Allergenics Allergenics

The Center for Biologics Evaluation and Research (CBER) regulates allergenic products. There are currently three types of allergenic products licensed for use: allergen extracts, allergen patch tests, and antigen skin tests.

Allergen extracts are used for the diagnosis and/or treatment of allergic diseases such as allergic rhinitis ("hay fever"), allergic sinusitis, allergic conjunctivitis, bee venom allergy and food allergy. Currently, there are two types of licensed allergen extracts:

• Injectable allergen extracts are used for both diagnosis and treatment and are sterile liquids that are manufactured from natural substances (such as molds, pollens, insects, insect venoms, and animal hair) known to elicit allergic reactions in susceptible individuals. Injectable allergen extracts for food allergies are used only for diagnostic purposes. Among the injectable allergen extracts, some are standardized; for these products there is an established method to determine the potency (or strength) of the product on a lot-by-lot basis. For the other injectable allergen extracts there is no measure of potency, and these are called "non-standardized."
• Sublingual allergen extract tablets are used for treatment only and are also derived from natural substances known to elicit allergic reactions in susceptible individuals, and are intended for the treatment of allergic rhinitis with or without allergic conjunctivitis.

Allergen patch tests are diagnostic tests applied to the surface of the skin. Patch tests are used by healthcare providers to determine the specific cause of contact dermatitis, and are manufactured from natural substances or chemicals (such as nickel, rubber, and fragrance mixes) that are known to cause contact dermatitis.

Antigen skin tests are diagnostic tests injected into the skin to aid in the diagnosis of infection with certain pathogens.
 

Allergen extracts

• Injectable allergen extracts
  • Injectable Allergen Extracts- Standardized 
  • Injectable Allergen Extracts- Non-Standardized
• Allergen extract sublingual tablets
  • GRASTEK
  • Oralair
  • RAGWITEK 

Allergen patch tests

• T.R.U.E. Test 
   

Antigen skin tests

• Candin
• Spherusol 
• Tuberculin, Purified Protein Derivative - Tubersol
• Tuberculin, Purified Protein Derivative - Aplisol

Vaccines for Use During Pregnancy to Protect Young Infants from Disease – FDA Update

Did you know that vaccinating pregnant women may protect the mother and/or her infant from infectious diseases?

Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure their safety and effectiveness.  Currently, there are no vaccines approved by FDA specifically for use during pregnancy to protect the infant.

On Thursday, June 30th, FDA will host a webinar on the use of vaccines during pregnancy to benefit both the mother and the infant.  Marion Gruber, PhD, Director, Office of Vaccines Research and Review with FDA’s Center for Biologics Evaluation and Research, will discuss how vaccinating mothers during pregnancy may protect young infants against infectious diseases, the global interest in this topic, and the role of FDA in assuring these vaccines are safe and effective.

After the presentation, there will be an opportunity to ask questions.

What does FDA regulate?

The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.

In general, FDA regulates:

Foods, including:

• dietary supplements
• bottled water
• food additives
• infant formulas
• other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)

Drugs, including:

• prescription drugs (both brand-name and generic)
• non-prescription (over-the-counter) drugs

Biologics, including:

• vaccines
• blood and blood products
• cellular and gene therapy products
• tissue and tissue products
• allergenics

Medical Devices, including:

• simple items like tongue depressors and bedpans
• complex technologies such as heart pacemakers
• dental devices
• surgical implants and prosthetics

Electronic Products that give off radiation, including:

• microwave ovens
• x-ray equipment
• laser products
• ultrasonic therapy equipment
• mercury vapor lamps
• sunlamps

Cosmetics, including:

• color additives found in makeup and other personal care products
• skin moisturizers and cleansers
• nail polish and perfume

Veterinary Products, including:

• livestock feeds
• pet foods
• veterinary drugs and devices

Tobacco Products, including:

• cigarettes
• cigarette tobacco
• roll-your-own tobacco
• smokeless tobacco

The following contact information is for government agencies that have functions related to that of FDA. (Contact information is given for agency headquarters offices, which are located in the Washington, D.C., area. Local offices, listed in the phone book under U.S. Government, may be available to provide assistance as well.)

Advertising

The Federal Trade Commission is a federal agency that regulates many types of advertising. The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace. Consumers may write to FTC at 6th St. and Pennsylvania Ave., N.W., Washington, DC 20580; telephone (202) 326-2222.

Alcohol

The Department of the Treasury’s Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates aspects of alcohol production, importation, wholesale distribution, labeling, and advertising. Consumers may write to TTB at 1310 G St. N.W., Box 12, Washington, DC 20005; telephone (202) 453-2000 or see the TTB Contact page.

Consumer Products

The Consumer Product Safety Commission (CPSC) works to ensure the safety of consumer products such as toys, cribs, power tools, cigarette lighters, household chemicals, and other products that pose a fire, electrical, chemical or mechanical hazard. Consumers may send written inquiries to CPSC, Washington, DC 20207. CPSC operates a toll-free hot line at (800) 638-2772 or TTY (800) 638-8270 for consumers to report unsafe products or to obtain information regarding products and recalls.

Drugs of Abuse

The Department of Justice’s Drug Enforcement Administration (DEA) works to enforce the controlled substances laws and regulations of the United States, including as they pertain to the manufacture, distribution, and dispensing of legally produced controlled substances. Inquiries regarding DEA activities may be sent to the Drug Enforcement Administration, Office of Diversion Control 8701 Morrissette Drive Springfield, VA 22152; telephone (202) 307-1000.

Meat and Poultry

The U.S. Department of Agriculture's Food Safety and Inspection Serviceregulates aspects of the safety and labeling of traditional (non-game) meats, poultry, and certain egg products. Consumers with questions regarding meat or poultry, including safe handling and storage practices, should write or call the Food Safety Inspection Service's Meat and Poultry Hotline, Room 2925S, Washington, DC 20250; telephone (800) 535-4555.

Pesticides

The Environmental Protection Agency (EPA) regulates many aspects of pesticides. EPA sets limits on how much of a pesticide may be used on food during growing and processing, and how much can remain on the food you buy. Public inquiries regarding EPA should be mailed to U.S. Environmental Protection Agency, Office of Pesticide Programs Public Docket (7506C), 3404, 401M St., Washington, DC 20460; telephone (202) 260-2080.

Vaccines for Animal Diseases

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), Center for Veterinary Biologics, regulates aspects of veterinary vaccines and other types of veterinary biologics. Public inquiries regarding APHIS’s Center for Veterinary Biologics should be mailed to Center for Veterinary Biologics, 1920 Dayton Ave, P.O. Box 844, Ames, Iowa, 50010; telephone (515) 337-6100 or see the APHIS Contact page.

Water

The Environmental Protection Agency (EPA) regulates aspects of drinking water. EPA develops national standards for drinking water from municipal water supplies (tap water) to limit the levels of impurities.

Clinical trials in India

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. Unfortunately, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials.

The Clinical Trials Registry- India (CTRI), hosted at the ICMR�s National Institute of Medical Statistics (NIMS), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20^th July 2007 (www.ctri.nic.in). Initiated as a voluntary measure, since 15^th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www.cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication^{1, 2}.

Today, any researcher who plans to conduct a trial involving human participants, of any intervention such as drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the Department of AYUSH (http://indianmedicine.nic.in/) is expected to register the trial in the CTRI before enrollment of the first participant. Trial registration involves public declaration and identification of trial investigators, sponsors, interventions, patient population etcbefore the enrollment of the first patient. Submission of Ethics approval and DCGI approval (if applicable) is essential for trial registration in the CTRI. Multi-country trials, where India is a participating country, which have been registered in an international registry, are also expected to be registered in the CTRI. In the CTRI, details of Indian investigators, trial sites, Indian target sample size and date of enrollment are captured. After a trial is registered, trialists are expected to regularly update the trial status or other aspects as the case may be. After a trial is registered, all updates and changes will be recorded and available for public display.

Being a Primary Register of the International Clinical Trials Registry Platform (ICTRP) (http://www.who.int/ictrp/search/en/), registered trials are freely searchable both from the WHO�s search portal, the ICTRP as well as from the CTRI (www.ctri.nic.in).

Mission

The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered, i.e. before the enrolment of the first participant.

While the mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrollment of the first participant currently, trials where patient recruitment has started or even completed are also being registered. Post-marketing surveillance studies as well as BA/BE trials are also expected to be registered in the CTRI.

Vision

The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own.

Trials registered in CTRI will be monitored to ensure increasing voluntary disclosure of all items in the register. These items have been selected in order to:

Improve transparency and accountability³: By disclosing all required details of the protocol of trials, public confidence in clinical trials is likely to be enhanced.

Improve the internal validity of trials: Empirical research has shown that some aspect of the methods of the trial are particularly important to produce reliable results by minimizing biases, confounders and the effects of chance or coincidence. These include the method of random sequence generation, adequate concealment of allocation of participants to interventions, adequate blinding of participants, investigators and outcome assessors, and inclusion of all participants' results^{4, 5}. The CTRI hopes that these items, though not mandatory at present, will be disclosed by all registrants, as incorporating such elements at the protocol stage is likely to increase the internal validity of the trial and also increase the chances of publication in a high impact journal that endorses the ICMJE requirement of reporting trials in accordance with the CONSORT statement^{6, 7}.

Conform to accepted ethical standards: The Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees⁸. Clearance by local ethics committees is mandatory for all clinical trials and the CTRI hopes that making disclosure of ethical clearance a mandatory field for registration, it will lead to better links with the ICMR's bio-ethics initiative.

Reporting of all relevant results of registered trials: The CTRI is working with the WHO ICTRP to ensure that results of all trials registered with the CTRI are adequately reported and publicly available.

First pill to treat all major forms of Hepatitis C

FDA approves first pill to treat all forms of hepatitis C

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WASHINGTON — Federal health officials have approved the first pill to treat all major forms of hepatitis C, the latest in a series of drug approvals that have reshaped treatment of the liver-destroying virus.

The Food and Drug Administration approved the combination pill from Gilead Sciences for patients with and without liver damage. The agency has approved a number of hepatitis C drugs in the last three years but all were targeted to specific strains of the virus or patients with various stages of liver disease.

Epclusa, the new pill from Gilead Sciences, combines the company’s first hepatitis drug, Sovaldi, with a new drug that attacks the virus using a different mechanism.

The list price will be $74,760 for a 12-week course of treatment, Chief Executive Officer John Milligan told Bloomberg by telephone.

Gilead’s hepatitis pills have raked in billions of dollars by replacing an older approach that involved a grueling pill-and-injection cocktail.

Children Treated as Lab Rats

THIRUVANANTHAPURAM, India , Aug 14 2012 (IPS) - Four-year-old Deepak Yadav, a mentally disabled boy from Indore city in the Indian state Madhya Pradesh, was being treated for stomach problems at Chacha Nehru Bal Chikitsalaya, a government hospital for children attached to the M. G. M. Medical College.

(Right to left) Clinical trial victims with medical right activist Dr. Anand Rai. Credit: CTVA, Indore.

But when repeated administration of the anti-ulcer drug Rabeprazole started to exacerbate his condition, his parents stopped treatment and sought help from the Clinical Trial Victims Association (CTVA), which discovered that the boy had been a lab rat for an untested drug.

“We should have been told an unknown drug was being tested on our innocent child and given the choice to say no,” Deepak’s father Sooraj told IPS.

Deepak is now almost entirely reliant on his mother for survival. The family is poor, yet “doctors did not take any steps to get us compensation,” his father added.

This family’s tragic story is just one example of a sinister pattern unfolding across India.

A spate of deaths over the last four years caused by illegal clinical trials of untested drugs has ignited the wrath of rights activists and prompted prominent legal institutions to consider tightening the country’s drug regulation laws.

In response to a Right to Information query filed by Indore-based medical rights activist Anand Rai, the Drug Controller General of India (DGCI) disclosed that 2,031 people have died as a result of serious adverse events (SAEs) during drug trials in the past four years.

SAE-related deaths for 2008, 2009, 2010 and 2011 were 288, 637, 668 and 438 respectively.

Rai, who is currently spearheading a campaign against unethical drug tests on human beings, has urged legal authorities and activists to raise their voices against clinical trials in which desperate people become easy prey for multinational pharmaceutical companies.

He told IPS that most of the victims were illiterate and poor people.

“Clinical trials on citizens without their consent is considered a violation of basic human rights and often results in the death of innocent persons, who were not even aware of the kind of tests being (performed) on them, since clinical research organisations use roundabout ways of acquiring the consent of patients and their relatives,” he said.

Many of the institutions involved in the drug trials fail to “provide the patients with copies of the informed consent form, patient’s information sheet or clinical trial liability insurance policy,” according to the CTVA. As a result, very few victims have access to compensation.

An intervention by the Supreme Court of India last month further exposed the unethical practices of clinical researchers and pharmaceutical companies.

A division bench headed by Supreme Court Justice R M Lodha stated in early July that it was “unfortunate” that humans are being treated as “guinea pigs” for testing of drugs and vaccines produced by multinational corporations.

Lax regulations breed impunity

Experts on medical law assert that tight regulations in Europe and the U.S. prompt many pharmaceutical companies and research organisations to look to India and other developing countries as cheaper and less restrictive sites for drug trials.

Dr. Mohan Rao, professor at the centre for social medicine and community health at Jawaharlal Nehru University in New Delhi, told IPS that India did not have a proper regulatory authority to monitor the trials of new drugs.

“The growth of local clinical research organisations has also contributed to this. Above all, we have a large and unregulated private medical sector with a culture of impunity. For the general public, and the elites, the lives of the poor do not matter,” Rao added.“We have unfortunately opened our health sector to global pharmaceutical companies for trials without the infrastructure to monitor and regulate them. It is cheaper for transnationals to locate trials in India, which has a large and captive (drug) market, in addition to doctors not constrained by ethics,” he said.

The CTVA said that many doctors give more importance to their earnings than to the lives of their patients.

“Lured by offers (from) big pharmaceutical companies, these doctors have deliberately violated all regulations and have reduced clinical trials to a money spinning exercise,” according to a statement on the CTVA website.

According to the Financial Express daily, stiff opposition from research organisations on how clinical trial victims should be compensated has dealt a blow to the health ministry’s efforts to legislate the practice.

The ministry was on the brink of making it mandatory for pharmaceutical companies sponsoring clinical trials to pay financial compensation to volunteers in case of a proven trial-related death or injury, the Financial Express reported on Jul. 4.

Eminent drug regulatory expert C M Gulhati believes compensation rules in the Motor Vehicle Act can serve as a basis to determine the amount of compensation, while other factors such as the age of the volunteer, number of dependents and prevalent morbidity in the community should also be taken into account in an effort to standardise such payments, according to the newspaper.

Activists say many clinical trials in the country have been conducted behind a veil of secrecy and with little transparency in clinical research.

One such dubious deal was brought to light in 2001, when a group of cancer patients was subjected to drug trials under an agreement between the Thiruvananthapuram-based Regional Cancer Centre and the renowned Johns Hopkins University in Baltimore.

Compounding the issue, according to Dr. Sree Kumar, a private medical practitioner in Chennai, “is the easy availability of a large population of patients in Indian hospitals displaying a broad spectrum of conditions.”

“Collaborative ventures between Indian hospitals and foreign pharmaceutical industries and academic institutions ensure that the lab-to-market journey of a new product is achieved at a low cost and shorter duration,” he added.

Ethical testing required

The flip side of the illegal testing coin can be equally problematic. A panel of lawmakers in the Indian Parliament headed by Brajesh Pathak recently discovered that many popular medicines were being sold without having undergone clinical trials at all.

Lambasting the collusive role of the Central Drugs Standard Control Organisation, the parliamentary standing committee for health and family welfare said that 33 new medicines were found to have been approved between January 2008 and October 2010 without undergoing trials.

Medical scientists claim that drug trials conducted on animals do not produce accurate results.

Dr. A. B. Salim, an independent researcher in Bangalore, told IPS that a drug tested successfully on animals could produce harmful side effects when administered to human beings.

“Therefore it is the duty of the ethics committee and the DCGI to monitor and ensure that the trials are done honestly,” he added.

Over 2,500 Deaths During Indian Clinical Trials

The Supreme Court has extended its ban on clinical trial of 162 new drugs till Dec. 16, 2013. Credit: epSos.de/ CC BY 2.0

KOLKATA, Nov 5 2013 (IPS) - More than 2,500 Indians have died in the course of clinical trials in recent years, government figures reveal.

According to an affidavit filed by the health ministry in the Supreme Court in response to a petition by health NGOs, there were 80 deaths due to clinical trials between January 2005 and June 2012. Between July 2012-August 2013 nine more such reported deaths occurred, making this total 89, according to the petitioner Swasthya Adhikar Manch (SAM), a health rights forum. Compensation was paid in 82 cases.

The ministry also admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012.

SAM challenges this number of 80 deaths said to have been caused by clinical trials – among the rest who are said only to have died during the course of the trials and not as a result of the trials.

“No standard protocol was followed, there were no post-mortems; so how can they arrive at this figure?” Amulya Nidhi of SAM told IPS. Compensation is paid only if a death was said to have been caused by the clinical trial.

India has become a hub of clinical trials for drugs over the last few years, mostly by pharmaceutical companies from abroad. Allegations of short-changing participants and of unethical practices have been rampant.

Government documents also say that around 11,972 “serious adverse events” (excluding death) were reported from Jan. 1, 2005 to Jun. 30, 2012, of which 506 were said to have been caused by clinical trials.

These figures have raised new opposition to the prevailing practices for conducting clinical trials.

India has become a hub of clinical trials for drugs over the last few years, mostly by pharmaceutical companies from abroad. Allegations of short-changing participants and of unethical practices have been rampant.

Responding to growing concerns by health activists, the ministry of health and family welfare set up a six-member expert panel under the Central Drugs Standard Control Organisation (CIDSCO) in February this year. The panel has recommended that these trials should only be carried out in accredited centres.

It recommended also that the principal investigator and the ethics committee of the institute where the trial is being carried out should be accredited.

Compensation is another contentious issue that is being dealt with in the new directive. Between 2010-2012, the Drugs Controller General had approved 1,065 clinical trials. Activists say that taking advantage of poverty, illiteracy and lack of awareness, pharmaceutical companies or middlemen, even doctors, often connive to deny compensation to participants when due.

The report clarifies: “Compensation need not be paid for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs.” The base amount and other calculations are still being worked out.

“The report deals with the issues we raised,” Chinmoy Mishra, coordinator of SAM, told IPS. “Now we must see these recommendations are properly implemented.”

Public health is in the hands of state governments in India’s federal system. The panel report noted that for implementation all stakeholders must be brought to the table.

SAM, based in Indore in Madhya Pradesh state, is a platform of various agencies working on issues related to health and health rights. It had filed a petition in court in January 2012 on the need for transparency in clinical trials in India.

The Economic Offence Wing of the state government had recorded 36 deaths between 2006-2010 during clinical trials in Madhya Pradesh state alone, SAM noted.

The National Human Rights Commission has pointed out that illegal trials were conducted on women in 2011 for a breast cancer drug.

In 2006, an investigation by health advocacy organisation WEMOS and the research organisation Centre for Research on Multinational Corporations (SOMO), both based in Amsterdam, prepared  an overview of 22 unethical clinical trials around the world; eight of them were in India.

According to the health ministry, more than half the clinical trials are conducted by foreign pharmaceutical companies and the rest by clinical research organisations and domestic companies.

SAM is petitioning for equal compensation across the board throughout the whole country, and according to international standards.

“Informed consent from each participant is a mandatory prerequisite for a clinical trial,” the CIDSCO report emphasises. This is an area that unethical practitioners have been taking advantage of, Mishra said.

“For example, the 16-page directive on this count is translated into local Hindi language that fits into a single page, and that too improperly translated. In Indore, at least 95 percent of participants did not know what it was all about and signed.”

On the other hand, lack of regulation has driven away some pharmaceutical companies from India to other countries such as Malaysia, China and Singapore. Many also hope that the new norms will bring these companies back, because this is a multi-billion dollar industry.

To reduce bureaucratic tangles, the present 12 drug advisory committees will be replaced by a single technical review committee for speedy clearance of applications.

The panel has said that the first phases of all clinical trials of new drugs developed in India, and to be marketed in India, will need to be carried out within India. Drugs undergoing trials outside India can undergo parallel phase II and phase III trials in India after carrying out a safety assessment through phase I trials.

Demands have been raised for greater benefits to those undergoing trials. “Some of the drugs that are clinically tested in India could be so expensive that the average person would not be able to afford it,” Sandhya Srinivasan , health journalist and researcher in Mumbai, told IPS. “So what’s the use of such tests in this country?”

Mishra said that “we are not against clinical trials in the country. But there should not be exploitation of participants. Human life is precious.”

According to documents submitted by the Drugs Controller General of India in the Supreme Court, between January 2005 and June 2012 India approved 475 clinical trials for “new chemical entities” not used as drugs elsewhere in the world.

Meanwhile, the Supreme Court has extended its ban on clinical trials of 162 new drugs till Dec. 16, 2013, directing the government to ensure a “foolproof” mechanism for regulating the experiments by pharmaceutical companies