Page 2 - Medicines

Kashmik Formulation targets ₹100 crore revenue in FY26, eyes IPO

The company currently produces around 25 crore units a month and is expanding its ground and first-floor production facilities to meet rising demand

US FDA to fast-track drug reviews for firms backing national priorities

US regulators will begin offering faster reviews to new medicines that administration officials deem as promoting the health interests of Americans, under a new initiative announced Tuesday. Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months. Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to challenge assumptions and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed. For the new program, the FDA will issue a limited number of national priority vouchers to companies aligned with U.S. national priorities,

Anti-infective drug sales surge in May as fever season grips country

Analysts indicate sales in the segment are expected to grow more during monsoon months

Study finds key drug shortages for diabetes, BP at rural health centres

A joint survey conducted by the ICMR and the WHO, along with other institutes, has revealed critical medicine shortages for managing diabetes and hypertension at rural health facilities, from sub-centres to sub-district hospitals, across 19 districts in seven states. The study has also found a shortage of specialists at the community health centre (CHC) level and these findings are similar to the rural health statistics report of 2020-21, indicating a shortfall of physicians (82.2 per cent) and surgeons (83.2.9 per cent) at the CHC-level. The study findings, published in the "Indian Journal of Medical Research (IJMR)" suggest that among public health facilities, PHCs, district hospitals and government medical colleges in India are better prepared to manage services for diabetes and hypertension. Across all the facilities, the domain score for equipment was the highest and for medicines, it was the lowest. However, the availability of all medicines was better at tertiary-care ...

Eli Lilly's tirzepatide shows superior weight loss to Novo's semaglutide

Phase 3b trial finds Lilly's tirzepatide delivers higher average weight loss and waist reduction than Novo's semaglutide in people with obesity or overweight

Donald Trump seeks to align US drug costs with cheapest ones abroad

The US government already negotiates prices for some of the highest-cost medicines used in Medicare health insurance under the Inflation Reduction Act

Doctors must prescribe only generic drugs, not branded medicines: SC

The Supreme Court has said doctors should prescribe only generic drugs. The court made the remark while hearing a PIL seeking tighter regulation of pharmaceutical marketing practices

Booster dose: India inches closer to regulatory framework for OTC drugs

DTAB has accepted sub-panel recommendation on OTC drugs list

Govt bans manufacture, sale of 35 unapproved fixed-dose combination drugs

Apex drugs regulatory body CDSCO has directed drug controllers of all states and Union territories to stop manufacture, sale and distribution of unapproved 35 fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics. They have also been asked to review their approval process for such fixed dose combination drugs (FDC) and ensure strict compliance of the provisions of the Drugs and Cosmetics Act 1940 and rules. FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. The regulator issued the directions after it found that certain FDC drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy, posing a serious risk to public health and safety. In a communication sent on April 11, Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi referred to the letter issued by his office on January 2013 where concerns were raise

Govt may fast-track food, medicines, farm trade under AEO framework

The AEO programme is implemented by the Central Board of Indirect Taxes and Customs (CBIC) under the aegis of the World Customs Organization's SAFE Framework

Sun Pharma launches Fexuprazan tablets for Erosive Esophagitis treatment

Sun Pharmaceutical Industries on Monday said it has introduced a medication for the treatment of Erosive Esophagitis of all grades. The Mumbai-based drug major, in a statement, said it has launched Fexuprazan tablets (40 mg) in India under the brand name Fexuclue, a novel potassium-competitive acid blocker (PCAB). The product is approved as a new treatment for adults with Erosive Esophagitis of all grades, it added. Sun Pharma has obtained rights from South Korea-based Daewoong Pharmaceutical to manufacture and commercialise the medication in India. As per the agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties, it said. "Erosive Esophagitis is a serious condition that greatly affects patients' quality of life. Despite available treatments, there remains a significant unmet need in its management. Fexuclue is a best-in-class treatment option with the potential to bridge this gap," Sun Pharma CEO India Business Kirti Ganorkar ...

Essential drug price cuts saved patients Rs 3,788 crore a year: Govt

Under the AMRIT initiative, medicines for cancer, cardiovascular diseases, and surgical implants are available at up to 50 per cent discounts in selected hospital pharmacies

Mankind Pharma sets sights on Novo Nordisk's anti-obesity drug Semaglutide

The firm is focusing on specialty chronic therapies like immunotherapy, antibody-drug conjugates, and gene therapy drugs, besides peptides like Glucagon-like peptide-1 (GLP-1)

Health Secy asks state bodies to curb illicit use of psychotropic drugs

While Tapentadol is a strong opioid used to relieve severe pain, Carisoprodol is a muscle relaxant for painful bone conditions

Kerala to launch 1st project on collection, disposal of expired medicines

The project titled ' nPROUD' (New Programme for Removal of Unused Drugs) will be inaugurated by Health Minister Veena George on February 22

Chemists' association seeks meeting with NPPA over price display issue

The NPPA, in an office memorandum (OM) dated February 4, had directed medicine retailers as well as online pharmacies to "conspicuously" display current drug price list

Health ministry releases first quality ratings for Internal Medicine Dept

The ratings, based largely on 2023 data, are being used to allocate funding to hospitals as part of a comprehensive plan to enhance public healthcare services

Medtech sector seeks standard GST rate, export incentives in Budget

The scheme aims to refund to exporters the embedded central, state, and local duties and taxes paid on inputs that were so far not refunded or rebated

Clinical trials of medicines often done in poor countries, says SC

Observing clinical trials of medicines and vaccines were often carried out in poor countries, the Supreme Court on Wednesday allowed a petitioner to file submissions and objections to the rules framed by the Centre on the issue. A bench comprising Justices Hrishikesh Roy and S V N Bhatti considered the submissions of Centre's additional solicitor general Archana Pathak Dave who said rules for new drugs and clinical trials were framed in 2019. "We know that the clinical trials are conducted in poor countries," the bench said. Following the rules, Dave said New Drugs and Clinical Trials (Amendment) Rules were notified in 2024 to streamline the approval process for clinical trials and new drugs in India which aimed to improve patient safety protocols and ensure compliance with global standards. Senior advocate Sanjay Parikh, appearing for NGO Swasthya Adhikar Manch, which filed a PIL in 2012 alleging large-scale clinical drug trials across the country by multinational pharmaceutical .

Booster shot as Medicity set to come up in 200 acres area in Chhattisgarh

Under the project, health facilities with about 5,000 bed capacity would be developed via private investment