Center for Drug Evaluation and Research

Centre issues National Treatment Guidelines for Antimicrobial Use in infectious diseases

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The Union government has issued the National Treatment Guidelines for Antimicrobial Use in infectious diseases. With no new drug on the horizon, the government has felt the need to bring out the existing levels of reported resistance of these drugs in the country. It has devised a syndromic approach for empirical therapy of common infections.
To contain further development of antimicrobial resistance, implementing hospital infection control practices, formation of active hospital infection control teams in each hospital working round the clock and monitoring and containing spread of infections are part of these norms. Preventing the acquisition of an infection by vaccination for different microbial infections will also help in reducing the need for prescription of antibiotics.

The government will also enforce an antibiotic stewardship programme to find out the lacunae and improve upon the rational use of antibiotics with appropriate interventions and strategies.
According to Kaushik Desai, general secretary, Indian Pharmaceutical Association, the move is excellent by the government. This also gels with global issue of fighting antimicrobial resistance. These norms explicitly state that antimicrobials should be prescribed only when they are necessary for treatment following a clear diagnosis. The key factor is that these guidelines must be understood by each pharmacist working not just in hospitals but retail pharmacies too. The need of the hour is to help in bringing awareness about antibiotic resistance and its misuse.
The guidelines lists recommended treatments for common infectious diseases that are based on scientific evidence, literature review and are consistent with the already existing international norms. It is formulated with the collective opinion of recognised national experts. Empiric treatment choices for different syndromes, infections of specific body sites, and in certain special settings; antimicrobial choices for multidrug resistant bacteria pathogens, monitoring use of antimicrobials; preventive strategies for healthcare associated infections, case definitions and diagnosis of common infections are clearly provided. The guideline has emphasised that not all patients need antibiotics and non-drug treatment may be suitable.
The content of these treatment guidelines will undergo a process of continuous review and in this regard the government has called for comments or suggestions for improvement. The norms provides only suggestive procedures. The protocols are general and may not apply to a specific patient. Therefore the norms should not replace clinical judgment, factors like hemodynamics of specific patients, availability of antimicrobials and local antibiogram of healthcare setting need to be considered.
Before starting presumptive therapy, medical experts should follow up on standard investigations for all suspected infections for accurate diagnosis and prognosis. The timing of initial therapy should be guided by the patient’s condition and urgency of the situation and can preclude opportunity to establish a microbiological diagnosis, which is critical in the management of these patients.
Merits and limitations of empiric versus definitive antimicrobial therapy should be clear to the doctor prescribing antimicrobials. Since laboratory results for  microbiological tests are not available for 24 to 72 hours, initial therapy for infection is often guided by the clinical presentation. Therefore, a common approach is to use broad-spectrum antimicrobial agents as initial empiric therapy with the intent to cover multiple possible pathogens commonly associated with the specific clinical syndrome. However, once laboratory results are available with identification of pathogen along with antimicrobial susceptibility data, every attempt should be made to narrow the antibiotic spectrum. This is critically helpful because it can reduce cost and toxicity besides significantly delay the emergence of antimicrobial resistance.

Source: 1

Health ministry issues notification on Japanese Encephalitis

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With a view to address the issue of Japanese Encephalitis in some regions of the country, the Union health ministry has issued a notification on Japanese Encephalitis (JE). The notification has been sent to the heads of state health departments and other health functionaries of all the state governments/UTs concerned.

Besides, chief secretaries of government of Assam, Bihar, Tamil Nadu, Uttar Pradesh and West Bengal where the number of JE cases has been reported to be high in the past, have been requested to issue necessary notification under the Clinical Establishment (Registration & Regulation) Act, 2010 or relevant Act/Rules as applicable, to ensure necessary monitoring, prevention and control of the disease.

During the discussion on a Calling Attention Motion in the Lok Sabha on 11.8.2016 regarding spread of J E in the country, especially Eastern Uttar Pradesh and steps taken by the government in this regard, Union health minister J P Nadda had made an assurance for making JE a notifiable disease. This notification issued by the health ministry is in response to the assurance given to Parliament by the minister.

As per the notification, JE is an important public health concern in the country accounting for substantial morbidity, mortality and disability. Early reporting of JE cases is necessary for effective implementation of preventive measures and case management.

In order to ensure early diagnosis & case management, reduce transmission, address the problems of emergency and spread of disease in newer geographical areas, it is essential to have complete information of all JE cases. Therefore, the healthcare providers shall notify every JE case to local authorities i.e. district health officer/chief medical officer of the district concerned and municipal health officer of the municipal corporation/municipality concerned every week (daily during transmission period).

Accordingly, all laboratory-confirmed cases of Japanese Encephalitis should be notified.


FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors

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The U.S. Food and Drug Administration  approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs).

NETs are rare noncancerous (benign) or cancerous (malignant) tumors that develop in the hormone-producing cells of the body’s neuroendocrine system. These cells are found throughout the body in organs, such as the stomach, intestines, pancreas, lungs and other locations. NETs have receptors for somatostatin, a hormone that regulates the endocrine system. Ga 68 dotatate, a positron emitting analogue of somatostatin, works by binding to such receptors.


“Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical,” said Libero Marzella, M.D., Ph.D., director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy.”

Netspot is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use. The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs. This uptake can also be seen in a variety of other tumor types or other pathologic conditions, or might occur as a normal variant. The uptake of Ga 68 dotatate may need to be confirmed by histopathology or other assessments.

Three studies established the safety and effectiveness of Netspot. The first compared Ga 68 dotatate images of NETs to images obtained with an approved drug, and then confirmed with computed tomography (CT) and/ or magnetic resonance imaging (MRI); the second evaluated Ga 68 dotatate images using histopathology (the study of tissue changes caused by disease), or clinical follow up as reference standards; and the third evaluated patients with NET recurrence using Ga 68 dotatate images. The results of all three studies confirmed the usefulness of Ga 68 dotatate images in finding the location of the neuroendocrine tumors.

Netspot contributes to overall long-term cumulative radiation exposure, and patients should drink and urinate as often as possible during the first hours following administration to help reduce this risk.  No serious adverse reactions have been identified.

The FDA granted Priority Review and orphan drug designations for Netspot. Priority review status is granted to applications for drugs that, if approved, would be a significant improvement in safety or effectiveness in the treatment of a serious condition. Orphan drug designation provides incentives such as tax credits, user fee waivers, and eligibility for orphan drug exclusivity to assist and encourage the development of drugs for rare diseases.

Netspot is marketed by Advanced Accelerator Applications USA, Inc.

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Exporters want India & Vietnam to work together on addressing drug testing issues in Vietnam

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The Central government has to come out with appropriate strategy to overcome the trade barriers put up by the Vietnam government against Indian pharmaceutical exports in recent months. The regulatory authorities in Vietnam  have been frequently finding fault with the quality of Indian pharmaceutical exports without much justification, according to some leading exporters.

This hostile attitude of the Vietnamese drug regulatory authority is resulting in issuing letters and blacklisting some Indian exporters citing compliance and quality issues. While the industry appreciated the pro activeness of the Indian government in reaching out to Vietnamese counterparts, the industry insisted that the government should take measures in interacting with the stakeholders as well to understand the ground realities.

Nipun Jain, chief executive officer, of Pharmachem stressed that Vietnam being a major export destination is an important market for the industry and thus pre-emptive measures should be taken to address the issue. To safeguard the interest of the Indian exporters, while maintaining a strong relation with the Vietnamese government, Jain who is also in the SME panel of Pharmexcil suggested that India and Vietnam should work together to collaborate on setting up a joint drug testing lab in Vietnam, which would ease up the tension and build the confidence among both the parties.

He also suggested that if not that the Vietnamese government can try to outsource the drug testing to a third party like SGS. If not that they can try adopting pre-shipment testing through a third party as being done for exports to Nigeria, where samples of drugs to be exported to the Nigerian market is tested through a third party testing laboratory in India itself before being exported.

“These are some of the practical solutions that can be adopted to address the issue. These steps will ease the exporters tension and uncertainity while exporting to Vietnam and will also help the Vietnamese authority in addressing their fears on quality issues, without affecting the exports,” Jain pointed out.

A highly placed source from the industry claimed that contrary to the claims made by the Vietnamese government, the fault does not lie with exporters alone, as the regulatory system in the country is equally to be blamed. On condition of anonymity a source revealed that there is a huge lacunae in the drug testing and regulatory system in Vietnam which is the main cause of concern for many. In fact, the source pointed that the testing labs and other facilities are not even updated and latest as per the internationally accepted guidelines.

“The ongoing situation cannot be sorted out without taking into cognizance of the deplorable state of the drug regulatory system in Vietnam, as well rather than playing the blame game they should take some constructive steps towards modernising their drug testing labs. May be then they will find out that the problem is not with the Indian drugs but is with their incapability in properly testing the products,” a source stressed.

Source: PharmaBiz