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Vol. I, Issue I

January 2020Vol. IV, Issue I

S&A PHARMANEWSLETTER

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S i n g h a n d A s s o c i a t e s

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Manoj K. Singh Founding Partner

EDITORIAL

Dear Friends,

It is a proven scenario that socioeconomic status affects an individual’s health outcomes and the health care they receive. People with lower socioeconomic status are more likely to face health issues and are more uncomfortable to report problems arising due to health issues. The socioeconomic health is not only for individuals but it is also relevant for a developing country with poor economy. As a result, the national health strategies and plans of governments and other health partners in these countries also gets affected by socioeconomic status.

We are pleased to present Vol. IV Issue I of S&A – Pharma Newsletter. Through this newsletter, we aim to share recent information allied to regulatory reforms and updates from pharmaceutical sector in India as well as from foreign jurisdictions, based on information collated through research and appraisal of applicable statutory provisions.

In the present issue, we start with a year review on Regulatory Action by CDSCO on drug adverse events, which summarizes the regulatory interventions taken by CDSCO in response to PvPI recommendations. The current edition then discusses the advisory issued by CDSCO on rational use of Antibiotics for limiting Antimicrobial resistance in the country. The issue goes on to put some light on a report released by ICMR which states that Lead exposure can possibly be one of the causes of Alzheimer’s disease; the report is based on a study conducted at National Institute of Nutrition, ICMR. Further, we give you another year-end review on the AYUSH system of medicine citing the achievements and objectives of AYUSH Ministry during 2019. Next, we share the good news of Indian molecular assay TrueNat to be included in WHO Global TB Programme for diagnosis of tuberculosis.

The volume also discusses on recent Healthcare updates from India presented as a separate section under India HealthCare Highlights January 2020.

From the international arena, separate sections highlight recent regulatory updates from US FDA and WHO the headings US FDA Pharma Updates January 2020 and WHO updates January 2020 respectively.

Note: All reasonable precautions have been taken to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the author and/or the firm be liable for damages arising from its use.

Trust you enjoy reading this issue as well. Please feel free to send your valuable inputs / comments at [email protected]

Thank you.

Contributors to the current issue: Mr. Manoj K. SinghMs. Vijaylaxmi RathoreMs. Arnika Sharma

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S&A Pharma NewsletterVolume IV, Issue IJanuary 2020

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Managing Editor Manoj K. Singh

Published by Singh & Associates

Advocates and Solicitors

1. Regulatory Action by CDSCO on Drug adverse events: A year-end review 04

2. CDSCO issues advisory on rational use of Antibiotics for limiting Antimicrobial resistance 06

3. Lead exposure, a possible risk factor causing Alzheimer’s disease: ICMR 08

4. AYUSH System of Medicine - Year End Review 2019 09

5. Indian molecular assay True Nat to be included in WHO Global TB Programme 12

6. India Healthcare Highlights January 2020 13

7. USFDA Pharma Updates January 2020 15

8. WHO Updates January 2020 16

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Regulatory Action by CDSCO on Drug adverse events: A year-end review

The Central Drugs Standard Control Organization (CDSCO), New Delhi, under the aegis of the Ministry of Health & Family Welfare, initiated a nation-wide Pharmacovigilance Program of India (PvPI) in 2010. The PvPI, with the aim to safe guard public health in the country, has set-up Adverse drug reactions (ADRs) Monitoring Centres (AMCs) across the country. The AMCs, in order to monitor ADRs, occuring due to use of medicines, vaccines, medical devices, herbal products etc., collect ADRs reports from pharma companies, healthcare professionals and consumers/patients. They further evaluate/validate the same before forwarding the reports to Indian Pharmacopoeia Commission (“IPC”) which is a National Coordinating Centre (NCC) for PvPI. The NCC analyses the PvPI database and raises alerts for risk-prone drugs to CDSCO. Further, NCC also shares this information with global ADR monitoring center (WHO-Uppsala Monitoring Centre (UMC)), Sweden, to contribute to the global ADRs data base.

NCC-PvPI identifies India centric drug safety signals after analyzing suspected ADRs and communicates its findings to CDSCO for appropriate regulatory action. Thereafter, the Subject expert committee (SEC) of CDSCO reviews the same and if in agreement, recommends the CDSCO to request all State/UT Drugs Controllers to instruct all the manufacturers licensed for the said product/drugs to include the ADRs in prescribing information (Package inserts and drug safety labels) of particular drugs. In case SEC is not satisfied with NCC-PvPI recommendations, they ask for more Individual Case Safety Reports/signals to support their recommendation.During 2019, in response to PvPI, the CDSCO issued a number of regulatory actions to all State/UTs drug controllers to direct the manufacturers of said tabulated formulations to incorporate details of ADR in the Prescribing information leaflet (PIL) of the drug marketed in the country. The year-end review summarizes the list of drug formulations with flagged ADRs1:

Sr. No. Suspected Drug Adverse drug reactions1 Tranexamic acid Seizure/convulsion2 Sulfasalazine Incorporate Drug Rash with Eosinophilia and Systemic Symptoms

(DRESS) Syndrome, Toxic Epidermal Necrolysis (TEN) and Steven Johnson Syndrome (SJS)

3 Sodium Valproate Gum Hyperplasia4 Quetiapine Urinary Incontinence5 Ofloxacin Stevens Johnson syndrome (SJS) I Toxic epidermal necrolysis (TEN)6 Cefotaxime Angioedema7 Cefixime Acute generalized exanthematous pustulosis (AGEP) and Mouth

Ulceration8 Terbinafine ACLIte Generalized Exanthematous Pustulosis (AEGP)9 Phenobarbital Drug Rash with Eosinophilia & Systemic Symptoms (DRESS) Syndrome10 Cefepime Urticaria

11 Fluconazole Hyperpigmentation12 Carvedilol Hyperkalemia

13 Amlodipine Gingival Hypertrophy and Alopecia

1 https://ipc.gov.in/mandates/pvpi/pvpi-updates/8-category-en/422-regulatory-actions.html


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Sr. No. Suspected Drug Adverse drug reactions14 Meropenem Hypokalemia15 Carbamazepine Drug Rash with Eosinophilia and Systemic Symptoms (DRESS)

16 A r t e m e t h e r + L .umefantrine

Steven Johnson Syndrome (SJS)

17 Diclofenac injection Nicolau’s Syndrome18 Proton Pump

InhibitorsAcute Kidney Injury

Note – Recently, NCC-PvPI was recognized as a WHO collaborating center for Pharmacovigilance in public health programs and health services due to its progressive contribution towards patient safety and wellbeing. At present 250 AMCs are active across the country. Of these centers, 21 AMCs play sentinel site for Revised National Tuberculosis Control Program (RNTCP), 20 for HIV control program on anti-retroviral Therapy (ART) and 6 are designated as Bedaquiline Cohort monitoring Centers.

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CDSCO issues advisory on rational use of antibiotics for limiting antimicrobial resistance

Antimicrobial resistance (AMR) is a broad term for resistance in different types of microorganisms such as bacteria, viruses, fungi and parasites, to antibiotics such as antibacterial, antiviral, antiparasitic and antifungal drugs. In recent years, AMR is posing a serious threat to human health and economy globally. AMR does occur naturally, but is aggravated by the inappropriate use (overuse and misuse) of antimicrobials in humans, animals and plants. AMR accelerates the natural evolutionary processes by which microbes become resistant to antimicrobial treatments. Consequently, some infections have become untreatable by existing antimicrobials. Projections suggest that AMR is likely to exacerbate global economic inequality, with the economic costs disproportionately affecting poorer countries.

In this regard, WHO has endorsed the Global Action Plan 2015 on AMR, where all member states were urged to develop a multisectoral National Action Plan within two years of endorsement. Further, 79 countries reported that they had a plan, with another 50 having a plan under development. While the two year target is still unmet, the WHO second tripartite (Food and Agriculture Organization of the United Nations (FAO), World Organization for Animal Health (OIE) and WHO) self-assessment survey 2018 shows that the countries are making significant steps in tackling AMR, yet serious gaps remain and require urgent action.

Tackling AMR in the countryThe Ministry of Health & Family Welfare (MoHFW), Government of India, identified AMR as one of the top 10 priorities for the ministry’s collaborative work with World Health Organization (WHO). The Health Ministry has introduced National Action Plan on Antimicrobial Resistance (NAP-AMR) 2017 – 2021. The strategic objectives of NAP-AMR are aligned with the Global Action Plan based on national needs and priorities, furthermore India also has its own priority of India-specific dealing with AMR which includes –international, national and sub-national collaborations between government bodies, industries and NGOs on AMR.

Regulatory steps taken under NAP-AMR:

y With a purpose to achieve the unified goal of reducing AMR, ICMR has invited Expression of Interest (EOI) from reputed, eligible and experienced firms offering Project Management Consultancy (PMC) Services to set up a Project Management Unit (PMU) in accordance with the Scope of Work (SoW) mentioned in NAP-AMR for a period of two (2) years commencing from date of start.

y Manufacturing, sale and distribution of Colistine and its formulation have been banned for food producing animals, poultry, aqua farming and animal feed supplements.

y The Ministry of Agriculture issued a circular directing Commissioner/Directors of Animal Husbandry of all states/UTs to advice state veterinarians, feed manufacturers and other involved in the treatment of ailing food producing animals for judicious use of antibiotics and hormones.

y Various notices/advisories have been issued to state & UT drug regulators to raise awareness in the public regarding adverse effects of misuse of antibiotics, and strict compliance with Drugs and Cosmetic Act, 1940 and Rule made thereunder.


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Subsequent to this, Central Drugs standard Control Organization (CDSCO) on December 23, 20191 issued advisory to all the stakeholders for joining the mission against AMR and support the judicious use of antibiotics and hormones towards safety and well-being of public, wherein;

y all State & UTs drug controllers were asked to sensitize their enforcement officials to keep strict vigil on sale of Schedule H and H1 drugs.

y Organizations of Chemist & Druggist across India were asked to co-operate with regulatory authorities and comply with Drugs and Cosmetics Act, 1940 and Rule made thereunder. Moreover, they were also advised to raise awareness regarding appropriate use of antibiotics.

y Pharma industry was advised to use their well-developed marketing network to discourage the pharmacists from selling such drugs without prescription.

Note – At present, tackling AMR is one of the top priorities of government; to comply with WHO’s Global Action Plan combined and sustained efforts across all government sectors and society are required.

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1 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTM3Nw==

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Lead exposure, a possible risk factor causing Alzheimer’s disease: ICMR

On January 13, 2020, the Indian Council of Medical Research (ICMR) reported ‘Lead exposure’ as a possible risk factor for causing Alzheimer’s disease based on a study conducted at National Institute of Nutrition (NIN- ICMR)1.Alzheimer’s is a neurodegenerative disorder and the most common form of dementia which usually affects the functioning of memory, thinking and behavior in brain. The pathophysiology of Alzheimer’s involves the formation of beta amyloid plaques and tangles in the brain. In addition, oxidative stress and inflammation are known to be involved in the progression of the disease, with loss of memory and neuronal cell death. In the early stage, dementia symptoms may be minimal, but with time the symptoms worsen. Currently there is no proven treatment available to halt and cure the Alzheimer’s disease from progressing, but there are medications to treat symptoms of dementia.

Lead (Pb) a common pollutant found in the environment is released from a number of items like paints, cosmetics, batteries, and glass. As a toxic material, lead can cause pathophysiological dysfunctions of the central nervous system. A recent study conducted at ICMR- National Institute of Nutrition (ICMR-NIN) has established the possible link between lead exposure and Alzheimer’s disease. Therefore, scientists are looking forward to find the possible molecular mechanism on lead induced Alzheimer’s disease through in-vitro studies.

In in-vitro study, brain cells are accumulated with beta amyloid peptides in case of Alzheimer’s disease and the effect of Lead exposure was then studied. The study showed increased cell death and increased levels of pro-apoptotic marker proteins. Further, the proteins involved in neurodevelopment and regeneration depleted. Such effects led to decreased expression levels of synaptophysin, finally leading to loss of memory as in Alzheimer’s disease. Maternal exposure to lead during pregnancy may also lead to a higher risk and early onset of Alzheimer’s disease in later life of the child.

ConclusionThere are numerous socio-economic factors which cause the progression of the disease. However, recently scientist have found that various pollutants such as lead exposure can also lead to disease progression and a team of scientists is working to find the cause and its treatment. Since lead exposure is possibly linked with Alzheimer’s disease, the study will help to find out preventive measures for Alzheimer’s caused due to lead exposure.

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1 https://www.icmr.nic.in/sites/default/files/press_realease_files/Press_Release_on_Alzheimer_Disease_0.pdf


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AYUSH System of Medicine - Year End Review 2019

Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH) - the traditional systems of medicine play a crucial role in public health in India. The AYUSH system has more importance in management of lifestyle related chronic conditions which are a growing threat to public health in our country.

It has been five (5) years since the Ministry of AYUSH was formed and worked towards popularizing alternative system of medicine in the country. In a process to streamline the AYUSH systems, the Ministry has prepared a robust and all-encompassing structure and projected seven broad activities, namely:

1. Improving Access to AYUSH Healthcare,

2. Promoting AYUSH Research,

3. AYUSH Education,

4. AYUSH Drugs and related matters,

5. Creation of Awareness,

6. Efforts for Globalizations of AYUSH Systems, and

7. Induction of IT into the AYUSH Sector.

In year 2019, the ministry continued its efforts to mainstream the AYUSH systems and has covered these seven (7) broad activities and achieved considerable success in the same1:

1. Improving Access to AYUSH Healthcare: The central government launched “National AYUSH Mission (NAM)” as a prime scheme for promoting access to AYUSH Healthcare, the scheme supports State/UTs Governments for the development of AYUSH healthcare. Under this scheme the Ministry has;

y operationalized 10% of the Health and Wellness Centers (HWCs) under Ayushman Bharat Scheme through State / UT Governments,

y provided grant-in-aid of Rs. 89.92 crore to 1,032 AYUSH Dispensaries under NAM,

y co-located 7620 PHCs, 2758 CHCs and 495 DHs with AYUSH facilities in different parts of the country,

y provided financial assistance for setting up of 91 up to 50 beds integrated AYUSH hospitals including 6 such hospitals assisted in the current year,

y supported 190 nurseries throughout the country for cultivation, distribution of quality medicinal plants,

y approved establishment of the National Institute for Sowa-Rigpa in Leh. Sowa-Rigpa is a traditional medical system of the Himalayan belt in India.

2. Promotion of Research Activities in the AYUSH Systems: The Central Councils of Research dedicated to AYUSH systems are to be the mainstay of AYUSH Research. In year 2019:

y The Central Research Councils of Ayurveda, Unani, Homoeopathy and Siddha together validated 140 classical medicines for 70 conditions by generating evidence on clinical safety and efficacy.

1 https://pib.gov.in/PressReleseDetail.aspx?PRID=1597195

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y The Ministry inaugurated National Research Institute of Unani Medicine for Skin Disorders, at Erragadda, Hyderabad.

y The Ministry inaugurated the Siddha Clinical Research Unit and Unani Medical Centre in Safdarjung Hospital, New Delhi for integrative medical research.

y The Central Council for Research in Homoeopathy (CCRH) successfully completed studies on Brain Fever (Encephalitis) in endemic area of Gorakhpur.

3. AYUSH Education: The Ministry succeeded in steering the AYUSH education sector along a path of growth and modernization during 2019 with comprehensive implementation of the National Eligibility Entrance Test (NEET) and a streamlined All India Post Graduate Entrance Test (AIPGET) for admission into Undergraduate and Post Graduate courses respectively.

4. AYUSH Drugs Policy and related matters: Regulation of AYUSH system in country for ensuring safety and efficacy of AYUSH drugs was one of the major focus during the year, with following achievements:

y A system for AYUSH Drug Control was formalized with the notifying 9 regulatory posts marking it one of the biggest achievements.

y E-Aushadhi Portal for online license applications was strengthened by getting the State Licensing Authorities on-boarded.

y AYUSH Medicines were included in the Jan Aushadi scheme. Essential Drug List of Ayurveda, Siddha, Unani & Homoeopathy was updated and revised.

y Pharmacovigilance for ASU&H drugs: 63 PPvCs have been established under one National and five Intermediary Centres. Reporting of adverse events caused due to consumption of ASU&H drugs started from January 2019 and nearly 250 cases of adverse effects of ASU&H drugs were reported in October 2019.

y Surveillance of misleading advertisements in the print and electronic media was intensified during the year.

y The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), Ghaziabad, an autonomous organization under the Ministry of AYUSH, continued its efforts to refine the AYUSH Pharmacopoeias.

5. Creation of awareness about AYUSH Systems: One of the biggest achievements in this regard was the successful conduct of the International Day of Yoga (IDY) 2019. Further, nearly 100 Seminars and Workshops for public and 50 patient education camps were held in different parts of the country on preventive and promotive aspects of AYUSH Healthcare by the Ministry and its autonomous bodies.

6. Globalization of AYUSH Systems: The Ministry of AYUSH has signed many MoUs at national & international levels. As a result, a landmark was achieved between the world’s two largest Traditional Medicine Administrations - India and China. Further, All India Institute of Ayurveda (AIIA) signed MoUs with international institutions such as College of Medicine, UK; Spaulding Rehabilitation Hospital, USA; Frankfurt Biotechnology Innovation Center, Frankfurt, Germany and Western Sydney University (WSU), Australia.

7. Induction of IT into AYUSH Sector: During the year the Ministry was able to implement many significant digital transformations including:

y Up-scaling of AYUSH-Health Information System by covering all the Central Research Councils.


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y Set-up of Monitoring Dashboard broadly covering all activities of the Ministry,

y Created Portals dedicated to IDY 2019 and Pharmacopia Commission,

y Standardised Terminologies were codified for AYUSH systems under International Classification of Diseases (ICD) of the WHO. This would further pave the way for the globalisation of these systems,

y Launched Yoga locator mobile app to support the public in finding nearby locations for Yoga training.

Conclusion AYUSH Ministry has made many achievements during 2019 in all seven projected activities. However the ministry hoping to streamline Aayush system of medicine in country before aiming to globalize the system in coming year.

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Indian molecular assay TrueNat to be included in WHO Global TB Programme

On January 16, 2020, Indian Council of Medical Research announced a significant development that the WHO Global TB Programme has included an Indian Molecular assay ‘TrueNat’ as initial test for TB and MDR-TB in view of its high diagnostic accuracy1.

In a continual effort to eradicate tuberculosis, health care professionals around the globe had made various policies and serious efforts at ground level too. It is a moment of pride for the Department of Health Research (DHR), Indian Council of Medical Research (ICMR) when WHO promoted an indigenous diagnostic technology developed by Indian scientists - “TrueNat” for diagnosis of TB and MDR/XDR–TB.

DHR and Department of Biotechnology (DBT) have reviewed various indigenous technologies for detection of TB and most promising kits were subjected to a double-blind validation in comparison to standard tests at 4 national reference laboratories of the country. After an extensive review and validation studies the ‘TrueNat’ was found competitive to internationally recognized molecular assay ‘Gene Xpert’ in terms of sensitivity and specificity and detection of rifampicin resistance. Further this testing was followed by National TB Elimination Programme after recommendations from ICMR.

ICMR conducted the interim analysis and funded the test in four countries (India, Ethiopia, Peru, and Papua-New Guinea). Based upon the data available from the analysis, WHO included ‘TrueNat’ into its global TB programme to diagnose TB by replacing sputum smear microscopy. ‘TrueNat’ assay kit is highly cost effective and can be used in a lab without AC and runs on solar operated battery as compared to the internationally recognized assay ‘Gene Xpert’.

ConclusionThe entry of ‘TrueNat’ in WHO global TB programme will help provide affordable TB detection and support TB elimination in developing countries and low income countries. The announcement is an achievement for Indian scientists for development of cost-effective and convenient diagnostic kits for TB.

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1 https://www.icmr.nic.in/sites/default/files/press_realease_files/PR_Molecular_TrueNat.pdf


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India Healthcare Highlights January 2020

This segment of the newsletter shares recent information related to regulatory reforms from Healthcare and Pharmaceutical sectors in India. This segment collates information on monthly basis via conducting research and appraisal of applicable statutory provisions. Below are the highlights for December 2019.

1. Government to launch AYUSH Export Promotion and Research CouncilOn December 19, 2019, the Ministry of AYUSH announced that Government of India will soon launch “AYUSH Export Promotion Council of India” and “AYUSH Export Research Council of India” to promote and facilitate the exporting community which may eventually increase exports.

The announcement came during the 2nd International Exhibition & Conference on AYUSH & Wellness sector - ‘International Arogya 2019’ jointly organized by FICCI with Ministry of AYUSH, Department of Commerce, Ministry of Commerce & Industry, and Pharmexcil. FICCI also launched a report on ‘Understanding the AYUSH Services Market in India’ during the event. Key takeaways of the report are:

y The Ayurveda Services Market was estimated at INR 7,700 Cr in 2018, and is anticipated to more than double by 2024, growing at a CAGR 13.1%

y The Domestic market is expected to grow at CAGR 10.2% during 2018–2024, while the Tourist segment is anticipated to grow at a CAGR 18.6% from 2018 to 2024.

y 7,718 manufacturing units were engaged in manufacturing of Ayurveda drugs as on April 01, 2018, of which 99.5% were privately owned.

y An upswing in number of accreditations started only in 2018, and it is anticipated to witness a sharp increase during 2019-2024, especially with the NABH coming up with an ‘entry level’ NABH certification in May 20191.

2. Cabinet gave ex-post-facto approval to India and Bill & Melinda Gates Foundation (BMGF) on cooperation in the field of HealthOn January 08, 2020, the Union Cabinet, chaired by the Prime Minister, has given its ex-post-facto approval on the Memorandum of Cooperation (MoC) between Department of Health & Family Welfare (DOHFW), Government of India and Bill & Melinda Gates Foundation (BMGF) on cooperation in the field of Health signed in November, 2019 during the visit of Mr. Bill Gates, Co-Chair and Trustee of BMGF to Delhi. The Memorandum of Cooperation (MoC) covers the following areas of cooperation:

y To reduce maternal, neonatal and child morbidity and mortality, improve key nutrition outcomes, by improving the reach, coverage and quality of essential primary health, immunization and nutrition services.

y To increase the basket of choice and quality for family planning methods, especially for reversible methods, and increase access amongst younger women.

y To reduce the burden of select infectious diseases [TB, Visceral Leishmaniosis (VL), Lymphatic Filariasis (LF)].

1 https://www.biospectrumindia.com/news/22/15380/govt-to-launch-ayush-export-promotion-and-research-council.html

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y To strengthen health systems, including aspects such as budget utilization, management and skills of human resources for health, digital health, strengthening supply chains and monitoring systems.

y A Program Action Committee (PAC) will be set up to further elaborate the details of cooperation and to oversee the implementation of this Memorandum of Cooperation2.

3. New pneumococcal vaccine from Serum Institute of India achieves WHO prequalificationOn December 19, 2019, the Serum Institute of India (SII) has received Prequalification for PNEUMOSIL® from World Health Organization (WHO). This approval marks a milestone for SII towards improving affordability of pneumococcal conjugate vaccine and enabling sustainable access for low- and middle-income countries. PNEUMOSIL® is a vaccine against a leading cause of deadly childhood pneumonia. The vaccine was developed though a collaboration spanning over a decade between Serum Institute of India, Pvt., Ltd. (SIIPL) and PATH; and with funding from the Bill & Melinda Gates Foundation, the vaccine is expected to provide protection for children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries.

Prequalification allows PNEUMOSIL® to be procured by United Nations agencies and Gavi, the Vaccine Alliance. This news marks an important milestone toward alleviating one of the biggest barriers – price - towards sustainable access to pneumococcal conjugate vaccine that countries face.3.

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2 https://pib.gov.in/PressReleseDetail.aspx?PRID=1598717

3 https://www.seruminstitute.com/news_pneumococcal.php


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US FDA Pharma Highlights January 2020

This section of the newsletter discusses recent drug approvals from U.S. Food and Drug Administration (USFDA) for various serious diseases. The section outlines the role of new drugs in the treatment of serious diseases such as cancer, heart disease and use of tobacco products. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

1. US FDA approved Ayvakit for treatment of rare mutation disease1

US FDA had approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to remove with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach or small intestine. Ayvakit is a kinase inhibitor, blocking an enzyme called a-kinase and helps keep the cancer cells from growing. FDA has given the approval to Blueprint Medicines Corporation.

2. US FDA approves first generics of Eliquis2

US FDA had approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. The FDA granted approval of the generic apixaban applications to Micro Labs Limited and Mylan Pharmaceuticals Inc.

3. US FDA finalizes enforcement policy against certain unauthorized flavored e-cigarettes3

USFDA has issued a policy prioritizing enforcement against certain unauthorized flavored, including fruit and mint flavored e-cigarette products that appeal to kids. . The final guidance outlining the agency’s enforcement priorities for electronic nicotine delivery systems (ENDS), such as e-cigarettes and e-liquids, came as the 2019 National Youth Tobacco Survey (NYTS). Cartridge-based ENDS products are a type of ENDS product that consists of or involves a cartridge or pod that holds a liquid that is to be aerosolized when the product is used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product.

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1 https://www.fda.gov/news-events/press-announcements/fda-approves-first-targeted-therapy-treat-rare-mutation-patients-gastrointestinal-stromal-tumors

2 https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-eliquis

3 https://www.fda.gov/news-events/press-announcements/fda-finalizes-enforcement-policy-unauthorized-flavored-cartridge-based-e-cigarettes-appeal-children

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WHO Pharma Highlights January 2020

This segment of the newsletter focuses on sharing the recent regulatory reforms and updates on Healthcare and Pharmaceutical domain from World Health Organization (WHO). This segment collates information periodically via conducting research and review of pharmaceutical updates from the WHO. Below are the highlights for the month of January 2020:

1. WHO revision of pain management guidelines1

On January 13, 2020, WHO has given a brief information on revision of its pain management guidelines. The WHO Secretariat is currently developing proposals for the guidelines for further submission to the WHO Guideline Review Committee (GRC). The GRC will consider the proposals, which include the scope of each guideline as well as the questions that will inform the recommendations that will be contained within the guidelines. The revision of the policy was done in order to reduce the complexities in managing chronic pain which results due to complex interaction between various biological, psychological and social factors.

2. WHO launches new report on Global Tobacco use trends2

WHO’s new report reveals that the number of males using tobacco has declined in the past years stating that government policies are effectively working to protect public from the damages caused by tobacco. The report titled Global Tobacco Report stated that government actions are protecting communities from tobacco and saving lives of people suffering from tobacco-related harm. Another key finding of the report states that approximately 43 million children (aged 13-15) used tobacco in 2018 and about 244 million women were using tobacco.

3. WHO organized the 23rd meeting of the Emergency Committee regarding the international spread of Poliovirus3

The twenty-third meeting of the Emergency Committee under the International Health Regulations (2005) (IHR) regarding the international spread of poliovirus was convened by the Director General on December 11, 2019, at WHO headquarters with members, advisers and invited Member States attending via teleconference, supported by the WHO secretariat.

4. Lack of new antibiotic development an alarming reason to combat drug-resistant infections4

Lack in the development of new antibiotics is undermining efforts to combat drug-resistant infections, says the World Health Organization (WHO). The reports - Antibacterial agents in clinical development – An analysis of the antibacterial clinical development pipeline and its companion publication and Antibacterial agents in preclinical development - also found that research and development for antibiotics is primarily driven by small- or medium-sized enterprises with large pharmaceutical companies continuing to exit the field.

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1 https://www.who.int/news-room/detail/13-01-2020-update-who-revision-of-pain-management-guidelines

2 https://www.who.int/news-room/detail/19-12-2019-who-launches-new-report-on-global-tobacco-use-trends

3 https://www.who.int/news-room/detail/07-01-2020-statement-o-the-twenty-third-ihr-emergency-committee-regarding-the-international-spread-of-poliovirus

4 https://www.who.int/news-room/detail/17-01-2020-17-01-2020-lack-of-new-antibiotics-threatens-global-efforts-to-contain-drug-resistant-infections

Vol. I, Issue I

January 2020Vol. IV, Issue I

S&A PHARMANEWSLETTER

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