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EDITOR'S EMULSION
Warm Greetings!
Welcome to yet another exciting month and pleasant reading of our newsletter.
Over the last 30 years, India’s disease burden has changed dramatically — child mortality has dropped, people are living longer lives and fewer people live in extreme poverty. We are still falling short of the funding levels required to ensure healthcare for all. There is a need to invest in strategies that focus on the entire circle of healthcare —from prevention to management and overall health behaviour change.
Lest we forget, we always remain at the risk of diseases making a comeback unless we continue to adapt our responses. Only by committing ourselves to funding health innovation in the long term will India be able to realise today’s most urgently-needed solutions, and lay the groundwork for the breakthroughs we cannot yet imagine.
Do not hesitate to mail your comments on this edition to help us further improve so please feel free to get in touch with us. You may find our previous issues on our website jagograhakjago.com or in the NEWS ARCHIVE section of every issue of The Prescription, in case you’ve missed any of them. You may also look us up on Facebook.
Stay Healthy. Stay Protected.
Pyush Misra
Editor-in-Chief
DOSE OF THE DAY
Indian pharma cos need to focus on innovation & complex generics. Open up pharma market, it will be win-win for Indian companies. There is relatively more stability in the market but it is very difficult to say that it is over as far as Indian companies are concerned. We have approached the government to set up dedicated funds to boost innovation and startups in the pharma space in India.
Mr. Sudarshan Jain
Secretary-general, IPA
Indian Pharmaceutical Alliance
Sponsor
PSM India Capsules
Indian Excipient Industry To Approach DCGI To Curb Irrational Usage Of Excipients In Domestic Market
Mumbai, 22 Nov 2019: The Indian excipient industry is planning to approach the Drugs Controller General of India (DCGI) to frame India specific guidelines to curb irrational usage of excipients in the domestic market. There cannot be dual set of specifications and guidelines for the international and domestic market in a scenario where 70 per cent of excipients are imported, industry experts pinpoint.
Niti Aayog Has Not Rejected Proposal To Bring Medical Devices Under CDSCO: Govt
NEW DELHI, 20 NOV 2019: The NITI Aayog has not rejected the proposal to bring medical devices under the Central Drugs Standard Control Organisation (CDSCO), the government informed Parliament on Tuesday. The CDSCO under the Ministry of Health regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.
Drug Laws & Policy Injections
Punjab Private Centres To Be Charged CADA Cess On BuprenorphineCHANDIGARH, 22 NOV 2019: The Punjab government will impose Punjab State Cancer and Drug Addiction Treatment Infrastructure Fund Act (CADA) cess on supply of buprenorphine to private drug de-addiction centres. Other than the cess, government will not be charging anything extra for the supply of the medicine.
Alternative Methods For Anti-Venom Production Costly, Take More Time, Firms Tell HC New Delhi, 21 Nov 2019: Companies manufacturing anti-venom and anti-toxins by using horses and mules have told the Delhi High Court that exploring alternatives to the practice, as sought by PETA in a PIL, will take time, cost more and have "catastrophic consequences" as such drugs may not be available in the interim.
Compliance Is The Main Mantra For Regulators: Maharashtra FDA CommissionerMumbai, 22 Nov 2019: “Compliance is the main mantra for regulators,” said Dr Pallavi Darade, Commissioner, Food and Drug Administration, Government of Maharashtra.
Centre Approves Proposal To Set Up Bulk Drug Park In HPNew Delhi, 21 Nov 2019: The central government has given in-principle approval for a proposal to set up bulk drug park in Himachal Pradesh, a state industries department official said on November 21. The proposal had been received from State Industrial Development Corporation Limited Solan, he added.
Risks From Pharma Residue In Water Unassessed: OECDMUMBAI, 19 NOV 2019: Risks from pharmaceutical residues entering the environment are not being assessed thereby endangering freshwater ecosystems. According to a report released by OECD, majority of about 2,000 active ingredients used in human and veterinary pharmaceuticals, have never been evaluated for environmental risks. Several dozen new active ingredients are typically approved for use every year.
Govt To Initiate Talks With Stakeholders On Drug Trade MarginsNew Delhi, 20 Nov 2019: The government will initiate discussions on the contentious issue of Trade Margin Rationalisation (TMR) on drugs and medical devices with the stakeholders in a meeting slated to be held on Friday. The Department of Pharmaceuticals (DoP) along with the Drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA) will discuss the issue of TMR with the stakeholders, in an effort to reduce prices of medicines and medical devices.
Pharma Injections
Gujarat HC Quashes Proceedings Against Pharma Companies Due To Delay By Drug InspectorsAhmedabad, 22 Nov 2019: The medicines were found substandard and spurious, but the pharma companies had to be let off because of lassitude on part of government’s drug inspectors who delayed the procedure for so long that the shelf life of the medicines got over and the re-testing of the drugs was not possible.
A Protein That Has Potential To Tackle DiabetesHyderabad, 21 Nov 2019: The scientists at CSIR-Centre for Cellular and Molecular Biology (CCMB) have discovered a protein that helps manage insulin levels thereby showing the potential to tackle diabetes and neuro-degenerative disorders like dementia and Alzheimers.
Gujarat FDCA In Association With DIA, US FDA, EMA & EDQM Rolls Out Series Of Workshops On API Regulations Mumbai, 20 Nov 2019: In order to understand how supply chain affects compliance of active pharmaceutical ingredients (API) and finished product quality, the Gujarat FDCA in association with Drug Information Association (DIA), US Food and Drug Administration (FDA), European Medicine Agency (EMA) and European Directorate for Quality of Medicine and Healthcare (EDQM) have jointly rolled out a series of workshops from November 18 to November 22, 2019 themed ‘Quality and supply chain integrity’ to help manufacturers and regulators understand the quality and regulatory requirements of APIs.
Punjab Govt To Relax Conditions For Sale Licenses Introduced As Part Of Amended Drug Policy 2019 Chennai, 20 Nov 2019: The government of Punjab has accepted the demands of the state chemist and druggist association (PCA) and relaxed the conditions for sale licences introduced as part of the Amended Drug Policy (ADP) 2019.
RMPs Told Not To Use ‘Clinic’, ‘Hospital’ Or Suffix ‘Dr.’ Hyderabad, 19 Nov 2019: Illegal practices by quacks or rural medical practitioners (RMPs) in the district have come under the scanner. The District Medical and Health Officer (DMHO) has served notices on over 25 RMPs not to use the words ‘clinic’, ‘hospital’, or suffix ‘Dr’ on the boards placed outside their establishments and instead use ‘first aid centre’.
CDSCO Mandates Processing Of Applications Of Non-Notified Medical Devices Through Sugam Portal Mumbai, 19 Nov 2019: The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers and state drug controllers (SDCs) to process applications of non-notified medical devices through SUGAM portal. This is applicable to products approved as medical devices which as of today comes under the ambit and definition of drug.
Drug Dopes
Unlicensed Cosmetic Products Found At E-Biz Site’s GodownMUMBAI, 19 NOV 2019: A raid by the state Food and Drug Administration (FDA) on the Bhiwandi warehouse of Nykaa, an e-commerce site for beauty products, on Friday led to the seizure of cosmetics manufactured by an unlicensed firm named Bellezza Italia which is based in Virar. 
Punjab: Tuberculosis Diagnosed As Cancer, Lab FinedCHANDIGARH, 20 NOV 2019: Wrongly diagnosing a bank manager with lung cancer instead of tuberculosis (TB) is going to cost a private laboratory Rs 2.15 lakh.
Agra Smart City Health Lab To Conduct 700 Tests For Up To 80% Lower Rates Agra, 17 Nov 2019: Equipped with advanced machines, a central health laboratory developed under the Agra smart city project with an investment of Rs 4.80 crore officially started working on Saturday. Mayor Naveen Jain inaugurated the facility and dedicated it for better health care of the people of Agra. He also got his blood test conducted at the laboratory and received the result within two minutes.
NPPA Fixes Retail Prices Of 12 Formulations Mumbai, 19 Nov 2019: The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 12 formulations under Drugs Prices Control Order (DPCO) -2013 based on 70th Authority meeting held on October 30, 2019.
Illegal Cancer Drugs From B’desh Flood Local Market Mumbai, 18 Nov 2019: It’s not just import of raw materials (active pharmaceutical ingredients, or APIs) from China that is giving sleepless nights to domestic pharma companies. Now, “illegal” import of drugs from Bangladesh and other neighbouring countries have added to their worries. These not only impact revenues but, more importantly, pose a risk to patients.
Superbugs Get Tough, 25% Patients In Mumbai Resistant To Strong AntibioticsMUMBAI, 17 NOV 2019: Here’s an indication that superbugs—microorganisms that can’t be killed easily by medicines—are gaining strength in Mumbai. Almost 25% of patients tested showed resistance to one of the high-potency antibiotics called flouroquinolones.
National Injections
Telangana To Use Blockchain To Deal With Spurious Drugs Hyderabad, 18 Nov 2019: Telangana, which successfully used blockchain’s distributed ledger technology for bringing reforms into land registrations, will shortly start two pilots. This time, it will focus on vehicle life-cycle management and to deal with counterfeits in drugs and medicines, said IT Principal Secretary Jayesh Ranjan.
DCGI Clarifies On Applicable Environmental Conditions For Equipment Regulated From Next YearMumbai, 18 Nov 2019: The Drugs Controller General of India (DCGI) has clarified that the environmental conditions as per Medical Devices (MD) Rules, 2017 will be applicable for the equipment which are to be regulated from next year.
SeeTB: New Diagnostic Tool For Detecting Tuberculosis New Delhi, 16 Nov 2019: Accounting for over a million deaths in 2018, tuberculosis (TB) remains a major healthcare burden for most developing countries, and India still leads the list with the largest number of cases. “The World Health Organization has aimed at eliminating TB by 2035, and the Indian government has vouched to do this by 2025.
New Strict Surrogacy Bill On The Anvil, Clinics Shut Shop Mumbai, 16 Nov 2019: Shutters are coming down on surrogacy in India, with several fertility clinics across Mumbai, Hyderabad and New Delhi refusing fresh cases as the new Surrogacy (Regulation) Bill, 2019, is set to be tabled in Rajya Sabha during winter session starting November 18. Lok Sabha has already passed the Bill.
Will E-Pharmacy Regulation See The Light Of Day? Mumbai, 10 Nov 2019: A group of ministers led by Union Minister Rajnath Singh met on October 30 to discuss and finalise a framework to regulate e-pharmacies in the country. Other ministers in the meeting were Minister of Health and Family Welfare Dr Harsh Vardhan, Minister of Commerce and Industry Piyush Goyal and Minister of Jal Shakti Gajendra Singh Shekhawat.
Marg ERP To Launch New Software ‘New Marg’ Mumbai, 16 Nov 2019: Marg ERP, a leading software application provider in Goods and Service Tax (GST), is looking to add 2.5 lakh plus chemist shops to be computerized in the next three years. The company is also planning to launch new software ‘New Marg’, which will focus on pharma retail and cater to their specific requirements.
Global Injections
Health Canada Creates New Medical Devices DirectorateOttawa, 22 Nov 2019: In a letter to stakeholders late Thursday, Health Canada announced the creation of a new Medical Devices Directorate to better respond to the challenges and opportunities related to the growing medical device industry.
China Plans To Add More Drugs To Price-Slashing Bulk-Buy ProgramBEIJING, 20 NOV 2019: China will add more drugs to its bulk-buy program in an effort to curb high medicine prices, the country's cabinet said, in a move that could increase downwards price pressure on multinational pharmaceuticals' off-patent established products.
Individuals Exposed To CT Scan Radiation Prone To Thyroid Cancer, Leukemia
Washington D.C., 19 Nov 2019: Individuals exposed to the radiation emanating from a CT scan are at an elevated risk of developing thyroid cancer and leukemia, a new study says.
Revamped HIV Guidelines Focus On Drug–Drug Interactions
BASEL, Switzerland, 13 Nov 2019: Updated guidelines from the European AIDS Clinical Society (EACS) suggest dual therapy with dolutegravir and lamivudine as an alternative option to triple therapy for the initial treatment of HIV.
US FDA Enhances Postmarket Drug Safety Surveillance Practices
Maryland, 8 Nov 2019: Janet Woodcock MD, director of FDA’s Center for Drug Evaluation and Research, issued a statement on Nov. 6, 2019 detailing efforts to strengthen the agency’s postmarket drug safety surveillance practices.
To Cut Insulin Prices, WHO To Certify Generic Versions
Geneva, 15 Nov 2019: With insulin prices skyrocketing and substantial shortages developing in poorer countries, the World Health Organization said on Wednesday that it would begin testing and approving generic versions of the drug.
PSM PILL
Canadian Doctors, Pharmacists, Patient Groups And Government Representatives Consider State Importation Proposals Unfeasible
November 21, 2019: In spite of recent efforts by legislators in Florida, Maine, Colorado, and elsewhere, Canadian patient groups are vocally opposing pending legislation that proposes importing prescription medications from the Canadian drug supply. Paul Blanchard of the New Brunswick Pharmacists’ Association told CBC News, “The country’s pharmacists association has been talking to the federal government … to make sure that the federal government and Canada is aware that the Americans are literally knocking on our door.”
Florida Couple Prosecuted For Selling Fake Botox Wholesale
November 13, 2019 : 2019 Infosheet for incidents of counterfeit drugs in Florida NBC Miami reports that a married couple, Jorge Nogueira and Jessyka Molina have been charged with selling bulk counterfeit Botox and other cosmetic pharmaceuticals via their website business Therapmedic. According to NBC Miami, the investigation of Nogueria and Molina was initiated by the Food and Drug administration in March 2018.
Frequently Asked Questions
What Antibiotics Can and Can't Do
Only bacterial infections can be killed with antibiotics. The common cold, flu, most coughs, some bronchitis infections, most sore throats, and the stomach flu are all caused by viruses. Antibiotics won’t work to treat them. Your doctor will tell you either to wait these illnesses out or prescribe antiviral drugs to help you get rid of them.
It’s not always obvious whether an infection is viral or bacterial. Sometimes your doctor will do tests before deciding which treatment you need.
Some antibiotics work on many different kinds of bacteria. They’re called “broad-spectrum.” Others target specific bacteria only. They’re known as “narrow-spectrum.”
SUBSCRIBER'S SYMPTOM
Kochi: Case Against Chemist For Denying Drugs To Girl
KOCHI, 20 NOV 2019: A case has been filed against a medical shop at Keecheri, Kanjiramattom, for not providing medicines free of cost under the state government's Arogyakiranam scheme.
Blog Addicts
Mr Prakash Gosain, MD Very good e-newsletter that is interesting and enjoyable to read.
Ms Disha Singh, Pharma expertAll the editions I have read so far are extremely insightful and capture the events in the Pharma world very well. Keep up the good work.
Mr Manohar Bhatt, MBBS
Like to read articles in the publications that are sent twice every month. Congrats to the Prescription team.
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