Life-saving drug for HIV patients inaccessible, says MSF

The Week- Namita Kohli

A drug that has been recommended by the WHO to treat cryptococcal meningitis has become inaccessible for patients suffering from the disease. Cryptococcal meningitis is an infection of the brain, which if left untreated, results in death for people living with HIV. According to Medecins Sans Frontières (MSF), about a year ago, the United State pharmaceutical company Gilead Sciences had announced its “access initiative” under which it had promised lower prices for liposomal amphotericin B (L-AmB) in 116 developing countries, including India. L-AmB is highly effective when used in combination with other medicines to treat cryptococcal meningitis, which is the second biggest killer of people living with HIV, after tuberculosis. About a year ago, this drug was recommended by the WHO as the preferred treatment for the disease, as opposed to a “suboptimal, more toxic treatment (AmB deoxycholate)”, keeping in mind the safety benefits and fewer side effects, MSF said in a statement. Use of this drug could improve treatment outcomes and management in low-resource settings where most cases of cryptococcal meningitis occur. “The WHO, however, recognised that the high prices and a lack of registration of L-AmB created major barriers to people accessing this drug in developing countries,” MSF said in the statement. Although Gilead publicised their pledge to reduce the price of the drug to a ‘no-profit’ price of $16.25 per vial in September 2018, L-AmB continues to be priced out of reach in many developing countries. In South Africa, for instance, the drug is priced at $200 per vial (at least $4,200 per full treatment course).

Healthcare News Monitor

Delhi government sets up an expert panel to inspect 35 state run hospitals

The Times of India- Durgesh Nandan Jha & Abhinav Garg

Delhi government has, on the directions of the high court, formed an expert committee to carry out inspection of 35 state-run hospitals, including G B Pant, Lok Nayak Jai Prakash, Guru Tegh Bahadur and Deen Dayal Upadhyay hospitals. The committee, which has eight members, is headed by D S Negi, principal secretary (health & family welfare). Delhi high court directed the government to form an expert committee for inspecting the hospitals in a recent order on a PIL filed by Madhu Bala, a schoolteacher in Karawal Nagar, who lost her baby during delivery at GTB Hospital due to alleged lack of medical facilities. Through advocate Prashant Manchanda the woman complained that the hospital did not conduct surgery claiming "non-availability" of an operating theatre (OT). In her plea, the teacher raised the issue in public interest and sought directions from court to improve the "dilapidated health system in public hospitals". During the course of hearing in April this year, Delhi government had conceded - by way of a status report - that there was an acute crisis of manpower in citys state-run hospitals. The court then put in place a committee and in the latest order HC left it to the "expertise and wisdom of the expert committee to decide the exact aspects of the hospitals listed above that are to be inspected and assessed." It, however, directed the panel to examine if these hospitals follow the Clinical Establishments (Registration and Regulation) Act, 2010 guidelines. As required under law, the norms empower the central government to prescribe certain standards for registration and continuation of every clinical establishment, including one that is owned, controlled or managed by a government or a government department. High Court elaborated that the Act prescribes minimum standards of facilities and services, minimum requirement of personnel, provision for maintenance of records and reports and other conditions for different levels of hospitals. In its order the court also directed Delhi government and the managing boards/administrating authorities of each of the hospitals "to render full cooperation and support to the committee set up by us, including by permitting access to and making available such records and documents to the expert committee, as the committee may desire." It warned that any act or omission on part of any of the parties to hinder the inspection exercise ordered by the court would invite penalty. The court added that the main purpose of carrying out scrutiny of these hospitals is that the panel should be able to place before it a comprehensive report of shortcomings and suggestions to improve these government-run entities.

Future is in doubt for cheaper versions of biologic drugs

ET Healthworld- AP

They were the drugs that were supposed to save the U.S. tens of billions of dollars. Called "biosimilars," they are near-copies of complex and expensive biologic drugs to treat cancer, rare diseases and autoimmune disorders like rheumatoid arthritis and colitis. But U.S. sales have been so limited that their future is in doubt. Already, one company has scrapped nearly all its biosimilar development projects. Worst-case scenario? Drugmakers could abandon biosimilar development, and makers of original biologic drugs could keep raising their six-figure-a-year prices indefinitely. Two years ago, the independent policy research group RAND Health predicted biosimilars would save the U.S. roughly $54 billion from 2017 through 2026. Thats looking optimistic. "This is a make-or-break period," said Dr. Scott Gottlieb, who led the Food and Drug Administration until April. "My fear is that some of the biosimilar-makers ... will say, Well just go back to doing other things," and other drugmakers wont enter the niche. Leigh Purvis, AARPs director of health services research, says the original biologic drugmakers "could kill this market before it ever takes off, and we desperately need it." THE PROMISE Biosimilars are akin to generic drugs, but true generics arent possible with biologic drugs.Pills are easily duplicated by mixing chemicals. Getting a generic version of a brand-name pill approved requires spending about $2 million and two years to conduct lab tests and show its chemically equivalent to the original medication. Manufacturing costs just pennies a pill. Biologic drugs, on the other hand, are made by manipulating living cells to produce a specific protein. They treat disorders often caused by faulty genes or immune systems, and they must be injected or delivered by infusion. The complex process needed to grow and purify the proteins means a copycat biosimilar will never be identical to the original drug. But it also cant have "clinically meaningful" differences.

TN govt to set up comprehensive pharma park with separate units for formulations, devices and APIs soon

Pharmabiz- Peethaambaran Kunnathoor

The Government of Tamil Nadu will soon announce its landmark decision to set up a comprehensive pharma park with three units each for formulations, APIs and medical devices. This was announced by J Jeyaseelan, chairman of TN IDMA at the inaugural session of the fifth Pharmac South Expo at Chennai Trade Centre on June 28. The government is holding discussions with the industry and other stakeholders and an announcement from government side is expecting in another six months, he informed the participants at the meeting. Another promotional impetus to the manufacturers of pharmaceuticals is that the government will increase the 10 per cent price preference currently giving to the manufacturers through Tamil Nadu Medical Services Corporation. Jayaseelan was delivering the welcome address at the inaugural function. While sharing an overview of Pharmac South with the audience, S V Veeramani, former president of IDMA, said the pharma park is likely to be set up in Gummidipundi, near Chennai and it will be very much helpful for all the pharma industrial units in Tamil Nadu. He said the government of India is supporting the pharma sector in a big way and now the government has decided to increase the total outlay for health to 2.5 per cent from the existing 1 per cent. He said the Indian pharma industry is growing at a rate of 10 per cent, while in the global level, pharma industry is growing at 5 per cent only.

GSK, RCB to jointly develop PhD programmes in bio-statistics and bio-informatics to boost research

Pharmabiz- A Raju

GSK Pharmaceutical Ltd has joined hands with Regional Centre for Biotechnology (RCB) under the Department of Biotechnology (DBT) to jointly develop PhD programmes in bio-statistics and bio-informatics to boost research in the country. RCB is an academic institution of national importance established by the DBT under the auspices of UNESCO. To start the collaboration, GSK launched the Trust in Science Programme to develop doctoral programmes (PhDs) in the fields of biostatistics and bioinformatics. Under this initiative, the RCB will develop programme content, manage logistics and oversee the running of the full-time programmes. GSK Pharmaceutical Ltd. will provide funding and ensure all course content is shaped to address current industry needs and opportunities. Students with a master’s degree in biostatistics, maths and bioinformatics are eligible for the PhD courses. The launch took place in the presence of Dr. Renu Swarup, secretary, DBT, Sir Dominic Asquith KCMG, British High Commissioner to India, Prof. Sudhanshu Vrati, executive director, RCB, and A Vaidheesh, MD, GSK Pharmaceutical Ltd. Dr. Renu Swarup during her address said, “We would like to create more opportunities in India for post graduate doctoral education in science. The GSK – RCB collaboration allows us to do just that, specifically in two niche, high-valued fields- biostatistics and bioinformatics. The goal is to provide students with a specialized course that addresses current industry needs and opportunities. This, we believe, will help them better contribute to India’s biopharma and medical research needs.”