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Lymphatic filaria eradication by 2020
A new three-drug combination, Ivermectin, Diethyl Carbamazine and Albandazole, pilot rollout will be initiated in five States; Uttar Pradesh, Bihar, Jharkhand, Karnataka and Maharashtra. The rollout will see a mass drug administration (MDA) campaign in endemic districts as half of Indias population is susceptible to LF infection. The case for three-drug combo is being made after India failed to control LF with the two-drug combo of Diethyl Carbamzine and Albandazole.
India has repeatedly missed deadlines to eliminate lymphatic filariasis, last one being in 2017. In 2002, National Health Police set a goal for wiping off LF in India by 2015, which was further extended to 2017. India has now extended the deadline to 2020
Mass drug administration reduces the bloodborne reservoir of microfilariae to a level below that required for sustained transmission by local mosquito vectors. Programs have been initiated in more than 60 countries and use various combinations of albendazole, ivermectin, and DEC. These programs have led to suppression of transmission to <1 percent (the predicted threshold for elimination) in several countries; many challenges remain.
In areas where lymphatic filariasis is endemic, management consists of triple-drug therapy with ivermectin, diethylcarbamazine, and albendazole. This approach is based on data demonstrating that a single dose of all three drugs is more effective than DEC and albendazole in reducing microfilaremia, without a dramatic increase in adverse events
diabetic ketoacidosis update
Giving children intravenous (IV) fluids to treat diabetic ketoacidosis — an emergency complication of untreated diabetes — does not appear to worsen the brain swelling that may accompany the condition, according to a study supported by the National Institutes of Health. The findings, published in the New England Journal of Medicine, contrast with widespread concern that providing too much IV fluid may result in serious brain injury.
Eliminating acute kidney injury by 2025: an achievable goal for India
(Volume 386, No. 9996, p855, 29 August 2015)
Aim: Zero deaths by 2025 due to acute kidney injury from the International Society for Nephrology, as stated in the Lancet Commission (June 27, p 2616).1, 2
Common causes of acute renal injury in rural settings in India
- Delayed reorganisation and referral of acute renal failure due to an envenoming snakebite
- Delayed administration of an appropriate dose of snake antivenom, or unnecessary surgical intervention that can cause profuse blood loss and secondary infection
- Improper use of many antibiotics (including nephrotoxic drugs for patients with acute septicaemia) to treat diarrhoea, respiratory or urinary tract infections
- Septic abortion handled by unqualified doctors
- Dengue fever, leptospirosis, chikungunya, HIV/AIDS, or malaria
- Herbal remedies are often given by unqualified practitioners for the treatment of jaundice, and these might contain heavy metals and renal-toxic plant material.
- Routine administration of oral, non-steroidal anti-inflammatory drugs for simple pain without monitoring the patients renal profile might “cause additional insults to a failing kidney”.
- Neglected and improper management of hypertension or diabetes and routine misuse of angiotensin converting enzyme inhibitors
- Chronic renal failure has also been reported in farmers due to heavy contamination of drinking water with cadmium, copper, and lead.4
Can country import drugs which have still not cleared phase III trials?
In public health emergency Yes.
India has done it in case of bedaquiline for MDR TB and anti Nipah virus medicine recently.
- Section 122A in The Drugs and Cosmetics Rules, 1945 permits permission to introduce bedaquiline
407 [ 122A Application for permission to import new drug. — 408 [ (1) (a) No new drug shall be imported except under, and in accordance with the permission granted by the Licensing Authority as defined in clause (b) of rule 21.
(b) An application for grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees: Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims is made, the fee to accompany such application shall be fifteen thousand rupees: Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by Appendix I or Appendix IA of Schedule Y, as the case may be.]
(2) The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in Appendix I to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given in Appendix II to the said Schedule: Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the licensing authority may, in public interest decide to grant such permission on the basis of data available from other countries: Provided further that the submission of requirements relating to Animal Toxicology Reproduction studies Teratogenic studies, Perinatal studies Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug subject to the other provisions of these rules.
409 [(3) The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue a import permission in Form 45 and/or Form 45A, subject to the condition stated therein: Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing and the conditions, which shall be satisfied before permission, could be considered.] ]
- Rules 122B of the Drugs and Cosmetic Act provide for approval for manufacture of a new drug respectively.
- Schedule Y of the Drugs and Cosmetics Act says: “For drugs indicated in life threatening/serious diseases or diseases of special relevance to the Indian health scenario, the toxicological and clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority.”
- On bedaquiline data of phase 2 and 2b trials are available. Even in absence of phase 3 data, WHO stated the pressing need for bedaquiline. In 2013, they issued their first guideline, recommending use of the drug.
- DCGI: “It has been decided that waiver of clinical trial in Indian population for approval of new drugs, which have already been approved outside India, can presently be considered only in cases of national emergency, extreme urgency, and epidemic and for orphan drugs for rare diseases and drugs indicated for conditions/ diseases for which there is no therapy.”
- DCGI: “Bedaquiline is approved in US, EU and other major countries. Bedaquiline is indicated for the treatment of pulmonary tuberculosis due to multi-drug resistant Mycobacterium tuberculosis, (MDR TB) for which presently no effective therapy is available in India. MDR TB is a serious life-threatening condition with high mortality and it is a disease of special relevance to Indian Health Scenario.”
- Bedaquiline was approved by the FDA in 2012 for treatment of MDR-TB
- The CDC issued provisional guidelines for use of bedaquiline in 2013 that extended recommendations to populations who were not included in the clinical trials for the drug (and hence were not covered by the FDA approval), including children, pregnant women, individuals with extrapulmonary MDR-TB, and individuals with human immunodeficiency virus (HIV) or other comorbid conditions
- The technical group on tuberculosis in the ministry of health has also given approval to Delamanid, which is in its phase 3 clinical trials. This is an alternative drug to Bedaquiline.
- Delamanid is an oral nitro-dihydro-imidazooxazole drug that inhibits mycolic acid synthesis. It has been conditionally approved for use in the treatment of MDR-TB by the European Medicines Agency (EMA) but has not yet received FDA approval for use in the United States. The WHO has advised that delamanid may be added to a TB treatment regimen in adults with pulmonary MDR-TB in circumstances when an effective and reasonably well-tolerated regimen cannot be composed with conventional second-line drugs. Patients for whom delamanid may be particularly useful include those with increased risk for poor outcomes (such as drug intolerance or contraindication, extensive or advanced disease, resistance to fluoroquinolones and/or aminoglycosides/capreomycin, and XDR-TB).
PM10 levels spike in Delhi-NCR due to dust storms
The air quality in Delhi-NCR has again deteriorated to ‘severe’ and ‘hazardous’ levels. The reason is the frequent dust storms that the capital has been facing recently. This ground level dust storm has increased suspended particulate matter in the air, particularly PM10, with levels higher than 500 and even crossing 800. Levels of PM 2.5 are not so high at less than 100.
AQI ranging between 0-50 is considered good, 51-100 satisfactory, 101-200 moderate, 201-300 poor, 301-400 very poor and 401-500 severe.
This picture is typically seen in construction sites, which generate high levels of dust. Dry sweeping also produces a significant amount of dust. Total VOCs may be normal in conditions of high dust levels.
Particulate matter or suspended particles less than 10 micrometer in diameter are called PM-10. When inhaled, they remain in the lungs and can damage the lining of the respiratory tract and lung alveoli and reduce lung capacity and exercise capacity causing asthma and COPD. Later on they may permanently damage the lungs.
PM2.5, on the other hand, is absorbed, enters the circulation and affects mainly the heart. It increases blood pressure and may cause heart attack and stroke.
Dust particles irritate the eye and also the airways and cause coughing, wheezing. The public should avoid exposure to such high levels of pollution. Patients of asthma and COPD in particular should take caution. They may need to increase the dose of their medications.
Temperatures more than 40.0°C is observed at some parts of Haryana and Delhi and at one or two pockets of Jammu division, Punjab, Rajasthan, Gujarat region, Madhya Pradesh, Bihar, Vidarbha and Andhra Pradesh
Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO