The Prescription: 1st May 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

To empower state drug controllers to issue stop sale order to drug wholesalers and retailers for non-compliance, the Union Ministry would soon amend Rule 66 of D&C rules. To know more on this and on setting up of PMRUs, barcoding of APIs used in drugs becoming mandatory, incorporating new recorded adverse effects in leaflets and more, read PSM India Capsules and Drug Laws And Policy Injections.

The country's pharmaceutical exports rose by 11 per cent to USD 19.2 billion in 2018-19, mainly driven by higher demand in regions such as North America and Europe, as per a commerce ministry data. The pharma exports in 2017-18 stood at USD 17.3 billion and USD 16.7 billion in the previous fiscal. Find this interesting read under Pharma Injections while going through an article on prescription medicines and antibiotics being sold over the counter in Delhi under Drug Dopes of this newsletter.

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Stay Healthy. Stay Protected.

Pooja Khaitan

Editor-in-Chief,
The Prescription

DOSE OF THE DAY

“One of the prime objectives of a regulator is to ensure safety of medicines marketed in the country. We have initiated Pharmacovigilance Programme of India. It gathers Adverse Drug Reactions (ADR) reported from across 250 ADR monitoring centres in the country. Majority of these centres are located in various medical colleges. You have to play an important role in communicating ADRs to concerned authorities.”

S. Eswara Reddy,
Drugs Controller General of India,
Central Drugs Standard Control Organisation,
Union Ministry of Health and Family Welfare

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PSM India Capsules
Many Essential Drugs Priced Much Higher Than Manufacturing Cost:WHO

Around 40% of the essential medicines in India with lowest MRP are priced significantly higher than estimated production costs, an assessment by the World Health Organisation (WHO) shows highlighting the “exorbitant” profiteering by pharmaceutical companies and the scope for lowering prices of drugs.

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2 Common Antibiotics Have Side-Effects: DCGI

Two commonly used antibiotics — ofloxacin and injectable cefotaxime — have been found to have side-effects that were hitherto unknown. Ofloxacin, which is used commonly to treat bacterial infections, has been found to cause a severe skin reaction called Stevens Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN) as an adverse drug reaction.

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Only Medical Colleges With Functional Hospitals For 3 Years May Get MCI Nod

Of the 89 new medical colleges that were approved in 2011-2018, 39 failed to clear inspection by the Medical Council of India (MCI), according to data available with the NITI Aayog. In most cases, the functioning of the hospital was found to be “deficient”. So the MCI Board of Governors (BoG) is now considering the option of restricting new medical colleges to institutions which have a functional hospital for at least three years.

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Drug Laws & Policy Injections
Health Ministry To Amend Rule 66 To Issue Stop Sale Order For Non-ComplianceMumbai, 23 April 2019: The Union health ministry will soon amend Rule 66 of Drugs and Cosmetics (D&C) Rules, 1940 to empower state drug controllers to issue stop sale order to drug wholesalers and retailers for non-compliance.Read More
CDSCO Releases Data Of SQ Drugs Along With NSQ Drugs Mumbai, 22 April 2019: In a move to boost the image of Indian drug manufacturers, the Central Drugs Standard Control Organisation (CDSCO) has for the first time released data of drugs declared as standard quality (SQ) by Central Drugs Laboratory (CDL) and Regional Drugs Testing Laboratories (RDTLs) along with monthly data of not of standard quality (NSQ) drugs.Read More
NPPA Directs State Drug Controllers To Expedite Setting Up Of PMRUsMumbai, 22 April 2019: The national drug pricing regulator, National Pharmaceutical Pricing Authority (NPPA), has asked the state drug controllers to expedite setting up of Price Monitoring and Resource Units (PMRUs) in their respective states for effectively tracking drug price violations by the pharma companies. The primary function of PMRUs is to assist NPPA in price monitoring and drug availability. Read More
Barcoding Of APIs Used In Drugs To Become MandatoryNew Delhi, 21 April 2019: The Union health ministry will make it mandatory for all active pharmaceutical ingredient (API) packages to be barcoded to detect spurious drugs and monitor imported and indigenously produced raw materials used to manufacture medicines. Read More
DCGI Directs Drug Manufacturers To Incorporate New Recorded Adverse Effects In LeafletsNew Delhi, 18 Apr 2019: The Drug Controller General of India (DCGI) has written to all state drug regulators to direct manufacturers of certain antibiotics and anti-psychiatric drugs to include their new recorded adverse effects in the leaflets inside the package to promote patients' safety. Read More
Health Ministry To Amend Rule 65 To Replace ‘Chemists & Druggists’ With ‘Pharmacy’Mumbai, 18 April 2019: In order to give retail trade a better professional recognition, the Union health ministry will soon amend Rule 65(15)(b) and Rule 65(15)(c) of Drugs and Cosmetics (D&C) Rules, to replace ‘Chemists & Druggists’ with ‘Pharmacy’. Once the amendment is done, all the medical shops in the country will be called as Pharmacy. Read More
Pharma Injections
Price Controls Hurting FDI In Medical Devices SectorNew Delhi, 23 April 2019: Blanket implementation of price controls has contributed to a drastic fall in Foreign Direct Investment (FDI) in the medical device sector, say industry insiders, pointing to a reduction from $439 million in 2016 to $66 million in 2018.Read More
Pharma Exports Rise In 2018-19New Delhi, 23 Apr 2019: The country's pharmaceutical exports rose by 11 per cent to USD 19.2 billion in 2018-19, mainly driven by higher demand in regions such as North America and Europe, as per a commerce ministry data. The pharma exports in 2017-18 stood at USD 17.3 billion and USD 16.7 billion in the previous fiscal.Read More
After Six Years Of Legal Battle, CBI Takes Over Probe On Tripura's Spurious Drug Case Agartala, 20 April 2019: Six years after a doctor from Tripura moved the Supreme Court against Vardhaman Pharma Private Limited, a Himachal Pradesh-based drug manufacturer for purportedly supplying 11 spurious life-saving drugs to the state government, Central Bureau of Investigation (CBI) on Friday took over the investigation of the case. Read More
3 Companies Restrained From Launching Diabetes Medicine AHMEDABAD, 21 APRIL 2019: A commercial court here has temporarily restrained three Gujarat-based pharmaceutical companies – Cadila Healthcare Ltd, Maan Pharmaceutical Ltd and West Coast Pharmaceutical Works Ltd – from manufacturing and launching in the market a medicine for Type-2 diabetes. Read More
New Legal Risks Emerge For Indian Pharma Mumbai, 19 April 2019: Investors in Indian pharma companies may have become tolerant of the patent law suits and FDA clampdowns, but there is a steadily emerging set of law suits – class action suits, anti-trust suits and whistle-blower suits – that threaten to exponentially increase the risk in investing in pharma stocks. Price collusion, pay-fordelay arrangements and manufacturing malpractices are the issues that potentially invoke litigations involving these companies.Read More
Complaint Is To Be Filed Against Bio-Med In Polio Vaccine Matter New Delhi, 19 April 2019: Authorities are set to file a complaint against the people responsible for running the affairs of Ghaziabad-based Bio-Med Pvt. Ltd for supplying “adulterated" polio vaccines, two people aware of the matter said.Read More
Drug Dopes
Delhi HC Allows Alembic, Natco Pharma To Export SorafenibNew Delhi, 22 April 2019: The Delhi High Court on Monday allowed Alembic Pharmaceuticals and Natco Pharma to export sorafenib, an active ingredient in Bayer’s cancer drug Nexavar, and rivaroxaban, the active ingredient in its blood thinner medicine Xarelto for research and development (R&D) purpose. Read More
DCGI To Seek WHO Inputs In Contaminated Polio Vaccine Supply CaseNEW DELHI, 22 APRIL 2019: The drug regulatory authority will seek inputs from the World Health Organisation (WHO) to corroborate and reinforce allegations in the complaint it plans to file against Ghaziabad-based firm BioMed for supplying polio vaccine contaminated with type 2 virus. Read More
Prescription Medicines, Antibiotics Being Sold Over The Counter In Delhi New Delhi, 22 April 2019: Many pharmacies across Delhi are selling prescription medicines for heart diseases, depression, pain and antibiotics for infection without a prescription, showed a visit to 10 pharmacies outside major public hospitals in central and south Delhi. Read More
Supplements May Lower Efficacy Of Select Drugs Hyderabad, 22 April 2019: Dietary supplements are becoming part and parcel of many patients’ lives but they are found to lead to adverse events due to the interaction between drugs the patient may be taking and the supplement. The effects are not often known to clinicians and are also less understood. It is always important to understand the contents of a supplement in terms of chemicals and micronutrients. Read More
Low-Cost Chinese APIs Pose Health Risk To People Mumbai, 18 April 2019: Low-cost Chinese active pharmaceutical ingredients (APIs) continue to throng the Indian market through illegal route, posing a health risk to the people. APIs such as erythromycin stearate, used to treat a wide variety of bacterial infections, are being imported by certain Indian drug companies /traders from China without requisite registration certificates and the material is being sold at a very low price in India. Read More
Vision-Blurring’ Drugs Dabigartan And Sertraline Put On AlertHyderabad, 18 April 2019: Two suspected drugs Dabigartan and Sertraine that are leading to severe adverse events in the vision and also the neuro system must be reported to the Pharmacovigilance Programme of India (PvPI) as the prescription of these drugs has to be revised. Read More
National Injections
Focus Of Research Should Be On TB And Malaria' Chennai, 23 April 2019: With India still predominantly being a generic drugs producing country, the focus should be on innovation, research and development especially on diseases of relevance to the Indian context such as tuberculosis, HIV and malaria, S. Eswara Reddy, Drugs Controller General of India, Central Drugs Standard Control Organisation, Union Ministry of Health and Family Welfare said.Read More
Haryana STF Busts Insurance Scam Using Dead Cancer PatientsCHANDIGARH, 20 APRIL 2019: The Haryana police's special task force (STF) on Friday unearthed a scam in which insurance claims were made for deceased cancer patients by "proving" their deaths to have been caused by accidents.Read More
IMA Slams Idea Of 'Bridge Course' For Dentists Kolkata, 20 April 2019: The Indian Medical Association (IMA) has condemned the idea of 'Bridge Course' to create cadres of mid-level health practitioners by allowing dentists to practice mainstream medicine in various health centres. Read More
Govt Plans To Hire 750 Officers To Regulate Medical Devices New Delhi, 17 April 2019: The Modi government plans to recruit 754 officers to exclusively regulate the sale of medical devices and monitor their efficacy in India, ThePrint has learnt. Read More
Tribal Girl Opens 1st Medical Store In Maoist Stronghold RAIPUR, 18 APRIL 2019: Chhattisgarh’s remote Abujmarh forest, a Maoist stronghold, has got its first medical store, thanks to the courage of a 23-year-old tribal woman. It’s just the sort of pep pill this inaccessible region needs. Read More
Ahmedabad Doctor Fined For Prescribing Vitamin B12 To Man With Stroke Symptoms AHMEDABAD, 16 APRIL 2019: The Gujarat state consumer court ordered a city-based neurosurgeon to pay Rs 4 lakh, with 9% interest, towards the treatment cost of a stroke patient. Read More
Global Injections
Drones To Deliver Vaccines, Blood And Drugs Across Ghana LONDON, 24 APRIL 2019: Hundreds of drones will begin delivering life-saving vaccines, blood and medicines to patients in Ghana this week in the largest scheme of its kind, the global vaccine alliance GAVI said on Wednesday. Read More
Febuxostat Used To Treat Gout Is Dangerous, US FDA WarnsMaryland, 21 April 2019: The U.S. Food and Drug Administration (FDA) has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. Read More

China Proposes Heavier Penalties On Counterfeit Vaccine Makers Beijing, 21 April 2019: China is intensifying its crackdown on makers of ineffective vaccines by introducing heavier penalties and more stringent regulations.Read More

Asthma Inhalers Emit As Much Carbon As A 290-Km Drive: Study London, 17 April 2019: Asthmatic patients are being encouraged to opt for environmentally friendly inhalers after it was revealed the most popular versions emit the same amount of greenhouse gas as a car journey between London and Sheffield.Read More

US FDA Releases New Guidance On Medical Devices Containing Nitinol Maryland, 18 April 2019: The U.S. Food and Drug Administration published a draft guidance titled, “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol,” which includes proposed recommendations on what manufacturers should include in their premarket submission of a device containing nitinol, an alloy of nickel and titanium.Read More

Mauritian Herbs Found To Stop Growth Of Cancer Cells: Research Washington, 22 April 2019: A recent study has claimed that the extracts of the endemic Mauritian medicinal herb stop the proliferation of oesophageal squamous carcinoma cells, one of the most deadly types of cancer. The details were published in the Journal of Acta Naturae.Read More

PSM PILL

Arizona Couple Indicted For Selling Counterfeit Pills Made With Fentanyl, Pills Implicated In Death Of Arkansas Man

Jacob Medina and his pregnant girlfriend, Diane Erika Marin, have been arrested in connection with a counterfeit pill distribution ring that is allegedly responsible for killing an Arkansas man, the KATV reports. According to KATV, the police stated that Medina and Marin are alleged to have sold counterfeit oxycodone made with fentanyl analogues to people all over the United States. The couple was arrested at their home in Glendale, Arizona on March 4th.

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Oncology Practice Managers: This “Drug Importation Proposal That Could Put Floridians At Risk”

This editorial by Michelle Flowers was published in the Palm Beach Post on April 22, 2019. Flowers is the president of the Oncology Managers of Florida. Point of View: Healthcare Costs Must Be Addressed, But Drug Importation Is Not The SolutionRead More

Frequently Asked Questions

Q1. What is Drug Fever?
Ans: Drug fever is a common condition that is frequently misdiagnosed. It may be defined as a disorder characterized by fever coinciding with administration of a drug and disappearing after the discontinuation of the drug, when no other cause for the fever is evident after a careful physical examination and laboratory investigation. Drug-induced fever is a symptom of an adverse drug reaction wherein the administration of drugs intended to help a patient causes a hypermetabolic state resulting in fever. The drug may interfere with heat dissipation peripherally, increase the rate of metabolism, evoke a cellular or humoral immune response, mimic endogenous pyrogen, or damage tissues. Read More>>>

SUBSCRIBER'S SYMPTOM

3 BP Readings Must For Right Diagnosis

Article contributed by Ms.Maya Chandok, Muzzafarpur, Bihar

MUMBAI, 15 APRIL 2019: The chances of a patient’s blood pressure readings not being accurate are high if not taken thrice during a visit, states a new Indian study. The study by the Public Health Foundation of India and All India Institute of Medical Sciences (AIIMS), New Delhi has calculated that there is a 63% higher prevalence of hypertension if only the first blood pressure reading is considered for diagnosis in comparison to the mean of the second and third readings.Read More

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