Creating Value for Doctors, Pharmacists and Patients Vol:4
ue s Is s i Th n I
Issue: 21 Feb 15-29
2008 Price Rs 20/-
Doctors Section 1- 2 & 11-12 Pharmacist Pages 3 - 4 & 9 -10 Patient Education 5 - 6 & 7- 8
SUGGESTIONS FOR CHANGES IN D & C ACT 1. Expiry date for Ayurvedic, Homeopathic, Siddha & Unani medicines to be compulsorily written on Label. 2. On Dietary Supplements/Nutritional Supplements/Nutraceuticals, etc – it should be mandatory to write on label “Not a Medicine/Drug”. 3. Sch K – Dispensing by doctors to be disallowed if there is a Pharmacy within 5 km radius of the clinic. 4. Minimum area for retail pharmacy to be at least 20 sq.m (preferably 30 sq.m). It could be 20sq.m for rural areas and 30sq.m for cities. 5. Minimum area for wholesale should be at least 20 sq.m. 6. There should be only 1 license – for Sch C & C(1) and other than C & C(1). 7. Definition of a prescription in the Act should now also include “typed” and “computer printout” prescriptions. They should however be SIGNED by the prescriber in indelible ink. 8. Act is silent on cutting of strips. Cutting of strips should be disallowed, and strip size should be fixed so as to ensure maximum rational in not cutting a strip. 9. Clause wherein it is mandatory for retailers to keep price list of medicines 0f should be deleted. 10. Create a list of OTC medicines. It should be clearly mentioned on their label that they can be purchased/sold without a prescription/ or “OTC Medicine”/”Non-prescription medicine”. 11. It should be mandatory to write storage temp, conditions on label of all medicines. Medicine without this should be termed as spurious/ etc. Storage condition should be put in a box, so that is easily visible to the consumer. 12. Schedule N should be modified so as to include GPP. GPP should be mandatory. 13.Remove the category “Chemists & Druggist”,, “Medical Store”, Dispensing Chemist”. Keep only 1 category – PHARMACY/Aushadhalay/ similar in other local languages….. 14. Clause which says maintaining register to write all the prescriptions dispensed, should be deleted. It should be mandatory only to maintain bill of sale with clear carbon copy (with signature of Pharmacist). 15. Need to consider inclusion of computerized billing. Make it mandatory that a bill can be generated only with a carbon copy, and that it should be signed by the pharmacist while dispensing (signature should clearly appear on the carbon copy). Carbon copies of bills to be maintained in serial order, day-wise, month-wise, year-wise – for a total period of 3 years minimum. 16.Ensure all AYUSH irrational combinations not supported by eminent text books are weeded out of market
RAJ VAIDYA HINDU PHARMACY, PANAJI, GOA
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V. Bhava Narayana Associate Editors
EDITORIAL BOARD Prof.B.Suresh, President Pharmacy council of India
Dr. Aniruddha Malpani, M.D Dr. Mahesh Sharma,
Dr. Jawahar Bapna, Rtd Director, IIHMR
S.W. Deshpande, DG, AIDCOC
Dr. P.Hanumantha Rao, ASCI, Hyd
This Publication is Only for the use of Medical & Pharmacy Professionals Printed, Published and Owned by V. Bhavanarayana, and printed at Kala Jyothi Process Pvt. Ltd., 1-1-60/5, R.T.C. 'X' Roads, Musheerabad Hyderabad - 20. Published at 3-3-62/A New Gokhale Nagar, Ramanthapur, Hyderabad - 500 013, R.R. Dist. Editor : V. Bhavanarayana * RNI No.: APBIL/2004/12036 Postal LIC NO : HSE 806/2004-06. C Pharmed Trade News, 2004 * Person responsible under PRB act for selection of news Pharmed Trade News does not neccesarily subscribe to the views expressed in the publication. All views expressed to the magazine are those of the contributors Pharmed Trade News not responsible or accountble for any loss incurred, directly or indirectly as a result of the information provided.
Consumer drug information in India The main conclusions that can be drawn from a situational analysis of the provision of consumer drug information in India are: The availability of consumer drug information in India is very low in
terms of quantity. Information is not provided in a user-friendly manner in most cases. It is provided mostly on allopathic drugs, and there is only limited information on traditional medicines, medical technologies and equipment, and on diagnostics. There is a particular lack of information relating to drug prices, and there is no single, dedicated actor concentrating only on consumer drug information. There is no coordination among different actors providing consumer drug information, and there is no level of consistency with respect to the information supplied. Information directed at consumers is largely aimed at awareness creation on preventive strategies and is not very technical in terms of providing medical details pertaining to the drugs or in terms of providing practical information regarding the usage and consumption of the drug. Most technical information with respect to drugs is directed to medical professionals and not consumers. Information to consumers in not made available in a simple manner, since this is usually done through the publication of books, booklets or CDs or other formats that would not normally be accessed by common consumers. Information is sometimes being provided in both English and local languages though for some sources of information such as labels on medicines or those in the internet, information is primarily in English. The current law and policy regime does not deal comprehensively with issues of consumer drug information. There is no comprehensive, single database of information, which contains technical information on drugs that has been approved by government. The Ministry of Consumer Affairs does not provide exclusive information on drugs. Government websites, such as that of the Ministry of Chemicals and Fertilizers, do provide information on prices in the form of relevant government orders, notifications and news dealing with the drugs under price control, lists of essential drugs, and so on. As against this, the US FDA site provides comprehensive and authentic information to consumers. This can be considered as a possible standard for the development of a similar database in India. The paper makes the following recommendations that need to be immediately implemented to address the pressing issues of consumer drug information: For bigger packs of medicines, leaflets and printed materials should be given. This should be made compulsory for drug companies, and a team of pharmacologists, clinical professionals, and consumers should review all drug-related information. Disseminating detailed information on drugs to consumers in a simple, easy to understand manner, and not only English but also in local languages.
Developing a forum wherein the actors involved in disseminating information can meet and deliberate as to the common steps to be taken to take forward the movement for advocating rational drug use, particularly regarding consumer drug information. Encouraging consumers to be more proactive in seeking information. Other recommendations that need to be implemented include developing a single, comprehensive, verified, and authentic source of information, which can be readily accessed by consumers; developing comprehensive regulations and guidelines and ensuring their implementation for all possible sources of consumer information and the actors providing this information; a format according to which information may be provided should be developed in the lines of the British National Formulary (BNF); considering the use of the Physician Drug Review (PDR) in the US as a standard for the comprehensive information to be provided; coordination among different actors to develop a common approach with respect to the standards and guidelines to be evolved, etc. Apart from the above, the paper also makes certain recommendations that can be specifically directed to each set of actors like governmental and quasigovernmental authorities, civil society and nongovernmental organisations, healthcare professionals, pharmaceutical companies, etc. In conclusion for the purpose of this paper, certain issues arise for consideration as future research questions and areas for examination. These include the necessity for understanding consumer drug information from the demand side as well. The provision of consumer drug information can be effective only if it meets consumer needs. There is a need for linking research done on the marketing and drug promotion strategies pursued by the pharmaceutical industry, with the mechanisms for the provision of consumer drug information and the quality of such information. The report also draws attention towards the need for a detailed study of advertisements, as they are a direct and predominant source of information for consumers. FOR FULL REPORT VISIT www.centad.org Or mail to email@example.com
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Making information on prices of drugs and comparisons between the prices of various branded and generic versions of the drug, more readily available for consumers.
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PHARMED NEWS HEPARIN ALERT The FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multipledose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses. The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection. Read the complete 2008 FDA MedWatch Safety Summary including a link to the FDA Public Health Advisory, Q & A Document, and News Release regarding this issue at: http://www.fda.gov/medwatch/safety/2008/ safety08.htm#HeparinInj2 Baxter Healthcare and the FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase
in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions. Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. See the recall notice for a list of affected lots. Read the complete 2008 FDA MedWatch Safety Summary including a link to the firm’s recall notice, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj
MERCK & COMPANY Has agreed to pay more than $650 million to resolve allegations that the pharmaceutical manufacturer failed to pay proper rebates to Medicaid and other government health care programs and paid illegal remuneration to health care providers to induce them to prescribe the company’s products, the Justice Department has announced. Not only is the combined recovery in these two cases one of the largest healthcare fraud settlements ever achieved by the Justice Department,” said Attorney General Michael B. Mukasey, “it reflects our continuing effort to hold drug companies accountable for devising pricing schemes that deliberately seek to deny federal health care programs the same lower prices for drugs that are available to other commercial customers.” H. Dean Steinke, a former Merck employee, alleged in his suit filed in Philadelphia that Merck violated the Medicaid Rebate Statute in connection with its marketing of its drugs Zocor and Vioxx.
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LAB TESTS ONLINE is a multilingual site about laboratory testing, initially developed by the American Association for Clinical Chemistry (AACC) in the US. It provides easy to understand, accurate and reliable information about laboratory tests, their related conditions and screening programmes in each country.
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Addressed both to citizens and primary care professionals, the site in the US already gets an average of 1.2 million visits per month. Due to its success, AACC and its partners are working to bring the site to Europe and beyond. The UK version was developed in cooperation with ACB, the British Association for Clinical Biochemistry, and the Australia and New Zealand website was produced with the Australasian Association of Clinical Biochemists. IMPROVING PATIENT COMPLIANCE “A major challenge in public health is that people do not take their medications, a phenomenon known as ‘medication nonadherence.’ In the US alone, it is estimated that this accounts for 10% of all hospital visits and costs the healthcare system $100 billion per year and $60 billion to the pharmaceutical industry. Now, an MIT research team thinks it has a solution to this problem that will save lives worldwide. They’ve developed the uBox, a convenient, palmsized, intelligent pill dispenser, ‘which reminds a patient when it is time to take his medication, records when a patient has taken a dose, and prevents a patient from double-dosing.’ The first large-scale trial with 100 uBoxes is scheduled to begin in May in Bihar, India, in a 6month long tuberculosis treatment program.”
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Its makers stopped commercial production years ago, because demand was so low. But an antibiotic long abandoned as a weak, low-dose treatment for tuberculosis (TB) may have found renewed purpose, this time as a potent, high-dose fighter against the most common and actively contagious form of the lung disease. “Rifapentine is back,” says Johns Hopkins infectious disease specialist Eric Nuermberger, M.D., whose studies in mice, published in the Public Library of Science journal PLoS Medicine online, have found it so promising as an initial treatment for active TB that clinical trials are scheduled to begin next year in at least eight countries.
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The mouse studies showed that substituting higher and daily doses of rifapentine for another antibiotic, rifampin, cured mice two to three times faster than the much older, standard regimen of drugs that includes rifampin. Researchers say if tests in people confirm the findings in mice, the average time to clear the potentially fatal bacterial infection could be reduced from six months to three or less.
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PATIENT EDUCATION SECTION
CANCER Introduction Our bodies are made up of millions of tiny cells. Most of our cells divide and multiply from time to time - when an old cell is worn out or damaged, a new cell is formed to replace it. Each cell contains genes (made up from our DNA). The proteins inside the gene control when the cell should divide and multiply. If the gene is damaged or altered (maybe because too much or too little protein is being made) the cell becomes abnormal. This abnormal cell can then divide and multiply, without knowing when to stop. When a group of abnormal cells clump together and grow a tumour forms. There are two types of tumour: benign and malignant. Benign tumours are not cancerous, and wont invade or spread to other parts of the body. Whereas malignant tumours are the real cancers. They can grow very quickly, invade nearby tissues and organs, and cause damage. They may even spread to other parts of the body and cause secondary tumours (metastases). But not all cancers form solid tumours - cancers of the blood, like leukaemia, develop from abnormal blood cells, which then attack other areas of the body by circulating in the bloodstream.
to know which common symptoms might indicate cancer. Early diagnosis is very important as in most cases it can improve your chances of survival. Some common signs of the disease are: ●
unexplained lumps and swellings,
anaemia (when you have less red blood cells in your blood than expected - symptoms may include tiredness).
All of these symptoms can be caused by conditions other than cancer, so there is no need to worry until you have seen your GP for a check up. Causes Cancer has many causes, and not all of them are known. Sometimes there is no clear reason why cancer develops. Certain cancers, like breast cancer, may be hereditary, meaning they can run in families. However, most cases of cancer do appear to be caused by a combination of factors, all of which are known to damage cells and therefore increase the risk of cancer. These factors include smoking, diet and environmental factors such as UV light from the sun.
There are two broad categories of cancers. Cancers that develop in the surface linings of organs are called carcinomas. Cancers that appear in the cells of solid tissues, such as muscles, bones and blood vessels are called sarcomas. Carcinomas are the most common.
Evidence linking cancer of the lung to cigarette smoking is overwhelming. Smoking can also cause cancer of the tongue, bladder and other parts of the body. Similarly, excessive sun exposure and sunburn are known to cause skin cancer in some people due to the radiation from ultra violet (UV) light in the sun.
There are about 200 different types of cancer. Some types are more serious than others, some are more easily treated, and others have better survival rates. Sadly, many of us will be affected by cancer at some point in our lives. If you are diagnosed with cancer, the doctors will need to find out what type you have, and if it has spread. That way they can decide on the best course of treatment for you.
Diet and other lifestyle factors can also increase the risk of cancer. An unhealthy diet, obesity, lack of exercise and drinking a lot of alcohol can all contribute, so it really is vital you try to lead a healthy lifestyle. For more detailed causes, see our encyclopaedia topics on the specific types of cancer.
Symptoms The symptoms depend entirely on what type of cancer has developed (see our encyclopaedia topics on specific cancers). Even so, its helpful
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Diagnosis Cancer is diagnosed in many different ways, depending on the type of cancer, how far advanced it is, and what part of the body is affected.
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Firstly, you will have a general examination with your GP, and answer questions about you and your familys medical history. Following this, doctors usually perform one or more of the following tests: ●
Ultrasound - this test uses high-frequency sound waves to create images of the inside of the body, such as blood vessels, tissues, and organs.
Computerised Tomography (CT or CAT) scan - instead of a single X-ray of the body several beams are sent from different angles at the same time.
Magnetic Resonance Imaging (MRI) scan - this scanning technique produces detailed, two-dimensional images of areas inside the body. MRI is especially useful for scanning the brain, spine, the soft tissue of joints, and the inside of bones.
Once the problem area is found, blood and tissue samples (biopsy) will be taken for analysis and testing to determine if, or how far, the cancer has spread in the body (this is called staging). If you are diagnosed with cancer make sure you take time to understand your illness, and think about your course of action before you rush into any treatment. Dont be afraid to ask your doctor any questions you may have - theyre there to help you. Be sure to discuss your concerns with a loved one, or contact a support group. Sometimes just talking about your fears and getting them out in the open can help.
harm the surrounding healthy tissue. Your treatment plan is created to suit your general health, the type of cancer you have and where it is. Radiotherapy affects people in different ways some people have side affects such as tiredness, lack of appetite, and depression, whilst some people have none. In women, radiotherapy to the pelvic area can sometimes kick start early menopause. If the cancer is too advanced for treatment, palliative care can be given to improve the quality of life for patients. The goal of palliative care is to relieve, rather than cure the illness, and help the patients live more comfortably. This usually takes place in a hospice, but can take place at home. Specially trained physicians and caregivers will give pain relief, control ongoing symptoms and offer counselling. Prevention Sometimes there is no clear reason why cancer develops, and sometimes the risk of getting a particular cancer may be inherited from a relative (for example, according to the Family Cancer Risk service website, around 5-10% of breast and ovarian cancer cases may be hereditary). But there are some recommended, simple guidelines we should all try to follow, to decrease the risk of getting cancer.
Treatment Treatment varies depending on the type of cancer and how far it has spread. Generally there are three main types of treatment: Surgery Surgical removal is the main treatment for most solid tumours, especially when the cancer is in the early stages and has not spread to other areas of the body. Some surrounding non-cancerous tissue and lymph nodes (small, bean-sized organs of the immune system) may also be removed to prevent the cancer returning. Chemotherapy Different drug combinations are given depending on the type of cancer. The drugs are given either by mouth, or more commonly by injection into a vein, to try and kill cancer cells or stop them spreading. Chemotherapy can also be given to shrink a tumour to make it easier for the surgeon to remove. In most cases, each cycle of chemotherapy is followed by a rest period of one to four weeks. There is usually a maximum of six cycles. Depending on the type of chemotherapy you have, you may be able to go home on the same day as you are given chemotherapy, or you may need to stay hospital for a few days. Again, depending on which drug combination you are given, there may be some side affects, such as sickness, diarrhoea, hair loss and mouth sores. Radiotherapy
Stop smoking, even if you have been smoking for many years, your risk of getting lung cancer will start to decrease as soon as you stop.
Eat a healthy diet, with plenty of fresh fruit and vegetables, starchy carbohydrates (bread, potatoes, pasta and wholegrain cereals) and protein rich foods such as chicken, fish and eggs.
Reduce your alcohol intake. The recommended safe limit of units of alcohol per day is 2 for women and 3 for men (for example, 1 unit = half a pint of beer, or a small glass of wine), but drinking less than this can only have positive benefits on your health and general well-being.
Be sure to protect yourself from the harmful effects of the sun. Cover up and use a high factor sunscreen of SPF 15 or above, and avoid sun between the hours of 11am and 3pm.
If you work around hazardous chemicals, such as gas and radiation, its essential you follow the health and safety guidelines at all times to protect yourself.
Radiotherapy aims to destroy the cancerous cells with radiation from X-rays. The dose of the radiation is carefully controlled so it doesnt
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TB Disease and transmission
10 Reasons Every Women Should Lift Weights Besides getting a great toned body, what else can you expect from weight training? The list goes on and on but here are my tip 10 favorite perks of picking up a weight. 1. Gain strength. Tired of not being able to carry all your groceries in one load? What about having to ask your significant other to open the pickle jar? The most obvious perk of weight training is increasing strength. 2. Build bone, fight osteoporosis. Strength training has shown to increase bone density, and what you do now affects your future. Build strong bones up today and in 20 years from now you might be the only one of your friends not taking medication for osteoporosis.
1. TB is a contagious disease that spreads through the air. 2. Only people with pulmonary TB are infectious. 3. Each person with infectious TB will infect on average between 10 and 15 people every year. 4. Someone in the world is newly infected every second. 5. Overall, one-third of the world’s population is currently infected. 6. People infected with TB will not necessarily get sick. The immune system ‘walls off’ the TB germs, which can lie dormant for years. 7. 5-10% of people who are infected with TB become sick at some time during their life.
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3. Increase metabolism. Lean muscle requires more energy than fat, so with each pound of muscle, you will be burning around 50 extra calories per day. And if you are burning more calories then taking in this means weight loss. And if you are not trying to lose weight, it means you will need to take in extra calories to feel the muscle. 4. Beat depression. Research has shown that exercise helps to decrease depression. Not only the chemicals that are released during exercise helps but also the results you see will increase confidence and make you a happier person. 5. Heart health. Being a regular at the gym makes for a healthy heart. Benefits include lowering cholesterol, blood pressure, and resting heart rate. Cardiovascular disease is the number one killer of women. Do what you can to ward off the disease. 6. Healthy habit. Everyone needs a hobby, and this is a great one to take up. Not only does it make you a better person but it’s a heck of a lot better than going bar hopping with friends, or veg out night with the girls. Plus, the gym is a great place to meet people with similar interests. 7. Better posture. From wearing heels, to typing at the computer all day many of us can use some improvement when it comes to posture. When building strength in the back and legs your body will naturally improve and you will look taller and leaner. I no longer hear my mom’s voice telling me to “bring my shoulders back.” 8. Feel sexy. When you look sexy then you feel sexy, its that simple. Strength training will tone and slenderize the body. Keep in mind no cardio workout on its own will give the same results. Want to look good in that new bathing suit. Then stop running and grab some free weights. 9. Burn calories even after the workout. After lifting weights, the muscles are in dire need of recovery. That keeps the metabolism spiked up for several hours after a workout. The same is not true for cardio workouts. So once gain, making it easy for the weight to come off. 10. Decrease risk of injury. Strength training strengthens not just the muscles but the ligaments, tendons and bones. It increases balance and stability and therefore works to decrease your changes of injury. Have back problems? Could be due to week core muscles. Most people agree that weight training (when done properly) helps to decrease existing problems.
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Do you or your child wake up coughing, or have a prolonged cough lasting for weeks? Parents should recognize that this is something potentially serious requiring medical attention, according to the American Academy of Allergy, Asthma & Immunology (AAAAI). ”Cough is the most common respiratory symptom for which patients seek medical attention,” said Alan B. Goldsobel, MD, FAAAAI, and Chair of the AAAAI’s Cough Committee. “Cough protects the body by removing mucus and irritating particles from the respiratory tract. Coughing is a useful function and does not always mean there is a problem with your child. However, coughing at night, after going to sleep indicates the need for medical attention.” Cough is a symptom with a variety of causes including: 1. Viral upper respiratory tract infections 2. Asthma 3. Nasal and sinus disease 4. Stomach and esophageal problems such as GERD 5. An inhaled foreign body
In South India, a siddha refers to a being who has achieved a high degree of physical as well as spiritual perfection or enlightenment. The ultimate demonstration of this is that siddhas allegedly attained physical immortality. Thus siddha, like siddhar or cittar (indigenisation of anskrit terms in Tamil Nadu) refers to a person who has realised the goal of a type of sadhana and become a perfected being. In Tamil Nadu, South India, where the siddha tradition is still practiced, special individuals are recognized as and called siddhas, or siddhars or cittars, who are on the path to that assumed perfection after they have taken special secret rasayanas to perfect their bodies, in order to be able to sustain prolonged meditation along with a form of pranayama which reduces the number of breaths taken by them considerably. Siddha medicine is a form of medical treatment of diseases using substances of all possible origins in a way that balances the possible harmful effect of each substance. This form of medicine was professed and practised by siddhars who wrote their recipes on palm-leaves for the use of future generations. Siddha medicine was developed by outstanding Dravidians (ancient Tamils), locally called Cittars. Preparations are made mainly out of the parts of the plants and trees such as leaves, bark, stem, root etc, but include also mineral and some animal substances. This form of medicine is still today well known in South India. The use of metals like gold, silver and iron powders (Sanskrit bhasma) in some preparations is a special feature of siddha medicine, which claims it can detoxify metals to enable them to be used for stubborn diseases. This claim is especially relevant in the case of mercury which is relatively often used in the system; that means medicine containing purified mercury should only be received from a highly qualified practitioner of the art.
6. Habit 7. Environmental irritants When to see an allergy/asthma specialist The AAAAI’s Referral Guidelines provide information to assist patients and health care professionals in determining when a patient may need consultation or ongoing specialty care by the allergist/immunologist. Patients should see an allergist/immunologist if they:
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1. Have a cough that lasts 3-8 weeks or more 2. Have a cough that coexists with asthma 3. Have coexisting chronic cough and nasal symptoms
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4. Have a chronic cough and tobacco use or exposure
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PHARMED NEWS NEW DCGI Dr Surinder Singh, Additional Director of Central Research Institute, Kasauli, Simla has been appointed new Drug Controller General of India (DCGI). He succeeds Dr M Venkateshwarlu who retired from the feb.1st Dr Singh assumed charge as the new DCGI. The appointment of Dr Singh as the new DCGI has come as a big surprise to both the industry as well as the officials as the present DCGI Dr Venkateshwarlu’s name was under the active consideration of the Union Health Ministry for extension for at least three months. But, the order appointing Dr Singh as the new DCGI came very late from the Prime Minister’s office. Dr Singh, additional director at the Central Research Institute, Kasauli in Himachal Pradesh assumed the charge officially this morning, sources at the DCGI office confirmed. He was heading the Central Drugs Laboratory (CDL) of the CRI besides being in-charge of the Regional Drugs Testing Laboratory at Chandigarh. Dr Surinder Singh, having done his MBBS and MD, has been in the quality control arena for long time and spent considerable time at CRI itself. He also served as deputy director (quality control) at the National Biological Institute earlier. .SHASUN In a world where 8.8 million new cases of tuberculosis occur each year, Chennai-based Shasun Chemicals and Drugs is manufacturing the key ingredient of a drug the World Health Organization will use to treat a virile form of the disease, as part of a public private partnership initiative to stop TB. Shasun is one of 14 organizations from five continents brought together by Eli Lilly to fight the emergence of drug resistant strains of TB. The disease is curable but resistance develops when normal treatment (rifampicin or isoniazid) is interrupted, not taken properly or not taken in the correct dosage. Shasun makes the active pharmaceutical ingredient in cycloserine, one of the few treatments available for MDR TB. WHO/FIP WORKSHOP The WHO in association with International Pharmaceutical Federation (FIP) is organizing a workshop on “WHO/FIP Training Workshop on Pharmaceutical Development with a Focus on Paediatric Formulations”. This is a part of the activities in encouraging the development of appropriate paediatric formulation. The workshop is meant to provide information and to stimulate pharmaceutical company to manufacture paediatric formulation. Details of the Workshop It is a four day workshop from 28th April to1st May 2008 and has a full panel of resource person who are experienced in paediatric formulation as well as paediatric clinical pharmacology. The workshop is for the technical people involved in the manufacture of paediatric formulations as well as those involved in the bioavailability studies and finally to those who put together the dossier. There will be sufficient time for one-to-one discussions with the resource persons.
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Technical people from Contract Research Organization are also invited for the workshop as these institutions would be involved in the bioavailability study. The website for further information is http://mednet3.who.int/prequal/ . No Registration Fees but your expenses have to be borne There are no registration fees but those from the industry would be expected to bear their own expenses for attending. The applications are to be submitted to the prequalification programme in headquarters – all instructions are given in the nomination forms. FDA The connection between Pfizer’s anti-smoking drug Chantix and serious psychiatric problems is ‘increasingly likely.’ The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill. The agency’s announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out.” ANTI-EPILEPTICS – MONITOR PATIENTS FOR RISK OF SUICIDALITY Medsafe would like to advise you of an emerging safety issue regarding anti-epileptic medicines and an increased risk of suicidal behaviour and ideation. The United States Food and Drug Administration (FDA) has issued an alert regarding an increased risk of suicidal behaviour and ideation (suicidality) in patients taking anti-epileptic medicines. This alert follows an FDA analysis of reports of suicidality from placebocontrolled studies of eleven anti-epileptics, which showed that patients taking anti-epileptics have about twice the risk of suicidal thoughts and behaviours, compared with patients receiving placebo. The key points are that: ❖ Patients who are currently taking anti-epileptic medicines should not make any changes without first talking to their doctor. ❖ All patients who are currently taking or starting any anti-epileptic medicine should be closely monitored for notable changes in behaviour that could indicate the emergence or worsening of suicidal thoughts or behaviour or depression. · Health professionals should inform patients, their families, and caregivers of the potential for an increase in the risk of suicidality so they are aware and able to immediately notify their doctor of any unusual behavioural changes.
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INSIGHT 2008 IES Management College successfully conducted their annual
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discussion by a presentation and demonstration of meditation and yoga techniques.
Pharma event INSIGHT’08, for the sixth time, on 2 February, Saturday. The event pertained to the health care & Pharma industry and provided a platform wherein leading Pharma companies, doctors and students came together and discussed about the latest trends in the Pharma industry. The event was inaugurated by chief guest Mr. Suresh Kare, Chairman & MD Indoco Remedies. For the first time IES Insight’08 introduced the Life Time Achievement Award to felicitate stalwarts who have provided a valuable contribution to the industry. This award was presented to Mr. Samprada Singh, Chairman, Alkem Laboratories, by the Chief Guest. The theme for the event was India: A Global Healthcare Destination. In sync with this theme, various sessions were organized such as The Indian Healthcare Market addressed by Mr. P K Guha, Deputy MD, Zuventus Healthcare, CRAMS Model
Mr. Suresh Kare, Chairman & MD Indoco Remedies. presenting to Mr. Samprada Singh, Chairman, Alkem Laboratories, Life time Acheivment award.
addressed by Dr. Suresh Bowalekar, MD Pharmanet. “In India, we wait till things go wrong” said Mr. Sohan Shah, GM McCann healthcare while discussing on the ‘Indian Healthcare Consumer’ in the post lunch session. Mr. Shah compared the trends and attitudes of people in India to that of western countries where people are more health conscious. He supported the changing scenario of the media business, buzzing with healthcare, with the help of ads customized for the Indian consumer.
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This was followed by a panel discussion on ‘Stress related cardio
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- diabetic disorders’ by leading doctors like Dr. Vijay Ajgonkar,
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Diabatelogist, Dr. Shekhar Ambardekar, Cardiologist and Dr. Manoj Bhatawdekar, Psychiatrist which threw more insights on coping up with stress. After which Dr. Geeta Dalal took further the
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FEB, 15-29, 2008
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