Misplaced Pages

#871128

66-618: RISUG has been patented in India, China, Bangladesh, and the United States. Phase III clinical trials were underway in India, and were slowed by insufficient volunteers. Beginning in 2011, a contraceptive product based on RISUG, Vasalgel , was under development in the US by the Parsemus Foundation , who were unable to bring the product to market over the next decade. In 2023, the patent for Vasalgel

132-589: A medical treatment . For drug development , the clinical phases start with testing for drug safety in a few human subjects , then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices , and new diagnostic assays . Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. When expressed specifically,

198-419: A candidate drug, vaccine, medical device, or diagnostic assay, the product candidate is tested extensively in preclinical studies . Such studies involve in vitro ( test tube or cell culture ) and in vivo ( animal model ) experiments using wide-ranging doses of the study agent to obtain preliminary efficacy , toxicity and pharmacokinetic information. Such tests assist the developer to decide whether

264-405: A clinical trial clinic, where the subject can be observed by full-time staff. These clinical trial clinics are often run by contract research organization (CROs) who conduct these studies on behalf of pharmaceutical companies or other research investigators. The subject who receives the drug is usually observed until several half-lives of the drug have passed. This phase is designed to assess

330-428: A clinical trial phase is capitalized both in name and Roman numeral , such as "Phase I" clinical trial. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over several years. Before clinical trials are undertaken for

396-510: A drug candidate has scientific merit for further development as an investigational new drug . Phase 0 is a designation for optional exploratory trials, originally introduced by the United States Food and Drug Administration's (FDA) 2006 Guidance on Exploratory Investigational New Drug (IND) Studies, but now generally adopted as standard practice. Phase 0 trials are also known as human microdosing studies and are designed to speed up

462-426: A higher dose. If unacceptable toxicity is observed in any of the three participants, an additional number of participants, usually three, are treated at the same dose. This is continued until pre-calculated pharmacokinetic safety levels are reached, or intolerable side effects start showing up (at which point the drug is said to have reached the maximum tolerated dose (MTD)). If an additional unacceptable toxicity

528-399: A male contraceptive. Despite this, pharmaceutical companies are reluctant to lose market share of a thriving global market for female contraceptives and condoms which bring billions of dollars of revenue each year. Initially, RISUG attracted some interest from pharmaceutical companies. However, considering that RISUG is an inexpensive, one-time procedure, manufacturers retracted. Smart RISUG

594-436: A negative and positive electric charge mosaic. Within an hour after placement the differential charge from the gel will rupture the sperm's cell membrane as it passes through the vas, deactivating it before it can exit from the body. The thoroughness of carcinogenicity and toxicity testing in clinical trials had been questioned after phase I of clinical trials on the basis of presence of styrene and maleic anhydride in

660-481: A pain or anesthesia Phase III trial may cost as much as $ 53 million. An analysis of Phase III pivotal trials leading to 59 drug approvals by the US Food and Drug Administration over 2015–16 showed that the median cost was $ 19 million, but some trials involving thousands of subjects may cost 100 times more. Across all trial phases, the main expenses for clinical trials were administrative staff (about 20% of

726-441: A polymer gel (rather than being cut and cauterized). In a matter of minutes, the injection coats the walls of the vasa with a clear gel made of 60 mg of the copolymer styrene/maleic anhydride (SMA) with 120 μL of the solvent dimethyl sulfoxide . The copolymer is made by irradiation of the two monomers with a dose of 0.2 to 0.24 megarad for every 40 g of copolymer and a dose rate of 30 to 40 rad/s. Dr Pradeep K. Jha,

SECTION 10

#1732873568872

792-553: A predetermined level. A short trial designed to investigate any differences in absorption of the drug by the body, caused by eating before the drug is given. These studies are usually run as a crossover study , with volunteers being given two identical doses of the drug while fasted , and after being fed. Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect. Phase II trials are performed on larger groups (50–300 individuals) and are designed to assess how well

858-603: A process called an "adaptive design". Examples are the 2020 World Health Organization Solidarity trial , European Discovery trial , and UK RECOVERY Trial of hospitalized people with severe COVID-19 infection, each of which applies adaptive designs to rapidly alter trial parameters as results from the experimental therapeutic strategies emerge. Adaptive designs within ongoing Phase II–III clinical trials on candidate therapeutics may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, and coordinating design changes for

924-478: A pulsed magnetic field. With this magnetic field, the polymer can change location inside the body to maximize sterility or can be removed to restore fertility. The polymer has magnetoelastic behavior that allows it to stretch and elongate to better line the vas deferens. The iron oxide component is necessary to prevent agglomeration. With the presence of iron particles, the polymer has lower protein binding and therefore prevents agglomeration. The copper particles in

990-420: A senior scientist, worked on the effects of gamma dose rate and total dose interrelation on molecular designing and biological function of polymer. The source of irradiation is cobalt-60 gamma radiation . The effect the chemical has on sperm is not completely understood. Originally, researchers thought it lowered the pH of the environment enough to kill the sperm. Guha theorizes that the polymer surface has

1056-506: A short follow-up period for evaluation, relative to the period of time the intervention might be used in practice. This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug. It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until

1122-401: A single dose of the drug while they are observed and tested for a period of time to confirm safety. Typically, a small number of participants, usually three, are entered sequentially at a particular dose. If they do not exhibit any adverse side effects, and the pharmacokinetic data are roughly in line with predicted safe values, the dose is escalated, and a new group of subjects is then given

1188-403: A slightly different formulation than RISUG, underwent animal trials in the United States, but reversibility proved unsuccessful. RISUG works by an injection into the vas deferens, the vessel through which the sperm moves before ejaculation . RISUG is similar to vasectomy in that a local anesthetic is administered, an incision is made in the scrotum , and the vasa deferentia are injected with

1254-710: A specific trial across its international locations. For vaccines, the probability of success ranges from 7% for non-industry-sponsored candidates to 40% for industry-sponsored candidates. A 2019 review of average success rates of clinical trials at different phases and diseases over the years 2005–15 found a success range of 5–14%. Separated by diseases studied, cancer drug trials were on average only 3% successful, whereas ophthalmology drugs and vaccines for infectious diseases were 33% successful. Trials using disease biomarkers , especially in cancer studies, were more successful than those not using biomarkers. A 2010 review found about 50% of drug candidates either fail during

1320-594: A time-bound, goal-oriented approach with clearly defined targets, specific time frames, standardised and uniform methodologies, and often a multicentric structure. Open-ended research is conducted on the basis of applications for grants-in-aid received from scientists in non-ICMR Research Institutes, Medical colleges and Universities located in different parts of the country. Collaborative research projects with other institutes such as that between Institute of Pathology, Delhi and NCRM are also undertaken. ICMR's Viral Research and Diagnostic Laboratories (VRDL) for diagnosis of

1386-404: A typical cancer phase II study might include fewer than 30 people to estimate the response rate. When a study assesses efficacy, it is looking at whether the drug given in the specific manner described in the study is able to influence an outcome of interest (e.g. tumor size) in the chosen population (e.g. cancer patients with no other ongoing diseases). When a study is assessing effectiveness, it

SECTION 20

#1732873568872

1452-473: A variable inconvenience fee for their time spent in the volunteer center. Before beginning a Phase I trial, the sponsor must submit an Investigational New Drug application to the FDA detailing the preliminary data on the drug gathered from cellular models and animal studies. Phase I trials can be further divided: Single ascending dose (Phase Ia): In single ascending dose studies, small groups of subjects are given

1518-535: A view to reduce the total burden of disease and to promote health and well-being of the population. In 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country. After independence, several important changes were made in the organisation and the activities of IRFA. It was redesignated as

1584-416: Is a newer version of the male contraception that was published in 2009. The polymer adds iron oxide and copper particles to the original compound, giving it magnetic properties and the name "Smart RISUG". After injection the exact location of the polymer inside the vas deferens can be measured and visualized by X-ray and magnetic resonance imaging . The polymer location can also be externally controlled using

1650-473: Is also the secretariat for Health Ministry's Screening Committee (HMSC) meeting organised monthly for consideration of international collaborative research projects. It also encourages human resource development in biomedical research through Research Fellowships, Short-Term Visiting Fellowships, Short-Term Research Studentships, and various training programmes and workshops conducted by ICMR institutes and headquarters. For retired medical scientists and teachers,

1716-478: Is determining whether a treatment will influence the disease. In an effectiveness study, it is essential that participants are treated as they would be when the treatment is prescribed in actual practice. That would mean that there should be no aspects of the study designed to increase compliance above those that would occur in routine clinical practice. The outcomes in effectiveness studies are also more generally applicable than in most efficacy studies (for example does

1782-456: Is no formal definition for these two sub-categories, but generally: Some Phase II trials are designed as case series , demonstrating a drug's safety and activity in a selected group of participants. Other Phase II trials are designed as randomized controlled trials , where some patients receive the drug/device and others receive placebo /standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials. In

1848-438: Is observed, then the dose escalation is terminated and that dose, or perhaps the previous dose, is declared to be the maximally tolerated dose. This particular design assumes that the maximally tolerated dose occurs when approximately one-third of the participants experience unacceptable toxicity. Variations of this design exist, but most are similar. Multiple ascending dose (Phase Ib): Multiple ascending dose studies investigate

1914-598: Is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, to obtain approval from the appropriate regulatory agencies such as FDA (US), or the EMA (European Union). Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up

1980-559: The developed world , the average time taken for a drug to go from concept to market is 10 to 15 years, whereas, it has been over four decades since Guha published his original paper on RISUG. RISUG aims to provide males with years-long fertility control, thereby overcoming compliance problems and avoiding ongoing costs associated with condoms and the female birth control pill , which must be taken daily. Pharmaceutical companies have expressed little interest in RISUG. One obstacle facing marketing of

2046-508: The "regulatory submission" that is provided for review to the appropriate regulatory authorities in different countries. They will review the submission, and if it is acceptable, give the sponsor approval to market the drug. Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere,

Reversible inhibition of sperm under guidance - Misplaced Pages Continue

2112-492: The 1970s, Guha modified his heart pump design to create a water pump that could work off of differences in ionic charges between salt water and fresh water in water treatment facilities. This filtration system did not require electricity and could potentially help large groups of people have access to clean water. India, however, decided that the population problem would be better served by developing more effective contraception. So Guha again modified his design to work safely inside

2178-679: The Indian Council of Medical Research (ICMR) in 1949, with a considerably expanded scope of functions. The governing body of the council is presided over by the Union Health Minister . It is assisted in scientific and technical matters by a scientific advisory board comprising eminent experts in different biomedical disciplines. The board, in its turn, is assisted by a series of scientific advisory groups, scientific advisory committees, expert groups, task forces, steering committees etc. which evaluate and monitor different research activities of

2244-815: The Phase III trial or are rejected by the national regulatory agency. In the early 21st century, a typical Phase I trial conducted at a single clinic in the United States ranged from $ 1.4 million for pain or anesthesia studies to $ 6.6 million for immunomodulation studies. Main expense drivers were operating and clinical monitoring costs of the Phase I site. The amount of money spent on Phase II or III trials depends on numerous factors, with therapeutic area being studied and types of clinical procedures as key drivers. Phase II studies may cost as low as $ 7 million for cardiovascular projects, and as much as $ 20 million for hematology trials. Phase III trials for dermatology may cost as low as $ 11 million, whereas

2310-1127: The apex body in India for the formulation, coordination and promotion of biomedical research , is one of the oldest and largest medical research bodies in the world. The ICMR is funded by the Government of India through the Department of Health Research, Ministry of Health and Family Welfare . In 2007, the organization established the Clinical Trials Registry - India , which is India's national registry for clinical trials. ICMR's 26 national institutes address themselves to research on specific health topics like tuberculosis , leprosy , cholera and diarrhoeal diseases , viral diseases including AIDS , malaria , kala-azar , vector control, nutrition, food & drug toxicology, reproduction, immuno-haematology, oncology, medical statistics, etc. Its 6 regional medical research centres address themselves to regional health problems, and also aim to strengthen or generate research capabilities in different geographic areas of

2376-539: The body does to the drugs). A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates to decide which has the best pharmacokinetic parameters in humans to take forward into further development. They enable go/no-go decisions to be based on relevant human models instead of relying on sometimes inconsistent animal data. Phase I trials were formerly referred to as "first-in-man studies" but

2442-413: The body, specifically inside the male genitalia. The non-toxic polymer of RISUG also uses differences in the charges of the semen to rupture the sperm as it flows through the vas deferens . Intellectual property rights to RISUG in the United States were acquired between 2010 and 2012 by the Parsemus Foundation , a not-for-profit organization , which has branded it as "Vasalgel". Vasalgel, which has

2508-400: The compound allow the polymer to conduct heat. When an external microwave applies heat to the polymer, it can liquify the polymer again to be excreted to restore fertility. Smart RISUG is therefore a better choice for men who want to use RISUG as temporary birth control, since it does not require a second surgery to restore fertility. The addition of metal ions also increases the effectiveness of

2574-481: The council offers the position of emeritus scientist to enable them to continue or take up research on specific biomedical topics. The council also awards prizes to Indian scientists, in recognition of significant contributions to biomedical research as well as those who work in the underdeveloped parts of the country. At present, the council offers 38 awards, of which 11 are meant exclusively for young scientists (below 40 years). The Indian Journal of Medical Research

2640-1001: The council. The council promotes biomedical research in the country through intramural as well as extramural research. Over the decades, the base of extramural research and also its strategies have been expanded by the council. Intramural research is carried out currently through the council's 30 permanent research institutes/centres which are mission-oriented national institutes located in different parts of India. The institutes pursue specific areas of research such as COVID-19 , tuberculosis , leprosy , cholera and diarrhoeal diseases, viral diseases including Rotavirus , dengue , COVID-19 , Ebolavirus , Influenza , Japanese encephalitis , AIDS , malaria , kala-azar , vector control, nutrition, food & drug toxicology , reproduction , immunohaematology , oncology , and medical statistics. Six Regional Medical Research Centres address regional health problems, and also aim to strengthen or generate research capabilities in different geographic areas of

2706-646: The country. The council's research priorities coincide with National health priorities such as control and management of communicable diseases , fertility control, maternal and child health, control of nutritional disorders, developing alternative strategies for health care delivery, containment within safety limits of environmental and occupational health problems; research on major non-communicable diseases like cancer, cardiovascular diseases, blindness, diabetes and other metabolic and haematological disorders; mental health research and drug research (including traditional remedies). These efforts are undertaken with

Reversible inhibition of sperm under guidance - Misplaced Pages Continue

2772-418: The country. It has also been involved in research related to rare diseases like Handigodu syndrome . Extramural research is promoted by ICMR by establishing Centres for Advanced Research in different research areas around existing expertise and infrastructure in selected departments of medical colleges, universities and other non-ICMR research institutes. The ICMR also funds task force studies which emphasise

2838-402: The development of promising drugs or imaging agents by establishing very early on whether the drug or agent behaves in human subjects as was expected from preclinical studies. Distinctive features of Phase 0 trials include the administration of single subtherapeutic doses of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics (what

2904-573: The disease. Phase II clinical programs historically have experienced the lowest success rate of the four development phases. In 2010, the percentage of Phase II trials that proceeded to Phase III was 18%, and only 31% of developmental candidates advanced from Phase II to Phase III in a study of trials over 2006–2015. This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice. Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon

2970-442: The disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have

3036-477: The drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorized as "Phase IIIB studies." While not required in all cases, it

3102-461: The drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Genetic testing is common, particularly when there is evidence of variation in metabolic rate. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects. Phase II studies are sometimes divided into Phase IIa and Phase IIb. There

3168-462: The drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market. The design of individual trials may be altered during a trial – usually during Phase II or III – to accommodate interim results for the benefit of the treatment, adjust statistical analysis, or to reach early termination of an unsuccessful design,

3234-456: The field generally moved to the gender-neutral language phrase "first-in-humans" in the 1990s; these trials are the first stage of testing in human subjects. They are designed to test the safety, side effects, best dose, and formulation method for the drug. Phase I trials are not randomized, and thus are vulnerable to selection bias . Normally, a small group of 20–100 healthy volunteers will be recruited. These trials are often conducted in

3300-428: The first stage, the investigator attempts to rule out drugs that have no or little biologic activity. For example, the researcher may specify that a drug must have some minimal level of activity, say, in 20% of participants. If the estimated activity level is less than 20%, the researcher chooses not to consider this drug further, at least not at that maximally tolerated dose. If the estimated activity level exceeds 20%,

3366-453: The formulation. In response, Guha argued that substances can be individually toxic in nature but harmless as compounds like pure chlorine, which can melt human flesh on its own, but, when combined with sodium, it becomes sodium chloride – the basic salt that people consume in their diets. When it did not persuade ICMR and the clinical trials did not resume by 1996, he went to the Supreme court and

SECTION 50

#1732873568872

3432-720: The lack of any evidence for adverse effects, trials were restarted in 2011. Guha says concerns over the safety and efficacy of the drug have mainly come from the NIH and WHO. By November 2019, the ICMR had successfully completed clinical trials of the world's first injectable male contraceptive, which was then sent to the Drug Controller General of India (DCGI) for regulatory approval. The trials were over, including extended, phase III clinical trials, for which 303 candidates were recruited with 97.3% success rate and no reported side effects. In

3498-419: The next round of clinical trials resumed afterwards. In October 2002, India's Ministry of Health aborted the clinical trials due to reports of albumin in urine and scrotal swelling in phase III trial participants. Although the ICMR has reviewed and approved the toxicology data three times, WHO and Indian researchers say that the studies were not done according to recent international standards. Due to

3564-409: The patient feel better, come to the hospital less or live longer in effectiveness studies as opposed to better test scores or lower cell counts in efficacy studies). There is usually less rigid control of the type of participant to be included in effectiveness studies than in efficacy studies, as the researchers are interested in whether the drug will have a broad effect in the population of patients with

3630-410: The pharmacokinetics and pharmacodynamics of multiple doses of the drug, looking at safety and tolerability. In these studies, a group of patients receives multiple low doses of the drug, while samples (of blood, and other fluids) are collected at various time points and analyzed to acquire information on how the drug is processed within the body. The dose is subsequently escalated for further groups, up to

3696-443: The product is that men generally perceive contraception as a woman's issue. Men may choose not to use alternative methods of contraception because there are fewer options for birth control for them than there are for women, or they may fear the side effects, or it may conflict with their cultural or religious beliefs. However, the same study published that in the year 2000, an international survey found that 83% of men were willing to use

3762-427: The researcher will add more participants to get a better estimate of the response rate. A typical study for ruling out a 20% or lower response rate enters 14 participants. If no response is observed in the first 14 participants, the drug is considered not likely to have a 20% or higher activity level. The number of additional participants added depends on the degree of precision desired, but ranges from 10 to 20. Thus,

3828-597: The safety ( pharmacovigilance ), tolerability, pharmacokinetics , and pharmacodynamics of a drug. Phase I trials normally include dose-ranging , also called dose escalation studies, so that the best and safest dose can be found and to discover the point at which a compound is too poisonous to administer. The tested range of doses will usually be a fraction of the dose that caused harm in animal testing . Phase I trials most often include healthy volunteers. However, there are some circumstances when clinical patients are used, such as patients who have terminal cancer or HIV and

3894-399: The spermicide. The low frequency electromagnetic field disintegrates the sperm cell membrane in the head region. This in turn causes both acrosin and hyaluronidase enzymes to leak out of the sperm, making the sperm infertile. The safety of Smart RISUG is uncertain and requires additional research. The spermicidal properties of the compound should not have negative effects on the lining of

3960-435: The sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs , or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials). The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than

4026-535: The total), clinical procedures (about 19%), and clinical monitoring of the subjects (about 11%). A Phase IV trial is also known as a postmarketing surveillance trial or drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. Phase IV trials involve the safety surveillance ( pharmacovigilance ) and ongoing technical support of a drug after it receives regulatory approval to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by

SECTION 60

#1732873568872

4092-453: The treatment is likely to make healthy individuals ill. These studies are usually conducted in tightly controlled clinics called Central Pharmacological Units, where participants receive 24-hour medical attention and oversight. In addition to the previously mentioned unhealthy individuals, "patients who have typically already tried and failed to improve on the existing standard therapies" may also participate in Phase I trials. Volunteers are paid

4158-399: The vas deferens. Albino rats used to develop the new polymer did not have any adverse symptoms. The original compound had been tested for over 25 years in rats. Phases of clinical research#Phase III The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as

4224-767: The viral and other infectious diseases is gradually evolving and is proposed to be the largest network of laboratories for timely identification of viruses and other agents causing morbidity significant at public health level and specific agents causing epidemics and/or potential agents for bioterrorism and undertake research for identification of emerging and newer genetically active/ modified agents. In addition to research activities, ICMR also provides international fellowship programme for research and training and exposure of Indian biomedical scientists in various countries as well as offering opportunities to scientists from developing countries to come and work in Indian institutes/laboratories. It

4290-477: Was acquired by NEXT Life Sciences , which plans to bring the technology to market under the name Plan A for Men . Sujoy K. Guha developed RISUG after years of developing other inventions. He originally wanted to create an artificial heart that could pump blood using a strong electrical pulse. Using the 13-chamber model of a cockroach heart, he designed a softer pumping mechanism that would theoretically be safe to use in humans. As India's population grew throughout

4356-618: Was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses; examples include cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx). The entire process of developing a drug from preclinical research to marketing can take approximately 12 to 18 years and often costs well over $ 1 billion. Indian Council of Medical Research The Indian Council of Medical Research ( ICMR ),

#871128