The Prescription: 1st May 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
News Archive
EDITOR'S EMULSION

Pooja Khaitan

Summer Greetings!

The internet brings many advantages, not least in being able to acquire medicines with relative ease. But there are drawbacks, especially for the unwary. Patients may encounter problems when using the internet to address their healthcare needs.

With advances in the field of technology, more and more people have started relying on the internet for their day-to-day activities. While it is always good to gain more knowledge through the internet, patients and doctors need to be aware of the dark side of the web. As the internet marketplace grows, the number of online pharmacies has increased exponentially.

When stuck with illness or a medical problem, some individuals opt for prescription drugs online as a means of quick access to the medications they think they require rather than go to the effort of seeing a GP and having to endure long waiting lists. Often, the risks associated with buying drugs online are not fully known to either the purchaser or even sometimes the health professionals, who may be asked about such sites.

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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@safemedicinesindia.in

Stay Healthy. Stay Protected.

Pooja Khaitan

Editor-in-Chief,
The Prescription

DOSE OF THE DAY

“India’s bold and ambitious National Health Protection Scheme is a priceless gift to people. This is an investment not only in a healthier future but in a safer future because when people can access health services close to their homes, outbreaks can be prevented and detected early. That’s why we say that UHC and national health security are two sides of the same coin.”

Tedros Adhanom Ghebreyesus
WHO Director General

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PSM India Capsules

Purchase Genuine Medicines Online

India is a step closer to putting in place laws to ensure that patients are able to purchase genuine medicines from authentic online pharmacies, with a new draft of rules circulated among states for their opinion. The Union health ministry has come out with a draft proposal to amend Drugs and Cosmetics Rules, 1945 to insert Part VIB to facilitate sale of drugs by e-pharmacy. The draft released by the ministry on April 18, 2018 proposes to insert Part VIB in D&C Rules after Rule 67H and before Part VII.

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Drug Laws & Policy Injections
DTAB Panel On FDCs Accepts Aidan Demand, Pushes Back Deadline For Data Submission To May 2New Delhi, 24 April 2018: A sub-committee of the Drugs Technical Advisory Board (DTAB), constituted in accordance with the Supreme Court order to re-examine the ban on 300-plus fixed dose combination (FDC) drugs, has set May 2 as the new deadline for petitioners and appellants to submit relevant data to substantiate their claims.Read More
Medical Colleges To Have MDR-TB Centres To Acquire Recognition Mumbai, 22 April 2018: In order to prevent tuberculosis deaths and reduce rising cases of multi-drug-resistant tuberculosis (MDR-TB) in the country, the government has issued a mandate to the Medical Council of India (MCI). It has asked the MCI to mandate MDRTB centres while recognising private and government medical colleges.Read More
Cell To Check Manufacture Of Substandard DrugsSolan,16 April 2018: In a bid to strengthen regulatory mechanism over pharmaceutical manufacturers in the state, an intelligence cell comprising officials from the state and central drug authorities has been constituted by the Drug Control Administration. Read More
Government Seeks To Define Stem Cells As DrugThe Union health ministry has proposed an amendment to the Drugs and Cosmetics Act that may finally bring stem cells and cellbased products under the ambit of the law. Interestingly, the Indian Council of Medical Research (ICMR)—an arm of the health ministry that has been at the forefront of demanding stringent rules for stem cell use and even formulated guidelines last year—was apparently not consulted. Read More
Government Sets Up High-Level Task Force To Formulate Roadmap For Reviving API SectorNew Delhi, 23 April 2018: The Central government has constituted a high-level task force to formulate a roadmap for reviving the active pharmaceutical ingredient (API) sector amid growing concerns over an overwhelming dependence on drug imports from China. Read More
Government Wants To Use Blockchain To Bust Fake Drugs In IndiaIndian policy thinktank Niti Aayog is working to put the entire inventory of drugs made and consumed in the country on blockchain with an intent to crack down on counterfeit and spurious drugs, according to two government sources. The government wants to complete a “proof of concept” (PoC) solution by the year-end and begin implementation in 2019. Read More
Pharma Injections
CDSCO Conducts Third Raid On Pharma Firms For Unapproved DrugsNew Delhi, 23 April 2018: After conducting surprise raids in Uttarakhand and Daman, the Central Drugs Standards Control Organisation (CDSCO) has now conducted raids on drug manufacturing firms in Sikkim. Of the two firms raided in the state, the drug regulator cancelled one license and suspended another.Read More
Karnataka DC Dept Grants Manufacturing License To KAPL For Oxytocin, Company Ready For Production Based On India’s RequirementBengaluru, 20 April 2018: In a major development to permit production of the much discussed drug oxytocin, the Karnataka drugs control department has issued manufacturing license to the Bengaluru-based 34-year-old public sector undertaking Karnataka Antibiotics and Pharmaceuticals Limited (KAPL).Read More
CDSCO Probe Against Jaipur's Malpani Hospital 23 April 2018: Glenmark has suspended clinical trial for one of its investigational new drug, GRC27864, at Malpani Multispecialty Hospital in Jaipur. The action comes due to a CDSCO probe against the hospital due to alleged unethical practices during the clinical trials. The company has said that the clinical trials for GRC27864 will continue at the other sites and will conduct an investigation into the matter. Read More
Eight Pharma Majors Show Interest To Maha FDA To Develop Bulk Drugs Park In Nagpur Mumbai, 23 April 2018: As a prelude to the meeting with Maharashtra Chief Minister Devendra Fadnavis and Union Minister for Road Transport & Highways Nitin Gadkari with pharmaceutical manufacturers towards developing Nagpur as a pharmaceutical hub, eight major pharmaceutical companies have shown interest to Maharashtra Food and Drug Administration (FDA) to develop bulk drugs park in Nagpur. Read More
Maha FDA Prosecutes Seven Hospitals For Overcharging And Reusing Balloon Catheters & Guiding Catheters Mumbai, 18 April 2018: The Maharashtra Food and Drug Administration (FDA) has filed prosecutions against seven hospitals based in Pune, Nagpur, Aurangabad and Mumbai for overcharging patients and also for reusing balloon catheters and guiding catheters on them in violation of Section 18 of Drugs and Cosmetics Act, 1940 and Rule 65. Read More
Prolonged Use Of Antacids Harms Kidneys Mumbai, 10 April 2018: Recent global studies suggesting that the prolonged use of widely prescribed anti-acidity pills to treat “gas” and heartburn might be linked to long-term kidney damage, acute renal disease and chronic kidney disease have sparked fresh debate in the medical community here. 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
Hope For Diabetics: An Artificial Pancreas From IIT-BMumbai, 21 April 2018: Following successful clinical tests on mice and pigs, the Indian Institute of Technology Bombay’s Chemical Engineering department has announced progress in the development of a bio-artificial pancreas that can be implanted in diabetics to help manage the disease. Though it is still years from being used on humans, its continued development holds hope for diabetics. Read More
Lack Of Air Filtration Level Norms In India Hits Pharmaceutical Quality20 April 2018: India, world's biggest exporter of generics, does not have air quality filtration level norms unlike USA and Europe thus giving free hand to manufacturers to opt for air filtration of their choice at manufacturing plants. Read More
Government Bans Imports Of Hormone Oxytocin 6 April 2018: The Union government on Friday banned imports of the hormone oxytocin to stop its misuse in the livestock industry, where activists say it causes hormonal imbalances and shortens the lives of milch animals. Read More
Uttarakhand DC Suspends Licences Of 50 Drug Makers For Manufacturing FDCs Without DCGI Approval 19 April 2018: The Uttarakhand Drugs Controller (DC), Tajber Singh has suspended manufacturing licences of around 50 pharmaceutical companies involved in manufacturing of fixed dose combinations (FDCs) without approval from the Drugs Controller General of India (DCGI). Read More
5 Cases Decided For Drug Adulteration In Delhi In 4 Years Delhi, 16 April 2018: In a recently released data on samples of drugs tested and actions enforced by State Drugs Controller between 2014 and 2017, it was revealed that only five cases were decided in the national Capital in 84 raids. While the prosecution for manufacturing, sale, and distribution of spurious/adulterated drugs was launched against 11. Read More
National Injections
Assam Gets New State Pharmacy Council After 30 Years; M C Deka Elected President 24 April 2018: After a long period of 30 years, a newly elected state pharmacy council has been constituted in the state of Assam. Munin Chandra Deka, a veteran regulator with expertise in enforcement and experience as registrar of state pharmacy council, has been elected as president of the council. Read More
53 Doctors Under Scanner For Fake PG Certificates18 April 2018: Doctors summoned on April 21 for questioning; role of College of Physicians and Surgeons, which offers PG diplomas and fellowships, to be probed too.Read More
Quacks Practising Medicine Great Risk To Society 13 April 2018: The Supreme Court expressed concern that a number of quacks practicing medicine are playing with the lives of people and posing a great risk to society. Read More
People With Severe TB Know Little About Side Effects Greater awareness about tuberculosis drugs and their side effects can help patients cope with their condition better and reduce the “default rate”, the number of people who quit their treatment midway, a study has revealed. Read More
Illegal E-Sale Of Abortion Pills Traced To Delhi 12 APRIL 2018: Officials of the Food and Drugs Administration (FDA) have tracked the firms involved in the illegal online sale of abortion pills to Delhi. These firms, including the manufacture and currier operators, have been served show-cause notices for violation of norms, the officials said. Read More
IIT Roorkee Develops A Potent Molecule To Treat Chikungunya Roorkee, 21 April 2018: A team of researchers at the Indian Institute of Technology (IIT) Roorkee has achieved a measure of success by finding a small molecule that has good antiviral activity against chikungunya virus. The antiviral activity was so high that the small molecule was able to achieve almost 99% reduction in the virus when 5 microMolar of the molecule was used. Read More
Global Injections
FDA investigating unauthorized herpes vaccine research, report says (CNN)William Halford had spent two decades researching and developing a vaccine that he believed could bring relief to the millions of people afflicted with herpes. Read More
Fighting Deadly Adverse Drug Reactions Through Precision Medicine Ohio, 18 April 2018: Lee Tan, a 41-year-old marketing professional and copywriter in Vancouver, Canada, was diagnosed with high blood pressure three years ago. Read More

Medication Use Increases In Newly-Diagnosed Dementia Patients Sydney, 22 April 2018: Researchers have found an increase in medication use by the patients who have been newly-diagnosed with dementia and they may consume unnecessary or inappropriate medicines that increase the risk of side effects.Read More

WHO Recommends Testing Before Use Of Sanofi's Dengue Vaccine PARIS/CHICAGO, 20 APRIL 2018: The World Health Organization (WHO) said on Thursday Sanofi's vaccine against dengue should only be used after testing on individuals to assess whether they have ever been exposed to the infection.Read More

US FDA Finalizes ICH Q7 Questions And Answers On GMPs For APIs Maryland, 19 April 2018: The US Food and Drug Administration (FDA) on Thursday finalized the International Council for Harmonisation’s (ICH) Q7 question and answer guidance on good manufacturing practices (GMPs) for active pharmaceutical ingredients (APIs).Read More

US FDA Issues Guidance On Developing New Genetic Tests For Diagnosis And Treatment Of Disease Maryland, 18 April 2018: The US Food and Drug Administration (FDA) has issued two sets of guidance to drive the design, development and validation of new genetic and genomic-based tests using next generation sequencing (NGS).Read More

Alliance For Safe Online Pharmacies Launches ASOP Canada To Protect Canadians From Unsafe Medicine Toronto, 6 April 2018: The Alliance for Safe Online Pharmacies (ASOP Global) has launched a local chapter in Canada to better protect Canadians from the illegal online sale of medical products. ASOP Canada joins ASOP Global's community in the United States, Europe, China, India and other regions to address illegal online sellers and protect consumers/patients from the sale of falsified, substandard and unapproved medicines by Health Canada.Read More

PSM PILL

Resources To Help Law Enforcement Offices Stay Safe From Fentanyl

April 23, 2018: Official figures for the human cost of the opioid crisis in 2017 are not yet in, but news reports from around the country make it clear that this crisis is far from over. The addition of fentanyl has increased the danger to members of the public and also to law enforcement officers. In response, law enforcement organizations have developed resources to help officers keep safe.

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New Hampshire Couple Who Distributed Millions Of Misbranded Pills Headed To Jail

April 20, 2018: The U.S. Department of Justice (DOJ) announced the sentencing of a New Ipswich, New Hampshire couple for their roles in a scheme to distribute misbranded prescription drugs purchased from India to customers around the U.S. John Hayes received a 30-month sentence and Plabpleung Hayes will serve one year and one day in prison.

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Frequently Asked Questions

Q. Does quality of medicines matter?
Ans: Yes, it matters. Medicines including vaccines save lives and prevent diseases and epidemics only if they are safe, efficacious, of good quality and are used rationally. The use of unsafe, substandard, ineffective and Spurious/falsely-labelled/falsified/counterfeit medical products (SFFC) and vaccines can be harmful to the health and well being of the individual patient as well as to a wider section of the population. They also undermine confidence in the health service, health professionals who treat patients, prescribers, as well as those who manufacture, distribute and dispense/sale medicines. The purchase of unsafe, substandard, ineffective and SFFC medicines is a waste of money for the government, the individual patient and the public.

Q. What should be done to ensure the safety, efficacy and quality of medicines?
Ans: Governments must regulate the manufacture, export, import, storage, distribution, supply and sale of medicines to ensure the safety, efficacy and quality of medicines.
Governments have to establish strong national medicines regulatory authorities (NMRAs). To enable the NMRAs to operate effectively, governments have to provide strong political support, adequate and sustainable human, financial and other resources, and legal power for enforcement. Ineffective regulation and control can result in the proliferation of unsafe, ineffective, substandard and SFFC medicines.
In addition, manufacturers have to produce medicines in accordance with good manufacturing practice (GMP) requirements and distributors have to store and distribute medicines in accordance with good storage and good distribution practices as provided in the WHO guidelines (Guide to good storage practices for pharmaceuticals, Annex 9, WHO Technical Report Series 908, 2003: http://whqlibdoc.who.int/trs/WHO_TRS_908.pdf#page=135 and Good distribution practices for pharmaceutical products, Annex 5, WHO Technical Report Series 937, 2006: http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf#page=191 )

SUBSCRIBER'S SYMPTOM

Challenges & Opportunities Of Blood Screening

A 10-year-old girl suffering from blood cancer, who had tested positive for HIV allegedly after getting a transfusion of infected blood in Kerala, died recently. Patients such as thalassemic children, accident victims, those undergoing surgery and cancer patients require frequent blood transfusion. A myriad of agents can potentially be transmitted through blood transfusions, including pathogens and viruses. Given the high prevalence of HIV and Hepatitis in India, the National Blood Policy states that every unit of donated blood should be tested for safety against transfusion transmissible infections. Read More

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