Thermo Fisher Scientific Expands Global Footprint to Support Cell and Gene Therapy Clinical Trials in Japan "A"

Thermo Fisher Scientific, the world leader in serving science announced the expansion of its Fisher BioServices cryogenic service capabilities in Japan.

This expansion enables its customers to seamlessly conduct clinical trials across multiple geographies and provides patients around the world with access to life changing therapies. As a leading service provider to the cell and gene therapy community, Fisher BioServices is uniquely positioned with the experience, resources, and global expertise to support its customers on their path towards commercialization.

The facility in Tokyo was expanded to include cryogenic storage and logistics by utilizing a combination of proven components and validated procedures developed with years of experience in the cell and gene therapy business. The new modules within this facility allow Fisher BioServices to configure and replicate each site to meet the specific requirements of individual clinical trials with minimal variation, regardless of volume or geographic location. The facility is also supported by a global comprehensive and integrated Quality System based on regulatory requirements, industry best practices and trained personnel.
“Japan is an increasingly important market for cell and gene therapy companies conducting clinical trials,” said Dennis Barger, Fisher BioServices vice president and general manager. “The addition of cryogenic services to this facility in Japan, combined with our existing capabilities in Europe and the US, enables us to seamlessly support our customers’ global trials as they develop and commercialize their therapies.”



source:http://www.worldpharmatoday.com/Clinical-Trials/thermo-fisher-scientific-expands-global-footprint-to-support-cell-and-gene-therapy-clinical-trials-in-japan

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Sun Pharma completes Rs 675-crore share buyback "A"

Sun Pharma on Friday said it has completed buyback of shares worth Rs 675 crore to return surplus funds to its shareholders.

"The company on October 18 completed buyback of 75 lakhs fully paid-up shares of the face value of Rs 1 each (representing about 0.31 per cent of the total outstanding pre-buyback shares of the company) at a price of Rs 900 per share for an aggregate amount of Rs 675 crore," Sun Pharma said in a BSE filing.

In June this year, the company had announced its decision to buy back shares.

"The buyback is being undertaken by the company to return surplus funds to the equity shareholders, enhancing the overall returns to the shareholders," the company had earlier said.

source:http://www.business-standard.com/article/companies/sun-pharma-completes-rs-675-crore-share-buyback-116102100231_1.html

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Those risk disclosures on drug websites? People don't read them, study says "A"

Consumers don’t always read the risk information on branded drug websites--even though they say they do, according to new eye-tracking research from the University of Tennessee. Risk disclosures are a hot-button issue in pharma marketing, with some critics accusing brands of downplaying the risks and marketers contending that they follow the rules laid out by the FDA.
For the eye-tracking study, two advertising professors used the technique on 29 seasonal allergy sufferers to determine where and how long they looked at a branded drug website, then followed up with interviews about how much the people read and what they remembered. The participants were told the study was looking at how people look for health information online and that the website was for a new prescription allergy drug.


The key finding? Even though 80% of the participants said they read half or more of the website information, they actually read much less than that and had limited recall of the drug’s risks. Further, the study found consumers focused on the drug’s benefit and generally ignored the risks.
That figure wouldn't necessarily hold true for other drugs, though. Mariea Hoy, who fielded the research along with former UT faculty member Abbey Levenshus, said perceived familiarity in the case of the seasonal allergy drug may have played a role in participants ignoring risks they thought they already knew about or didn’t believe would affect them.

“There are so many factors that may be influencing a person when looking at the drug website. Our study found that for individuals who perceived themselves to be familiar with the condition and the drugs that treated it, and subsequently thought ‘it's just an allergy drug,’ they were only looking for benefits and subsequently ignored the risk information,” Hoy said in an email interview with FiercePharma.

source:http://www.fiercepharma.com/marketing/eyes-don-t-lie-eye-tracking-study-finds-people-don-t-really-read-risks-drug-websites

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Anti-inflammatory drugs could help treat symptoms of depression "A"

Anti-inflammatory drugs similar to those used to treat conditions such as rheumatoid arthritis and psoriasis could in future be used to treat some cases of depression, concludes a review led by the University of Cambridge, which further implicates our immune system in mental health disorders. Researchers from the Department of Psychiatry at Cambridge led a team that analysed data from 20 clinical trials involving the use of anti-cytokine drugs to treat a range of autoimmune inflammatory diseases. By looking at additional beneficial side-effects of the treatments, the researchers were able to show that there was a significant antidepressant effect from the drugs compared to a placebo based on a meta-analysis of seven randomised controlled trials. Meta-analyses of the other types of clinical trials showed similar results.
When we are exposed to an infection, for example influenza or a stomach bug, our immune system fights back to control and remove the infection. During this process, immune cells flood the blood stream with proteins known as cytokines. This process is known as systemic inflammation.



source:http://www.worldpharmanews.com/research/3667-anti-inflammatory-drugs-could-help-treat-symptoms-of-depression 

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Dr. Reddy's launches anti-mental disorder tablets in US "A"

source: http://www.moneycontrol.com/news/business/dr-reddys-launches-anti-mental-disorder-tabletsus_7616261.html

Dr Reddy's Laboratories today said it has launched Aripiprazole tablets used to treat certain mental/mood disorders in the United States market. The drug, a therapeutic equivalent generic version of Abilify (Aripiprazole) tablets, has been introduced in the world's biggest pharma market after getting approval from the US Food and Drug Administration (USFDA), the city-based company said in a statement. The tablets are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. The Abilify brand and generic tablets had the US sales of approximately USD 3.1 billion for the 12 months ended in August 2016 according to IMS Health, it said. Aripiprazole is used to treat certain mental/mood disorders such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder. Abilify is a registered trademark of Otsuka Pharmaceutical Company.

Read more at: http://www.moneycontrol.com/news/business/dr-reddys-launches-anti-mental-disorder-tabletsus_7616261.html?utm_source=ref_article

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FDA Approves First Generic Version of Widely Used Influenza Drug Tamiflu "A"

The FDA is committed to improving patient access to safe and effective generic drugs. Generic drugs approved by the FDA have the same high-quality and strength as brand-name drugs. The generic manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.


The most common side effects reported by people using oseltamivir phosphate in clinical trials included nausea and vomiting.

Patients must use oseltamivir phosphate as directed by their health care provider. Oseltamivir phosphate does not take the place of receiving a flu vaccination. Talk to your health care provider about when you should receive an annual flu vaccination.

Oseltamivir phosphate does not treat or prevent illness caused by infections other than the influenza virus, and oseltamivir phosphate does not prevent bacterial infections that may happen with the flu. The FDA does not know if oseltamivir phosphate is effective in people who start treatment after two days of developing symptoms, or have weakened immune systems.

Patients and health care providers may find more information on oseltamivir phosphate in the drug label.

source:https://www.drugs.com/news/fda-approves-first-version-widely-influenza-tamiflu-62221.html

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First human clinical trial for nicotinamide riboside "A"

In the first controlled clinical trial of nicotinamide riboside (NR), a newly discovered form of Vitamin B3, researchers have shown that the compound is safe for humans and increases levels of a cell metabolite that is critical for cellular energy production and protection against stress and DNA damage.

Studies in mice have shown that boosting the levels of this cell metabolite -- known as NAD+ -- can produce multiple health benefits, including resistance to weight gain, improved control of blood sugar and cholesterol, reduced nerve damage, and longer lifespan. Levels of NAD+ diminish with age, and it has been suggested that loss of this metabolite may play a role in age-related health decline.
These findings in animal studies have spurred people to take commercially available NR supplements designed to boost NAD+. However, these over-the-counter supplements have not undergone clinical trials to see if they work in people.
The new research, reported Oct. 10 in the journal Nature Communications, was led by Charles Brenner, PhD, professor and Roy J. Carver Chair of Biochemistry at the University of Iowa Carver College of Medicine in collaboration with colleagues at Queens University Belfast and ChromaDex Corp. (NASDAQ: CDXC), which supplied the NR used in the trial. Brenner is a consultant for ChromaDex. He also is co-founder and Chief Scientific Adviser of ProHealthspan, which sells NR supplements under the trade name Tru NIAGEN®.
The human trial involved six men and six women, all healthy. Each participant received single oral doses of 100 mg, 300 mg, or 1,000 mg of NR in a different sequence with a seven-day gap between doses. After each dose, blood and urine samples were collected and analyzed by Brenner's lab to measure various NAD+ metabolites in a process called metabolomics. The trial showed that the NR vitamin increased NAD+ metabolism by amounts directly related to the dose, and there were no serious side effects with any of the doses.
"This trial shows that oral NR safely boosts human NAD+ metabolism," Brenner says. "We are excited because everything we are learning from animal systems indicates that the effectiveness of NR depends on preserving and/or boosting NAD+ and related compounds in the face of metabolic stresses. Because the levels of supplementation in mice that produce beneficial effects are achievable in people, it appears than health benefits of NR will be translatable to humans safely."
The next step will be to study the effect of longer duration NR supplementation on NAD+ metabolism in healthy adults, but Brenner also has plans to test the effects of NR in people with diseases and health conditions, including elevated cholesterol, obesity and diabetes, and people at risk for chemotherapeutic peripheral neuropathy.

source:https://www.sciencedaily.com/releases/2016/10/161010135418.htm

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PHARMA NEWS: Pfizer sells off global infusion unit to ICU for $1 billion "A"

Pfizer's is selling its global infusion therapy business, Hospira Infusion Systems (HIS), to ICU Medical, in a cash/stock deal worth $1 billion.
The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with ICU Medical's existing businesses, will create a leading infusion business, with estimated pro forma combined revenues of around $1.45 billion.
Under the terms of the deal, Pfizer will receive approximately $400 million in newly issued shares of ICU Medical common stock, giving it ownership in the firm of around 16.6 percent, as well as $600 million in cash.



source"http://www.pharmatimes.com/news/pfizer_sells_off_global_infusion_unit_to_icu_for_$1_billion_1155540

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Five diabetes drugs amongst top selling drugs in the country "A"

Five anti diabetes drugs are amongst the top ten selling drugs in the country. Control of non-communicable disease has been one of the greatest challenges for the country. This is a major shift from the earlier trend when the organised retail pharma market was dominated by anti infectives and antibiotics.
   
The anti-diabetic therapy segment is estimated to be worth INR 8500 crore and is growing at a strong rate of 12 per cent as per data from AIOCD Awacs. Human Mixtard, Glycomet GP, Lantus, Galvus Met and Janumet are the 5 top selling anti diabetics drugs. The number of diabetes drugs in the top 10 selling drugs has increased from 1 in June 2013 to 5 in June 2016.


Experts state that there have been multiple factors for the surge in the number of brands in the diabetes segment including an increase in new launches and detection cases, rise in the number of patients with the disease, early diagnosis, long survival rates for patients, availability of better drugs and treatment and patients responding well to treatment. The diabetes drugs are also used to treat other malfunctions like polycystic ovaries, obesity, insulin resistance, fatty liver. There has also been a shift from plains (single molecule) to combinations. While on the other hand, there have been supply constraints in anti infectives leading to slippages.

source:http://www.brandindiapharma.in/news/five-diabetes-drugs-amongst-top-selling-drugs-in-the-country

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PHARMA NEWS: Maximum human lifespan has already been reached "A"

   A study published online today in Nature by Albert Einstein College of Medicine scientists suggests that it may not be possible to extend the human life span beyond the ages already attained by the oldest people on record. Since the 19th century, average life expectancy has risen almost continuously thanks to improvements in public health, diet, the environment and other areas. On average, for example, U.S. babies born today can expect to live nearly until age 79 compared with an average life expectancy of only 47 for Americans born in 1900. Since the 1970s, the maximum duration of life - the age to which the oldest people live - has also risen. But according to the Einstein researchers, this upward arc for maximal lifespan has a ceiling - and we've already touched it. "Demographers as well as biologists have contended there is no reason to think that the ongoing increase in maximum lifespan will end soon," said senior author Jan Vijg, Ph.D., professor and chair of genetics, the Lola and Saul Kramer Chair in Molecular Genetics, and professor of ophthalmology & visual sciences at Einstein. "But our data strongly suggest that it has already been attained and that this happened in the 1990s."

Dr. Vijg and his colleagues analyzed data from the Human Mortality Database, which compiles mortality and population data from more than 40 countries. Since 1900, those countries generally show a decline in late-life mortality: The fraction of each birth cohort (i.e., people born in a particular year) who survive to old age (defined as 70 and up) increased with their calendar year of birth, pointing toward a continuing increase in average life expectancy.

source:http://www.worldpharmanews.com/research/3653-maximum-human-lifespan-has-already-been-reached 

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Indian nutraceuticals market may touch $6.1 billion by 2020: Study "A"

Indian nutraceuticals market may touch $6.1 billion by 2020: Study

Due to rising awareness about health, fitness and changing lifestyle, India's nutraceuticals market is likely to touch $6.1 billion by 2020 from the current level of $2.8 billion, growing at compounded annual growth rate (CAGR) of 17 per cent, a study showed. 

Nutraceutical product is a food or fortified food product that not only supplements the diet but also assists in treating or preventing diseases (apart from anaemia),providing medical benefits. 

The study also estimated that the global nutraceuticals market may cross $262.9 billion by 2020 from $182.6 billion at present, growing at a CAGR of about 8 per cent. 

According to a joint study by Assocham and RNCOS, the US has the largest market for nutraceuticals, followed by Asia-Pacific and European Union. Functional food is the fastest growing segment in the US nutraceuticals market. Germany, France, the UK and Italy are the major markets in the European Union for nutraceuticals. 

The study also estimated that the global nutraceuticals market may cross $262.9 billion by 2020 from $182.6 billion at present, growing at a CAGR of about 8 per cent. 

According to a joint study by Assocham and RNCOS, the US has the largest market for nutraceuticals, followed by Asia-Pacific and European Union. Functional food is the fastest growing segment in the US nutraceuticals market. Germany, France, the UK and Italy are the major markets in the European Union for nutraceuticals. 

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Megamerger finalized as ‘QuintilesIMS’ is born "A"

The world’s largest CRO and one of the biggest healthcare data and consultancy firms have become one major $19 billion 50,000-strong company this week as QuintilesIMS comes into life.
Announced with some surprise to the market back in May, the deal sees NC-based Quintiles merge with Danbury-headquartered IMS Health, although the union is not one of exact equals, as IMS owns slightly more of the combined shares of the new company than Quintiles does.
On top of this, the dual chair and CEO is taken by Ari Bousbib, who was the chief of IMS Health before the merger.

But the ticker symbol $Q, previously used just for Quintiles, has become the new co’s ticker, and Quintiles has been allowed to go first in the naming stakes.
The company said that shares of IMS Health were halted from trading this week on the NYSE as it trades under the new entity.
QuintilesIMS has launched with a new website and corporate video as it looks to consolidate and explain its new company after the markets reacted fairly negatively to the merger when first announced.
The new company merges the real-world clinical applications of Quintiles’ business with IMS Health’s data gathering and analysis, as well as its access to patient, prescription and other key healthcare data, giving the new company a pool of information for drugmakers.
It will also likely encroach deeply into the offerings of Quintiles' main big CRO, North Carolina rivals, which have also been looking to expand into consultancy, digital and analytics in recent years.

source:http://www.fiercebiotech.com/biotech/megamerger-finalized-as-quintilesims-born

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Sun Pharma founder Dilip Shanghvi heads this year's list of Asian pharma billionaires "A"

Topping the list of the Asian pharma elite is India's Dilip Shanghvi, who founded Sun Pharmaceuticals along with partner Pradeep Ghosh in 1982. The company's acquisitions of Caraco Pharma, Taro Pharma and, more recently, fellow Indian company Ranbaxy Laboratories have made Sun Pharma into India's largest drugmaker.
Shanghvi stepped down as chairman and CEO of the company in 2012, but he remains managing director, as well as chairman of Sun Pharmaceutical Advanced Research, which is spearheading the group's push into proprietary medicines. His $16.7 billion fortune ranks him at number 44 in the overall Forbes list.

In second position among Asia's pharma rich is Cyrus Poonawalla, chairman of the Poonawalla Group, which includes Serum Institute of India, India's largest biotech company, which specializes in manufacturing pediatric vaccines.

Poonawalla set up Serum Institute of India in 1966, at a time when lifesaving vaccines were in short supply in India, and those were imported at high prices. The company has since grown to become the world's largest vaccine producer in terms of the number of doses produced and sold globally. With a net worth of $8.5 billion, Poonawalla sits at position 133 in the Forbes list.

source:http://www.fiercepharma.com/pharma-asia/sun-pharma-s-dilip-shanghvi-heads-list-top-asian-pharma-billionaires

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Chinese Medicine: Miracle in Dementia "A"

A new study of classical Chinese medical texts identifies references to age-related memory impairment similar to modern-day Alzheimer's disease, and to several plant-based ingredients used centuries ago -- and still in use today -- to treat memory impairment. Experimental studies of five of these traditional Chinese medicines suggest that they have biological activity relevant to Alzheimer's disease, according to an article in The Journal of Alternative and Complementary Medicine, a peer-reviewed publication from Mary Ann Liebert, Inc.

Charlie Xue, PhD and coauthors from Guangdong Provincial Academy of Chinese Medical Sciences and Guangdong Provincial Hospital of Chinese Medicine, China, and RMIT University, Australia, performed a comprehensive, systematic search of the Encyclopedia of Traditional Chinese Medicine, a database of more than 1,000 Chinese medical books dating back to the fourth century.

In the article "Memory Impairment, Dementia and Alzheimer's Disease in Classical and Contemporary Traditional Chinese Medicine the authors describe specific mentions of signs and symptoms of memory impairment associated with aging and the formulas and ingredients most commonly used to treat these disorders.

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FDA approves first absorbable stent for coronary artery disease "A"

FDA approves first absorbable stent for coronary artery disease

The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.

“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health.

Coronary heart disease is responsible for about 370,000 deaths each year in the U.S., according to the National Heart, Lung, and Blood Institute. The condition develops when cholesterol-containing deposits build up and narrow the coronary arteries, decreasing blood flow to the heart. This can cause chest pain (angina), shortness of breath, fatigue or other heart disease symptoms. Doctors often treat coronary artery disease with a procedure called angioplasty to widen the artery using a metal stent. Scar tissue can form within the stent causing the artery to narrow again (restenosis). Drug-eluting stents temporarily release a drug, typically for a few months after stent placement, to combat the formation of scar tissue.

In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. After one year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8 percent, which was clinically comparable to the rate of 6.1 percent observed in the control group. In addition, after one year, the rate of blood clots forming within the devices was 1.54 percent for the Absorb GT1 BVS and 0.74 percent rate for the control.

Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

Source: https://www.drugs.com/news/fda-approves-first-absorbable-stent-coronary-artery-61848.html

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Future Of Clinical Trials In India "A"

"Clinical Trials" and debates associated with it have been in headlines since past few months pursuant to the strict view taken by the apex court on the matter. The number of deaths in India resulting from clinical trials has increased to an unendurable figure of 2,868 during the period 2005-2012. If on the one hand this figure relating to number of deaths resulting from clinical trials is fearful, on the other hand the decline in the number of clinical trials and approval given for conducting such trials in last few months is equally shocking. Till April 2013, only 12 (twelve) clinical trials have been approved by the authority as compared to almost a three digit figure in last year. This certainly raises a concern for the future of clinical trials in India- country which once was perceived as a fertile place for growth of clinical trials by most of the multi-national corporations. Currently estimated at USD 500 million, India's clinical research market was projected to more than double and cross USD one billion mark by 2016 driven by favorable factors like diverse and accessible population, availability of low cost and effective resources


The controversies relating to clinical trials are not something which can be decided in black and white. Rather it's an interface of elements like law, ethics, scientific development, human rights and social good. As these scientific tests and trials involve application of advanced technologies, there is a need for well framed rules and laws for the conduct of these tests and trials. Certainly it's not easy to set an order of priority or precedence among these elements.
This Article is an attempt to analyze the current controversy revolving around the clinical trials in India and to come out with feasible suggestions to ensure the ethical conduct of such clinical trials without undermining the need of scientific research and development and its benefits to society. However before proceeding further, it is necessary to understand in nutshell what does "clinical trial" actually means and how are they regulated in India.
What are "Clinical Trials"? Clinical trials in layman's language mean any investigation on human subjects carried out by pharmaceutical experts in order to discover or verify the clinical and pharmacological effects of any investigational medicinal product(s) and/or to identify any adverse reactions of such medicinal products(s) and/or to study such investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy. Like any standard scientific and research activity, clinical trials are carried out with a definite aim through well- defined procedure and under closed conditions.
Applicable laws and regulatory framework: Clinical trials, in addition to national laws, are governed by well established guidelines and directives at international level like EU regulations and directives, ICH- Good Clinical Practices (GCP) guidelines, recommendations of World Medical Association Declaration of Helsinki, Guidelines for Good Pharmacoepidemiology Practices and ICMR guidelines. These guidelines, recommendations and opinions are considered as "soft law" and are not legally binding but play an important role in regulating these clinical trials. Most of the multi -national corporations carrying out clinical trials worldwide voluntarily and as a good practice follow these guidelines and recommendations. These guidelines and directives primarily aim at protecting the subject from taking undue risk in participating in a clinical trial; enforce both voluntary consent to research and the continual assessment of risk and benefit. In India, Central Drugs Standard Control Organization (CDSCO) (headed by Director Control General of India) is the primary authority and "Drugs and Cosmetics Act, 1940" (along with the rules framed there under) is the principal legislation for the regulation of clinical trials. Schedule Y of the Drugs and Cosmetics Rules, 1945 ("Rules") provides for the detailed conditions, and compliances relating to clinical trials in India.
Recent amendment to Schedule Y of Drugs and Cosmetics Rules, 1945: Recently on 30^th January 2013⁴, Government of India came out with certain amendments to Schedule Y of the Rules with a view to tighten the norms relating to the conduct of clinical trials especially in terms of taking informed consents from the trial subjects and providing them or their legal representatives (as the case may be) compensation in case of any trial related injury or death. The amendment has imposed complete and ultimate liability on the sponsor of the clinical trial to reimburse any cost incurred by the trial subjects for the medical treatment of "any injury" suffered by the trial subjects as well as financial compensation for such injury or death. Further in case the sponsor fails to provide the proper medical treatment and/ or the financial compensation as per the orders of the licensing authority to the trial subjects (or their representatives as the case may be), then the authority may cancel or suspend the license of the sponsor to carry out the clinical trials and may even debar it from carrying any clinical trial in future in India. The amendment also mandates GCP compliance and adverse event reporting. The amendment has certainly acted as a deterrent on the multi-national corporations and is a negative catalytic agent to the prospects of clinical trials in India.
Ins and outs of the amendment: The aforesaid amendments to Schedule Y of the Rules came as a response to demands from the apex court, which were outraged by the lack of supervision and regulation of these clinical trials in India. As per the law existing prior to the said amendment, sponsors of the clinical trials were required to pay compensation "for deaths that results from clinical trials". Further there was no prescribed formula or minimum amount for determining such compensation and the time lines for making such payments by the sponsor in the Rules. Consequently only 45 out of 2,868 were reported to receive the compensation by the sponsors in last 7 years⁵. Additionally, there were no minimum clinical standards for trials prescribed under the law, for instance the requirement of registrations of the entities/ clinical research organizations conducting such trials, defined conditions and ethical standards to be complied with while conducting such trials.
After instances of unethical trials and unpaid compensations reached the courts and CDSCO early this year, CDSCO as a measure to bring about a planned change to the law relating to clinical trials in India decided to bring on table the amendments to schedule Y of Rules.
Also as a response to the public interest litigation(s) filed by few NGOs working for the human rights of the vulnerable sections, the apex court has acknowledged the lack of proper standard of care adopted by the clinical research organizations, lacunas in the existing legal framework and has shown serious concerns over the use of Indian subjects as "guinea pigs" in the conduct of clinical trials by the multi- national giants. This further triggered the CDSCO and Ministry of Health and Welfare to tighten the norms relating to the conduct of clinical trials and also the approval mechanism for such clinical trials.
While the human rights activists and NGOs are supporting the amendments to Schedule Y of the Rules, the pharmaceutical industry, sponsor pharmaceutical companies and clinical research organizations are certainly not unanimous with respect to supporting these amendments. As a result of stricter compliances and uncertain approval process, the number of clinical trials coming to India has decreased significantly in the recent past. One of the reasons for the decrease is due to the unpredictable nature of the regulatory timelines for clinical trial approval and the unreasonable demands of the authorities like protocol amendments, site selection etc. which in turn further increases the unpredictability and timelines associated with regulatory approvals. There are some who argue that this will just increase the cost of doing clinical trial in India, eventually pricing out local drug manufacturers and making India affordable only for multinational corporations. However it cannot be overlooked that as a result of aforesaid amendments and uncertain approval mechanism, the multi-national corporations would prefer other locations for carrying out the clinical trials like China, South Korea and Russia which provide a comparatively flexible and less strict regulatory atmosphere for carrying out clinical trials.
Not only the sponsors are affected by the change in regulatory scenario but also the doctors and investigators involved in the clinical trials are facing the consequences of these amendments. For example, as per the amended Schedule Y of the Rules, the investigators have an obligation to report any serious adverse effect of the drug under investigation within 24 hours of the "occurrence of such effect". Also sponsor has a responsibility to forward such reports within 10 days of the occurrence of such serious adverse event. However it is not practically possible to do so in most of the cases. Since such effects are not always physical or visible, it can be reported by the investigators only once they themselves became aware about the adverse effects of the drug through the subject or its representatives. Reporting of adverse effects and serious adverse effects are important since the same are directly related to the clinical trial injury and payment of financial compensation by the sponsors and hence the ambiguity in the amended language needs to be clarified by the authorities soon to avoid any ambiguity.
Striking out a balance between need for strict regulatory regime and the growth of clinical trials in India: Clinical trials not only contribute to the scientific research and development but also ensure better patient care than normal clinical practice and in long run is a boon for the society as it eventually leads to the development of new generic drugs and medicines. It is unfortunate that India is losing out the opportunity to other nations because of the uncertainties in the regulatory framework and approval mechanism.
Without undermining the need of amending the existing regulations relating to the clinical trials thereby making the clinical trials safer and preventing the exploitation of vulnerable subjects participating in such trials, it is necessary to appreciate that we as a developing economy with the conditions so suitable for clinical trials like diverse population, cost effective facilities and resources, presence of reputed pharmaceutical companies including subsidiaries of such multinational corporations willing to act as a sponsor and trained investigators, should not restrict the growth of clinical trials and instead try to promote a strong culture of research and development in the health sector in India.
No company or institution desires to be get publicized negatively or defend itself over ethical issues like violation of human rights or unethical treatment of patients, for any reason whatsoever. In today's diverse and competitive business environment, one must acknowledge that law often embodies ethical principles, but law and ethics are far from co-extensive. Regulators have to and should take into account other elements like social utility, economic growth etc. also while framing laws and hence it is not necessary that law would always prohibit something which is considered as unethical and the vice versa holds good.
There is a strong requirement for liberalizing the regulatory environment in favor of the sponsors conducting such trials and at the same time balancing the interest of the subjects involved in such trials. Further the approval mechanism needs to be more transparent and time efficient. Concerns raised by the human rights activist and NGOs are genuine, but rejecting or delaying the approval to the applications for conducting clinical trials is in no way a solution to the problem. Law should be for the "regulation" of the clinical trials and not for "restricting" the clinical trials. Instead of dismissing clinical trials or delaying the approval process, what is required is to identify and fix the loopholes in the regulatory framework and implement existing laws effectively to ensure that clinical trials are conducted with utmost transparency and diligence. Otherwise we would end up losing the prospects of growth of clinical research activities in India, which would certainly be a huge loss to our health care sector.
Way Forward: Following are some of the changes suggested in the existing law, which can go a long way to strike a balance between the interest of the subjects and the growth of clinical trials in India:

1. Informed consent: Improvement in the system of obtaining informed consent from the subjects. Audio/ visual techniques of recording should be used while explaining the subjects about the process, the likely side effects and taking their consent. Further, subjects should be clearly informed about the past records of such clinical trials and number of adverse effects/deaths reported due to such clinical trials. Merely poverty and free treatment should not be the basis of engaging subjects in the clinical trials. Investigators and sponsor should be morally responsible in this regard.
2. Restricting the liability of sponsors: Restricting the liability of the sponsors to the injury or death of the subject which are resulting directly or sufficiently attributable to the participation of the subjects in the clinical trials. With as many as 2,868 deaths during clinical trials from 2005 to 2012, only 89 have been attributed directly to such trials⁶. The timelines for payment of compensation should be liberalized depending upon the case to case basis. A fixed timeline in all type of adverse events and claims may not serve the purpose. Further the amount of financial compensation (over and above the cost of medical treatment) should be quantified or objective criteria to determine the same should be ascertained. For example, a terminally ill patient who chooses to be the subject of a clinical trial need not be given the same compensation as a healthy individual who has opted to become the subject for clinical trial. It should not be left at the sole discretion of the licensing authority or ethics committee.
3. Institutionalization and registrations: Independent research and trials should be restricted and only institutionalized clinical trials to be carried out. It is commonly seen that investigators and doctors at individual level carry out unregulated clinical research in private clinics and hospitals. This is required to be checked by the authorities. Registration of clinical trials with Clinical Trials Registry India and registration of clinical research organizations should be mandatory. This is already in place, however the effective implementation of the same should be ensured.
4. Approval mechanism: Fast and time efficient approval mechanism is required. Objective criteria for accepting or rejecting the applications, transparency in the entire process and the decisions for rejection or pending applications should be supported with the appropriate reasons. It is to be noted that the approval time for initiating drug trials in India typically runs from six to eight months, compared to 28 days in Europe and Canada.⁷
5. Transparency: Transparency from the side of investigators and institutions is also very important. It is one of the core guiding principles in the ICMR Ethics Guidelines. Institutions and investigators should be open to public about regarding kind of investigation, standard of care taken, subjects involved, etc.
6. Inspection and auditing: Officials of the CDSCO or licensing authority carrying out the inspection of the site should be of the same field with adequate knowledge and expertise on the subject. Also the use of CCTV camera at the trial site to administer the whole procedure of trial should be implemented. Further, involvement of the experts from the industry and legal field in the ethics committee and more emphasis on institutionalization of the ethics committee is also necessary. These would help the ethics committee and regulatory authority to investigate the matter more efficiently.
7. Applicability of stringent laws: Multi-national corporations which are voluntarily following the internationally recognized guidelines and directives or are governed by laws of other home countries which are materially equivalent strict in terms of following the good clinical standards and protecting the interest of the subjects, should not be made to comply with more procedural compliances and practices and should be provided a conducive regulatory atmosphere for coming to India and carrying out clinical trials.
8. Drugs with serious side effects: It is seen that most of the deaths occurred in the past few years is due to some specific drugs which were time and again put to investigation and every time resulted in the severe adverse effects. Special care should be taken in approving the clinical trials of such drugs and only in exceptional cases and depending upon the utility of such drug the permission should be given.
9. Role of media: Negative publicity of clinical trials and multi- national corporations involved in such trials should be avoided and discouraged. Media should be responsible in spreading any critical report relating to the clinical trials and same should be approved by the licensing authority in advance. In past it is seen that out of the 2,868 deaths reported only 89 of them were taken place due to clinical trials⁸. Rest were either remotely related to the trial or were in regular course due to the disease of the subjects. Such negative publicity discourages the sponsor and creates uncertainties in the mind of the subjects. Rather media should emphasize on spreading awareness about such clinical trials targeting the vulnerable sections who mostly get involved in trials as subjects.
10. Pending actions from the side of Government: The proposal of Ministry of Health and Family Welfare with respect to forming a committee comprising of science and regulatory experts that would formulate policy on drug approvals, clinical trials and drug bans should be implemented promptly. Also the draft bill on Biomedical Research on Human Participants (Promotion and Regulation) prepared by the Indian Council of Medical Research should be tabled in the parliament on priority basis. It would be beneficial if the comments and suggestions of the experts from the industry are taken.
11. Clarification: Removing the loopholes in the language of the amended schedule Y (for instance as mentioned above the time period with respect to the reporting of serious adverse events) and bringing clarity to the same.

The ethical concerns of the clinical trials cannot be removed completely. But the above suggestions, if implemented, can certainly give bright prospect to the growth of clinical trials and research in the health care sector in India and would help in regaining the lost confidence of the multi-national corporations interested in carrying out clinical trials in India. At the cost of repetition, I would like to reiterate: Law should be for the "regulation" of the clinical trials and not for "restricting" the clinical trials!

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