influx across cell membranes with selectivity. A stronger effect of amlodipine is exerted on vascular smooth muscle cells than on cardiac muscle cells. Direct actions of amlodipine on vascular smooth muscle result in reduced blood pressure

At the recent SEC meeting for Cardiovascular held on 11th December 2024, the expert panel reviewed the proposal for a fixed dose combination (FDC) of Amlodipine besylate IPeq. to Amlodipine plus Bisoprolol Fumarate IP (2.5 mg + 2.5 mg, 2.5 mg + 5 mg) along with justification for BE and phase III CT waiver.

After detailed deliberation, the committee considered the request for BE and Phase III CT waiver and recommended the grant of permission for manufacturing and marketing of the FDC with the condition to conduct the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee.

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