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!

The IPC, an Autonomous Institution of the Ministry of Health and Family Welfare, Govt. of India, created to set standards of drugs in the country with its basic function to update regularly the standards of drugs commonly required for treatment of diseases prevailing, had our founder director Bejon Misra over as chief guest on our Independence Day. Read more on this and how India is witnessing an alarming rise in the rate of carbapenem-resistant bacteria underlining the need for enhanced antimicrobial surveillance and prevention of antibiotic misuse in PSM India capsules.

The Government of India is introducing various constructive laws and policies along with the high court in matters relating to clinical establishments violating rules, printing of generic name in double the font size than brand name, price-ceiling list, over dependence on China for import of bulk drugs, among others. Get an insight into this under Drug laws and Policy Injections.

This issue of The Prescription holds some interesting articles in Pharma Injections on how fixed dose combo ban hits the retail Pharma business and how the rising cost of Chinese raw materials is eating into margins of Indian Pharma companies. While you review the list on new drugs approved till date under the section named Drug Dopes, catch up on spurious drugs being unearthed in India and the world over in National and Global Injections respectively.

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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

“The most important activity should be to develop a robust communication strategy to reach out to the citizens and engage them in detecting spurious and not of quality standards medicines in the supply chain”

Prof. Bejon Kumar Misra
Founder Director, PSM Patient Safety and Access Initiative of India Foundation

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PSM India Capsules

Message by PSM India Founder-Director, Bejon Misra during his visit to the Indian Pharmacopoeia Commission (IPC) on the occasion of the 72nd Independence Day as Chief Guest

Patient Safety and Quality Healthcare should be paramount in the culture of IPC and we must appreciate our responsibility towards the community to improve research and development in the interest of patients and encourage innovation in Science to lead discoveries in India for the Global Community. Even though we are the Pharmacy of the World, we are yet to communicate the role of IPC to the citizens and make them understand the constructive role we are all playing to empower them with quality healthcare at the most affordable cost.

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Drug Of Last Resort’ Losing Out To Pathogens

India is witnessing an alarming rise in the rate of carbapenem-resistant bacteria underlining the need for enhanced antimicrobial surveillance and prevention of antibiotic misuse. Carbapenem-resistant pathogens are a major public health challenge as carbapenems are the last line of treatment for patients with serious infections.

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Drug Laws & Policy Injections
Seal All Clinical Establishments Violating Rules: Uttarakhand High Court To GovtNAINITAL, 24 AUG 2018: In a landmark order, Uttarakhand high court directed the state government to seal all the clinical establishements which are not registered under the Clinical Establishments (Registration and Regulation) Act, 2010.Read More
MoH To Issue Notification To Do Away Printing Of Generic Name In Double The Font Size Than Brand Name Mumbai, 21 Aug 2018: The Union health ministry is soon likely to come out with a notification doing away with the mandatory requirement to print/write the generic name in double the font size making it bigger than the brand name on drug packs.Read More
Key Diabetes, Anti-Cancer Drugs Among 92 In Price-Ceiling ListNew Delhi, 17 Aug 2018: India’s pharma regulator revised and set the prices of 92 drugs and their combinations, including key anti-diabetic and anticancer medicines, all made by local companies including Sun Pharmaceutical Industries, Dr Reddy’s Laboratories and Lupin. Read More
Parliamentary Panel Bats For Taking Aggressive Measures To End Over-Dependance On China For Import Of Bulk Drugs New Delhi, 18 Aug 2018: The Parliamentary Standing Committee on Commerce has made a strong case for taking aggressive measures, following the example set by the United States and the European Union, to check import of bulk drugs from China. The committee has also stressed the need for monitoring, surveillance and enforcement of the trade remedies. Read More
Maha FDA, CDSCO Start Risk-Based Inspections Of Sch M Units For Compliance To NormsMumbai, 17 Aug 2018: Following responses of self-audit from around 800 manufacturers in the state, the Maharashtra Food and Drug Administration (FDA) has started risk-based inspections for an effective oversight on the drug manufacturers in the state for compliance to good manufacturing practices (GMPs). Read More
MoH Publishes Draft On Standards For Medical DevicesNEW DELHI, 15 AUG 2018: In the first of it’s kind document to spell out standards for medical devices in the country, the Union Health Ministry has come out with an exhaustive draft, covering simple items such as ice-bags and tongue-depressors on one end of the continuum and very sophisticated items such as cardiac-pacemakers and proton-therapy devices on the other end. Read More
Pharma Injections
Fixed-Dose Combo Ban To Hit Retail Pharma BizMumbai, 24 Aug 2018: The proposed government ban on over 340 combination medicines (fixed-dose combinations, or FDCs) will impact over 2% — nearly Rs 2,900 crore — of the organised retail market, with popular cough syrups, painkillers and flu medicines — like Phensedyl, Saridon, Sumocold, and Vicks Action 500 — facing action. Read More
Freebies May Be Freed Of GST Payment Burden NEW DELHI, 23 AUG 2018: Buy one and get one, free samples and additional quantities for the same price — the mainstay of marketing for FMCG, pharmaceutical and textile companies and food and retail chains — may no longer be taxed. Tax authorities had sent notices to companies in these sectors that had offered such freebies, which had become taxable after the goods and services tax was rolled out last year.Read More
Rising Cost Of Chinese Raw Materials Eat Into Margins Of Indian Pharma Companies Hyderabad, 16 Aug 2018: Indian drug makers are staring at diminishing margins as raw material imports from China has increased while drug prices have stagnated. The cost of raw materials sourced from China has risen after Chinese government started cracking down on facilities that violate the country’s pollution control norms. Read More
Use Of Auto Disposable Syringe By Govt Hospitals Launched In Andhra Pradesh VIJAYAWADA, 17 AUG 2018: Chief Minister N Chandrababu Naidu launched the auto disposal syringes, reportedly first-of-its-kind to be used by any State government in the country, on Thursday, during a review meeting conducted with the Health department officials. Read More
Telangana: DCA Lab To Get Analysts To Check Drug Samples HYDERABAD, 16 AUG 2018: The inordinate time it takes to know if medicines are spurious, adulterated or of lesser quantity would get reduced as the laboratory at Telangana Drug Control Administration (DCA) is going to be provided with additional lab analysts and infrastructure. Read More
Domestic Pharma Retail Mkt Grows 13% In July Mumbai, 16 Aug 2018: Domestic pharma retail market posted a robust growth of nearly 13% in July indicating it may be back on track after facing GST blues last year. The growth came on the back of higher sales of anti-infectives, which rebounded after a dip in June, while respiratory, dermatology, and chronic therapies continued to clock strong numbers. Read More
Mohali: Two Pharma Firm Owners Booked For Misleading FDA Mohali, 14 Aug 2018: Two businessmen, dealing in medicines used for drug de-addiction, were booked by Kharar police on Sunday. The accused duo, based in Amritsar, are brothers and directors of a private firm. They were booked on charges of misleading the Punjab Food and Drug Administration department to get a certificate to sell medicines for drug de-addiction patients. 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
Illegal Internet Drugs Pharmacy Busted In Delhi, 4 HeldNew Delhi, 19 Aug 2018: An illegal internet pharmacy, allegedly shipping drugs to overseas locations like the US and Canada, based in Delhi has been busted by the NCB with the apprehension of four people and seizure of over 41,000 psychotropic tablet strips, a senior official today said. He said the pharmacy was based in west Patel Nagar area of the national capital and was allegedly sending these drugs under the garb of auto parts and religious items. Read More
Man Selling Alprazolam To Auto Drivers, Labourers HeldHYDERABAD, 19 AUG 2018: A 35-year-old man P Rajesh, who allegedly sold alprazolam (psychotropic medicine) to auto drivers, daily wage labourers and others was caught with 8,260 tablets on Saturday. Rajesh used to procure the tablets from Raichur, Yadgir, Karnataka at Rs 5 a tablet and sold it anywhere between Rs 50 and Rs 100 in Hyderabad. Read More
Maha Paramedical Council Directs Local Bodies Not To Act Against Labs Run By Non-Pathologists Mumbai, 17 Aug 2018: Thousands of technicians facing action from local bodies for running clinical laboratories independently in the state in violation of the Supreme Court order have found solace in Maharashtra Paramedical Council order directing stoppage of action against them. Read More
Govt Asks TV Channels Not To Air Magic Pill Ads New Delhi, 16 Aug 2018: Companies offering magic pills for ailments ranging from common illness to life threatening diseases such as cancer and AIDS are now under the government scanner. The I&B ministry through advisories has asked television channels not to air their promos. Read More
Diabetes Drug Empagliflozin May Help Treat Fatty Liver Too NEW DELHI, 18 AUG 2018: A medicine used commonly for diabetes treatment has shown positive result when used to treat fatty liver for which there are few approved drugs at present. Read More
National Injections
Thane Pathologist Loses Registration For 6 Months For Ethics Breach MUMBAI, 20 AUG 2018: The licence of a Thane pathologist has been suspended for six months for his alleged association, in terms of lending his name and registration number, to nearly a hundred laboratories across Mumbai, Thane and Raigad which he didn't physically visit or supervise. Deeming this "unethical", the Maharashtra Medical Council (MMC) found it was physically impossible for the doctor to supervise or perform tests at all the centres, some 100km apart. Read More
Over 4.9 Lakh Persons In India Developed Paralysis Between 2000 To 2017 Because Of Oral Polio Vaccine: StudyMumbai, 20 Aug 2018: In a study, published in the International Journal of Environmental Research and Public Health, leading doctors in two reputed hospitals in Delhi have reported that over 4.9 lakh persons in India developed paralysis between 2000 to 2017 because of oral polio vaccine (OPV). The study calls for judicious use of OPV schedule to prevent vaccine induced paralysis.Read More
Spurious Henna Turns Festivities Off-Colour, Unsafe Jaipur, 18 Aug 2018: After two months of heat wave, monsoon has brought a bit of relief and also heralded a spell of festivities - starting with Teej and then Rakshabandhan. And, no celebration in the country, including Rajasthan, is complete without henna or mehndi that has a universal appeal. Cutting across religious lines, it holds a special place in people’s life and adds to their happiness. Read More
HC Upholds MCI’s Decision Of Punishing Doctor For Negligence New Delhi, 16 Aug 2018: The Delhi High Court has upheld the decision of the Medical Council of India (MCI) ordering removal of a doctor’s name from the Indian Medical Register for 15 days for negligence during childbirth which left the mother with permanent paraplegia (paralysis of the legs and lower body). Read More
2 Arrested With 2,086 Bottles Of Phensedyl In Chapainawabganj Dhaka, 15 Feb 2018: RAB found 2,086 bottles of phensedyl in their pickup truck at Dariapur truck stand in Sadar upazila around 7:30am on Wednesday. The pickup truck was also seized. Read More
Assam: Centre ‘Punishing’ Drug Analyst For Exposing Spurious Drugs Networks GUWAHATI, 21 AUG 2018: Is the Ministry of Health trying to “protect” the interest of suppliers of “substandard” and “spurious” drugs in Assam and is all out to “punish” the drug analyst who nailed them? Read More
Global Injections
A Simple Paper Test Detects False Or Substandard Antibiotics Colorado, 21 Aug 2018: Antibiotics medicines that treat bacterial infections have saved millions of lives worldwide since their discovery in the early 20th century. When we fill a prescription at the doctor’s office or pharmacy today, most of us take for granted that these commonly prescribed medicines are real and good quality. Read More
US FDA Alerts Drugmakers Of A Recall Of Porcine Thyroid API From China Maryland, 18 Aug 2018: The US Food and Drug Administration is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, and compounders that China-based Sichuan Friendly Pharmaceutical is recalling certain lots of porcine thyroid API due to inconsistent quality of the API. Read More

China Sacks 6 Senior Officials Over Vaccine Scandal Beijing, 18 Aug 2018: China has sacked six senior government officials for their neglect of duty and misconduct following a drug-safety scandal in which a pharmaceutical company manufactured substandard vaccines, including that for rabies, exported to India and other countries.Read More

WHO Announces Important Changes To Multi Drug Resistant TB Treatment MUMBAI, 18 AUG 2018: Ahead of the first-ever United Nations High level Meeting next month, the World Health Organisation on Friday announced crucial changes to the multi drug resistant TB treatment regimen, which includes expanding the usage of the latest tuberculosis drug, Bedaquiline. It also calls on countries to minimize the use of injectibles, which are known to cause serious side effects in patients.Read More

Scientists discover chemical that causes brain cancer cells to self-destructs British researchers were experimenting with various chemicals that they hoped might slow down the growth of glioblastoma — the most aggressive cancer that starts out in the brain. To their surprise, one synthetic chemical called KHS101 did far more than expected, basically destroying the cancer cells completely. These surprising findings may pave the way for a novel drug treatment that might one day save people’s lives from a very aggressive form of cancer.Read More

US FDA Officials Visit Gujarat FDCA For Capacity Building Towards Global Regulatory Harmonization Mumbai, 24 Aug 2018: A team of US FDA officials recently visited Gujarat Food and Drug Control Administration (FDCA) as part of the global harmonization programme for capacity building, training, networking, knowledge sharing and compliance.Read More

PSM PILL

Counterfeit Medicines And Fentanyl Pills In Top Ten Of Seized Items By CBP

August 17, 2018: A recent article in USA Today listed pharmaceuticals and personal care products as the seventh most frequently seized type of shipments by Customs and Border Protection (CBP). In fiscal year 2017, CBP processed over 278 million cargo and postal shipments only to seize and destroy 34,143 shipments containing counterfeit items.

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Over Half Of U.S. States Have Now Seen Fatalities From Counterfeit Drugs Made With Fentanyl

PHOENIX, August 16, 2018 : During a roundtable discussion focused on the nation’s worsening opioid crisis, advocates for ensuring a safe drug supply shared new data detailing the increasing prevalence of counterfeit medications and the rising number of deaths tied to them.

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Frequently Asked Questions

Q: What is meant by Track and Trace in medicines?
Ans: Track and trace technology in medicines is a simple and effective way to leverage basic serialization and protect patients and consumers against counterfeiting (spurious) and substandard medicines. Pharmaceuticals companies and governments of countries worldwide believe that drug counterfeiting can be reduced significantly by implementing product serialization. Serialization requires a comprehensive system to track and trace the passage of prescription drugs through the entire supply chain. Every product needs to be identified by a unique serial number in addition to the origin, shelf life and batch number. This will allow the product’s lifecycle to be traced from production, through distribution and finally to dispensation to patients at the drugstore or hospital. Read More>>>

SUBSCRIBER'S SYMPTOM

Be Careful with ‘Alternative’ Therapies

Article contributed by Home maker, Ms.K.Saundarya, Chennai

Due to adverse reports about modern allopathic medicines, a lot of many people are moving towards alternative therapies and healing techniques. But have you ever wondered how effective these are? The point to be noted here is that almost everyone wants to make money by exploiting the fears of others. This is a sad but also a bitter truth. Read More

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Moraji patient care Association blogs: Thanks to PSM-India for acting as a pivotal force in eradicating spurious medicines all over India!
Dr. Amanda Bhatt, Health Care professional:Days are changing drastically. People are now much concerned of their health and rational use of medicines. We are together with PSM India in their diligent work of stopping use of all type of falsified medicines in India.
Mrs. Radhika, Homemaker tweets: I am a regular reader of “The Prescription” as it provides me much information regarding safeguarding of health of our family.
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Disclaimer : Our newsletter endeavors to compile patient safety information from various sources . PSM India may not be held responsible for any article published in The Prescription.