The Prescription: 17th December 2019 Issue

Editor’s Emulsion PSM 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

EDITOR'S EMULSION

Pyush Khaitan

Warm Greetings!
Welcome to yet another exciting month and pleasant reading of our newsletter.

The Drug Controller General of India (DCGI) has sent a directive to the state drug regulators to take “necessary action” in accordance with the Delhi High Court’s order of December 2018 that barred online sales of medicines without a licence.

At present, no licence is issued for online pharmacies as such as there are no comprehensive rules to regulate the sector. According to the draft rules for e-pharmacies, only government-registered e-portals can sell medicines. They have to also retain the prescriptions and verify the details of patients and doctors. On Tuesday, Digital Health Platforms, an association of entrepreneurs operating in the digital health industry, held a press meet in the Capital where it raised concerns around the delay in notifying the rules.

Do not hesitate to mail your comments on this edition to help us further improve so please feel free to get in touch with us. You may find our previous issues on our website jagograhakjago.com or in the NEWS ARCHIVE section of every issue of The Prescription, in case you’ve missed any of them. You may also look us up on Facebook

Stay Healthy. Stay Protected.
Pyush Misra
Editor-in-Chief

DOSE OF THE DAY

“We are in favour of online pharmacies…but it cannot come at the cost of health and safety. You can’t let anything to do with health to go without regulation.”

Bejon Misra
Founder
Patient Safety and Access Initiative of India

Sponsor

PSM India Capsules

3rd Edition Of MTaI MedTekon To Be Held In Delhi On Dec 2020

Mumbai, 7 Dec 2019: The 3rd edition of Medical Technology Association of India (MTaI)’s flagship event ‘MedTekon’ will be held on 20th December 2019 in New Delhi. The theme of the event is ‘Fostering & Fortifying Ayushman Bharat’s Foundations’.

Lok Sabha Members Support Bill On E-Cigarettes But Question Wide Use Of Tobacco

New Delhi, 27 Nov 2019: Members in Lok Sabha on Tuesday supported a bill that seeks to prohibit production, manufacture, import, export, transport, sale or distribution of electronic cigarettes but said the Centre should also take steps to curb use of cigarettes and other forms of tobacco use which was much more widely prevalent.

Drug Laws & Policy Injections

Indore: Aadhaar Must To Avail Services At IVF CentresIndore, 7 Dec 2019: Now, Aadhaar card is must to avail any service at ART/IVF centre in Indore while oocyte/semen donors will have to be registered with Pre-Natal Diagnostic Techniques Act (PCPNDT) Cell. The district administration has also fixed age-limit and registration for donors along with other parameters as part of new guidelines issued to strengthen the monitoring of centres and keep a check on grey areas and irregularities, if any, for use of the technology in infertility treatment.

Will A Separate Medical Devices Authority Reinvigorate The Sector In India? New Delhi, 6 Dec 2019: A robust regulatory mechanism has been a fairly long wait for India’s semi-regulated medical devices industry. At a time when healthcare experts are expecting a separate regulatory framework for medical devices, the government is in the process of formulating a Medical Devices Authority (MDA) for the vast range of products in the sector.

Proposed Cap On Trade Margins Will Not Hurt Pharma Cos: FitchNew Delhi, 4 Dec 2019: India's proposal to cap the trade margins available to drug distributors will not significantly hurt the profitability of pharmaceutical companies, Fitch Ratings said on Wednesday. Trade margin is the difference between the price at which manufacturers/importers sell to stockists and the price charged to consumers.

Doc’s Physical Presence Must To Validate Lab Reports: MCINagpur, 5 Dec 2019: When you go for a blood test or for sonography, ensure that the pathologist or radiologist who authenticates your report is present. The Medical Council of India (MCI), while answering a query under the right to information (RTI) Act, made it clear that physical presence of a doctor is necessary to authenticate laboratory as well as radiology reports.

Ban Not To Impact Internet Pharmacies With Licenses To Sell DrugsNew Delhi, 4 Dec 2019: A recent letter from India's top drug regulator to state drug controllers to ban unlicensed pharmacies will not disrupt growth of India's online pharmacy business, according to top CEOs of India's internet pharmacies. A Reuters report today quoting a senior government official said India's drugs regulator has asked all the states to enforce Delhi High Court directive prohibiting online medicine sales by unlicensed players, till the court takes a final decision.

Govt To Set Up Panel To Scrutinise Ad ClaimsNEW DELHI, 2 DEC 2019: In a first such move, the Centre will set up a committee to scrutinise and regulate product-feature claims made in advertisements, seeking to fix accountability on manufacturers and help consumers choose food items objectively. “The committee will scrutinise advertising claims, examine complaints, and subsequently take appropriate action,” national food regulator FSSAI’s chief executive Pawan Agarwal told ET. “A lot of businesses thrive on inducing fear in the public mind, which is incorrect.”

Pharma Injections

DCGI Directs Manufacturers To Submit PSURs Every Six MonthsMumbai, 5 Dec 2019: The Drugs Controller General of India (DCGI) has directed manufacturers to submit Periodic Safety Update Reports (PSURs) every six months for the first two years for veterinary products in India as part of the Pharmacovigilance Programme of India (PvPI).

Delay In Notification Of Rules Affecting E-Pharma IndustryNew Delhi, 3 Dec 2019: The e-pharmacy industry has urged the government for immediate release of new e-Pharmacy Rules without any further delay. Digital Health Platforms, which is an association of entrepreneurs operating in digital health Industry on Tuesday raised their concern on the impact of the delay in the industry. The indecision on the rules by the government is making it tough for investors to invest in online pharmacies, making it hard to retain employees and challenging the trust of consumers.

Antivenom Therapy In India Is Bitten By Shortcomings: Study BENGALURU, 6 DEC 2019: A new study conducted by scientists at the Indian Institute of Science (IISc) in collaboration with Gerry Martin Project and the Madras Crocodile Bank Trust and Centre for Herpetology shows that commercially available antivenoms in India can be ineffective in treating bites from certain medically important neglected snakes.

Price Ceiling On 4 Medical Devices: Centre Tells Lok Sabha New Delhi, 3 Dec 2019: Four medical devices -- cardiac stents, drug-eluting stents, condoms and intrauterine -- have been included in the national list of essential medicines and ceiling on their prices have been fixed, Union Minister Mansukh L Mandaviya said in Lok Sabha on Tuesday.

Over 300 Hospitals Get Show-Cause Notices For Submitting Forged Claims Under Ayushman Bharat Scheme New Delhi, 4 Dec 2019: Over 300 hospitals have been served show-cause notices and de-empanelled, and penalties of over Rs 3 crore have been levied on them for submitting forged claims under the Ayushman Bharat Health Insurance Scheme, government told Rajya Sabha on Tuesday. Some instances of creation of fake cards and submission of manipulated/forged claims under the Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) have come to the notice, Minister of State for Health Ashwini Choubey said.

Blow To E-Pharmacies As Centre Orders A Halt To Sales New Delhi, 4 Dec 2019: The government has ordered a halt to online drug sales as it works on rules to regulate the sector, in a setback for companies that have ploughed in millions of dollars to open up a new business arena amid lack of regulation.

Drug Dopes

No Trace Of 5.3 Crore Buprenorphine-Naloxone TabletsChandigarh, 3 Dec 2019: The illegal sale of over five crore tablets of de-addiction drug Buprenorphine-Naloxone by private centres in 11 months has shocked the Punjab Government which has issued a notice to 23 de-addiction homes and a pharma company under the NDPS Act.

Gujarat FDCA Books 217 Retailers For Illegal Sale Of Codeine Containing Cough SyrupsMumbai, 6 Dec 2019: In a major crackdown on retailers selling narcotic drugs illegally, the Gujarat Food and Drug Control Administration (FDCA) has booked 217 drug retailers for illegal sale of codeine containing cough syrups at exorbitant prices.

Thane: 10 Patients Develop Complications Post Antibiotic Injections Thane, 3 Dec 2019: Ten patients, including eight women, developed various health complications after they were administered an antibiotic medicine at a hospital in Thane district of Maharashtra, an official said on Tuesday.

Fake Doctor Running Hosp In City Nabbed Jaipur, 4 Dec 2019: Deputy collector Jaipur (South) Jagat Rajeshwar along with a team of officials from health department and police caught a compounder who was running a hospital and posing himself off as a doctor.

No Conclusive Data To Establish Air Pollution As Cause Of Death Or Diseases: Govt New Delhi, 3 Dec 2019: There is no conclusive data available in India to directly establish air pollution as the cause of deaths or diseases, the government informed Parliament on Monday. Air Pollution is one of the many factors affecting respiratory ailments and associated diseases.

US FDA To Train Gujarat FDCA Inspectors On System Based Drug Batch Manufacturing RecordsMumbai, 3 Dec 2019: In order to ensure quality and integrity of APIs, US FDA regulatory team would be training Gujarat Food and Drug Control Administration (FDCA) inspectors on system based drug batch manufacturing records (BMR) and Electronic Common Technical Document (ECTD) through a series of workshops to address data integrity issues.

National Injections

Marg ERP Unveils New Platform PharmaNxt For Retailers To Get Info About Drug Mumbai, 3 Dec 2019: Marg ERP Limited has created a platform for retailers known as PharmaNxt, where the chemist can get information about any drug, its substitutes, its HSN code, etc. This platform will empower a chemist to find his nearest distributor according to his location, who deals in the specific item or company and it will help the chemist to retain his customer and grow his business. The chemists can also check the information of tax percentage, MRP, manufacturing company, etc.

Biocon Biologics To Reduce The Cost Of Human Insulin And Cancer DrugsBengaluru, 2 Dec 2019: Biocon Biologics is focusing on innovative business models to reduce the cost of human insulin and cancer drugs, as it looks to build a pipeline of 28 biosimilars across global markets, the company’s chief executive said.

Abortion: Self-Medication By Teens Worries Doctors BENGALURU, 1 DEC 2019: Abortion-inducing drugs, which require a prescription, are increasingly being bought over the counter, and doctors and counsellors are concerned about the way they are being used by ill-informed or scared young women.

DCGI Constitutes Sub-Committee To Frame Guidelines On Post Approval Changes Mumbai, 2 Dec 2019: The Drugs Controller General of India (DCGI) has constituted a sub-committee to frame guidelines on post approval changes to pharmaceutical products in line with the global regulatory framework and followed in regulated markets.

Monitor All Adverse Reaction To Medical Devices, CDSCO Directs State Drug Controllers New Delhi, 1 Dec 2019: Through a recent notification, the Central Drugs Standard Control Organisation (CDSCO) has informed all the State Drug Controllers about its move to step up Materiovigilance Programme of India (MvPI) in the country and direct them to encourage all clinicians and healthcare professionals to mandatorily adopt reporting of medical devices adverse event to MvPI-Indian Pharmacopoeia Commission (IPC).

Govt's Public Procurement Directive To States May Restrict Competition: MTaI New Delhi, 29 Nov 2019: Government's directive to states to prefer domestically manufactured medical devices for public procurement could lead to restricting of competition, industry body Medical Technology Association of India (MTaI) has said. The timing of the directive, issued this month, is surprising as the industry is actively discussing the means to streamline public procurement of medical devices without disturbing the demand-supply equation, MTaI said in a statement.

Global Injections

Health Canada Creates New Medical Devices DirectorateOttawa, 22 Nov 2019: In a letter to stakeholders late Thursday, Health Canada announced the creation of a new Medical Devices Directorate to better respond to the challenges and opportunities related to the growing medical device industry.

First China Made Biosimilar Trastuzumab To Be Out SoonSingapore, 24 Nov 2019: Trastuzumab, a drug used for breast cancer patients may shortly be available in its biosimilar form. A randomised phase -3 study of the first China manufactured biosimilar called 'H LX02' was reported at the ESMO 2019 taking place in Singapore.

Popular Diabetes Drug May Contain A Carcinogen Washington, 5 Dec 2019: The FDA has begun testing samples of the diabetes drug metformin for the carcinogen N-Nitrosodimethylamine (NDMA), the agency announced Wednesday. Contamination with this same substance led to recalls of blood pressure and heartburn medications within the last 2 years.

US Scientific Body Launches Largest Collection Of Formulations Data In India Washington, 5 Dec 2019: A division of the American Chemical Society (CAS), specialising in scientific information solutions, has launched Formulus , the world's largest collection of formulations sourced from journals, patents and product inserts in India.

Johnson & Johnson Says New Tests Show No Asbestos In Johnson's Baby Powder NEW BRUNSWICK, N.J., 3 DEC 2019: Johnson & Johnson Consumer Inc. today reaffirmed that its Johnson's Baby Powder is safe and free of asbestos after a comprehensive investigation into the United States Food and Drug Administration's (FDA) earlier reported finding of sub-trace levels of asbestos (no greater than 0.00002%) in samples from a single bottle of Johnson's Baby Powder.

DNA-Labelled Excipients Allow On-Dose Authentication Of Meds London, 27 Nov 2019: DNA tags added to excipients during the manufacture of tablets remain stable and can be used for authentication – even after months of challenging environmental conditions.

PSM PILL

2019 NABP Report Finds Fentanyl-Laced Fake Opioids For Sale Everywhere On The Internet

November 26, 2019 : Screen capture of counterfeit Xanax and oxycodone for sale on Instagram November 22nd. In their latest report on fake online pharmacies that ply their trade in the United States, the National Association of Boards of Pharmacy (NABP) found more than 1,500 new websites that it considers “Not Recommended,” and of these, 31% are offering illicit prescription drugs, such as codeine, fentanyl, oxycodone, Adderall, Valium, and Xanax. 99% of the websites offering these drugs for sale do not require a prescription, and 94% are selling medications that lack FDA-approval.

Canadian Doctors, Pharmacists, Patient Groups And Government Representatives Consider State Importation Proposals Unfeasible

November 21, 2019 : In spite of recent efforts by legislators in Florida, Maine, Colorado, and elsewhere, Canadian patient groups are vocally opposing pending legislation that proposes importing prescription medications from the Canadian drug supply. Paul Blanchard of the New Brunswick Pharmacists’ Association told CBC News, “The country’s pharmacists association has been talking to the federal government … to make sure that the federal government and Canada is aware that the Americans are literally knocking on our door.”

Frequently Asked Questions

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SUBSCRIBER'S SYMPTOM

Booster Dose For Indian Medical Device Makers

NEW DELHI, 26 NOV 2019: In a boost for Indian medical device makers, the government has asked states to consider doing away with the requirement of US and European regulatory certification for equipment to be purchased for state-run institutions and hospitals.

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Mr Prem Burman, Professional Excellent articles being published every edition. Very enjoyable.

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