Page 37 - Pharma Sector

Zydus Lifesciences gets USFDA nod to mfg generic version of Varenicline

Zydus Lifesciences on Tuesday said it has received final approval from the US health regulator to manufacture and market the generic version of Varenicline tablets indicated to treat smoking addiction. The approval by the US Food and Drug Administration (USFDA) is for Varenicline tablets of strengths 0.5 mg and 1 mg, Zydus said in a regulatory filing. The product will be launched shortly. It will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India, it added. Varenicline tablets, 0.5 mg and 1 mg had annual sales of USD 501 million in the US, the company said citing IQVIA MAT March 2023 data.

BioNTech faces several lawsuits in Germany over Covid vaccine side effects

German drug company BioNTech is facing hundreds of lawsuits, worth one million euros, in country for alleged health damage due to its Covid-19 vaccine, co-developed with American pharma giant Pfizer

Quality check: India needs to restore faith in the 'world's pharmacy'

For more than a decade, it has been clear that too many medicine makers in India have not been doing their duty by their customers, here and abroad

In a first, Centre to review PLI scheme to sort out teething issues

Interactions with line ministries lined up to seek feedback

Pharmacists have finger on pulse of small towns as demand increases

The Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) is another major reason for the growth in demand for medicines in smaller towns

NPPA fixes retail prices of 23 drug, including diabetes, blood pressure

National drug pricing regulator NPPA on Friday said it has fixed retail prices of 23 formulations, including the medications to treat diabetes and high blood pressure. The National Pharmaceutical Pricing Authority (NPPA) has fixed the prices under the Drugs (Price Control) Order, 2013 based on the decision of 113th Authority meeting dated May 26, 2023. As per the notification, the NPPA has fixed the price of one tablet of diabetes drug Gliclazide ER and Metformin Hydrochloride tablets at Rs 10.03. Similarly, the retail price of one tablet of Telmisartan, Chlorthalidone & Cilnidipine tablets at Rs 13.17. The retail price of one tablet of pain reliever medication Trypsin, Bromelain, Rutoside Trihydrate and Diclofenac Sodium tablets has been fixed at Rs 20.51. The NPPA said it has also revised ceiling price of 15 scheduled formulations under Drugs (Prices Control) Order, 2013 (NLEM 2022). It has also fixed ceiling price of two scheduled formulations. Besides, it has fixed and revise

Additional disclosures required for trade of medicinal products from Jul 1

These additional disclosures will reduce queries of Customs officials, which are frequently posed to EXIM traders dealing in medicinal plants and chemicals

India a prime example of successfully growing pharma industry: UNICEF

India is a prime example of successfully growing a domestic pharmaceutical industry capable of meeting global supply needs, a top UNICEF official said. India can share its expertise and learnings from the model it used to foster the pharmaceutical industry with countries and regions trying to build capacities including how to incentivise the private sector, ensure regulatory and quality assurance systems in place and develop a globally competitive industry, Tara L Prasad, Senior Manager, Centre for Health Emergency Strategy and Partnerships at UNICEF, said. She is here to attend the third G20 Health Working Group meeting that is being held from June 4 to 6. "Further, India can share lessons on how to create an enabling environment, including investments in human and physical capital, as well as its learnings in moving beyond generic industry to expanding research and development innovator industry," Prasad said. The G20 more broadly can call upon its industry to ensure manufacturer

Sun Pharma receives China NMPA's nod for treatment of plaque psoriasis

Ilumetri is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy

Pharma sector should focus on quality. affordable manufacturing: Mandaviya

The domestic pharmaceutical industry should focus on quality and affordable manufacturing in order to compete globally, Union minister Mansukh Mandaviya said on Saturday. Speaking at a round-table conference with CEOs of leading pharmaceutical companies, Mandaviya also asked the industry to have enhanced focus on research and innovation in the sector. "The industry is progressing at a rapid rate, and to maintain our stature as the 'Pharmacy of the World', we need to focus on quality and affordable manufacturing with an increased focus on research and innovation," Mandaviya said in the meeting as per a government statement. The chemicals and fertilisers minister urged the stakeholders to capitalise on the current opportunities, stating that substantial investment in terms of production linked incentive schemes as well as upcoming drug parks are bearing fruitful results. To catalyse growth, the industry must maintain a degree of competitiveness to consolidate presence in the world, .

Tweaks in quality norms will drive the pharma product exports higher: DGFT

More pharmaceutical products can be brought under mandatory quality improvement norms if needed to comply with global standards for export from India if the health ministry issues an advice in this regard, a top official said on Tuesday. Director General Foreign Trade (DGFT) Santosh Kumar Sarangi said all pharmaceutical products must meet global standards and quality requirements. His remarks come a day after the Directorate General of Foreign Trade in a notification said cough syrup exporters will have to undertake testing of their products at specified government laboratories from June 1 before getting permission for the outbound shipments. The direction came in the wake of quality concerns raised globally for cough syrups exported by Indian firms. "This is a continuous effort which has been started with cough syrup. It is our endeavour that any cough syrup exported from India must meet minimum benchmark requirement of quality standards. Therefore they will be exported after bein

Cough syrup exporters need to undertake testing at govt labs from June 1

Cough syrup exporters will have to undertake testing of their products at specified government laboratories from June 1 before getting permission for the outbound shipments. The direction has come after quality concerns were raised globally for cough syrups exported by Indian firms. The export of cough syrup shall be permitted to be exported subject to export samples being tested and production of certificate of analysis issued by any of the laboratories, with effect from June 1, 2023, the Directorate General of Foreign Trade (DGFT) said in a notification on Monday. The specified central government labs include Indian Pharmacopoeia Commission, regional drug testing lab (RDTL - Chandigarh), central drugs lab (CDL - Kolkata), central drug testing lab (CDTL - Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments. Explaining further, an official said that to ...

Centre considering testing drugs at govt laboratories before exporting

Amid quality issues being raised globally for the cough syrups exported by Indian firms, the Centre is actively considering a proposal of testing drugs at government laboratories before they are dispatched to other countries. The apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO) has proposed testing the drugs (finished products) at government labs before exporting, official sources said. According to the proposal, exporters will have to produce the certificate of analysis of the batches issued by authorised laboratories after which only the Directorate General of Foreign Trade (DGFT) will clear the release of the consignment for export. The analysis of the sample from the export consignment is proposed to be tested at Indian Pharmacopoeia Commission, Central Drugs Standard Control Organization (CDSCO) labs viz.,L (Chandigarh), CDL (Kolkata), CDTI (Chennai), CDTI (Hyderabad), CDTL (Mumbai),I. (Guwahati)) and NABL-accredited drug testing labs of .

Gland Pharma profit declines by 56% on soft demand in March quarter

Its earnings before interest, taxes, depreciation, and amortisation (EBITDA) margin contracted to 21% from 32% a year earlier

GlaxoSmithKline Pharma's pre-tax profit falls 8% on govt pricing caps

India's GlaxoSmithKline Pharmaceuticals Ltd reported an 8.6% fall in its pre-tax profit for the fourth quarter on Wednesday, hurt by the government's curbs on pricing of some essential medicines

Assisted reproductive technology market to exceed $440 million by 2030

Improvements in Assisted Reproductive Technology (ART) have enabled millions of across world facing infertility to conceive over past few decades, and this trend is likely to continue well into future

Indian medical devices sector to emerge as global leader in innovation: MoS

Backed by growing healthcare needs and the government's commitment to facilitate growth, the Indian medical devices industry has the power to emerge as the global leader in manufacturing and innovation in the next 25 years, Union Health Minister Mansukh Mandaviya said on Tuesday. The medical devices sector is an essential and integral constituent of India's healthcare sector, he said during his interaction with representatives of Japanese medical devices companies in Tokyo. "The sector's contribution became even more prominent as India supported the domestic and global battle against COVID-19 pandemic through large scale production of medical devices and diagnostic kits," he said. Dr Mandaviya noted that the medical devices sector has the potential to grow from its current size of USD 11 billion to four times by 2030. He further stated that backed by growing health care needs and the government's commitment to facilitate growth, the Indian medical devices industry has the power to

Biphore, Zenara gets approval for Cannabidiol that treats neuro disorders

Biophore India Pharmaceuticals has announced that it has received approval from Central Drugs Standard Control Organisation (CDSCO) for manufacturing of Cannabidiol active ingredient in India

Pricing regulator sets mechanism to fix prices of off-patent drugs

Prices to be capped at 50% of innovator price; to be reviewed after one year

Sanofi consumer brands get a shot in the arm on demerger decision

Company says split will allow it to unlock business potential in pharmaceuticals and consumer healthcare