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Vol. I, Issue I

December 2019Vol. III, Issue XII

S&A PHARMANEWSLETTER

E-337, East of KailashNew Delhi - 110065, INDIA

GURUGRAM7th Floor, ABW Tower, MG Service RoadSector 25, IFFCO Chowk, GurugramHaryana - 122001, INDIA

BENGALURUUnit No. 101, 10th Floor Sakhar Bhavan, Plot No. 230Ramnath Goenka MargNariman Point, Mumbai - 400021, INDIA

Condor Mirage, 101/1, 3rd FloorRichmond Road, Richmond TownBengaluru - 560025, INDIA

[email protected]

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

The regulatory body of any country shall be the strongest body as it is responsible in tak-ing all necessary action in its jurisdiction to maintaining the quality of the drug during its research, manufacturing and distribution. It plays an important role in running the health care system of the country. Any amendments made in acts and regulatory guide-lines should be placed on the public domain to make an easy access of such amendments and guidelines to public and various stakeholders dealing with drug manufacturing.

We are pleased to present this Vol. III Issue XII 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 infor-mation collated through research and appraisal of applicable statutory provisions.

In the present issue, we start with development of validated herbal product NBRMAP-DB by Council of Scientific and Industrial Research (CSIR) for treatment of diabetes. Going ahead the volume mentions recent development of a drug by Mankind Pharma for treat-ing infertility in India. Moving further, the current volume discusses the increase in the ceiling price of the essential medicines due to increase in price of active pharmaceutical sourced from China. The issue then describes the release of the National Action Plan for Drug Demand Reduction by the government to lessen the adverse consequences of drug abuse primarily focusing on the youth population through a multi-pronged strategy.

The volume also discusses on recent Healthcare updates from India presented as a sepa-rate section under ‘India HealthCare Highlights December 2019’.

From the international arena, a separate section which discusses on recent regulatory up-dates from US FDA and WHO are also discussed under the heading ‘US FDA Pharma Updates December 2019’ and ‘WHO updates December 2019’ 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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SINGH & ASSOCIATES ADVOCATES & SOLICITORS

NEW DELHI E-337, East of KailashNew Delhi - 110065 INDIA GURUGRAM7th Floor, ABW Tower, MG Service RoadSector 25, IFFCO Chowk, Gurugram Haryana - 122001 INDIAMUMBAI Unit No. 101, 10th Floor Sakhar Bhavan, Plot No. 230Ramnath Goenka MargNariman Point, Mumbai - 400021, INDIA, BENGALURU Condor Mirage, 101/1, 3rd FloorRichmond Road, Richmond TownBengaluru - 560025, INDIA

Ph: +91-11-46667000Fax: +91-11-46667001

Email: [email protected]: www.singhassociates.in

All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means without the prior permission in writing of Singh & Associates or as expressely permitted by law. Enquiries concerning the reproduction outside the scope of the above should be sent to the relevant department of Singh & Associates, at the address mentioned herein above.

The readers are advised not to circulate this Newsletter in any other binding or cover and must impose this same condition on any acquirer.

For internal circulation, information purpose only, and for our Clients, Associates and other Law Firms.

Readers shall not act on the basis of the information provided in the Newsletter without seeking legal advice.

All ©Copyrights owned by Singh & Associates S&A Pharma Newsletter

Volume III, Issue XIIDecember 2019

2019 © Singh & Associates

www.singhassociates.in


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Managing Editor Manoj K. Singh

Published by Singh & Associates

Advocates and SolicitorsC

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ts1. CSIR Develops Anti-diabetes Medicine 04

2. Government’s first National Policy to Tackle Drug Abuse 05

3. NPPA revises price of 21 essential medicines under Drugs (Prices Control) Order 07

4. Mankind Pharma launches infertility treatment drug in India 13

5. India Healthcare Highlights December 2019 14

6. USFDA Pharma Highlights December 2019 15

7. WHO Pharma Highlights December 2019 16

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CSIR Develops Anti-diabetes Medicine

On December 06, 2019, the Council of Scientific and Industrial Research (CSIR), announced the development of a scientifically validated herbal product NBRMAP-DB as anti-diabetic formulation. This anti-diabetic formulation was developed by two Lucknow based CSIR laboratories - Central Institute of Medicinal & Aromatic Plants (CSIR-CIMAP) and National Botanical Research Institute (CSIR-NBRI). Its manufacturing and marketing rights have been assigned to M/s AIMIL Pharma Ltd., Delhi, who will commercialize the anti-diabetic formulation, as BGR-34, across the country.

AIMIL Pharmaceuticals has carried out the clinical study of BGR-34 (CTRI/2016/11/007476) at Banaras Hindu University (BHU), Varanasi. The study has shown therapeutic efficacy for treating newly diagnosed type 2 diabetes.

Diabetes control and regulation through Ayurveda formulationsThe Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under Ministry of AYUSH, has been engaged in research in Ayurveda for the management of Madhumeha (Diabetes Mellitus). Following are the core activities of CCRAS:

1. CCRAS in collaboration with the Directorate General of Health Services, Ministry of Health & Family Welfare (MoHFW), has implemented and executed a programme called NPCDCS (National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases & Stroke), which was launched in 2016 in three districts in 3 states - Bhilwara in Rajasthan, Surendranagar in Gujarat and Gaya in Bihar to cater health care services and to reduce the burden of NCDs, including Diabetes, by combining the strength of Ayurveda and Yoga. At present, the programme is successfully functional in 52 centres (49 CHCs and 3 District Hospitals) at the 3 identified districts, through AYUSH- NPCDCS Clinic/Lifestyle modification Clinics.

2. CCRAS had also developed the AYUSH82 formulation for diabetes management through scientific process of drug development and commercialized through National Research Development Corporation (NRDC) for wider public utility.

3. CCRAS has conducted various efficacy & safety trials of classical Ayurveda formulation on Diabetes Mellitus - Nishamalki churna, Saptvinsti Gugullu, Yasad bhasm, Guduchi churna, Chandraprabha vati, Haridra churna anmd Gokshuradi Gugullu.

4. Apart from this CCRAS is also involved in spreading diabetes awareness to the public via publishing informative documents on regular basis1.

Ayurveda drug development and regulation in countryThe commercial manufacturing of Ayurvedic medicines is regulated by Central and State governments. Manufacturers have to take prior licenses from their respective State Drug Controlling Authority for running an Ayurvedic Pharmacy business. Ayurveda formulations, whether traditional or patented proprietary medicine, need a clearance from the competent authority before starting any commercial manufacturing.

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1 https://pib.gov.in/PressReleseDetail.aspx?PRID=1595264


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Government’s first National Policy to Tackle Drug Abuse

On December 03, 2019, the Ministry of Social Justice and Empowerment has released a ‘National Action Plan for Drug Demand Reduction (NAPDDR)’ for the period 2018-2025. The aim of NAPDDR is to lessen the adverse consequences of drug abuse primarily focusing on the youth population, through a multi-pronged strategy which includes organizing awareness camps in schools/colleges/universities, workshops/seminars/ with parents, community based peer-led interactions, intervention programmes for vulnerable adolescent and youth in the community, provisioning of treatment facilities and capacity building of service providers.

The ministry also implements a “Central Sector Scheme of Assistance for Prevention of Alcoholism and Substance (Drug) Abuse” which offers a financial assistance to eligible Non-Governmental Organizations (NGOs) for running Integrated Rehabilitation Centres for Addicts and to offer composite/integrated services for the rehabilitation of addicts including adolescents1.

A National Survey on ‘Extent and Pattern of Substance Use 2018’ has reported the prevalence percentage and estimated population of various psychoactive substances users as given in a table below:

Substance Children & Adolescents (10-17 years) Adults (18-75 years)Prevalence (%) Estimated no. of users Prevalence (%) Estimated no. of users

Alcohol 1.30 30,00,000 17.10 15,10,00,000Cannabis 0.90 20,00,000 3.30 2,90,00,000Opioids 1.80 40,00,000 2.10 1,90,00,000Sedatives 0.58 20,00,000 1.21 1,10,00,000Inhalants 1.17 30,00,000 0.58 60,00,000Cocaine 0.06 2,00,000 0.11 10,00,000ATS 0.18 4,00,000 0.18 20,00,000Hallucinogens 0.07 2,00,000 0.13 20,00,000

The report presents its major findings in two groups ranging 10-17 years and 18-75 years using eight categories of substances and estimated the proportion of affected users by substance use disorders. The report highlights that Alcohol is the most commonly used psychoactive substance followed by Cannabis and Opioids in India.

National Crime Record Bureau, under the Ministry of Home Affairs, has informed that a total number of 874, 750 and 778 people have died during 2014, 2015 and 2016 respectively, due to drug overdose in the country. Out of the total 543, 493 and 471 people between the age group of 14 and 45 have died during 2014, 2015 and 2016 respectively2.

Note - In India, the Narcotic Drugs and Psychotropic Substances (NDPS) Act (1985) provides the current framework to regulate drug abuse in the country. The Act empowers Central Government (Government of India) to take necessary measures for identification, treatment, aftercare, rehabilitation of addicts and preventive education, and also empowers to establish, maintain and regulate treatment centres.

Apart from the NDPS Act and Ministry of Social Justice and Empowerment, there are various ministries which play major role in drug abuse regulation in the country - the Ministry of Health and Family Welfare, the Ministry

1 https://pib.gov.in/newsite/PrintRelease.aspx?relid=195345


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of Welfare and the Ministry of Human Resource Development (Department of Youth Affairs, Education) and Information and Broadcasting. However, India being a federal state, a large number of responsibilities also lie with the State governments3.

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3 https://www.unodc.org/documents/india/ddch6.pdf


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NPPA revises price of 21 essential medicines under Drugs (Prices Control) Order

On December 13, 2019, the National Pharmaceutical Pricing Authority (NPPA) has upwardly revised the ceiling prices of 21 essential medicines including Bacillus Calmette–Guérin (BCG) vaccine, anti-malaria drug - Chloroquine, anti-leprosy drug - Dapsone, the antibiotic - Metronidazole, and vitamin C among others.1

The government’s decision to increase the ceiling price of essential medicines was due to a sharp rise prices of active pharmaceutical ingredients (APIs) imported from China. As a result the pharmaceutical companies urged the government to look into the matter of price regulation since the existing price ceiling of the medicines was not enough to meet the rising cost of API, cost of production, exchange rates etc.

Background In the 62nd meeting of the NPPA, manufacturers forwarded an application to the authority requesting price change of 72 formulations seeking upward revision of ceiling price. In the 65th meeting, a committee was formed comprising Adviser DGHS and Deputy Drug Controller, DCGI under the convenorship of Director (Pricing), NPPA for examining the cases under Drug Price Control Order. In the second meeting of the standing committee on affordable medicines and health products (SCAMHP) it was decided that repeated increase in the ceiling price of the medicines is not feasible in the interest of public health. Hence, to make drugs available to public without causing any harm to their health, and as an exceptional measure in the public interest as advised by SCAMHP, the price of the medicines was revised upwards by 50% from the present ceiling price. To make such a revision, NPPA used its extraordinary power in public interest under para 19 (which states that both the versions of scheduled formulations at a price higher than the ceiling price plus local taxes as applicable so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price )2 of DPCO 2013 for upward revision of the ceiling prices of the twenty one scheduled formulations of 12 drugs by giving one time increase of 50% from the present ceiling price.3

The list of essential medicines included under revised ceiling price are Bacillus Calmette–Guérin (BCG) vaccine, anti-malaria drug Chloroquine, anti-leprosy drug Dapsone, the antibiotic Metronidazole, vitamin C etc. Following the hike, the price of a BCG vaccine now will be capped at ₹8.75 per dose, while it will now cost up to ₹1.16 for a tablet of 150 mg chloroquine. A 400mg tablet of metronidazole will now be ₹1.25.

ConclusionIncrease in the price of the active pharmaceutical ingredients was a major concern since many pharmaceutical companies refused to manufacture essential medicines. Seeking to avert a major risk to public health, the government decided to revise the ceiling price of these essential medicines for final time to make it available to the public without causing any setbacks to the health sector.

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1 http://www.nppaindia.nic.in/wp-content/uploads/2019/12/Notification_English_with-SO.pdf

2 https://upload.indiacode.nic.in/showfile?actid=AC_PB_82_966_00012_00012_1556080598458&type=notification&filename=dpco2013.pdf

3 http://www.nppaindia.nic.in/wp-content/uploads/2019/12/Notification_English_with-SO.pdf

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

Recently, Singh & Associates team congregated to celebrate its maiden Annual Day termed “Spectrum” on Dec. 20 2019 at The Oberoi, Gurugram.

Just as the name suggests, Spectrum signifies the diversity of professionals, many accomplishments, and varied services at Singh & Associates. The event was aimed to share long-term vision with the colleagues, providing them with an outline of milestones accomplished, and perspective of where the firm is heading to. The event was also our way of high-fiving every one of our colleagues who helped the firm to get where we are today.

Welcoming the colleagues, Mr. Manoj K Singh, Founding Partner, S&A, delivered the opening address and took us briefly through the S&A journey starting from one room and a team of two back in 2002. Growing multi-directionally, S&A is now amongst the leading law firms, staffed by a team of over 150 professionals with a strong core. He mentioned the upshot is not the contribution of an individual but a team impact.

Ms. Gunita Pahwa, Joint Managing Partner, S&A, took us through the company deck and inspired the colleagues to continue the great work. She shared firm’s aspirations of becoming the front-runner in the industry and strengthening various practice groups through partnerships and collaborations.

Mrs. Daizy Chawla, Managing Partner, Mr. Vijay K Singh, Senior Partner and others further enriched the audience with their thoughts, significant cases and its achievements.

To mark the occasion, star performers were applauded with awards for their noteworthy contribution. The true spirits and ideals of S&A were commemorated when Mr. Manoj struck up an open dialogue with the employees seeking their feedback. The event wrapped up with a dash of humour from one of the best stand-up comedians of the country.


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In Quest of Resolving Commercial DisputesArbitration is the preferred dispute resolution mechanism for resolving of commercial disputes

Recently, Singh & Associates (S&A) team gathered up to celebrate QUEST 2.0, a one-of-a-kind event, with the theme, “Arbitration - Legal Insights & Updates”, at The Oberoi, Gurugram. The event was organized in association with Knowledge Provider - EY Forensic & Integrity Services; and Magazine Partner - Legal Era. The stage was set for yet another hallmark event. Welcoming the delegates, industry leaders and other stakeholders, Gunita Pahwa, Joint Managing Partner, S&A, delivered the opening address saying, “QUEST has been conceptualised by S&A as a knowledge exchange series. QUEST 2.0 focuses on the role of arbitration and examines the ways forward. As the Indian economy and the dispute resolution mechanism are maturing so is the alternate dispute resolution mechanism.” The event was graced by Hon’ble Justice Mr. Dipak Misra, Former Chief Justice of India, as Chief Guest, in the presence of Hon’ble Justice Ms. Hima Kohli, Judge, Delhi High Court, as Guest of Honour, Dr. Lalit Bhasin, President of the Society of Indian Law Firms, and the Bar Association of India as Guest of Honour. The Keynote Speakers at the event included Mr. Neeraj Kumar, Group CEO & Whole-time Director, Jindal SAW Ltd.; Mr. Jawed Zia - Vice President, Established Pharmaceuticals, ABBOTT India and Mr. Arpinder Singh, Partner and Head - India and Emerging Markets, Forensics and Integrity Services, Ernst & Young.

Hon’ble Justice Mr. Dipak Misra, Former Chief Justice of India, as Chief Guest, said, “If a certain objection was not taken up in an arbitral tribunal or high court, the Supreme Court is not going to entertain the objection either in the petition.”

Dr. Lalit Bhasin, President of the Society of Indian Law Firms, and the Bar Association of India, as Guest of Honour said, “I can say with daring certainty that the book by Mr. Manoj Singh must be a brilliant piece of work, for the reason that I know the author’s competence and knowledge in the field.”

Highlighting the recent developments in Arbitration, Mr. Neeraj Kumar, Group CEO & Whole-time Director, Jindal SAW Ltd, delivered the Keynote Address said, “Arbitration should be the first port-of-call for any commercial dispute resolution at a first stage”

Jawed Zia, Vice President, Established Pharmaceuticals, ABBOTT India, addressed the gathering saying, “Pharmaceutical Industries faces complex and high-value disputes in everyday dealings many of which are resolved through Arbitration process effectively.”

Hon’ble Justice Mr. Dipak Misra, Former Chief Justice of India, as Chief Guest, and Dr. Lalit Bhasin, President of the Society of Indian Law Firms, and the Bar Association of India as Guest of Honour, unveiled the book, Infrastructure Arbitration: A Perspective, authored by Manoj K Singh, amidst a round of applause from the audience

The first Panel Discussion session, on ‘Recent judicial development in Arbitration’, included the Panellists - Manish Lamba, Senior VP Legal, DLF Cyber City Developers Ltd; Sanjeev Gemawat, Executive and Director, Dalmia Bharat Group; Atulya Sharma, Director Legal, Max Healthcare; Neeti Sachdeva, Secretary-General & Registrar at Mumbai Centre for International Arbitration. The session was moderated by Manoj K Singh, Founding Partner, S&A. The imminent Panellists gathered at Panel 1 exchanged their experience and thoughts on recent legislative and judicial trends and developments with respect to Arbitration and Conciliation Acts.

The second Panel Discussion, on ‘Role of Expert witness and importance in Arbitration’, included the Panellists - Parvesh Kheterpal, GC (Head Legal & CS), Feedback Infra Group; Sameer Chugh, Group General Counsel at Bharti Airtel; Sameet Gambhir - Joint VP (CS) at DCM Shriram Ltd; Sudhir Narang, GM, Contract Management, Hitachi India; and Arcoprovo Mitra - EY Partner Forensics. The session was moderated by Manoj K Singh, Founding Partner, S&A. In Panel 2, imminent Panellists gathered to discuss the role and importance of an expert witness in arbitration proceedings

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Mankind Pharma launches infertility treatment drug in India

On December 5, 2019, Mankind Pharma launched its generic drug - Dydrogesterone tablet for treatment of infertility and pregnancy related complications in the Indian market.1

BackgroundInfertility has a common problem prevailing in present generation due to sedentary lifestyle, stress and other factors contributing to it. Infertility may result from an issue with either partner, or a combination of factors that prevent pregnancy. The main symptom of infertility is not being able to conceive. Sometimes there may be no other obvious symptom. Or a woman suffering from infertility may have irregular or absent menstrual periods. In some cases, a man with infertility may have some signs of hormonal problems, such as changes in hair growth or sexual function.

These factor raises concern among health leaders and various pharmaceutical companies to come up with an innovative treatment option for treating infertility. Fortunately, there are many safe and effective therapies that significantly improve chances of conception. Mankind Pharma has recently launched its generic Dydrogesterone tablets for treatment of infertility and pregnancy related complications in the Indian market. According to the source information, with this launch Mankind Pharma has become the first Indian and second global firm to develop the drug. The medicine is a generic version of Abbott’s Duphaston tablets.

The manufacturing process of Dydrogesterone is very complex as it involves conversion of natural progesterone, the statement said. Progesterone is a natural hormone involved in menstrual cycle, implantation and in successful maintenance of pregnancy. Any deficiency of progesterone during different stages of reproductive process can cause infertility, menstrual disorders and miscarriage, it added.

ConclusionInfertility is raising alarm for pharmaceutical companies and other health leaders to come up with some preventive measures for mitigate the problem. With the launch of the drug for infertility, Mankind Pharma is able to produce a drug globally for patients undergoing infertility treatment.

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1 https://www.mankindpharma.com/media/press-release/mankind-pharma-launches-drug-for-treatment-of-infertility-in-india

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India Healthcare Highlights December 2019

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.

Cabinet approves MoU between CDSCO and Saudi Food and Drug AuthorityOn December 11, 2019, the Union Cabinet chaired by the Prime Minister has approved ex-post facto the Memorandum of Understanding (MoU) between Central Drugs Standard Control Organization (CDSCO) and Saudi Food and Drug Authority in the field of Medical Products Regulation. The MoU was signed on October 29, 2019, during Prime Minister Shri Narendra Modi’s visit to Saudi Arabia. The MoU is expected to facilitate better understanding of the regulatory aspects between the two sides and help in increasing India’s export of medical products to Saudi Arabia. It will also enable better coordination in international fora.1

India and Sweden sign Memorandum for India-Sweden Healthcare Innovation CentreThe India-Sweden Healthcare Innovation Centre, in collaboration between the Swedish Trade Commissioner’s Office and AIIMS Delhi and Jodhpur, aims to develop an ecosystem of open innovation that start-ups and the healthcare delivery stakeholders can use to collaborate and address current and future challenges in the healthcare sector. It will operate on well-defined services for stakeholders to build capabilities and methodologies and help socialize and scale up innovative solutions across the country’s healthcare delivery network. A holistic view of innovation shall be taken which shall include technology, data, protocols and processes, skill development and business models. The key components of this Centre to drive innovation are innovation challenges, incubation, and mentorship, live centre of excellence, skilling, global reach, conferences, digital showroom, white papers and support to access capital sources. This initiative will be in alignment with the Government of India’s Skill India and Start-up India initiatives, as well as the priorities agreed between India and Sweden for bi-lateral cooperation. The Innovation Centre’s objectives and strategic direction will be owned and driven by a pre-defined governance structure manned by representatives from all three collaborators. The Centre will run for an initial period of three years. Its impact will be assessed periodically to enable potential expansion at the end of the initial period of 3 years.2

DCGI mandates veterinary drug manufacturers to submit PSURs data as a condition for license grantOn December 02, 2019, the Drugs Controller General of India (DCGI) has directed veterinary drug manufacturers to submit Periodic Safety Update Reports (PSURs), as a condition for grant of approval, in accordance with Form 45 and Form 46 of the Drugs and Cosmetics (D&C) Act, 1940 and rules there under. The submission of PSURs is required to be submitted every six months for the first two years and then annually for subsequent two years in India as part of the ongoing Pharmacovigilance Programme of India (PvPI)3.

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1 https://pib.gov.in/PressReleseDetail.aspx?PRID=1594727#


3 https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTM0MQ==


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USFDA Pharma Highlights December 2019

This segment discusses the recent drug approvals from the United State Food and Drug Administration (USFDA). The write-ups cover the approval of a new drug in the treatment of serious conditions such as rare blood disorders, drugs to treat heart conditions etc. and also discusses the recall of substandard drugs. The US FDA is the one of the strictest regulatory body globally which takes care of health of the public by assuring the safety and effectiveness of the human drugs, medical devices and other products used and approved in the United States.

FDA approves first generics of GilenyaOn December 05, 2019, the USFDA approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. MS is a chronic, inflammatory, auto-simmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is amongst the most common causes of neurological disability in young adults and occurs more frequently in women than men. The FDA granted approvals of generic fingolimod applications to HEC Pharma Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited1.

FDA warns companies for offering unapproved umbilical cord blood products that may cause risk to the patientsOn December 06, 2019, the USFDA sent warning letters to two companies namely Liveyon Labs Inc. and Liveyon LLC, and their presidents and chief executive officers, for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination and deficient environmental monitoring. These deviations create potential significant safety concerns that put patients at risk. The companies’ unapproved products derived from umbilical cord blood are under the brand names PURE and PURE PRO. The agency also recently sent 20 letters to manufacturers and health care providers noting that it has come to USFDA’s attention that they may be offering unapproved stem cell products, reiterating the FDA’s compliance and enforcement policy2.

FDA authorizes first test to aid in newborn screening for rare genetic disorderOn December 12, 2019, the USFDA granted marketing approval for the first test to ‘GSP Neonatal Creatine Kinase-MM kit’ to aid in newborn screening for Duchenne Muscular Dystrophy (DMD) to PerkinElmer. DMD, while rare, is the most common type of muscular dystrophy. It is caused by an absence of dystrophin, a protein that helps keep muscle cells intact. The first symptoms are usually seen between 3 and 5 years of age and worsen over time. The disease often occurs in people without a known family history of the condition and primarily affects boys, but in rare cases it affect girls also. DMD occurs in about 1 in 3,600 male live-born infants worldwide. The GSP Neonatal Creatine Kinase-MM kit authorized today is intended to aid in screening newborns for DMD. Newborn screening is a series of tests to help health care professionals identify serious diseases and conditions shortly after birth3.

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1 https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-gilenya

2 https://www.fda.gov/news-events/press-announcements/fda-sends-warning-companies-offering-unapproved-umbilical-cord-blood-products-may- put-patients-risk

3 https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-test-aid-newborn-screening-duchenne-muscular-dystrophy

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WHO Pharma Highlights December 2019

This segment of the newsletter is focused on sharing the recent regulatory reforms and updates in 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 November 2019:

1. WHO demands raising efforts to reduce infections and deaths in pregnant women and children affected from malaria 1

1. According the WHO malaria report, the number of pregnant ladies and children protected from malaria in recent years has gone up but there is a need to for additional actions to reduce infections and deaths in the hardest-hit countries, as progress plateaus. According to reports, malaria reduces the immunity in pregnant women as well as in children, hence, proper measures are required to eradicate the disease from root level.

2. WHO received recommendations from health leaders for treating deadly non communicable diseases2

2. Global health leaders have sent 8 recommendations to WHO for treating non communicable diseases. The recommendations suggest that governments across nations should involve health department and introduce several programmes for preventing snon-communicable disease and mental illnesses.

3. WHO launches Online Training on Climate and Health in the UN climate negotiations3

3. In preparation of the COP25 UN Climate Negotiations, to be held in Madrid from December 01 to 13, 2019, the World Health Organization (WHO) has launched an online training course. The course is structured to give participants a good understanding of the UN climate change negotiations and the main topics being discussed at COP25 and beyond, as well as how to include the health aspects of climate change in the UN climate negotiations.

4. 25th UN Climate Conference to finalize rulebook for the Paris Agreement on climate change.

4. The 25th UN Climate Conference (COP25) will be a key occassion to finalize the rulebook for the Paris Agreement on climate change. It will have a strong focus on increasing climate ambition, strengthening the implementation of climate policy, and dealing with the climate change impacts the world is already experiencing.

1 https://www.who.int/news-room/detail/04-12-2019-more-pregnant-women-and-children-protected-from-malaria-but-accelerated-efforts-and- funding-needed-to-reinvigorate-global-response-who-report-shows

2 https://www.who.int/news-room/detail/10-12-2019-who-gets-new-advice-on-curbing-deadly-noncommunicable-diseases

3 https://www.who.int/news-room/detail/28-11-2019-who-launches-online-training-on-climate-and-health-in-the-un-climate-negotiationshttps:// www.who.int/news-room/detail/28-11-2019-5-key-actions-for-cop25-to-bolster-global-health


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notes

Vol. I, Issue I

December 2019Vol. III, Issue XII

S&A PHARMANEWSLETTER

E-337, East of KailashNew Delhi - 110065, INDIA

GURUGRAM7th Floor, ABW Tower, MG Service RoadSector 25, IFFCO Chowk, GurugramHaryana - 122001, INDIA

BENGALURUUnit No. 101, 10th Floor Sakhar Bhavan, Plot No. 230Ramnath Goenka MargNariman Point, Mumbai - 400021, INDIA

Condor Mirage, 101/1, 3rd FloorRichmond Road, Richmond TownBengaluru - 560025, INDIA

[email protected]

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