The Prescription: 1st January 2019 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

Wishing all our readers and their family a Very Bright, Happy, Healthy and Prosperous 2019! May we step into this year with new hopes, renewed aspirations and magical dreams and the capacity to fulfil them all.

While the coming months would see stricter implementation of quality standards and increased awareness of the risks of online pharmacy, NITI Aayog has pitched for reform in the Health sector. The Goods and Services Tax (GST) Council will soon consider a proposal that makes it mandatory for hospitals to bill medicines and hospitalisation charges separately, a move that could help plug any leakage in GST collection from healthcare providers. Such a measure is also seen benefiting consumers as it will make hospital bills more transparent.
If a patient did not get a particular medicine from drug distribution counter, which was listed in free medicine scheme, he has the right to lodge his complaint at vigilance or supervisory committee at RMSCL level; revision of guidelines for tackling NSQ drugs and uniform implementation of new labelling norms all make up interesting reads under PSM India Capsules and Drug Laws And Policy Injections.

The year 2019 shall see positive changes with a major turnaround for the Indian Pharma sector and industry and regulators collaborating to understand patient requirements. Read more on this under Pharma Injections while catching up on drug hauls and drug safety guidelines under Drug Dopes.

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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

“Regulators’ intention is not to kill the industry but to oversee and standardize the processes. To protect public health, and control discrepancies, both intentionally and unintentionally, we need to have a strong and effective regulatory system.”

Dr.S.Eswara Reddy
Drugs Controller General (India)

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PSM India Capsules

Faulty medical devices: Govt sets up panel to frame rules for compensation; PSM India Founder part of sub committee

MUMBAI: In good news for patients, the government has set up an expert panel to frame rules for compensation in case of an adverse event due to a faulty or unsafe medical device. Read More

70th Indian Pharmaceutical Congress concludes

Discussions were held on how in the coming months the sector will see stricter implementation of quality standards and increased awareness of the risks of online pharmacy.
The three-day 70th Indian Pharmaceutical Congress, inaugurated by Vice President of India, Venkaiah Naidu, concluded at the Amity University Campus, Noida. The event was graced by her holiness, Anand Murti Guru Maa as the Chief Guest and Bejon Misra as the Guest of Honor.

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Hospitals May Have To Split Medicines, Services Bill For Tax

The Goods and Services Tax (GST) Council will soon consider a proposal that makes it mandatory for hospitals to bill medicines and hospitalisation charges separately, a move that could help plug any leakage in GST collection from healthcare providers. Such a measure is also seen benefiting consumers as it will make hospital bills more transparent.

Read More
Drug Laws & Policy Injections
NPPA Revises Retail Prices Of 24 FormulationsMumbai, 26 Dec 2018: The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 24 formulations under Drugs Prices Control Order (DPCO) 2013 in related notification dated 21 December, 2018.Read More
Vigilance Panel For Free Med Scheme Set To Be Revived Jaipur, 26 Dec 2018: Vigilance and supervisory committee for free medicines scheme, which is lying almost defunct, will get active. Soon after the implementation of free medicine scheme in 2011, a cell for supervision and vigilance of free scheme was constituted at the level of Rajasthan Medical Services Corporation Limited (RMSCL), which is a body responsible for proper implementation of free medicine scheme.Read More
Govt To Amend D&C Rules To Prohibit Promotion Of Schedule G DrugsNew Delhi, 26 Dec 2018: In a bid to prevent pharmaceutical companies from making misleading claims about the curative abilities of drugs specified under Schedule G, the Central government is getting ready to amend the Drugs and Cosmetics (D&C) Rules of 1945 to incorporate a new clause in conditions for obtaining a manufacturing license. Read More
NITI Aayog Pitches For Enactment Of National Medical Commission BillNew Delhi, 23 Dec 2018: Government think-tank NITI Aayog has pitched for enactment of the National Medical Commission (NMC) Bill, 2017, observing that regulatory bodies the Medical Council of India and the Nursing Council of India have "failed" to ensure adequate availability and quality of health professionals. Read More
Govt To Revise Guidelines For Tackling NSQ DrugsNew Delhi, 24 Dec 2018: The pharmaceutical regulators will soon get more teeth to deal with poor-quality medications that are manufactured and marketed in India. A government proposal to revise the guidelines for taking action on producers of ‘not of standard quality’ (NSQ) drugs has been approved by the Drug Technical Advisory Board, the country’s top pharmaceutical advisory body. Read More
MoH Notifies Uniform Implementation Of New Labelling Norms From April 1, 2019Mumbai, 24 Dec 2018: The Union health ministry has come out with draft notification implementing 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. Read More
Pharma Injections
Indian Pharma Sector Set For A TurnaroundMumbai, 22 Dec 2018: The Indian pharmaceutical industry, after facing a tough time last year, is headed for a turnaround in FY19. The sector’s year-on-year revenue growth was coming back on track, as per an EY presentation at a recent CPhI CEO Roundtable 2018.Read More
Industry And Regulators Collaborate To Understand Patient Requirements At IPC 2018New Delhi, 22 Dec 2018: Day 2 of IPC 2018 saw industry captains and regulatory authorities come together with the aim of building better synergies and strengthen their relationship to serve patients better.Read More
Demand For Separate Tribunal To Resolve Pharma Cases New Delhi, 21 Dec 2018: Members of the Indian Pharmaceutical Congress Association (IPCA) will ask the drug controlling authority to set up a separate tribunal for resolving legal cases pertaining to the industry. Read More
No Restrictions On Online Sales Of Medicines For Now: Madras HC Chennai, 21 Dec 2018: A division bench of the Madras High Court on Thursday observed that there is no ban on the sale of online drugs until it delivers the final order. Read More
Pharma Industry Upset With Govt’s Hike In Fee For Drug Licenses, But Welcomes Import Duty Hike Bengaluru, 21 Dec 2018: Pharma industry across India including those under the banner of the Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) are now in the dock with the recent notification from the ministry of health and family welfare on the revision in the drug license fee and related levies.Read More
DCGI Asks Manufacturers Of 49 FDC Formulations To Submit Data To Justify Therapeutic Claims New Delhi, 19 Dec 2018: The irrationality of many fixed dose combination (FDC) drugs in the Indian market would be back in the spotlight as the Drugs Controller General of India (DCGI) has asked manufacturers of 49 combination medications to submit clinical trial protocol or post marketing surveillance (PMS) data to justify therapeutic claims. Read More
Drug Dopes
4 Arrested For Running Drug FactoryNoida, 25 Dec 2018: Four persons, including a woman, were arrested on Monday morning for allegedly running a marijuana packing factory in Noida Sector 18 and selling it outside colleges, schools and other public places, the police said on Monday. Read More
Drug Peddler Arrested By Hanumangarh CopsJAIPUR, 24 DEC 2018: The Hanumangarh police claimed a major breakthrough after the police arrested one drug peddler with 1,40,400 tablets of highly addictive Tramadol which the accused had smuggled from New Delhi through a cargo delivery company. Read More
CDSCO Issues Safety Guidelines For Isotretinoin New Delhi, 20 Dec 2018: The Central Drugs Standard Control Organisation (CDSCO) has issued safety guidelines for Isotretinoin, an oral drug, which is used in the treatment of severe acne. Read More
DCGI Orders J&J Not To Use Talc Raw Material For Any Production Till Further Orders NEW DELHI, 21 DEC 2018: The Drugs Controller General of India (DCGI) has ordered Johnson and Johnson not to use talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for any production till further directions. Read More
MoH Prohibits Distribution, Sale Of Buclizine As 'Appetite Stimulant' New Delhi, 19 Dec 2018: The Union Health Ministry has prohibited the distribution and sale of anti-histamine drug Buclizine as an appetite stimulant "in public interest" under the Drugs and Cosmetics Act. Read More
Chennai: Man Held For Selling Prescription Drugs Hidden Inside MatchboxesCHENNAI, 19 DEC 2018: A 28-year-old man, who runs a grocery store, was arrested on Tuesday for selling Schedule H drugs without prescriptions in St Thomas Mount. Based on a tip-off, a police team led by St Thomas Mount inspector Valarmathi, raided his shop and seized 10 strips, each containing 10 tablets from his shop. Read More
National Injections
CAG Report Reveals 63% Shortfall In Inspections In Manufacturing Units By Maha FDA Mumbai, 24 Dec 2018: Performance audit of Maharashtra Food and Drug Administration (FDA) done by Comptroller and Auditor General (CAG) for the period from March, 2012 to April 2017 has revealed shortfall in inspections to the extent of 35 per cent in case of drug manufacturing units and 63 per cent in case of drug retail units.Read More
India Wants China To Allow Import Of Drugs Cleared By US, EuropeNEW DELHI, 22 DEC 2018: India has requested China to allow imports of Indian drugs cleared by the drug administrators of the United States, European Union and Japan, as China recognises these approvals. It has also sought a special price category for Indian generics so that they don’t compete with branded products.Read More
Make India The International Capital For Generic Medicines: Vice President Noida, 21 Dec 2018: The Vice President of India, Shri M. Venkaiah Naidu has called up on the pharmaceutical industry to work towards making India an International Capital of Generic Medicines. Read More
Delhi HC Seeks Govt Reply On Unsafe Drugs Ban Plea NEW DELHI, 21 DEC 2018: The Delhi High Court has given the health ministry time till January 4 to respond to a lawsuit seeking a ban on certain medicines sold in India even after government experts flagged them for safety issues several years ago, ET has learnt. Read More
Maha FDA Urges CDSCO To Place Intraocular Lenses Under NLEM To Prevent Overcharging Mumbai, 21 Dec 2018: Maharashtra Food and Drug Administration (FDA) has submitted its study report on the overcharging of intraocular lenses at the point of care to the Central Drugs Standard Control Organisation (CDSCO). The purpose of the study is to bring intraocular lenses under the National List of Essential Medicines (NLEM) to protect patients from being overcharged in hospitals. Read More
Healthcare Firm Told To Pay 5,000 For Charging Rs 40.79 Extra PANCHKULA, 18 DEC 2018: The District Consumer Disputes Redressal Forum has directed a healthcare company to pay Rs 5,000 to a Panchkula resident for charging Rs 40.79 extra in its bill. Read More
Global Injections
Isotretinoin For Severe Acne Alters Skin Microbiome: Study New York, 21 Dec 2018: Isotretinoin, a form of vitamin A, has been prescribed to treat acne for decades. It reduces oil production in the skin, which helps prevent acne from forming. Read More
Antibiotic Overuse Is High For Common Urology Procedures New York, 21 Dec 2018: A new study suggests that antibiotics are being overused in up to 50 percent of patients undergoing common urological procedures. The study, led by Daniel Livorsi, MD, University of Iowa Read More

Over 100 New China-Developed Medicines Certified BEIJING, 22 DEC 2018 (Xinhua): A total of 117 new medicines developed by Chinese researchers have been certified thanks to support from a major national project, a health official said Saturday.Read More

AI Can Predict Risk Of Infection After Surgery London, 16 Dec 2018: Scientists have developed an artificial intelligence (AI) tool that can successfully predict whether a patient is at risk of developing a serious, and possibly life-threatening infection after surgery.Read More

US FDA Releases Final Rule On Classification, Reclassification Of Medical Devices Maryland, 14 Dec 2018: The FDA issued a final rule that implements modifications made by the FDA Safety and Innovation Act, as well as updates and clarifies the Part 860 regulations without making substantive changes to existing practices for the classification and reclassification of medical devices.Read More

US FDA Looks To Modernize Generic Drug Labels Maryland, 13 Dec 2018: FDA Commissioner Scott Gottlieb, MD, announced that FDA was withdrawing the 2013 proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, that would have allowed generic-drug makers to update and distribute safety information in their drug labeling. The action comes after consideration of the cost such a rule may have imposed on generic-drug manufacturers. In addition, the agency is updating labels on certain generic cancer drugs with new safety and efficacy information so that prescribers and patients have the most up-to-date information.Read More

PSM PILL

Multi-State Counterfeit Pill Drug Trafficking Organization Halted By 400+ Law Enforcement Officers On December 5th And 6th

A series of drug seizures by the Bremerton Police Department last year has led Federal authorities to a massive drug trafficking organization that was responsible for bringing thousands of counterfeit oxycodone pills made with fentanyl into Skagit and Snohomish counties, the Department of Justice (DOJ) reports.

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Thousands Of Fake Pills Purchased From China Shipped To Man In New York State

December 19, 2018: According to the Democrat & Chronicle, a Rochester, New York man pleaded guilty in federal court to two counts of smuggling counterfeit pills into the country. Court documents stated that a package mailed from China to Samuel McFarland via DHL was flagged by U.S. Customs and Border Protection (CBP) for inspection on January 8, 2018. Inside the package shipped from the Guangdong Province in China, agents found 100 bottles that each contained 30 Cialis pills. The package’s manifest listed the contents as “free trade samples” valued at $1 each.

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Frequently Asked Questions

Q1. What are Nutraceuticals?
Ans: Nutraceuticals are products that provide health and medicinal benefits, including the prevention and treatment of diseases in addition to the basic nutritional value found in foodstuff. They are used to promote general well-being, control symptoms and prevent malignant processes. Nutraceuticals are broadly classified as Functional foods and Dietary Supplements. Read More>>>

SUBSCRIBER'S SYMPTOM

End Of Wrong Treatment? ICMR’s Bid To Provide Quality Diagnosis

Article contributed by Prof. Rex Sengupta from Kolkata

New Delhi, 15 Dec 2018: Today, many people are unable to get tested for diseases because they cannot access diagnostic services while many others are incorrectly diagnosed, leading to a situation where they do not receive the required treatment or even the wrong treatment. In order to ensure quality diagnosis at all levels of healthcare facilities, the Indian Council of Medical Research (ICMR) has articulated a new list of essential diagnostics. The new draft is on the lines of the essential medicines list and is scientifically designed.Read More

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Ms. Vaani Manchandaa, Pharma Academician: Thank you PSM India. Continue the good work!
Dr. Naresh Kumar, Research Scholar:The Prescription is at all times trying to keep us up-to-date with the latest medication news, fake drug alerts and approvals which is indeed praiseworthy!
Dr. S. Chakravarty, Principal of a reputed Pharma and allied Health Sciences Institution states: My earnest gratitude and applauds to PSM-India for the continuous action they have taken in fighting menace of unsafe medicines in India!
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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.