Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, has received the the US Food and Drug Administration, (FDA) final approval for its Abbreviated New Drug Application, (ANDA) for bromfenac ophthalmic solution, 0.09 per cent (Once-A-Day), the generic for ISTA Pharmaceuticals’ Bromday ophthalmic solution, 0.09 per cent.
The product is used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Hi-Tech plans to launch the product immediately.
On August 27, 2013, the Company entered into a definitive agreement under which Akorn, Inc. will acquire the Company for $640,000,000 or $43.50 per share in cash. The acquisition will be subject to customary conditions, including termination of the waiting period under the provisions of the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Pending the satisfaction of such customary conditions, the Company anticipates closing the transaction in the first quarter of 2014.
Hi-Tech is a specialty pharmaceutical company developing, manufacturing and marketing generic and branded prescription and OTC products.
As securing approvals for clinical trials becomes time-consuming under the New Drug Advisory Committee (NDAC), pharmaceutical companies are increasingly considering shifting clinical trials abroad to expedite the process.
“We have noted with mounting concern the increasing reluctance in the Central Drugs Standard Control Organisation (CDSCO) to grant approvals for new drugs, even if these are approved in developed countries, and allow clinical trials or bio-studies for exports. This is evident from the significant decline in the grant of drug approvals in the recent period,” it said.
CDSCO data show new drug approvals dropped from 264 in 2008 to 98 in 2011 and just 15 in 2012 (till May). Industry sources said in 2013, just five-seven new drugs were approved.
While Biocon recently indicated it was forced to move some trials abroad, Lupin had also moved some trials to the US and EU. Cadila Healthcare (Zydus Cadila) is considering shifting some of its trials to the US. Sources in Zydus said while the cost of conducting trials was higher abroad, one couldn’t jeopardise investments in developing a drug due to inordinate delays.
Dhananjay Bakhle, executive vice-president, medical research (novel drug discovery and development), Lupin, said, “The regulatory environment and volatility therein and the high degree of uncertainty over the last two years had already discouraged us from conducting clinical trials in India. We started conducting our clinical trials in other geographies such as Europe about one and half years ago.”
Sources in Alembic, which has conducted a few of its bio-equivalence studies outside India (to meet regulatory requirements related to gene pool variance or trials to be conducted in certain geographies), said there was a lag in the process, the requirement to conduct trials outside India was growing.
A Torrent Pharma spokesperson said, “We have faced difficulties on uncertainties in the requirements and the time to clear study permissions. However, we have not moved our ongoing studies out of India. Our first-in-man studies have generally been carried out outside India to ensure we have regulatory consent from relevant countries…We do not believe we need to deviate from this strategy in general.”
Sun Pharma, Glenmark, Cadila Pharmaceuticals and Dr. Reddy’s Laboratories did not respond to queries till the time of going to press. Sources indicated Sun Pharma had conducted a few trials outside India.
Clinical research organisations have taken a hit due to the slowdown in clinical trials in India. Apurva Shah, group managing director, Veeda Clinical Research, said, “Due to the lack of transparency and certainly in the regulatory process, not only have global clinical trials stopped coming to India, but local pharma companies have also started looking elsewhere to execute their trials in a timely manner. The delays have cost us millions of dollars in lost revenue, hundreds of jobs for the educated and smart professionals and disappointment for our dreams to discover and develop our own drugs in India.”
A few organisations are already taking steps to increase focus on other geographies. For instance, Veeda has already set up a phase-I unit in Malaysia, while Lambda Therapeutic Research has opened its first centre in Thailand, following a request from the Thai government.
In the long run, India may lose its cost-competitiveness vis-a-vis Southeast Asian economies as a clinical trial destination. Shah said, “If things do not work in the stipulated time, the costs go up significantly. While India is indeed a cheaper destination to conduct clinical trials compared to many countries, on a case-to-case basis, costs here, at times, catch up with US or EU levels.”
Bakhle said, “Indian companies are conducting clinical trials for developing new products, and this is bound to have an adverse impact on the number of new drugs being introduced in India. Similarly, if global companies are discouraged in carrying out trials in India, their interest in bringing new drugs to India will also fall. The net result is reduced treatment options for patients in India.”
Last year, Chennai-based healthcare services provider Apollo Hospitals and clinical trials global major Quintiles had shut a clinical trial unit for phase-I studies in Hyderabad “due to a challenging external business environment”. An Apollo Hospitals official said the group, which managed about 200 clinical trials a year ago, was now handling only 120-130 clinical trials.
Source: Business Standard
The Food and Drug Administration (FDA) is working to increase the participation of people in racial, ethnic and other minority groups in the clinical trials that test new medical products.
Why is this important?
Ensuring meaningful representation of minorities in clinical trials for regulated medical products is fundamental to FDA’s regulatory mission and public health, says Jonca Bull, M.D., director of the agency’s Office of Minority Health (OMH). Racial and ethnic minorities include African American, American Indian, Alaska Native, Asian American, Hispanic American, Native Hawaiian and Pacific Islander communities.
OMH project manager Christine Merenda, M.P.H., R.N. explains that clinical trials are the proving ground for new drugs, vaccines and devices. They provide the data that will determine whether FDA approves a manufacturer’s application for marketing approval.
“Potential racial, ethnic and other differences in response to drugs are important to FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved,” she says.
Considering Genetic Differences
Bull explains that there are biological differences in how people process drugs. For example, variations in genetic coding can make a cancer treatment more toxic in one ethnic group than it would be in another. These variations can make also make drugs like antidepressants and blood-pressure medications less effective in one group than another.
Getting more data on these differences is essential for FDA to truly know that a medical product will truly work and be safe for all patients, Bull says.
Members of minority groups may be more vulnerable to certain diseases. “We know, for example, that African-Americans and Hispanics have higher rates of diabetes, HIV/AIDS, obesity and cardiovascular disease,” says Bull. Native Americans and Asians have been shown to have higher rates of hepatitis, while Hispanics are disproportionately affected by diabetes.
But historically, both women and minorities have been under-represented in clinical trials. For example, according to a 2011 report from the conference “Dialogues on Diversifying Clinical Trials,” sponsored by FDA’s Office of Women’ s Health and the Society for Women’s Health Research and supported by OMH:
- African Americans represent 12% of the U.S. population but only 5% of clinical trial participants;
- Hispanics make up 16% of the population but only 1% of clinical trial participants; and
- Men make up more than two-thirds of the participants in clinical tests of cardiovascular (heart and blood vessel) devices.
At the conference, more than 200 representatives from government and industry came together with patient advocates and the scientific community to discuss strategies for increasing the participation of women and minorities in clinical trials.
Why the Disparity?
Bull says there are different reasons why minorities have been under-represented in clinical trials.
One reason may be a lack of trust because of past abuses, Bull says. One notorious example was the Tuskegee Syphilis Study, experiments conducted between 1932 and 1972 by the U.S. Public Health Service. Health officials recruited poor black sharecroppers in Alabama to study the natural progress of syphilis. However, while the study was in progress, penicillin was discovered to treat syphilis. The study was not stopped and the men were not treated with penicillin that could have cured them.
According to a recent university study, however, this attitude seems to be changing. The study was designed to learn the health concerns and research perceptions among under-represented groups. When asked about their overall interest in medical research, 91 percent of African-Americans expressed interest in participating.
Nonetheless, recruiting people to participate in clinical trials—no matter what race or ethnicity—is difficult in general, Bull notes. FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial.
There are many benefits to minority participation for researchers that extend, in a larger sense, to society. Minority participation helps researchers find better treatments and better ways to fight such diseases as cancer, diabetes, heart disease and HIV/AIDS. In addition, it uncovers differences by gender, race, and ethnicity that may be important for safe and effective use of therapies.
Safeguards and Resources
Safeguards for clinical trial participants include oversight by institutional review boards (IRBs), composed of at least five members, including scientists, doctors, and lay people. IRBs ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research.
Though it’s too soon to tell, Bull says that the FDA Safety and Innovation Act (FDASIA) signed into law by President Obama in July 2012 could have a helpful effect in supporting efforts to enhance minority participation in clinical trials. FDASIA requires that FDA report to Congress by July 9, 2013 on the diversity of participants in clinical trials and the extent to which safety and effectiveness data based on such factors as sex, age, race and ethnicity are included in applications submitted to FDA.
Based on these findings, FDA and others involved in clinical research will be able to identify needs and opportunities to increase minority representation, says Bull.
In the meantime, Bull encourages consumers to take a more proactive approach. If you’re undergoing treatment and your condition is not improving, she says, you may want to talk to your health care professional about the availability of clinical trials that address your condition.
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Dy drug controller Chandrasekhara Rao arrested by CBI for taking bribe from a blood bank in Hyderabad
The Central Bureau of Investigation (CBI) has arrested Deputy Drug Controller of India, A Chandrasekhara Rao for allegedly accepting a bribe of Rs.50,000 from Janani Voluntary Blood Bank in Secunderabad for extending the license.
After receiving a complaint from Laxmi Reddy, CEO and president of Janani Blood Bank, a team of CBI led by Superintendent of Police V Chandrasekhar put a trap to nab the corrupt officer.
According to sources, Rao agreed to extend the license of Janani Voluntary Blood Bank only if Rs.4 lakh is paid to him. As a part payment, the CEO of the Blood Bank agreed to give Rs.50,000. But, annoyed with the attitude of Rao, the CEO of the Blood Bank finally complained to the CBI and helped it nab the corrupt officer.
As part of the plan to nab the officer, Laxmi Reddy was told to put the cash in a cover, which Rao slipped into a drawer just as the agency sleuths entered his office and caught him red handed.
The CBI team also conducted search of the Deputy Drugs Controller’s house and seized Rs.26 lakh in cash, gold ornaments, and property documents that are being verified to find out whether they are disproportionate to his known sources of income. The CBI is also looking into another written complaint from another pharmaceutical company against the Deputy Drugs Controller. It is also verifying the complaint and may take more actions on the officer.
Rao who is also the head of Hyderabad Zone of the Central Drugs Standard Control Organization (CDSCO) has been arrested under the Prevention of Corruption Act and is produced in the court in Hyderabad.
“There are many sincere and honest officers working in the drug control administration in the state, this incident has really brought a black mark,” opined an officer at DCA.
With more complaints from the pharma companies, the investigating agency is also verifying them and planning to initiate action as and when it gets proper clue.
The Union health ministry has issued the draft rules to amend the Drugs and Cosmetics Rules to prohibit the testing of cosmetics on animals, in line with the demand from various quarters and also in accordance with the recommendations by the Drugs Technical Advisory Board (DTAB).
The Ministry has issued the notification with the draft rules that would be made into effect after examining responses from the stakeholders and interested parties within the stipulated 45 days after the publishing of the draft rules.
“These rules may be called the Drugs and Cosmetics (first amendment) Rules, 2014,” said the notification which sought to insert a new provision in the Drugs and Cosmetics (D&C) Rules, 1945, after the rule 148-B. According to the notification, Rule 148-C will read as “prohibition of testing of cosmetics on animals: No person shall use any animal for testing of cosmetics.”
“After consultation with the DTAB, it is hereby published for the information of all persons likely to be affected thereby, and the notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of 45 days,” the notification said, inviting objections and suggestions.
The call for banning use of animal for cosmetic test was first made by activist leader Maneka Gandhi, MP. The Bureau of Indian Standards, which prepare standards for cosmetics, in the meeting of the Cosmetics Sectional Committee involving DCGI, hence decided to amend the Indian standards (IS 4011:1997-Method of Test for Safety Evaluation of Cosmetics).
The European Union had in 2009 initiated measures for banning marketing of cosmetics tested on animals. In March, 2013 EU has imposed prohibition of the marketing of the cosmetics and their ingredients which have been tested on animals irrespective of the fact that whether alternate method in place of toxicity study to prove the safety of the cosmetic products is in place or not. However, other countries of the world including USA, Australia, Japan etc. has not yet made such provision which prohibits the marketing of cosmetics tested on animals.