Page 35 - Pharma Sector

After drive against spurious drugs, DCGI collating data on pharma plants

The DCGI, in a letter dated September 4, has instructed state drug controllers to obtain the details from the firms under their jurisdiction

DCGI issues advisory as US-based Abbott recalls batches of Digene gel

The DCGI has cautioned against the consumption of Abbott's antacid Digene gel citing safety concerns, even as the US-based drugmaker recalled several batches of the medicine manufactured at its Goa facility. According to a letter by the Drugs Controller General of India (DCGI), it was reported on August 9 that a bottle of Digene Gel (mint flavour), batch no 51030307, used by customers was of regular taste (sweet) and light pink in colour whereas another bottle of the same batch was of white colour with bitter taste and pungent odour as per a complaint. "Accordingly, M/s Abbott India Limited, Verna Industrial Estate, Salcette, Goa- vide letter dated August 11, 2023, informed DCGI office for voluntary recall of impugned product Digene Mint flavour batch no 51030307 and Digene Gel orange having batch no 50035107, 50035207, 50035307, 50035407 and voluntary stopped production of all variants of Digene Gel manufactured at their Goa facility," the DCGI letter stated. Further, Abbott India

Biocon Biologics completes integration of Viatris biosimilars business

Biocon on Wednesday said its arm Biocon Biologics has completed the integration of the acquired biosimilars business from Viatris in North America with effect from September 1, 2023. Since the acquisition agreement closed in November 2022, Biocon Biologics has executed a robust integration plan to ensure a seamless transition of partners, people, systems, and processes, Biocon said in a regulatory filing. In February 2022, Biocon Biologics had inked a pact to acquire Viatris Inc's biosimilars business for a consideration of up to USD 3.33 billion (about Rs 24,990 crore). Later, in November same year the company completed the acquisition. "Our successful North America (US and Canada) transition marks the second wave of our integration of the Viatris biosimilars' business, quickly following Emerging Markets and ahead of schedule," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said the company would be leading the commercial operations in the US and Canada

Ind-Swift Labs to sell pharma ingredients ops to Synthimed Labs for $198 mn

Ind-Swift Labs will sell its active pharmaceuticals ingredients (API) and contract research and manufacturing services (CRAMS) business

Generic medicines: Indian pharma market is at crossroads of systemic shift

Companies must start preparing their business models to adjust to the reality of the shift to medical practitioners prescribing only generic molecule names

2,000 bottles of banned cough syrup seized, three arrested in Bengal

Around 2,000 bottles of banned cough syrup Phensedyl were seized and three people were arrested on Tuesday in West Bengal's Nadia district which borders Bangladesh, police said. Acting on a tip-off, police intercepted two vehicles in Natunpara in Bhimpur police station area and seized the cough syrup bottles, while arresting the occupants, a police officer said. The arrested persons are residents of Nadia's Karimpur, which is close to the India-Bangladesh border. Phensedyl contains codeine, which is a narcotic drug that causes addiction when used in large quantities over a period of time. The cough syrup is used as an intoxicant in Bangladesh as an alternative to alcohol.

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Biocon acquires Eywa Pharma's US-based manufacturing facility for $7.7 mn

Centre invites bids for privatisation of Indian Medicines Pharmaceutical

Interested buyers in Indian Medicines Pharmaceutical should submit initial bids to the government by Oct 15, according to the government document

Govt likely to extend export benefits under RoDTEP scheme for pharma, steel

The government is expected to extend export benefits under the RoDTEP scheme to iron and steel, chemicals and pharmaceutical sectors beyond September 30, according to a senior official. In December 2022, the government extended the benefits under the Remission of Duties and Taxes on Exported Products (RoDTEP) Scheme to chemicals, pharmaceuticals and products of iron and steel till September 30 this year. "As exports are not doing good for the last few months, there is a demand to extend it for about six months till March 2024. It is under consideration. We may extend it," the official said. These three sectors were late entrants into the scheme that aims to refund duties, taxes and levies at the central, state and local level that gets added to the cost of products meant for exports. This scheme is a replacement for the Merchandise Exports from India Scheme (MEIS) which ended last year. At present, over 10,342 export items get the RoDTEP benefits. The incentive is paid in the for

Strides Pharma arm gets USFDA approval for generic Mycophenolate Mofetil

Strides Pharma Science Ltd on Wednesday said its wholly-owned arm, Strides Pharma Global Pte. Ltd, Singapore, has received approval from the US health regulator for generic Mycophenolate Mofetil for oral suspension indicated in organ transplant patients to avoid rejection. The approval granted by the US Food & Drug Administration (USFDA) is for Mycophenolate Mofetil for oral suspension of strength 200 mg/ml, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), CellCept for oral suspension, 200 mg/m; of Roche Palo Alto, LLC, it added. The approval bolsters the company's Mycophenolate Mofetil portfolio, which already includes numerous products, it added. The product will be manufactured at the company's facility in Bengaluru, Strides said. Mycophenolate Mofetil for oral suspension has a market size of USD 41 million, the company said citing IQVIA data.

Lupin gets USFDA nod to market generic lung disease treatment capsule

Pharma major Lupin Ltd on Tuesday said it received approval from the US health regulator to market its generic Pirfenidone capsules used for the treatment of lung disease known as idiopathic pulmonary fibrosis. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing. The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin's Pithampur facility in India, it added. Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.

India aspires to become global leader in innovative drugs: Report

This will lead to a sustained global competitive advantage and contribute to quality employment generation in the country

Billion-dollar pharma cos set to face their first US price negotiations

For taxpayers, the savings could be significant: Negotiations could save the US $36.5 bn from 2026 to 2028, according to Wells Fargo Securities. Drugmakers are suing the government to stop the squeeze

Economy on growth path; auto, pharma, tourism sectors to add new jobs: PM

Prime Minister Narendra Modi on Monday said the Indian economy was on the path of rapid growth which had led to creation of big opportunities for employment of the youth. Addressing a Rozgar Mela where he distributed over 51,000 appointment letters to the youth, he said automobile, pharma, tourism and food processing sectors were expected to grow at a rapid pace and open up employment opportunities for the youth. Modi addressed the Rozgar Mela virtually as the new appointees in central paramilitary forces, Narcotics Control Bureau and the Delhi Police joined in from 45 locations across the country. The prime minister said India had emerged as the fastest growing economy and would soon be among the top three economies in the world during this decade and bring benefits to the common man. "For any economy to grow, it is imperative that every sector develops. From the food sector to pharmaceuticals, from space to start-ups, when every sector grows the economy will move ahead," he said

Drug retailer Rite Aid Corp preparing to file for bankruptcy: Report

Regionally focused Rite Aid operates more than 2,330 stores in 17 U.S. states, although it is much smaller than rivals like Walgreens Boots Alliance and CVS Health

AstraZeneca sues US govt over Medicare drug price negotiation plans

The British drugmaker, which filed its complaint in a Delaware district court, joins other drugmakers and business groups claiming that the program would restrict the development of new medicines

Roche Pharma India launches customer experience centre in Chennai

Roche Pharma India launched an industry-first customer experience center to spur collaboration with healthcare professionals, researchers and educational institutions to shape the future of healthcare, the company said on Thursday. The center will offer immersive and interactive healthcare content, comprehensive insights into medical science and information about Roche's innovative, life-changing product portfolio and technologies that have redefined healthcare for over 125 years, the wholly owned subsidiary of the Basel-headquartered Roche Group, said. Doctors and other stakeholders will be able to visualise disease pathways, drug-action in the human body, and co-create better solutions leading to better patient outcomes by using the latest 4IR (Fourth Industrial Revolution) digital technologies such as Augmented Reality (AR), Virtual Reality (VR) and AI, a release here said. "The Roche Experience Center reflects the company's mission to empower communities with scientific insights

Maharashtra govt issues order on free of cost treatment at public hospitals

Health services, including treatment, in all government hospitals in Maharashtra falling under the public health department's jurisdiction have been made available free of cost for patients, the state government said on Wednesday. Medical tests, treatment and all other services provided on public-private partnership, excluding blood supply, are available free of cost to patients from August 15, said a government resolution (GR). The decision to provide free treatment and other health services at all government hospitals in Maharashtra was taken by the state cabinet in its meeting on August 3.

Wockhardt shareholders reject proposal to raise Rs 1,600 cr from promotor

Shareholders of Wockhardt have rejected a proposal to raise Rs 1,600 crore from a promoter entity, according to a regulatory filing. The board of Mumbai-based drug firm had sought shareholder approval for a related party transaction with Khorakiwala Holdings and Investments Pvt Ltd (KHIPL) to raise up to Rs 1,600 crore for a period of five years. KHIPL, a promoter entity, is an RBI registered NBFC. About 50.12 per cent votes came in against the proposal while 49.87 per cent of the votes polled favoured the resolution, Wockhardt said in a regulatory filing. In a note, proxy advisory firm IiAS said it had sought approval for the proposal but it was defeated. "Wockhardt's resolution for a related party transaction with Khorakiwala Holdings and Investments Pvt Ltd (KHIPL) for an amount up to Rs 1,600 crore for a period of five years, was defeated," it noted. IiAS said the proposed related party transaction with KHIPL was intended for borrowing of funds for an amount up to Rs 1,600 cr

Hikal appoints Berjis Desai, Ramachandra Vinnakot as independent directors

Pharmaceuticals and crop protection firm Hikal on Sunday said it has appointed Berjis Minoo Desai and Ramachandra Kaundinya Vinnakota as additional directors to its Board. The appointments as independent directors extend for five-year terms, effective October 1, 2023, pending approval by the company's shareholders, Hikal Ltd said in a statement. "Their extraordinary expertise, diverse insights, and proven leadership will undoubtedly enrich our governance and bringing heft to our strategic decisions, fostering our continued growth," Hikal Founder and Executive Chairman Jai Hiremath stated.