Page 33 - Pharma Sector

Pharma industry needs to focus on innovative products, says Mandaviya

The domestic pharmaceutical industry needs to focus on the research and development of innovative products in order to move up the value chain and achieve global leadership in the sector, Union minister Mansukh Mandaviya said on Tuesday. The Union health minister, who also helms the Chemical and Fertilisers ministry, asked the medical technology companies to produce critical equipment in India for the global markets. While formally unveiling the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector here, Mandavya said the domestic pharmaceutical companies invest less on research and development when compared to multinational companies. "International MNCs spend 20-25 per cent of their profits in research and innovation while for Indian companies the average is around 10 per cent...Till the time we do not come out with research-led innovative products, we cannot lead the segment globally," he noted. He said the government wants to make the pharma ...

Strides Pharma to spin off CDMO, soft gelatin biz into a new entity

The company's board has approved a scheme of arrangement amongst Strides Pharma Science, Steriscience Specialties and Stelis Biopharma, the drug firm said in a regulatory filing

Abbott India warns of laxatives shortage in tussle with Goa regulator

The two laxative brands together have estimated annual sales of $70 million in India, healthcare data firm Pharmarack says

Biocon Biologics gains EU approval for Aflibercept biosimilar, YESAFILI

According to market research firm IQVIA, Aflibercept generated about $1.8 billion in annual sales in the EU in 2022

Aurobindo's Andhra plant receives 1 observation from USFDA after inspection

Aurobindo Pharma on Wednesday said the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. The US Food and Drug Administration (US FDA) inspected the Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing. At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added. "We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest," Aurobindo Pharma stated. As per the USFDA a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading ...

Govt may soon tweak PLI schemes for pharma, textiles to boost investment

The government may soon tweak the production-linked incentive scheme for pharmaceuticals, drones and textiles sectors to encourage investment and boost manufacturing, an official said. These sectors have been identified after inter-ministerial consultations on the performance of the scheme for various products. The official also said that disbursement of production-linked incentives (PLI) for white goods (AC and LED lights) would start this month and that would push the amount of disbursement, which was only Rs 2,900 crore till March 2023. The scheme was announced in 2021 for 14 sectors such as telecommunications, white goods, textiles, manufacturing of medical devices, automobiles, speciality steel, food products, high-efficiency solar PV modules, advanced chemistry cell battery, drones and pharma with an outlay of Rs 1.97 lakh crore. "We have identified the sectors. We are going to send the combined note to seek approval of the Union Cabinet. The changes include extending some ti

Drugmaker Biocon appoints Peter Bains as group CEO effective immediately

Bains, who was named as an independent director of the Biocon board in December last year, stepped down on Monday to assume the top charge, the company said in a statement

Zydus Lifesciences gets USFDA nod for pregnancy prevention medication

The company said that this is the third hormonal transdermal patch to be approved from Zydus' generics portfolio

India to procure 20 more doses of monoclonal antibody for Nipah treatment

India will procure from Australia 20 more doses of monoclonal antibody for the treatment of Nipah virus infection, ICMR DG Rajeev Bahl said on Friday. "We got some doses of monoclonal antibody from Australia in 2018. Currently the doses are available for only 10 patients," he said. According to him, no one so far has been administered the medicine in India. "Twenty more doses are being procured. But the medicine needs to be given during the early stage of the infection," he said, adding it can only given as compassionate use medicine. Bahl also said mortality among the infected is very high in Nipah (between 40 and 70 per cent) in Nipah compared to the mortality in Covid, which was 2-3 per cent. He asserted that all efforts are on to contain the spread of the virus in Kerala. All patients are contact of an index patient, he said. On why cases keep surfacing in Kerala, Bahl said, "We do not know. In 2018, we found the outbreak in Kerala was related to bats. We are not sure how th

Goa state warns Abbott India on antacid Digene license suspension

The state authorities have given Abbott seven days to respond to the notice to defend its position

Sun Pharma, Pharmazz enter agreement to introduce Sovateltide in India

Sun Pharma said in a filing that it has been granted rights for marketing Sovateltide in India under the brand name Tyvalzi

NHRC sends notice to Centre, DGCI over circulation of falsified drugs

The NHRC has issued notices to the Union health ministry and the Drugs Controller General of India over the reported circulation of falsified liver drug Defitalio and cancer drug Adcetris, officials said on Wednesday. The National Human Rights Commission, in a statement, observed that the content of the news report, if true, raises a serious issue of violation of human rights, which is a matter of concern, it said. The NHRC has taken "suo motu cognisance of a media report that after the alert from the World Health Organization (WHO), the Central Drugs Standard Control Organization (CDSCO) has asked the state regulators, doctors and patients to remain vigilant about two medicines - liver drug Defitalio and cancer drug Adcetris, as the falsified versions of these drugs are circulating in four countries, including India", it said. "Reportedly, the falsified versions of Adcetris injection 50 mg, detected in four countries, including India, are most often found to be available at the ...

DCGI asks states to keep vigil on sale of falsified versions of 2 drugs

The Drugs Controller General of India (DCGI) has directed the drugs controllers of all states and Union territories to keep a strict vigil on the sale and distribution of falsified versions of two drugs, liver medication Defitelio and Takeda's cancer drug Adcetris (injection), following alerts issued by the World Health Organisation (WHO). In an advisory on September 5, the DCGI said the WHO has issued a safety alert identified with multiple falsified versions of Adcetris injection 50 mg manufactured by Takeda Pharmaceutical Company Limited, identified in four different countries including India. "These products are most often available at the patient level and distributed in the unregulated supply chains (mainly online). The products have been identified in both regulated and illicit supply chains, sometimes at patient levels as well. WHO has reported that there are at least eight different batch numbers of falsified versions in circulation," the DCGI said in a communication to the

Glenmark eyes double-digit revenue growth; to focus on debt reduction

Glenmark Pharmaceuticals aims to grow its revenues by 10-11 per cent with a focus on free cash generation to reduce debt in the current financial year, according to Chairman and Managing Director Glenn Saldanha. The Mumbai-based drug major is also looking at enhancing EBITDA margins while expanding presence in various therapeutic segments like oncology and dermatology. "For the new financial year, we aim to grow by 10-11 per cent in revenues, expand our EBITDA margin to 19-20 per cent, and continue to focus on enhancing free cash generation for further debt reduction," Saldanha said in the company's Annual Report for FY23. In FY23, the company's consolidated revenue from operations stood at Rs 12,990 crore, up from Rs 12,305 crore in FY22. Besides, the drug maker reported an EBITDA of Rs 2,278 crore during the 2022-23 fiscal with margins at 17.5 per cent. Glenmark reported net debt of Rs 2,905 crore for the fiscal ended March 31, 2023. Addressing the company's shareholders, he not

Strides Pharma gets USFDA approval for generic Sevelamer Carbonate

Strides Pharma Science Ltd on Saturday said its arm, Strides Pharma Global Pte Ltd Singapore, has received approval from the US health regulator for its generic Sevelamer Carbonate for oral suspension indicated for patients with chronic kidney disease on dialysis to prevent dangerous increases in phosphates. The approval by the US Food & Drug Administration (USFDA) is for Sevelamer Carbonate for oral suspension of strengths 0.8g and 2.4g, Strides Pharma Science said in a regulatory filing. The product is bioequivalent and therapeutically equivalent to the reference listed drug Renvela for Oral Suspension, 0.8g and 2.4g of Genzyme, the company said. "The approval completes the company's Sevelamer Carbonate portfolio...The product is a complex generic with limited players having both the tablets and oral suspension," it said adding, the approved medicine will be manufactured at the company's facility in Bengaluru. The Sevelamer Carbonate market for both tablets and oral Suspension ..

Siddhanta Medicity partners with UK firm to raise $108 mn for cell therapy

Bhopal-based healthcare institution Siddhanta Medicity looks to raise around USD 108 million (around Rs 826 crore) in partnership with a UK-based firm for advancing clinical research and development in the field of cell therapies, a release said on Saturday. The investment of USD 108 million will play a pivotal role in establishing stem cell research centres, treatment facilities, and advanced laboratories, Dr. Subodh Varsheny, the managing director of the Bhopal-based health institution said. The institution has tied up with UK-based SRAM &AM Group to raise funds to advance clinical research and development in the field of NK Cell and Mesenchymal Stem Cell Therapies, the statement said. The SRAM &AM Group has also tied up with biopharmaceutical company Cellaax, which is engaged in the research and development of advanced cellular therapy.

Natco Pharma, Celgene Corp, others sued in US for generic cancer drug

Natco Pharma on Friday said the company and other drug makers have been named defendants in an antitrust lawsuit regarding a generic cancer treatment drug in the US. The Hyderabad-based drug firm along with Celgene Corporation, Bristol Myers Squibb, Breckenridge Pharmaceutical Inc and others have been named defendants by Louisiana Health Service & Indemnity Company, D/B/A Blue Cross and Blue Shield of Losisiana and HMO Louisiana Inc, regarding anti-cancer treatment medication Pomalidomide. The company believes this matter is without merit, Natco Pharma said in a statement. Breckenridge is the abbreviated new drug application (ANDA) holder and distribution partner for the generic product in the US, it added. Natco Pharma shares were trading 3.13 per cent down at Rs 885.00 apiece on the BSE.

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