The Prescription: 1st July 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

Warm Greetings!

Yet another positive step by the Drug Controller General of India (DCGI) who had called a meeting with all major pharmaceutical companies on June 25 to discuss the proposal regarding introduction of trace and track mechanism for top 300 drug brands that are sold in India. This mechanism will be implemented across India on a trial basis to spot out counterfeit drugs. Read more on this and other important drug laws and policy injections in this edition of The Prescription.

The Centre is trying to plug a legal loophole that allows major drug manufacturers to sell and market products, such as emergency contraceptives and anti-obesity and fertility formulations, which haven't undergone clinical trials to establish their risk and efficacy.
Our Pharma injections covers this in depth along with other articles such as how Indian Pharma companies should partner with Chinese manufacturers for greater market access and how CCI is to issue an order on a case related to unfair drug trade practises in Madhya Pradesh.

In our drug dopes, get an insight on all the police and drug inspectors’ fake medicine busts around the country while catching up on the news of 20 states signing up for implementing the AB-NHPM. Read this under National Injections as you gather clarity on calcium supplements in our frequently asked questions section.

Read More>>>

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 are starting universal screening. At the age of 30 years, everyone will have to be screened not just for diabetes, hypertension and cancers, but also for tuberculosis and leprosy.”

Shri Jagat Prakash Nadda
Union Minister of Health and Family Welfare and member of Rajya Sabha from Himachal Pradesh and Parliamentary Board Secretary of Bharatiya Janata Party

FB Tw SUBSCRIBE
PSM India Capsules

Government of Odisha Organised a State Level Workshop on "Consumer Protection Act and Its Implementation" in Bhubaneswar, Odisha

23rd June 2018: Government of Odisha Organised a State Level Workshop on "Consumer Protection Act and Its Implementation" in Bhubaneswar, Odisha. The Workshop was inaugurated by Shri Surjya Narayan Patro, Hon'ble Minister, Food Supplies & Consumer Welfare & Cooperation, Govt. of Odisha and was presided by Shri Vir Vikram Yadav, IAS, Commissioner and Secretary to Govt. of Odisha, FS&CW Department and Justice Bijoy Krishna Patel, President, Odisha State Consumer Dispute Redressal Commission.

Read More
Drug Laws & Policy Injections
DCGI Called Meeting To Introduce Trace And Track Mechanism For Top 300 Drug BrandsNew Delhi, 19 June 2018: The Drug Controller General of India (DCGI) has called a meeting with all major pharmaceutical companies on June 25 to discuss the proposal regarding introduction of trace and track mechanism for top 300 drug brands that are sold in India. This mechanism will be implemented across India on a trial basis to spot out counterfeit drugs.Read More
CDSCO To Accept Only Online Applications For New Drugs, SNDs And FDCs From June 22 New Delhi, 18 June 2018: The Central Drugs Standard Control Organisation (CDSCO), as part of its efforts to promote e-governance, has decided not to accept physical applications for approval of new drugs, fixed dose combinations (FDCs) and Subsequent New Drugs (SNDs). All applications should be mandatorily filed on Sugam, an online portal developed by the health ministry. The new rule will come into force on June 22.Read More
Niti Aayog Draws Plans For Comprehensive Trade Margin Regulation Of Medical DevicesNew Delhi, 14 June 2018: Government think-tank NITI Aayog has sought stakeholder suggestions for firming up a policy to rationalise the trade margins of all categories of medical devices sold in India. The $10 billion industry, pegged to double its size in a couple of years, is largely unregulated. Read More
MoH Comes Out With Suspected ADR Form And Medicine Side-Effect Reporting Form For Intensive ADR MonitoringMumbai, 15 June 2018: In its bid to take proactive action for reporting adverse drug reactions (ADRs) towards focused Pharmacovigilance (PV) for approved drugs in the country, the Union health ministry has come out with suspected ADR form for healthcare professionals and medicines side-effect reporting form for consumers besides a toll free helpline number in the interest of patient safety. Read More
Now, A Rack For Generic Drugs In Private Chemist ShopsNEW DELHI, 13 JUNE 2018: Soon you could see cheaper generic drugs being stocked in separate racks in private chemist shops. To ease woes, in a scenario where patients pay through their nose for buying drugs, the Drug Controller General of India (DCGI) has issued instructions to all State drug controllers to ensure that private retail chemist shops have separate shelves or racks to make generic medicines available. Read More
Govt Amends Rules To Ease Regulation To Import Unapproved Life-Saving Drugs In Small Quantities For Personal UseNew Delhi, 12 June 2018: The Union health ministry has relaxed regulations to facilitate speedy availability of unapproved drugs, medications which are not permitted to be imported or marketed in the country, in small quantities for personal use. The decision is expected to bring some relief for patients who are in dire need of such imported life-saving medicines. Read More
Pharma Injections
Indian Pharma Cos Should Partner Chinese Manufacturers For Greater Market Access: StudyNew Delhi, 18 June 2018: Indian pharma companies should enter into strategic alliances and partnership with local manufacturers and distributors in China for getting greater market access in that country, a commerce ministry sponsored study has recommended.Read More
CCI To Issue Order On Case Related To Unfair Drug Trade Practices In Madhya Pradesh SoonMumbai, 18 June 2018: The Competition Commission of India (CCI) is expected to soon finalise its order on alleged unfair business practices carried out by Madhya Pradesh Chemists and Druggists Association (MPCDA) and its associates - Indore Chemists Association (ICA) and Jabalpur Chemists and Druggists Association (JCDA) in connivance with 12 leading drug companies thus violating the provisions of the Competition Act, 2002.Read More
Big Pharmaceutical Companies Face Action For Marketing Unapproved Drugs NEW DELHI, 17 JUNE 2018: The Centre is trying to plug a legal loophole that allows major drug manufacturers to sell and market products, such as emergency contraceptives and anti-obesity and fertility formulations, which haven't undergone clinical trials to establish their risk and efficacy. Read More
2 Amritsar Pharma Firms Lose Licence Chandigarh, 12 June 2018: The Punjab Drugs Controller has banned two Amritsar-based firms from manufacturing and exporting Tramadol tablets after a consignment of 24 million tablets, meant for a Dubai firm, was found being diverted to Islamic State militants in Libya. The Tribune broke the story in November last year. Read More
Maha FDA Seizes Fake Ayurvedic Drug Cos Having Mfg Base In Uttarakhand, Punjab, J&K, Raj, MP, Guj And Maharashtra Mumbai, 14 June 2018: In a major crackdown on companies for flouting norms, the Maharashtra Food and Drug Administration (FDA) has raided and seized spurious drugs worth over Rs.11 lac from retail outlets of 13 ayurvedic manufacturers in Maharashtra in contravention to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMR Act), recently. Read More
Yogi Government To Insulate Investors Against Policy Changes Lucknow, 11 June 2018: In the backdrop of Uttar Pradesh welcoming private investment, the Yogi Adityanath government has assured investors that in event of future policy changes, their units would continue to get incentives as promised under the original policy. 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
Gujarat FDCA Prosecutes Spurious Drug Manufacturer For Supplying Fake Medicine To US MarketMumbai, 19 June 2018: The Gujarat Food and Drug Control Administration (FDCA) has prosecuted a herbal drug manufacturer based in Ahmedabad for supplying spurious herbal drugs to the US market in the name of dietary supplements. Read More
Police Bust International Drug Racket, Canadian Among 4 HeldCHANDIGARH, 18 JUNE 2018: The Punjab Police on Sunday claimed to have busted an international module of drug smugglers reportedly controlled from Canada. They have arrested four people, who were using the courier service route to smuggle opium and potent date rape drug Ketamine. The drugs were concealed in cooking bowls used in community kitchens. Besides discovering the modus operandi, the police seized 4.75 kg of date rape drug and 6 kg of opium. Read More
15 More Biosimilar Drugs To Enter Indian Market Hyderabad, 14 June 2018: With 15 more biosimilars set to enter the Indian market by the year-end, the World Medical Association has asked the Indian Medical Association to draw up proper guidelines for their use, effectiveness of treatment and safety of patients. Read More
NPPA Revises Retail Prices Of 22 Formulations Mumbai, 14 June 2018: The National Pharmaceutical Pricing Authority (NPPA) has revised retail prices of 22 formulations under Drugs (Prices Control) Order, 2013 in a notification dated 12 June 2018. Read More
Drug Seized From Bus, One Person Arrested KALPETTA, 6 JUNE 2018: A team of excise officials seized 695 painkiller tablets from a traveller at the excise checkpost in Tholpetty on the Kerala-Karnataka border on Wednesday morning. Read More
National Injections
BioMérieux To Equip Guj FDCA Inspectors On Auditing Drug Quality Mumbai, 18 June 2018: To raise the bar ahead in terms of drug quality, French company BioMérieux will train Gujarat Food and Drug Control Administration (FDCA) inspectors to check contamination in medicines imported and exported as per global regulatory requirements. Read More
Human Clinical Trial Of First India Made Heart Valve BeginsLUCKNOW, 16 JUNE 2018: Human clinical trial of first ever 'Made in India' biological heart valve has begun with city's Sanjay Gandhi Post Graduate Institute of Medical Sciences on board.Read More
Local Bodies In Maharashtra Gear Up To Curb Operation Of Illegal Pathology Laboratories Mumbai, 15 June 2018: Close on the heels of Supreme Court and Maharashtra State Human Rights Commission (MSHRC) directions, the local bodies in the state have stepped up efforts to curb operation of illegal pathology laboratories. Read More
20 States Sign MoU For Implementing Ayushman Bharat – National Health Protection Mission (AB-NHPM) New Delhi, 14 June 2018: Shri J P Nadda, Union Minister of Health and Family Welfare exchanged the Memorandum of Understanding with the State Health Ministers of 20 States marking their commitment towards the launch of the Ayushman Bharat – National Health Protection Mission (AB-NHPM) at a Health Ministers conclave, here today. Shri Ashwini Kumar Choubey and Smt. Anupriya Patel, Ministers of State for Health and Family Welfare, Shri Amitabh Kant, CEO NITI Aayog, Dr. Vinod Paul, Member Health, NITI Aayog, Smt Preeti Sudan, Secretary (Health) and Shri Indu Bhushan, CEO, AB-NHPM, were also were also present at the function. Read More
Need To Develop New Methods To Tackle Bacterial-Drug Resistance Chandigarh, 18 June 2018: A day-long symposium on the pressing issue of the increasing presence of drug-resistant bacteria or “superbugs” in hospitals was organised at the Institute of Microbial Technology (IMTECH) here on Monday to develop new collaborative research networks for building multi-institutional projects focused on discovering novel anti-bacterials, exploring policy measures and developing tools to tackle anti-microbial resistance. Read More
Maha State Medical Education Dept Reviews Proposal To Mandate Issuance Of Ayurvedic Medicine Sale License Mumbai, 11 June 2018: Even as Maharashtra Food and Drug Administration (FDA) has upped its ante in dealing with non-compliance to Drugs and Magic Remedies (Objectionable Advertisement) Act (DMR Act) 1954, its proposal to mandate issuance of sale license for ayurvedic drugs would soon be approved as it has been taken up for review by the state medical education department. This is followed by finally sending the proposal for approval to the state cabinet. Read More
Global Injections
Depression Is A Potential Side Effect Of Over 200 Common Prescription Drugs, Scientists Warn Chicago, 13 June 2018: One-third of adults in the U.S. may be unwittingly using prescription drugs that could cause depression or raise the risk of suicide, a study has found. Read More
NAFDAC Wants Stiffer Penalty For Drug Counterfeiters Abuja, Nigeria, 18 June 2018: The National Agency for Food, Drug Administration and Control (NAFDAC), has proposed stiffer penalty for drug counterfeiters in the country to serve as deterrent to others. Read More

Are Vitamin And Mineral Supplements Useful To Prevent Critical Illnesses? Toronto, 18 June 2018: Are the vitamin and mineral supplements you take of much benefit to your health? A study led by researchers at St Michael's Hospital (Canada) and the University of Toronto and published in the Journal of the American College of Cardiology, shows that supplements provide neither consistent health benefit nor do any harm. The study was a systematic review of existing data and single randomised control trials done between January 2012 and October 2017.Read More

Now, A Spider Silk Based Capsule To Deliver Vaccines Geneva, 13 June 2018: Scientists have developed microcapsules made of spider silk that can deliver vaccines directly to the heart of immune cells.Read More

Risk Of Burnout Can Be Estimated By Analysing Saliva Samples : Study Vienna, 15 June 2018: According to calculations from the World Health Organisation, depression occupies first place in the global "disease burden" and, by 2030, experts estimate that there will be three mental illnesses in the Top 5: depression, Alzheimer's and other forms of dementia and alcohol addiction. Even Austria is seeing an increase in mental problems such as burnout and, since 2010, these have been the main reason for invalidity retirement. Researchers from MedUni Vienna and the Health Insurance Agency’s Health and Prevention Center have now shown that burnout can be identified by means of a simple saliva test. The hormone cortisol is the marker used for this.Read More

Researchers Create The First Antimicrobial Medical Examination Gloves London, 31 May 2018: At an event in London, British researchers at the University of Nottingham unveiled to the world the very first medical gloves designed to prevent the spread of infection. The team predicts that their product will be a game changer, selling in the billions in the coming years.Read More

PSM PILL

On June 7, 2018 The Partnership For Safe Medicines Hosted The 2018 Interchange At The National Press Club In Washington, DC.

Visit the 2018 Interchange page to watch prosecutors, law enforcement, advocates, regulators and families of counterfeit drug victims discuss the difficulty of stopping foreign drug counterfeiters, the terrible impact of counterfeit prescription pills on American families, and the threat fentanyl poses to law enforcement. jagograhakjago.com

Read More

House Of Representatives Passes The STOP Act, Bringing U.S. One Step Closer To Closing Global Postal Loophole Fueling Opioid Epidemic

June 15, 2018, Washington, D.C. : Today, the U.S. House of Representatives came together across party lines to pass the Synthetics Trafficking and Overdose Prevention (STOP) Act, introduced by Representatives Mike Bishop (R-MI) and Bill Pascrell (D-NJ), by a vote of 353-52. The bill now heads to the Senate for debate and passage.

Read More

Frequently Asked Questions

Q. Calcium Supplements: Should You Take Them?
Ans: Many people take calcium supplements hoping to strengthen their bones. However, they may have drawbacks and even health risks, including raising the risk of heart disease. The answers below to the frequently asked questions explain what you need to know about calcium supplements, including who should take them, their health benefits and potential risks. Read More>>>

SUBSCRIBER'S SYMPTOM

Serial drama: seven steps to avoid falling foul of FMD

Article contributed by Mark Davison, Head of Operations in the EU for frxcel

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. Mark Davison, Head of Operations in the EU for rfxcel, outlines everything you need to know and what you need to do for a seamless serialisation process – before regulators remove your right to trade. Read More

Upcoming Events
UpComing Events
Laughter Dose
Blog Addicts
Samriddhi Help-care blogs : “The content of PSM News-‘The Prescription’ is highly inspiring and informative for every common individual”
Ayush Healthy Life organization says:“PSM India has empowered us for fight against fake medicines!”
Dr. Gupta twits : “PSM India is worthy of appreciation for its endeavour against spurious drugs! Continue the informative content in The Prescription.”
This Newsletter is brought to you by
© 2011 Partnership for Safe Medicines India
F-9, 2nd floor, Kailash Colony, New Delhi -110048
jagograhakjago.com; www.jagograhakjago.com;
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.