The Prescription: 17th August 2018 Issue
Editor’s EmulsionPSM INDIA Capsules Drug Laws & Policy Injections Pharma Injections DRUG DOPES National Injections Global Injections PSM Pill DOSE OF THE DAY FAQ Subscriber's Symptom UpComing Events Laughter Dose Blog Addict Contact Us
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EDITOR'S EMULSION

Pooja Khaitan

Greetings on yet another issue of The Prescription!

Strengthening healthcare delivery system will not only improve accessibility but will assure universal health coverage of high quality and safety. Read about this in PSM India capsules as the 1st regional quality conclave on Universal Health Coverage through Ayushman Bharat was held in Varanasi. Another interesting read in this section is how a new technique for precisely targeting molecules within cells is paving the way for safer medicines that are free of side effects.

Important drug laws and government body policies are getting implemented such as drugs irrespective of branded or generic are required to comply with the same standards, uniform implementation of new labeling norms, review of production and distribution of oxytocin, working on Blockchain technology for drug industry and drug controllers to get power to issue NOCs for Drug meant for export.

Indian Pharma companies are constantly on the run be it either with increasing their market share in the US generic market, gearing up with copycat versions of Viagra, dealing with the Oxytoxin ban or developing new medical devices that are set to change the face of healthcare in India. Read about it all in our Pharma Injections while updating yourselves on medicines that have been recently approved, banned and proven dangerous to health in our drug dopes section.

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Do not hesitate to mail your comments on this edition to help us further improve. We appreciate your support and trust in us and are happy to have you as our loyal reader.
Feedback is what keeps us going. Should you have any query or question, please feel free to get in touch with us. Write to me on pooja@jagograhakjago.com

Stay Healthy. Stay Protected.

Pooja Khaitan

Editor-in-Chief,
The Prescription

DOSE OF THE DAY

“We have to do something but my own hypotheses is that the Ayushman Bharat scheme itself is going to encourage private sector to come up in poor areas. Why we don't have good services in poor areas, one reason is that there is no paying capacity. If private sector is motivated by profit then why would they open hospitals where people cannot pay, but now they can, now the poor don't pay themselves but can make the government pay.”

Indu Bhushan,
CEO, Ayushman Bharat

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PSM India Capsules

1st Regional Quality Conclave on Universal Health Coverage through Ayushman Bharat : Assisting Implementation


9th August, Varanasi: First Quality Conclave on Universal Health Coverage through Ayushman Bharat Assisting Implementation at BHU Varanasi on 9th August 2018 took off with a galaxy of experts in the healthcare delivery system in India and more than 600 participants representing all the stakeholders including active Patients’ Groups and Consumer Organisations. The event was inaugurated by Dr. Rakesh Bhatnagar Vice Chancellor of Banaras Hindu University and the Key Note Address was given by Dr V. K. Shukla, Director of Institute of Medical Sciences and Guest of Honour was Dr. N K Ganguly, former Director of ICMR. Welcome Address was given by Dr Ravi Singh Secretary General of QCI and Vote of Thanks by Prof Bejon Misra, GB Member QCI and founder director PSM India Initiative.

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Creating medicines without side effects: Big benefits expected in battle against cancer, autism, Alzheimer's, more

A new technique for precisely targeting molecules within cells is paving the way for safer medicines that are free of side effects. Researcher J. Julius Zhu, PhD, of the University of Virginia School of Medicine, and his colleagues have developed a way to manipulate molecules from compartment to compartment within individual cells. Amazingly, the same molecules do different things depending on their location, the researchers determined. By manipulating the molecules, scientists can determine exactly which locations to target, while avoiding locations that would cause harmful side effects.

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Drug Laws & Policy Injections
Drugs Irrespective Of Branded Or Generic, Are Required To Comply With The Same Standards: Mandaviya New Delhi, 7 Aug 2018: Minister of State for Ministry of Road Transport & Highways, Shipping and Chemicals & Fertilizers, Shri Mansukh L. Mandaviya, while giving a written reply to a question on steps taken by the Government to ensure the quality of medicines made under generic names and its availability at affordable prices to common people, in Lok Sabha today stated that drugs manufactured in the country, irrespective of whether branded or generic, are required to comply with the same standards as prescribed in the Drugs and Cosmetics Act, 1940Read More
Manpower At CDSCO Increased To 510 & Labs Are Being Strengthened To Improve Drug Standard: Minister New Delhi, 9 Aug 2018: The number of sanctioned posts at the Central Drugs Standard Control Organisation (CDSCO) has been increased from 111 in 2008 to 510 in 2018 and the testing capacities of laboratories under the regulator are being strengthened to expedite testing of drug samples in the country.Read More
DTAB Gives Green Signal To Uniform Implementation Of New Labelling Norms From April 1, 2019 Mumbai, 8 Aug 2018: The Drugs Technical Advisory Board (DTAB) of the Union health ministry has given its green signal to the DCGI's proposal to implement labelling change for drug packs uniformly from April 1, 2019 thus bringing the much needed respite to pharmaceutical industry from complying with changes in drug label twice within a couple of months. Read More
MoH Reviewed The Production And Distribution Of Oxytocin New Delhi, 6 Aug 2018: The Health Ministry today held a video conference with the States/UTs on various issues relating to regulation of Oxytocin including the status of preparedness of the State Governments for implementing the amended rules in regard to manufacture, distribution and sale of Oxytocin. The video conference also assessed the stock of Oxytocin in the States to ensure that there is no shortage after the restriction order on its manufacture for domestic use comes into effect from 1st September, 2018. Read More
Niti Aayog Working On Blockchain Tech For Drug IndustryHYDERABAD, 4 AUG 2018: Niti Aayog is working with Apollo Hospitals and information technology major Oracle on applying blockchain (decentralised) technology in pharmaceutical supply chain management to detect spurious drugs, Chief Executive Officer of NITI Aayog Amitabh Kant said here on Friday. Read More
State Drug Controllers Get Power To Issue NOCs For Drugs Meant For ExportHyderabad, 3 Aug 2018: State drug controllers have been given complete jurisdiction to issue no objection certificates (NOCs) for the manufacture of unapproved, banned or new drugs that are solely meant for exports. Read More
Pharma Injections
Pharma Cos Bag 40 percent Of US GenericsMumbai, 9 Aug 2018: The volume share of Indian pharma companies in the US generic market has grown to nearly 40% in August despite regulatory woes and pricing pressures. A steady increase in drug approvals and portfolio rationalisation by MNCs resulted in India’s volume share rising by 5% over the last few months, though value is still impacted due to price erosion.Read More
Indian Companies Gear Up With Copycat Versions Viagra Mumbai, 7 Aug 2018: With pharmaceutical giant Pfizer set to lose the patent of its blockbuster drug Viagra in the US, Indian companies are gearing up with copycat versions of the iconic blue pill, hoping to tap into a lucrative market.Read More
Oxytocin Ban: Mylan Knocks On Delhi High Court’s Door MUMBAI, 24 JULY 2018: The high-decibel discussion over the hormone Oxytocin has taken a legal turn with the US generic drugs major Mylan approaching the Delhi High Court. Read More
Novartis Restrains Local Pharma Cos From Making Patented Diabetes Drug Ahmedabad, 6 Aug 2018: The Swiss multinational pharmaceutical company Novartis has obtained court orders restraining five city-based pharma companies from manufacturing its patented drug for diabetes. Read More
PGI Doctor's New Device To Make Biopsy Redundant CHANDIGARH, 2 AUG 2018: The PGI in collaboration with the Central Scientific Instruments Organisation (CSIO) and Semi Conductor Laboratory (SCL), Mohali, have developed a device that can spot abnormalities in intestines (ulcers, cancer or wheat allergy). Read More
IIT Kharagpur To Develop Coin-Sized Biological Chips For Medical Treatment Kharagpur, 2 Aug 2018: IIT Kharagpur has set up India's pioneering Bioelectronics Innovation Laboratory to develop futuristic battery-free implantable medical devices for treatment of brain, nerve, muscle or spinal cord disorders that are untreatable by using standard medical practices, according to the institute. Read More
Drug Dopes
Updated LIST OF NEW DRUGS APPROVED FROM 01-01-2018 TILL DATE BY NEW DRUGS DIVISION, CDSCO, FDA Bhawan, New Delhi List of New Drug Approved by FDA Read More
Commonly Used Chemotherapy Drug Doxorubicin Can Lead To Heart Failure: StudyLondon, 8 Aug 2018: A chemotherapy drug, widely used for treatment of ovarian, bladder, lung, thyroid and stomach cancers, has the potential to cause heart toxicity that can lead to congestive heart failure, a study led by a professor of Indian origin, has found. Read More
Oxytocin: Drug Regulator Calls For ‘Strict Vigil’New Delhi, 7 Aug 2018: The Central Drugs Standard Control Organization (CDSCO) has directed all its port offices and zonal offices to keep a “strict vigil” to ensure that Oxytocin is not imported and that imported stocks of the drug are not used “in any form or name”. Read More
2 Dead, 7 Critical After Being Administered The Antibiotic Drug At RIMS SRIKAKULAM, 5 AUG 2018: Two people died and seven are critical after being administered an antibiotics drug at Rajiv Gandhi Institute of Medical Sciences (RIMS) here. They were given a dose of Ceftriaxone on Friday evening and started developing severe reactions to it by night, following which the three worst affected were rushed to King George Hospital in Visakhapatnam, but two of them — E Sailaja, 24, from Kasipuram village in Kotturu mandal and S Anitha, 38, from Palasa — succumbed to the medicine’s side effects on Saturday morning. Read More
210 Abortion Kits And Banned Drugs Seized During A Raid Sirsa, 2 Aug 2018: A person was arrested as a huge cache of banned drugs, including more than 200 medical terminations of pregnancy (MTP) kits, were seized during a raid at a house in Haryana’s Sirsa district, police said. Police arrested Shekhar Chand near Bhagat Singh Chowk in Sirsa administrative division after allegedly recovering prohibited medicines from him. Read More
Maha FDA Detects Inter-State Spurious Drug Racket Having Mfg Base In UP Mumbai, 4 Aug 2018: The Maharashtra Food and Drug Administration (FDA) has yet again achieved a major breakthrough in taking head on unscrupulous drug dealers involved in selling ayurvedic medicines containing scheduled allopathic drugs like sildenafil citrate and anesthetic medicine -lignocaine hydrochloride. Read More
National Injections
IPC Issues First 'Standards For Medical Devices - A Reference Document' To Provide Information On Quality Parameters New Delhi, 10 Aug 2018: Nearly eight months after the implementation of the Medical Device Rules 2017, the Indian Pharmacopoeia Commission (IPC) has brought out the first reference document for medical devices manufactured and sold in the country. Framed mainly on the basis of MD Rules, the 241-page draft rule book is expected to provide manufacturers, licence holders, regulators and healthcare professionals with requisite information on regulatory and technical requirements under one umbrella. Read More
Mahavir Institute Of Medical Sciences Fined Rs 2 Crore For FraudNew Delhi, 9 Aug 2018: The Supreme Court has fined a medical college Rs 2 crore for trying to deceive inspectors by projecting healthy people as patients as it dismissed a plea the institute had filed to reverse a decision the Medical Council of India had taken.Read More
Profitability Of Hospitals Touch A Multi-Year Low: ICRA New Delhi, 30 July 2018: The health of the hospital sector has been deteriorating since early CY2017 due to several factors that have adversely affected its profitability. Read More
Gujarat FDCA Serves Closure Notices To Three Blood Banks For Putting Patient Safety At Risk Mumbai, 7 Aug 2018: The Gujarat Food and Drug Control Administration (FDCA)'s inspections on 17 blood banks which was meant to address the growing challenge of blood safety finally culminated into three blood banks being served closure notices for endangering patient safety. Read More
1,104 People Die During Clinical Trials In India In 3 Years New Delhi, 6 Aug 2018: A total of 1,104 people have died during clinical trials of various drugs and procedures in India in the last three years, according to the ministry of health and family welfare. Read More
Medical Negligence Case Registered Against Pvt Hospital In Jaipur Jaipur, 1 Aug 2018: A case of medical negligence was registered against a prominent private hospital in the city following the direction from a local court here, police said today. Read More
Global Injections
US FDA Publishes Final Guidance: Elemental Impurities In Drug Products Maryland, 7 Aug 2018: FDA has issued a final guidance entitled, Elemental Impurities in Drug Products. The guidance finalizes a draft guidance document issued July 1, 2016. Read More
How Former Drug Company Labs Are Becoming Contract Research Firms England, 4 Aug 2018: Europe’s drug industry is going through an efficiency drive to cut costs, raise productivity, and focus on more profitable therapeutic areas. Read More

US FDA Seals Loophole That Allowed Some Drugmakers To Avoid Pediatric Clinical Trials Maryland, 27 July 2018: The Food and Drug Administration moved Friday to close a loophole that had inadvertently excused some drugmakers from having to conduct clinical trials in children for drugs to treat diseases that commonly affect adults.Read More

Bacterial Superbugs Have Become Up To 10 Times More Tolerant To Alcohol-Based Hand Sanitizers Canberra, 3 Aug 2018: Many hospitals around the world have installed hand sanitizers for staff, visitors, and patients to use. However, the bacteria was quick to react. A new study found that superbugs found in Australian hospitals have become up to ten times more tolerant to alcohol exposure, the key ingredient in hand sanitizers.Read More

Enzyme Could Make 'Smart' Cancer Drugs A Reality Texas, 20 July 2018: A type of enzyme called matrix metalloproteinase could be key to the development of “smart” cancer drugs, according to new research.Read More

Anti-Depressants Linked With Blood Clot Condition: Study London, 25 July 2018: Increased use of anti-depressants -- drugs used to treat major depressive disorders -- may be associated with developing a high risk of fatal blood clot condition, says a study.Read More

PSM PILL

Counterfeit Fentanyl Pills And Powder Being Seized In Ever Larger Amounts In Arizona

August 9, 2018: Reports coming in from Arizona paint a worrisome picture in the state’s battle against counterfeit fentanyl pills. As the Daily Miner reported, fake Xanax pills made with fentanyl have been reported in Kingman, a town of approximately 30,000.

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New York Residents Charged After Being Found With Over 12 Kilos Of Counterfeit Xanax Pills

August 9, 2018: In June 2018, the U.S. Department of Justice (DOJ) announced the results of a year-long national operation that used undercover agents to target vendors selling illicit drugs on the internet. The investigation identified 65 targets and resulted in indictments against 35 vendors.

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Frequently Asked Questions

Questions about Antibiotic Resistance
Q: What is antibiotic resistance?

Ans: Antibiotic resistance occurs when bacteria develop the ability to defeat the drugs designed to kill them. When bacteria become resistant, antibiotics cannot fight them, and the bacteria multiply. Read More>>>

SUBSCRIBER'S SYMPTOM

Are you Ready for EU FMD Urgency, Consistency and Planning are Key - Vikash Pushpraj

Article contributed by Tea Rajic, Marketing Manager, rfxcel, San Ramon CA

With the deadline looming for enactment of EU FMD and US DSCSA, Vikash Pushpraj, SVP, rfxcel, explains how achieving compliance is about much more than technology. Companies not yet set up for serialisation will need to adopt best practices and leverage the know-how of implementation experts in their methodology to go-live on time. Read More

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