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"The free sample of medicines given to the medical practitioners is only to prove the efficacy and to establish the trust of the doctors on the quality of the drugs. This again cannot be reckoned as freebies given to the doctors or for promotion of its products," the petition that was heard by a division bench headed by Acting Chief Justice Alok Aradhe claimed.
India's drug regulator has allowed the export of the first produced-in-India vaccine against malaria, developed by scientists at the University of Oxford and manufactured by Serum Institute to the UK, official sources said.
Drug firm Lupin on Thursday said it has received a warning letter from the US health regulator for its Tarapur-based manufacturing facility in Maharashtra. The US Food and Drug Administration (USFDA) inspected the site from March 22, 2022 to April 4, 2022.
"Accordingly, and for all the aforesaid reasons, the writ petitions shall stand allowed. The impugned orders dated July 5, 2018, and June 26, 2018, pertaining to Bharat Serums and the order dated October 22, 2020, as well as the demand notice dated November 7, 2019, relating to Bard, shall stand quashed," Justice Yashwant Varma said in the 90-page verdict.
The United States Food and Drug Administration (US FDA) has issued a warning letter to Lupin's Tarapur, Maharashtra facility, the company said in a stock exchange filing on Thursday. Lupin in a statement said it does not believe that the warning letter will have an impact or disruption of supplies or the existing revenues from operations of this facility.
Eisai Co, a Tokyo-based pharmaceutical company with a family bent and market capitalisation of $14 billion, crossed the finish line before behemoths valued nearly 20-fold higher, including industry leaders Roche Holding AG and Eli Lilly & Co
IHH had won a bid for a 31% stake in Fortis in 2018, which triggered an open offer for another 26% as per Indian regulations. Minority shareholders of Fortis would have had the right to tender their shares at a fixed price during this period. However, it could not be triggered.
"Multilateral organisations such as the United Nations and the World Trade Organisation should take it upon themselves to harmonise the certification of vaccines," he told PTI on the sideline of the conference, adding that "the world needs it if we want to be prepared in the future."
The committee is supposed to submit its report in 90 days. It has been tasked to examine the provisions of stakeholder departments with respect to pharmaceutical marketing practices and align the interventions for effective implementation among health care providers and industry. The committee will also examine the related issues on the requirement of "legally enforceable mechanism" for regulating marketing practices, including study of the practices across the globe".
The fresh funds from Temasek along with those from existing investors such as Motilal Oswal Alternates, will help the company accelerate development and commercialisation of new technologies based on clinical need gaps, Molbio Diagnostics said in a statement.
Founded in 2004, Optimus is a vertically integrated manufacturer of pharmaceutical products, including advanced intermediates, active pharmaceutical ingredients (APIs), and finished drugs. It currently exports more than 100 products to 40 countries.
Production-linked incentive schemes should also focus on companies providing packaging materials and other services in addition to manufacturers of branded pharmaceutical items to reduce import dependence, according to Bharat Biotech Executive Director Sai Prasad.
Globally, the biopharma drugs are expected to constitute over 40 per cent of the pharma market by 2030, presenting a significant opportunity for the Indian companies, it added. India is currently the third largest pharma industry in terms of volume and a source of 60,000 generic brands across 60 therapeutic categories.
"We have discussions going on with a few players," Nitiz Murdia, director and cofounder of Indira IVF, said, adding the company plans to close these transactions in the next 4-6 months. Murdia said Indira is also evaluating possibilities of acquiring IVF chains in Europe next year.
The patient, a native of Farrukhabad in Uttar Pradesh, had a kidney failure and was awaiting a transplant for the past five years, said Dr Anup Kumar, head of the department of Urology, Robotics and Renal Transplant, who performed the surgery.
The Group acquired a 31% controlling stake in Fortis in 2018, which triggered a mandatory open offer to acquire another 26% of Fortis shares from the market. The open offer has not proceeded due to ongoing legal proceedings due to the matter pending before the Supreme Court.
"Given that prevalence of people with T1D is projected to increase in all countries to up to 17.5 million cases in 2040, our results provide a warning for substantial negative implications for societies and healthcare systems," said Graham Ogle from Sydney Medical School, University of Sydney, who is, one of the authors of the study.
The panel includes secretary of the department of pharmaceuticals S Aparna, Union health secretary Rajesh Bhushan, and Central Board of Direct Taxes (CBDT) chairman Nitin Gupta as members, and a joint secretary (policy) from the department of pharmaceuticals as member secretary.
The company has built a chain of 18 hospitals across 8 cities in the country post the AHH investment in 2016 and has invested around 200 crores in consolidating its presence in the city of Bangalore and is planning to make an additional investment of 50 crores.
Covaxin - and has submitted the data to the Drugs Controller General of India (DCGI) for the review. Hyderabad based Bharat Biotech has sought market authorisation approval from Drugs Controller General of India (DCGI) for their intranasal heterologous booster in the 5-18 age group.
"The health authorities need to be vigilant. The Kerala mode of containment and contact tracing is praiseworthy and the prompt diagnosis made by NIV, Pune by achieving the gold standard of having cultured and sequenced the virus in a shortest possible time is encouraging by way of capacity building and the rapid response ecosystem having come of age in India," he added.
"India recorded the second highest number of attacks, with a total of 7.7 per cent of the total attacks on the healthcare industry in 2021," according to cyber security intelligence firm CloudSEK's report seen by PTI. US healthcare industry faced 28 per cent of the total global attacks, the report titled Increased cyber attacks on the global healthcare sector said.
The fresh round of talks with global buyout giants was initiated after the Texas-based private equity fund's attempts to sell the shares back to Manipal's Pai family didn't fructify.
"In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels," Sarah McMullen, country director - India at US Food and Drug Administration (USFDA) told ET, at the sidelines of a recent industry event in Mumbai.
The study, recently published in the Journal of Allergy and Clinical Immunology, found that children with certain immunodeficiency diseases carry mutations in genes that regulate the body's immune system against viral infections.
The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers has sought tweaking of paragraph 19 of the DPCO for the fixation of the maximum retail price (MRP) of any class of non-scheduled drugs under TMR.
"We are working on Lumpy Skin Disease virus," Ramdev told reporters. He said around one lakh cows have died because of this disease. Ramdev said the disease also affected many cows in his shelter house at Haridwar but not even a single cow died. "We treated cows with ayurvedic medicines like Giloy. Cows having better immunity were not infected with this disease," he said.
Glenmark had gross debt of ₹3,765 crore as of June 30, 2022. The company over the years accumulated debt to fund its innovation-led R&D and fund capex, but with growth in key US market stuttering, it has been focusing on cutting debt and improving cash flows. In FY22, Glenmark reduced its debt by around ₹1,200 crore.
As many as 34 new drugs were added and 26 dropped from an updated list of essential medicines.For the first time patented drugs like anti-TB drugs Bedaquiline and Delamanid, anti-HIV Dolutegravir and anti-hepatitis C Daclatasvir are also a part of the NLEM 2022 and their prices are set to get cheaper. Union health minister Mansukh Mandaviya released the revised NLEM on Tuesday.
The inclusion of treatments for diabetes, HIV, tuberculosis and cancer, along with contraceptives, hormonal medicines and anaesthetics in the essential medicines list will bring down out-of-pocket expenses further, which, despite the reductions, continues to be high. This can only be resolved by increasing investment in health. Capital expenditure on health in 2018-19 was less than 10%.
Several anti-cancer drugs, antibiotics and vaccines will now become more affordable as they are among 34 new additions to the National List of Essential Medicines, with the government saying this will reduce "patients' out-of-pocket expenditure".
Earlier this month, Bharat Biotech announced that its iNCOVACC (BBV154),the world's first intranasal COVID-19 vaccine, has received approval from the Drugs Controller General of India for restricted use in emergencies for those 18 and older. The vaccine is yet to be marketed.
Under Section 20 of the RTI Act, if CIC is convinced that information denial was unjustified and arising out of malafide intention, it may impose a penalty of Rs 250 from the day the information became due to the day it was furnished subject to a maximum limit of Rs 25,000 which would be deducted from the salary of the CPIO.
Medicines and devices listed in the NLEM must be sold at the prices set by National Pharmaceuticals Pricing Authority (NPPA), while those in the non scheduled list are allowed a maximum annual price increase of 10%. The revision of the NLEM aims to ensure that antibiotics are available when needed, and that the right antibiotics are prescribed for the right infections.
"The research has suggested there is a window of opportunity just prior to, during, and immediately after surgical removal of primary cancer when anti-cancer interventions could reduce the risk of development of disseminated stage-four metastatic cancer later in the lifespan of the patient," the hospital said.
