My Clinical Trials Diary

 According to a new market research report "Contract Research Organization Services (CROs) Market by Type (Discovery, CMC, Preclinical, Clinical Research, Laboratory Services), Therapeutic Area (Oncology, CNS, Cardiovascular), End User (Pharmaceuticals & Medical Device) - Global Forecast to 2023", published by MarketsandMarkets™, the global market is projected to reach USD 56.34 Billion by 2023 from USD 39.13 Billion in 2018, at a CAGR of 7.6%. Continue reading here ᐧ

Scientists have been developing an eye drop that can be self-administered, thus revolutionizing treatment for age-related macular degeneration (AMD) — the leading cause of blindness in the developed world. Currently treated by injections of sight-saving drugs into the eye which must be administered by medical professionals, it is estimated that, by 2020 there will be about 200 million people worldwide with AMD. However, scientists at the Britain's University of Birmingham have been developing an alternative treatment in the form of an easy-to-use eye drop. After earlier proving that the drop has a similar therapeutic effect as injections do in rodents, the team began investigating the drug in rabbits and pigs, which have eyes that are similar to those of humans. The new study demonstrated that the eye drops can deliver a therapeutically effective amount of the drugs to the retina of the larger mammalian eye. "For several years, our team has focused on the challenge of deliveri...

Experts in the clinical trial arena are of the view that there is an urgent need for a predictable regulatory environment in the country to create global trust in India as a stable clinical trial market. But, they rued that developments in the last few years have dented the confidence of sponsors in doing clinical research in India.   India is on a slow recovery period and there is a need to ensure that it continues the growth trajectory. "Various factors, including reports of alleged irregularities in clinical trials have also led to a lot of misinformation and negative perceptions of clinical trials in India. Besides this, some of the clauses of The Draft Clinical Trial Rules 2018 around compensation are regressive and, if implemented, could force sponsors  both domestic and foreign to reconsider doing clinical trials in India,"explains Naz Haji, Managing Director, IQVIA India.   Formed through the merger of IMS Health and Quintiles, IQVIA is a leading global provider o...

Tuberculosis causes 250,000 deaths in India each year Researchers at the Indian Institute of Science (IIS) have discovered a new drug combination that promises better outcome in treating Tuberculosis (TB), which causes 250,000 deaths in India each year. Animal studies on mice shows that the drug Pranlukast (PRK) not only killed tuberculosis bacteriumbut also compromised its survival strategies within the cells, said the research, published in the February issue of online journal, EMBO Molecular Medicine. "The problem with TB is the bacterium keeps developing resistance against new drugs and at least 15 drugs have been abandoned so far, either due to resistance against the drug or severe toxicity," says Dr Avdhesha Suroli, lead researcher of the project. "Our research has proved this combination could work better and be an effective addition to the TB drug pipeline that needs to be reinvented frequently. We need the government or pharma companies to come forward a...

The researchers at IIT Roorkie are conducting in-depth research on the drug piperazine, and have discovered its anti-viral properties could be used to tackle the disease. While the WHO report on Chigunya shows that over the years there has been no specific antiviral drug treatment for chikungunya or no commercial chikungunya vaccine, researchers at the Indian Institute of Technology (IIT) in Roorkee are on a mission to develop a cure. In the absence of a vaccine or antiviral drug available in the market, the course of treatment currently revolves around alleviating symptoms associated with the viral infection. Their research has shown that the spread and replication of the Chikungunya virus can be efficiently curbed in a lab setting with the existing drug piperazine. The focus is now on testing the molecule on animals so they can take it one step forward to clinical trials. ​ Continue reading ​ ᐧ

India is a land full of opportunities for players in the medical devices industry. The country has also become one of the leading destinations for high-end diagnostic services with tremendous capital investment for advanced diagnostic facilities, thus catering to a greater proportion of population, writes Dr P Siva Kumar, CEO, Trivitron Healthcare, in this insightful article on the Indian healthcare industry. Healthcare has become one of India's largest sectors – both in terms of revenue and employment. Healthcare comprises hospitals, medical devices, clinical trials, outsourcing, telemedicine, medical tourism, health insurance and medical equipment. The Indian healthcare sector is growing at a brisk pace due to its strengthening coverage, services and increasing expenditure by public as well private players. India's competitive advantage lies in its large pool of well-trained medical professionals apart from being cost competitive compared to its peers in Asia and Western coun...

With researchers finding in a trial involving 10,000 adults that an existing anti-inflammatory drug has the potential to lower lung cancer risk, doctors in India have expressed hope for better tackling of the critical disease. According to a study published in the journal Lancet, death from cancer was reduced by half in a group of people who received the highest dosage of the drug known as Canakinumab and also led to 67 per cent reduction in lung cancer incidence. Canakinumab was found to lower inflammation, without affecting cholesterol level — which was the widely used approach for many years. It was also found effective against heart attack, stroke and cardiovascular death. "As a rule, anti-inflammatory drugs have a role in prevention of cancer. With the rise in pollution levels across the country, there will be added burden on the lungs of those who may be suffering for lung cancer," Dinesh Katiyar, Senior Consultant (Surgical Oncologist) at Venkateshwar Hospital here, to...

​ Thanks to ancient science Ayurveda which came up with a unique wonder drug under the name of S.Compound. Work on herb was started in the year 1974 and ultimately it was confirmed that the herb has great potential in inflammatory conditions. However, its role on arthritis was explored because it was the most neglected disease by the scientists and Medical fraternity. The available pain killers were causing huge harm to our body systems and some of the available pain killers were even banned in Europe. The herbal medicine S.Compound was compared with Phenylbutazone by the scientists of Central Drug Research Institute Lucknow in the year 1983 and was found better in efficacy Controlled Clinical trials were carried out on human beings suffering from Rheumatoid arthritis; Is not only its efficacy was confirmed but it was also found safe in long duration. The research work was published in Eastern Pharmacist which was reported by country's premier News Agency United News of India on 21...

A research team at the University of Nebraska Medical Center College of Public Health has determined that a special mixture of good bacteria in the body reduced the incidence of sepsis in infants in India by 40 percent at a cost of only $1 per infant. The findings are reported in the Aug. 16 issue of the journal Nature. Pinaki Panigrahi, M.D., Ph.D., professor, epidemiology and pediatrics, Center for Global Health and Development, and his colleagues in the College of Public Health, led the international research team. The results reflect a culmination of 15 years of research and could seriously impact infant health worldwide. The special mixture included a probiotic called Lactobacillus plantarum ATCC-202195 combined with fructo-oligosaccharide (FOS), an oral synbiotic preparation developed by Dr. Panigrahi. Probiotics are live bacteria and yeasts that are good for your health, especially your digestive system. Synbiotics are combinations of probiotics with an FOS supplement that promo...

Doctors have urged caution against the use of two medications widely prescribed for chronic low back pain after a systematic review of medical evidence found they carry significant risks of adverse effects without any proven benefit. The available evidence does not support the use of gabapentin and pregabalin for treating chronic low back pain, the doctors based in Canada and India said after reviewing multiple earlier studies comparing these drugs with placebo treatment, or sham pills. Chronic low back pain is a common health disorder with studies indicating prevalence rates of four in every 100 persons between 24 and 39 years to 20 in every 100 persons between 20 and 59 years. Doctors typically use non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics to treat acute low back pain. But patients with chronic low back pain often receive prescriptions for gabapentin or pregabalin, which have been shown to be helpful in treating nerve-linked pain. "There is no justification f...

A national research institute of 'Unani' medicine will be set up at a village in Faridabad district, a spokesman of Haryana government said today. The institute, which will provide healthcare facilities in the field of non-communicable diseases, would also include a 120-bedded in-patient department, the spokesman of the Ayush department said. Chief Minister Manohar Lal Khattar has approved a proposal to allot land of Kheri Gujran village for the institute. The institute would be developed as a state-of-the-art research centre with facilities for pre-clinical studies, clinical trials, drug standardisation and cultivation of medicinal plants used in 'Unani' system, the spokesman said. It would also offer facilities such as research and geriatric OPDs, speciality clinics, he said. The institute would have laboratories for bio-chemistry, pathology, radiology and USG, drug standardisation, immunology, pharmacognocy and phytochemistry, besides regimental therapy unit, library...

Some medically useful compounds of cannabis may open the door for medical marijuana in India through a new government policy IN India, the controversial cannabis plant is a league of its own in legal, cultural, and religious spheres. A video on Swami Ramdev's YouTube channel about medical use of Indian hemp by Acharya Bal Krishan, CEO of Patanjali, underlines its scope in ayurveda. Even though the Narcotic Drugs and Psychotropic Substances Act banned the production and sale of cannabis resin and flowers, it left the leaves and seeds for the states to regulate. For all you know, medical marijuana may already have made its way into India. Ram Vishawakarma, director of CSIR-India Institute of Integrative Medicine in Jammu, uses the word cannabidiol (CBD) instead of medical marijuana. At the institute, he is conducting a research on medical uses of CBD, an extract from the cannabis plant. Quoting studies published in top medical journals such as Nature, Vishawakarma says CBD has been a...

While cholera vaccines work quite well for adults, they provide significantly less protection for children under 5, a population particularly at risk for dying from this diarroheal disease, says a study based on a review of research literature. The review, which considered seven clinical trials and six observational studies, found that the standard two-dose vaccine regimen reduced the risk of getting cholera on average by 58 per cent for adults but only by 30 per cent for children under age 5. The findings, published online in the journal The Lancet Infectious Diseases, could help inform policymakers on how and when to use the vaccine, particularly in outbreak settings such as the ongoing epidemic in Yemen, which has seen an estimated 400,000 suspected cases and as many as 1,900 associated deaths since the outbreak began in April 2017. Cholera is transmitted through an oral-fecal route, with outbreaks and endemic transmission tending to occur in areas with poor sanitation and a lack of...

Mylan's anti-Tuberculosis drug Delamanid's treatment will be limited to those patients who have stopped responding to most of first and second line of treatment. Indian unit of US drug maker Mylan Inc. has received approval from the country's drug regulator DCGI to market Delamanid, a new class of anti Tuberculosis (TB) medicine discovered to specifically treat Multi Drug Resistant TB (MDR) in India. Like Bedaquiline, which was the first TB drug launched in 40 years in 2016, Delamanid's treatment will be "limited" to those patients who have stopped responding to most of first and second line of treatment. The drug billed as "wonder drug" will be rolled out in government-run-TB programme. Prior to this, the ministry of health and family welfare had in 2016 launched Bedaquiline drug for treatment of drug resistant TB for 600 patients across India. It was made available in five cities-Delhi, Chennai, Mumbai, Guwahati and Ahmedabad. With cases of multi d...

The Union health ministry is reported to be considering to do away with the mandatory three phase clinical trials before launching new drugs if they have proved their safety and efficacy in developed countries. For this exemption, these new drugs should have been approved and marketed for at least two years in the markets of European Union, UK, US, Australia, Canada and Japan. The health ministry already sent the draft proposal in this regard to the ministry of law and justice for clearance. Permission to market new drugs are usually granted by the regulatory authorities in any country including in India only after carefully assessing the adverse drug reactions during the clinical trials.  The health ministry thinks that the decision can avoid unnecessary repetition of trials and speed up the introduction of new drugs in the country. The health ministry thinks that change in trial rules should make it easier for the pharmaceutical companies to introduce drugs in India which are already...

The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent. In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients. Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan. A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce n...

For the first time, genetically modified human embryos have been developed in the US and Kashmir-born doctor Sanjeev Kaul has played a lead role in this breakthrough. Scientists have now demonstrated an effective way of using a gene-editing tool to correct a disease-causing gene mutation in human embryos and stop it from passing to future generations. Though this is not a full-fledged start of a revolution of having designer babies, the first steps, however, have been laid. China attempted this earlier. A team of scientists has altered human embryos using a new technique called CRISPR CAS9 that edits genes and in this case it helped remove a fatal mutation that leads to heart attacks. This now opens up an ethical Pandoras Box if germline repairs and enhancements may become a thing in vogue. As of now, the human embryos were not implanted in humans. But this now opens up exciting prospects of the world having designer babies soon. The research published in British journal Nature shows t...

The move to abolish clinical trials of proven drugs will reduce time taken to introduce new drugs in India to just 45 days from 5-6 years. In a move aimed at speeding up the availability of new drugs, the government has proposed doing away with clinical trials for drugs that have proved their efficacy in developed markets. According to a proposed new set of rules, a part of which has been reviewed by Mint, the government suggested waiving local clinical trials for drugs that have not had any major adverse effects on patients. These drugs should have been approved and marketed for at least two years in the European Union, UK, US, Australia, Canada and Japan. The ministry of health and family welfare has sent the draft proposal to the ministry of law and justice for vetting before it can be notified. The move is expected to reduce the time taken by a company to introduce new drugs in the market from 5-6 years to as few as 45 days. According to the drug regulator, the move will also lower...

Common anti-allergy medicines could prove to be an effective treatment for potentially fatal blood clots in the legs, a study has claimed. The research by the University of Birmingham in the UK could lead to new treatments that prevent deep vein thrombosis (DVT), a blood clot that develops within a deep vein in the body, usually in the leg, and causes swelling, aching and difficulty walking. It can be caused by prolonged periods of immobility, such as after surgery or during a long flight. If the clot becomes dislodged it can travel to the lungs and block a blood vessel. This is known as a pulmonary embolism (PE). An estimated 30 per cent of PEs cause sudden death. The team discovered that mice genetically depleted of mast cells, a type of immune cells, are protected from developing DVT. The current treatments for DVT include anti-clotting drugs such as heparin and warfarin. These drugs are relatively effective but put patients at increased risk of bleeding. ​Finish reading this articl...

St. Jude Children's Research Hospital recently announced that it has signed a licensing agreement granting Serum Institute of India exclusive rights to complete the development of the hospital's respiratory syncytial virus, or RSV, vaccine. Through this agreement, Serum Institute of India will be able to design and conduct clinical trials investigating the intranasal SeVRSV vaccine and commercialize the vaccine in South America, Africa and much of Asia, according to a press release. "RSV remains a serious threat to infants worldwide during their first year of life and to anyone, including pediatric cancer patients, whose immune response has been weakened by illness or age," James R. Downing, MD, president and CEO at St. Jude, said in the release. "We are pleased that Serum's staff and leadership have recognized the life-saving potential of this vaccine. We look forward to working closely with them to make this vaccine accessible around the globe." RSV is...