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

Drug updates

New drugs approved for marketing in India during November-December 2011

Source: http://cdsco.nic.in

Diazinon Flea Drops Spot on Dogs 30.0% w/w	For dogs infected with fleas.
Cabazitaxel Injection 60mg / 1.5ml	In combination with prednisone for treatment of patients with hormone-refractory metastatic prostrate cancer previously treated with a docetaxel-containing treatment regimen.
Trifluridine Eye Drops 1% w/v	For the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex viruses type 1 and 2.
Fosaprepitant (as Dimeglumine) for Injection 150mg.	1. Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults. 2. Prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.
Abiraterone Acetate Tablets 250mg	In combination with prednisone for the treatment of patients with metastatic castration-resistant prostrate cancer who have received prior chemotherapy containing docetaxel.
Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg	For prevention of stroke, systemic embolism and reduction of vascular mortality in adult patients with atrial fibrillation.
Crizotinib  hard gelatin Capsules 200mg/250mg	For the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) – positive as detected by an FDA-approved test.

Drugs  banned in India in 2011

Source: http://cdsco.nic.in

1.      Gatifloxacin

2.      Tegaserod

3.      Nimesulide for children below 12 years.

4.      Cisapride

5.      Phenyl propanolamine

6.      Human placental extract

7.      Sibutramine

8.      R-Sibutramine

FDA approvals in January 2012

Source: http://drugs.com

1.      Fentanyl Sublingual Spray

Opioid analgesic sublingual spray formulation indicated for the treatment of breakthrough cancer pain.

2.      Glucarpidase Injection

Carboxypeptidase enzyme indicated for the treatment of toxic plasma methotrexate levels in patients with delayed methotrexate clearance due to impaired renal function.

3.      Ciclesonide Nasal Aerosol

Corticosteroid nasal spray indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.

4.      Ingenol mebutate Topical Gel

Inducer of cell death indicated for the topical treatment of actinic keratosis.

5.      Axitinib Tablets        

Kinase inhibitor indicated for the treatment of advanced renal cell carcinoma

6.      Exenatide Extended-Release Injectable Suspension

Glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

7.      Vismodegib Capsules

Hedgehog pathway inhibitor for the treatment of patients with advanced basal cell carcinoma (BCC).

8.      Ivacaftor Tablets

Cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.

Top 10 news in 2010

The year 2010 saw a lot of ‘hustle and bustle’ in the medical circle. Here are the Top 10 stories as viewed by pharmanews

1. Overhauling of Medical Council of India: The major story of the year was the arrest of MCI President Dr. Ketan Desai, dissolution of the MCI; appointment of six out of seven Board of Governors; subsequent release of Dr. Ketan Desai on bail, common entrance exam for MBBS; reduction in forensic faculty requirement; increase in retirement age to seventy and the suspense behind 7th seat of Board of Governors etc.
2. Medical Council of India action against Indian Medical Association: MCI took action against the IMA President and Secretary for violation of MCI Ethics on the ground that IMA should not have endorsed Pepsi products. The IMA had to approach High Court to take a stay. The matter is now in the High Court. Is that a start of MCI actions against ethics violations? Will it act against the cut system?
3. Delhi Bug: A huge controversy arose when British Medical Journal broke a story about NDM1 bug being named after New Delhi. The medical circle in India said that it was unfair and was an attempt to sabotage the medical tourism in India. The new bug is a gram negative bacteria showing resistance to all present antibiotics. New Delhi metallo–beta–lactamase (NDM–1) is an enzyme that makes bacteria resistant to a broad range of beta–lactam antibiotics. These include the antibiotics of the carbapenem family, which are a mainstay for the treatment of antibiotic–resistant bacterial infections. The gene for NDM–1 is one member of a large gene family that encodes beta–lactamase enzymes called carbapenemases. Bacteria that produce carbapenemases are often referred to in the news media as “superbugs” because infections caused by them are difficult to treat. Such bacteria are usually only susceptible to polymyxins and tigecycline. NDM–1 was first detected in a Klebsiella pneumoniae isolate from a Swedish patient of Indian origin in 2008. It was later detected in bacteria in India, Pakistan, the United Kingdom, the United States, Canada, Japan and Brazil. The most common bacteria that make this enzyme are Gram negative such as Escherichia coli and K. pneumoniae, but the gene for NDM–1 can spread from one strain of bacteria to another by horizontal gene transfer.
4. H1N1 havoc: H1N1 created great havoc, but ultimately, proved to be a ‘much hyped’ virus with mortality even lower than the regular human flu virus. Most of the hospitals who had started special H1N1 virus wards, now do not have these wards.
5. Chikungunya epidemic: The latest epidemic in the North India was that of Chikungunya with patients presenting with fever, rash and joint pains. It complicated the pre–existing dengue epidemic in the society.
6. Dengue with a difference: This year dengue was different than other years, came with more GI symptoms, pancreas involvement, dengue hepatopathy and lot of skin reactions. The platelet count dropped to less than 10000 but most required no platelet transfusion.
7. Diabetes diagnosis: The year saw a new advancement where A1C is to be used for diagnosis of diabetes and not fasting sugar. An A1C >6.5% means diabetes.
8. New pill for HIV prevention: A new pill is now available for HIV prevention along with condoms. It is to be used before the act and continues for seven days. In a trial involving nearly 2,500 HIV–negative, but high risk, gay men in six countries, researchers found that a combination antiretroviral pill (tenofovir and emtricitabine) reduced the risk of HIV infection by 44%, compared with placebo. When scientists looked more carefully at the study volunteers who took the medication most faithfully, on a daily basis, they found that the risk of contracting HIV was even lower — 73% lower than the placebo group. More studies will need to confirm the benefit of antiretrovirals in the prevention of HIV, and public health experts warn that even if the results hold up, it would not replace the best method of prophylaxis: safe sex and consistent use of condoms. That’s because the way so–called pre–exposure prophylaxis, or PrEP, works is to load up high–risk people with HIV–disabling antiretroviral drugs before exposure to the virus, which allows the medication to hit HIV as early as possible. But the drugs do not work as a vaccine would, by priming the immune system to actually prevent infection.
9. National Programme for Prevention & Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) started in the country:At last, Govt. of India, Ministry of Health and Family Welfare has started the above program.
10. New drug for premature ejaculation: The year ended with the launch of an SOS drug for premature ejaculation. This will be breakthrough for the community. Premature ejaculation, the most common sexual problem apart from erectile dysfunction, has been often found to put marriages under strain. While the existing drugs, which are not specific to treat premature ejaculation, need to be taken regularly, the new pill can be popped just a few hours before intercourse. It works by altering levels of serotonin, a chemical in the brain. The drug, dapoxetine, comes from a family of drugs called selective serotonin reuptake inhibitors, which block the reabsorption of the neurotransmitter serotonin.