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EDITOR'S EMULSION
Warm Greetings!
Welcome to yet another exciting month and pleasant reading of our newsletter.
While shaping public health outcomes, the industry has contributed to India’s economic growth. Estimates suggest that the industry directly and indirectly provides employment to over 2.7 million people, in high-skill areas like R&D and manufacturing. The industry generates over USD 11 billion of trade surplus every year and is amongst the top five sectors contributing to the reduction of India’s trade deficit. The Indian pharmaceutical industry as attracted more than USD 2 billion in FDI inflows over the last three years, making it one of the top eight sectors attracting FDI.
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
“Generic drugs are just as safe and effective as their branded drug counterparts… Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits,”
23rd FDA commissioner Scott Gottlieb
Ex US Food and Drug Administration (USFDA) chief
Sponsor
PSM India Capsules
DCGI Clarifies On Implantable Medical Device
Mumbai, 13 Nov 2019: The Drugs Controller General of India (DCGI) has clarified on implantable medical device for its effective regulation as per new Medical Device (MD) Rules, 2017. In a notice, DCGI has defined implantable medical device as a medical device intended to be totally or partially introduced into the human or animal body or a natural orifice.
Around 6 Lakh Indians With TB Yet To Be Notified To National TB Programme: NGO
Benglauru, 9 Nov 2019: Swasti Health Catalyst has noted that around 600,000 Indians with TB are yet to be notified to the national TB programme, which means that they are most likely not even accessing the care they needed. The NGO sees that it will have serious implications on the Indian government’s End TB programme.
Drug Laws & Policy Injections
Regulator Waives Off Clinical Trials, Clears Sanofi TB DrugNEW DELHI, 4 NOV 2019: India’s drug regulator has approved Sanofi (India)’s new anti-tuberculosis drug rifapentine, waiving local clinical trials in a move to bolster efforts to prevent latent infections from progressing into active TB. “We have recently received final approval for rifapentine from the Indian regulatory authorities.
Patanjali's Plea To Set Up Unit In J and K Rejected Srinagar, 14 Nov 2019: The Jammu and Kashmir government has rejected the proposal of Baba Ram Dev-owned Patanjali Ayurved Limited for setting up a manufacturing unit worth Rs 1,007 crore in the newly created Union Territory.
Herbal Cancer Therapies Do More Harm Than Good: ExpertNew Delhi, 14 Nov 2019: A medical expert has said that cancer patients should tell doctors treating them about the herbal products they may be taking since some ingredients could affect their treatment. Maria Joao Cardoso, the head breast surgeon at the Champalimaud Cancer Centre in Lisbon, Portugal, said that there was no evidence that herbal therapies or creams worked. If in doubt, it is best not to take anything, she added.
Digital Thermometer, BP Monitoring Devices To Come Under Regulation From January 1, 2020Mumbai, 15 Nov 2019: In order to address misdiagnosis, the Central Drugs Standard Control Organisation (CDSCO) will bring devices like digital thermometer and blood pressure monitoring devices under regulation as per new Medical Device (MD) Rules, 2017 from January 1, 2020.
India Woos Japanese Medical Device CompaniesNew Delhi, 12 Nov 2019: The government is exploring all possibilities to attract Japanese investment in India’s medical devices sector, a move which is likely to reduce the country’s dependence on US manufacturers. Price curbs imposed on medical devices have irked US companies and become a key trade issue between Washington and New Delhi. Even as the US is sparring with India over this, the focus is now on fast-tracking investments from other countries, especially Japan, said people who are part of the discussions in the government.
NPPA Fixes Retail Prices Of 75 FormulationsMumbai, 14 Nov 2019: The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 75 formulations under Drugs Prices Control Order (DPCO) -2013 based on 70th Authority meeting held on October 30, 2019.
Pharma Injections
Punjab Asks Centre To Regulate Price Of BuprenorphineChandigarh, 11 Nov 2019: After cracking whip on private de-addiction centres in the state by putting a cap on price of detoxification medicine, the Punjab government has asked the National Pharmaceutical Pricing Authority (NPPA) to regulate the price of buprenorphine-naloxone under the Essential Commodities Act.
Baclofen Could Cause Mental Disorientation In Kidney Patients: StudyOntario, 10 Nov 2019: Patients with kidney dysfunction are prone to land up in a hospital with severe disorientation within a few days of taking baclofen, a commonly prescribed muscle relaxant warns a new study.
Govt's Go-Ahead For 4 Medical Device Parks New Delhi, 10 Nov 2019: The government has given approval for setting up four medical device parks with a view to support Make in India initiative and provide world-class products at affordable price for treatment. The four parks will be set up in Andhra Pradesh, Telangana, Tamil Nadu and Kerala, sources said, adding that Uttarakhand and Gujarat have also approached the Centre for a go-ahead for such parks.
New Policy Likely To Resolve Drug Name Anomaly NEW DELHI, 9 NOV 2019: Have you ever bought a medicine only to return home and discover that the brand name is correct, the packaging is same, but the drug is not what you wanted? The brand name Medzole, for example, is used to market different kinds of medicines.
Pune Doc Files Complaint Against Traditional Medicine Practitioner Coimbatore, 9 Nov 2019: A Pune-based doctor on Friday said the medical services authority was yet to look into a complaint that he lodged against a traditional medicine practitioner in Pollachi some 20 days ago, seeking action against him as he appeared to be a quack. The health services department, however, said it had sent a team to Pollachi to investigate the issue.
APEDA To Extend NPOP Certification Services To Ayush Products To Boost Exports From India Mumbai, 9 Nov 2019: The Agricultural Processed Food Products Export Development Authority (APEDA), a statutory body under the Union ministry of commerce, will be extending the National Programme for Organic Production (NPOP)’s certification services programme to Cosmetics and Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush) products to boost organic products exports from India.
Drug Dopes
Pharmacist Uses 108 Ambulance To Buy DrugsLudhiana, 11 Nov 2019: A pharmacist of Punjab government’s ‘108 Ambulance’ service was allegedly caught with drugs and intoxicating pills on Sunday afternoon by the sarpanch of Talwandi village, which is infamous for drug supply. 
Two Years After Launch, AIIMS Team To Assess Punjab De-Addiction CentresCHANDIGARH, 12 NOV 2019: For strengthening its drug de-addiction programme, the Punjab government has decided to get its outpatient opioid-assisted treatment (OOAT) clinics evaluated by the All India Institute of Medical Sciences (AIIMS), New Delhi.
Govt May Extend Anti-Dumping Duty On Imports Of Chinese Chemical New Delhi, 12 Nov 2019: The government may extend existing anti-dumping duty on imports of a Chinese chemical used in pharmaceuticals industry as the commerce ministry insisted on continuation of the levy. The continuation of the duty on imports of 'Sodium Nitrite' from China was recommended by the ministry's investigation arm Directorate General of Trade Remedies (DGTR) after concluding a probe into it.
Experts Are Mulling To Group Antibiotics Into Categories To Combat Misuse New Delhi, 5 Nov 2019: In a bid to combat the problem of overuse and underuse of antibiotics in India, experts are mulling if antibiotics can be grouped into categories with recommendations when each category should be used. In a revision of the antibiotics section in the National List of Essential Medicines (NLEM) public health experts that met today are deliberating if the WHO’s action plan on antimicrobial resistance which aims to ensure the best use of antibiotics-can be replicated in India.
Online Services Firms Are Building Systems To Ensure Delivery Of Genuine Medicines Bengaluru, 3 Nov 2019: At least twice a day, a van drops off a consignment of medicines worth several lakhs of rupees at a fulfilment centre of Medlife, an online health services firm. The fulfilment centre is in Sahakar Nagar in northern Bengaluru, on the top floor of a small building that also houses a diagnostic centre run by Medlife.
Hyderabad: Quacks’ Miracle Cure May Blind DiabeticsHyderabad, 9 Nov 2019: Quacks in the city are promising an effective treatment for diabetic retinopathy. Doctors practising modern medicine are dealing with patients who are reporting severe complications and also irreversible blindness as a consequence of this unscientific treatment.
National Injections
Now, PPIs Must Carry ‘Kidney Injury’ Warning Mumbai, 6 Nov 2019: In a bid to promote patient safety, widely-sold antacids (anti-acidity pills) will hereon need to carry a side-effect warning of ‘acute kidney injury” as part of their package insert leaflets. A directive to that end was issued by India’s Drugs Controller General on Tuesday, asking all state regulatory authorities to direct manufacturers of Proton Pump Inhibitors (PPIs) — a large chunk of the antacid market — to incorporate ‘acute kidney injury’ as an adverse drug reaction (ADR). The warning will be inserted in the packaging of these formulations, including Pantoprazole, Omeprazole, Lansoprazole, Esomeprazole, and their combinations.
Bengalurean’s Anti-Cancer Kit A Breakthrough: USBENGALURU, 12 NOV 2019: The US Food and Drug Administration (FDA)’s Centre for Devices and Radiological Health has designated a medical invention by a Bengaluru-based scientist as a “breakthrough device” in liver, pancreatic and breast cancer treatment.
Path Lab Issues Wrong Dengue Report, Health Dept Cancels Licence Lucknow, 13 Nov 2019: Health department on Tuesday cancelled the registration of a private pathology in Keshavnagar for issuing false dengue positive reports. The action came after a health department team conducted surprise inspection and found that though the reports given by the pathology mentioned that dengue test was done through ELISA (Enzyme-Linked Immunosorbent Assay), no equipment used for the test was present in the lab.
NPPA Asks Cos To Ensure Critical Drugs Are Available Mumbai, 13 Nov 2019: Keeping in mind patient interest, drug prices regulator National Pharmaceutical Pricing Authority (NPPA) took a slew of decisions, including directing certain companies to ensure availability of critical medicines, and exempting a “novel” oncology formulation from price control.
DCGI To Recommend DTAB To Exempt Drug Sale License For Import Of High Tech Equipment Mumbai, 13 Nov 2019: The Drugs Controller General of India (DCGI) is planning to recommend Drug Technical Advisory Board (DTAB) to exempt drug sale license for import of high tech equipment like X-Ray, MRI, PET, Ultrasound and CT Scan based on stakeholders suggestions.
Charges In All Private Hospitals Can’t Be Same, Clarifies Delhi HC NEW DELHI, 12 NOV 2019: Delhi high court has refused to direct authorities to fix uniform rates to be charged by private nursing homes and hospitals as the amount would depend upon the nature and type of disease as well as the quality of treatment provided.
Global Injections
Johnson & Johnson Says 15 Tests Show No Asbestos From The Same Bottle Of Baby PowderWASHINGTON, 29 OCT 2019: Johnson & Johnson said Tuesday that 15 new tests from the same bottle of Johnson's Baby Powder previously tested by the U.S. Food and Drug Administration found no asbestos in the product.
Counterfeit Cases Up By 15 Per Cent In 2019: ASPANew Delhi, 7 Nov 2019: The number of counterfeit cases have increased by nearly 15 per cent in the January-October period this year, according to the estimates by the Authentication Solutions Providers’ Association (ASPA). ASPA is a self-regulated,
Chinese Traditional Medicine Must Be Regulated: Europe Doctors
Paris, 7 Nov 2019: Top European medical bodies demanded Thursday that Chinese traditional medicines be subject to the same regulatory oversight as conventional Western methods, despite recent WHO recognition of their use.
Sanofi Inks Pact With Unitaid; To Reduce TB Drug Rifapentine Price By 70%
HYDERABAD, 31 OCT 2019: In a landmark development, global biopharmaceutical company Sanofi will lower the price of Rifapentine, a critically important drug used to prevent tuberculosis (TB), as part of the agreement with Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria, an official release said on Thursday.
Delegation Of Beijing Municipal Science & Technology Commission's Visit Of FDCA-Gujarat
Ahmedabad, 24 Oct 2019: “China Pharmaceuticals Industry Internationalization Strategy Summit and China-India Pharmaceutical Business Convention” at shanghai, China jointly organized by Shengjie, China and IPA, India during 16-17 May 2019 in which two senior officers of the Health & Family Welfare Department, Government of Gujarat were invited. In follow up to the above summit a pharma delegation comprises of Mr. Zheng Huanmin, Vice Director.
Indian Drug Market Will Soon Rule The World: Dr VG Somani
Warangal Urban, 1 Nov 2019: Stating that the pharmacy industry had grown manifold in the country, Dr VG Somani, Drug Controller General of India (DCGI), said India’s drugs market share in the world is 40 per cent including in the US, Europe, Japan and Africa.
PSM PILL
Loving South Carolina Father Poisoned By Counterfeit Anxiety Medicine
The May 10, 2016 death of Eric Highsmith Griffin in Lexington, South Carolina came as a shock to his friends and family. The 38-year-old father of two small children lived with his older sister, Nicole, caring for her after a hospitalization, while she supported him through a hard break-up and custody battle with the mother of his children.
Bloomberg Misses The Mark In Its Article About Drug Importation Advocacy
October 23, 2019 : In case you missed it, Bloomberg’s Ben Elgin has published an “in-depth” piece on the connection between PhRMA and the Partnership for Safe Medicines. However, this has been public and widely reported on for years. More concerningly, the story misses the broader point about the clear safety concerns of foreign drug importation.
Frequently Asked Questions
What are the Side Effects of Ranitidine ?
Headache, constipation or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: blurred vision, mental/mood changes (e.g., agitation, confusion, depression, hallucinations), easy bleeding/bruising, enlarged breasts, severe tiredness, fast/slow/irregular heartbeat, signs of infection (such as sore throat that doesn't go away, fever, chills), severe stomach/abdominal pain, dark urine, yellowing skin/eyes.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
SUBSCRIBER'S SYMPTOM
Patanjali’s Plea To Set Up Unit In J&K Rejected
Srinagar, 14 Nov 2019: The Jammu and Kashmir government has rejected the proposal of Baba Ram Dev-owned Patanjali Ayurved Limited for setting up a manufacturing unit worth Rs 1,007 crore in the newly created Union Territory.
Blog Addicts
Mr Loknath Harish, Pharma Professional It is enjoyable to read the newsletter and to know about the developments in the industry. Keep up the good work.
Mr Ram Athawale, MDThe reader is delighted with the articles you publish every fortnight or bi-monthly. Prescription newsletter is very good.
Mr Malik Jethani, MBBS
Good newsletter which brings an in depth understanding of news events in the Pharma world both nationally and globally. Keep up the good work.
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