Page 16 - Pharma Industry

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 ...

Indian pharma industry to log in 8-10% revenue growth this fiscal: CRISIL

The Indian pharmaceuticals industry is expected to log in a revenue growth of 8-10 per cent in current fiscal aided by a steady domestic growth and increased exports to regulated markets, even as semi-regulated markets face headwinds, according to a report. A study of 186 drug makers, which accounted for about half of the Rs 3.7 lakh crore annual revenue of the sector last fiscal, indicates as much, Crisil said on Monday. "Similar to last fiscal, domestic growth in fiscal 2024, will be led by 5-6 per cent increase in realisations, supported partly by high price hikes allowed by the National Pharmaceutical Pricing Authority (NPPA) for drugs under price regulation," Crisil Research Director Aniket Dani said. In addition, sale of existing drugs and new launches will drive 3-4 per cent volume growth, he added. Operating profitability is also seen improving 50-100 basis points (bps) to 21 per cent this fiscal, supported by moderation in input and logistics costs, and abating pricing ...

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.

Piramal Pharma is aiming to achieve zero waste to landfill by FY25

To achieve zero waste to landfill by FY2025, the company is taking a number of measures, including installing solvent recovery plants at its API and chemical plants

Lupin to sell generic respiratory drugs on Mark Cuban's online pharmacy

The partnership with Cuban-backed Cost Plus Drugs is expected to bolster Lupin's U.S. business, which already accounts for nearly 33% of its 2023 revenue

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

Cough syrups to painkillers: Bar codes on 11 habit-forming drugs soon

According to the health ministry, this is being done to stop the misuse and illicit trade of these drugs

India's pharma industry likely to take 5-6% price hikes this year

NPPA permits 12.1% increase for NLEM drugs in 2023

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

USFDA grants VAI classification to Torrent's Gujarat manufacturing site

The US health regulator has granted Voluntary Action Indicated classification to Torrent Pharmaceutical's manufacturing site in Dahej, Gujarat. A VAI classification means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action. As per the information available on its website, the United States Food and Drug Administration (USFDA) has granted Voluntary Action Indicated (VAI) classification to the plant. The Dahej site was earlier placed under 'Official Action Indicated (OAI)' classification based on a March 2019 inspection outcome. OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The Dahej site was re-inspected by the USFDA between May 17 and May 25, 2023 and the officials had issued Form 483 with two observations. Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has ..

Allow prescribing both generic, brand names: Pharma lobby, doctors to govt

The pharmaceutical industry has also aired concerns about quality if only generic names are penned in prescriptions

Centre rolls out Rs 5,000 crore RLI scheme for pharma, med-tech sectors

Govt rolls out research-linked incentive scheme to boost infra

Lupin receives USFDA approval for generic blood pressure lowering drug

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator to market its generic Metoprolol Succinate extended-release tablets used for lowering blood pressure. The approval by the US Food and Drug Administration (USFDA) for the abbreviated new drug application is for Metoprolol Succinate extended-release tablets of strengths 25 mg, 50 mg, 100 mg, and 200 mg, Lupin said in a regulatory filing. These are generic equivalent of Toprol-XL Tablets of Sequel Therapeutics, LLC. This product will be manufactured at Lupin's Pithampur facility in India, the company said. Metoprolol Succinate extended-release tablets had an estimated annual sales of USD 305 million in the US, the company said citing IQVIA MAT June 2023 data.

What are generic medicines and how India became the 'pharmacy of the world'

India is the world's largest producer and exporter of generic drugs. But how did it manage to do so? Let us find out here

Defer implementation of NMC regulations: IMA to govt on generic drugs

The Indian Medical Association (IMA) on Monday demanded deferring the implementation of the National Medical Commission regulations that make it mandatory for doctors to prescribe generic drugs, stating the biggest impediment to such medicines is the uncertainty about their quality. The IMA stated that less than 0.1 per cent of the drugs manufactured in India are tested for quality. "This step should be deferred till the government can assure the quality of all the drugs released into the market. Patient care and safety are not negotiable," the association said in a statement. The National Medical Commission (NMC) in its "regulations relating to professional conduct of registered medical practitioners" stated that all doctors must prescribe generic drugs, failing which they will be penalised and even their licence to practise may be suspended for a period. It also asked doctors to avoid prescribing branded generic drugs. Rather than taking the NMC route the government should take

Pharma industry in a huddle after fresh NMC regulations for doctors

"Power thus shifts to chemists instead of doctors. Whichever company offers better incentives, the chemist would prefer it," the industry feared

Medical Council guidelines bar doctors from taking freebies from firms

Industry insiders feel this is a step towards implementing and codifying the Uniform Code of Pharmaceutical Marketing Practices

India has started manufacturing 38 APIs in past 1.5 years: Mandaviya

India has started manufacturing 38 active pharmaceutical ingredients, or APIs, in the last one and a half years on which it was import-dependent, under the production-linked incentive (PLI) scheme for the sector, Union Health Minister Mansukh Mandaviya said here Saturday. Mandaviya said that the 2017 border standoff with China at Doklam triggered India to rethink its self-reliant strategy regarding active pharma components as it was dependent on just one country for the import of 95 per cent of APIs for the formulation industry. The health minister was speaking at the inaugural event of the Healthcare Summit organised at the Indian Institute of Management Ahmedabad (IIMA). Through the PLI scheme, we tried to ensure that the country does not have to import 54 APIs from abroad and our formulation industry gets APIs domestically. I am happy to share that in just a year and a half, India has started manufacturing 38 APIs, which is an example of Atmanirbhar Bharat, he said. The governme

Indian drugs regulators took action against 105 pharma firms, says minister

Indian drugs regulators have taken action against 105 pharmaceutical companies after a risk-based inspection and audit of manufacturing plants, the health minister said on Tuesday

Divis Lab, Sun Pharma: Current breakout may lead Pharma index to new peak

Pharm index has broken out on upside, with the positive rally anticipated to hit 14,450