Page 2 - Medicines

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

Akums announces new facility for lyophilized, sterile dosage manufacturing

Lyophilisation is the process of extracting water from drug particles at freezing temperatures, maintaining the drug's value and preserving the stability

Govt will curb manufacturing, sale of counterfeit medicines in UP: CM Yogi

The Uttar Pradesh government is committed to putting a stop on the manufacturing and sale of counterfeit medicines in the state, Chief Minister Yogi Adityanath said on Monday. Responding to a starred question raised by Samajwadi Party MLA Sachin Yadav during the Question Hour, the chief minister, in a written reply, said the government is taking stringent measures to curb this illicit trade. Yadav had asked whether the government intends to curb the manufacturing and sale of counterfeit medicines in the state and if details of actions taken against those involved would be presented before the House. The chief minister said the Food Safety and Drug Administration department has conducted a total of 24,492 enforcement actions, including 22,151 inspections and 2,341 raids. A total of 26,225 samples were collected, out of which 301 cases of counterfeit medicines were identified. Medicines valued at an estimated Rs 19.76 crore were seized, and legal cases were filed for 250 instances of

Flipkart's 10-minute medicine delivery to shake up online pharmacy market

Flipkart to launch 10-minute medicine delivery under its 'Flipkart Minutes' service, partnering with local chemists to tap into quick commerce and expand its online pharmacy footprint

Drug regulator CDSCO flags 3 drugs as spurious, 56 not of standard quality

CDSCO made the revelation in its monthly update for October; drugs include those used to treat acid reflux, lower cholesterol and reduce risk of heart disease

Alembic Pharmaceuticals gets USFDA nod for hypertension treatment capsules

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules of strengths 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, Alembic Pharmaceuticals Ltd (Alembic) said in a statement. These capsules are indicated for the treatment of hypertension. These capsules may be used alone or in combination with other antihypertensive medications. Moreover, Diltiazem Hydrochloride is also indicated for the management of chronic stable angina and angina due to coronary artery spasm, the company said. Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for the 12 months ended June 2024, the company ...

Teva faces fine for disparaging rival multiple sclerosis medicine: Report

The EU competition enforcer's tough line underscores its concerns that such practices could stifle innovation in the pharmaceutical industry

Special medical stores to be opened in tehsils for AYUSH medicines: Jadhav

Union Minister Prataprao Jadhav on Monday said special medical stores will be opened in every tehsil of the country to ensure adequate availability of AYUSH medicines. The Union AYUSH Minister also said the government is mulling on ways to ensure Ayurvedic medicines based on traditional knowledge get due recognition. "The traditional knowledge of Ayurveda has been passed on from generation to generation. There are very good medicines in Ayurveda, but they have no recognition. We are wondering how these drugs can be recognised," he told PTI here. "Only a few AYUSH medicines are available in common medical stores, due to which patients and doctors prescribing these medicines face problems. The government wants to ensure AYUSH drugs come into the market in abundance after research. These medicines should be available everywhere. For this, we are trying to open at least one special medical store of AYUSH medicines in every tehsil of the country," he said. AYUSH hospitals are also being