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EDITOR'S EMULSION
For over 10 years at least, a battle has been raging on whether science or commerce dictates a company’s decision to market an FDC. With there being multiple levels of scrutiny, the end to this discussion seemed nigh and there was a ban on 328 drugs. But with pro-health groups saying that FDCs account for half the domestic drugs market and half that segment is irrational, the battle on combination drugs seems far from over. Get an insight into this interesting article in PSM India capsules.
Government is working on policies and laws to better the healthcare sector like bringing in an Indian standardization of medical devices or constituting committees to check the safety and efficacy of FDCs. Read more such news under drug laws and policy injections while going through articles under Pharma injections such as on drug firms retaining their brand names for new medicines or diagnosis of diseases to get cheaper and more accurate.
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The Prescription
DOSE OF THE DAY
“I dream of a Digital India where quality healthcare percolates right up to the remotest regions powered by e-Healthcare.”
Hon’ble Prime Minister of India,
Shri Narendra Modi
PSM India Capsules
No Remedy In Sight For War On Combination Drugs
As the furore over fixed dose combination (FDC) drugs goes into another loop of litigation, it may well open up a new flank in terms of regulatory scrutiny on these drugs. FDC medicines involve two or more medicines in a single pill. For over 10 years at least, a battle has been raging on whether science or commerce dictates a company’s decision to market an FDC.
Why banned drugs usage is on the rise?
The healthcare system in India is delivered not only by allopathic doctors and hospitals but also ayurvedic practitioners and holy healers. These two extreme divisions in the healthcare sector makes any implementation of policy in the country difficult. The Indian healthcare system is already facing many challenges in trying to serve its 1.3 billion population.
Drug Laws & Policy Injections
Govt To Soon Bring Indian Standardisation For Medical Devices: Senior OfficialNew Delhi, 20 Sept 2018: A range of medical devices, old or new, will soon have an 'Indian standard' and nearly 1,000 products are presently being benchmarked, a top government official said Thursday. NITI Aayog member V K Paul, in his address at a conference here, said the standardisation is expected to be completed in the next two months.
Expert Panel Says Firms Failed To Submit Coherent Data On Safety, Efficacy Of FDCs New Delhi, 19 Sept 2018: The subcommittee of Drug Technical Advisory Board (DTAB), which recommended a ban on 343 fixed dose combination (FDC) drugs and restricted another six, said most companies failed to generate safety and efficacy data to justify their FDCs.
Centre Plans Law To Hold Medical Device Makers Liable For DefectsMUMBAI, 20 SEPT 2018: In an apparent response to the Johnson & Johnson faulty implant case, which will get a lot of support from patients and consumer groups, the government is set to introduce a legal provision under which a company manufacturing medical devices will have to offer compensation to patients in case of an adverse event.
SC Exempts Saridon, Piriton Expectorant From Government's Ban ListNEW DELHI, 17 SEPT 2018: The Supreme Court has allowed the sale of Saridon, Piriton Expectorant and Dart--three brands that found themselves in a long list of combination medicines that the health ministry banned last week for being "irrational" and "risky" for patients.
GRH Doc Finds Tissue Equivalent For Radiation TherapyMadurai, 15 Sept 2018: A doctor at the Government Rajaji Hospital here has found a tissue-equivalent material made of polymer gel and paraffin oil, which when placed on a patient’s skin, ensures maximum radiation to the tumour.
New Rules To Make Epharma Registration Simpler And Regulation ClearerExercising the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940, the Indian government has now released a notification, a set of new draft rules that will amend the section 67 of the Act.
Pharma Injections
USP Education-Hyderabad Institute Offers QC, QA And R&D Training For Pharma ProfessionalsHyderabad, 22 Sept 2018: After successfully delivering its first batch of well trained pharmaceutical professionals this academic year, the USP Education-Hyderabad Institute is offering to continue its professional training for the students and employees of pharma Institutes and companies and is aiming to admit new admissions into QC and QA training courses from October 1, 2018 at its campus in G Pulla Reddy College in Hyderabad.
Drug Firms Retaining Brand Names For New Medicines New Delhi, 21 Sept 2018: What’s in a name? A lot, according to pharmaceutical companies, many of whom have already launched or are gearing up to introduce new fixed dose combinations (FDCs) by tweaking the compositions but retaining the same brand name as the original product.
CCI Probe Finds Unfair Practices By Three Drug Companies NEW DELHI, 20 SEPT 2018: A preliminary investigation by the Competition Commission of India has found that three pharmaceutical companies and a few regional chemist bodies used unfair trade practices to distribute drugs, a senior government official said.
Diagnosis Of Diseases To Get Cheaper, More Accurate Vadodara, 17 Sept 2018: Diagnosis of cancer and non-cancerous Alzheimer’s, heart diseases, drug addiction and traumatic brain injury is set to become cheaper and easy.
Hyderabad High Court Dismisses Plea Against Pharma Firm Hyderabad, 14 Sept 2018: A two-judge bench of the High Court at Hyderabad comprising Chief Justice TBN Radhakrishnan and Justice S V Bhatt on Friday dismissed a writ appeal filed by the TS Medical Services and Infrastructure Development Corporation (TSMSIDC) against an order of a single judge in a writ petition filed for blacklisting of Zinc Sulphate Dispersible Tablet.
Wockhardt Moves HC Against Ban On Its Fixed Dose Combination Drug New Delhi, 15 Sept 2018: The Delhi High Court said Friday no coercive steps be taken against Indian pharma major Wockhardt for sale of stocks of its banned anti-inflammatory medicine which is already in the market, subject to the company stopping production of the drug.
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 
Is Oxytocin Ban Based On Any Data Or Study, Asks Delhi High CourtNew Delhi, 21 Sept 2018: Questioning the rationale behind the ban by the Central government on the manufacture, distribution, sale and import of Oxytocin by private companies, the Delhi High Court yesterday asked the Centre if the decision was based on any empirical data, study or material.
HC Imposes Cost Of Rs 1.5 Crore On 2 Pharma Cos For Dishonest Conduct In Copyright DisputeMUMBAI, 22 SEPT 2018: In another case involving the sale of counterfeit drugs and medicines, the Bombay High Court has imposed costs amounting to Rs 1.5 crore on habitual offenders Twin Impex and National Laboratories.
Gujarat FDCA Lodges FIR Against Wholesaler For Supplying Spurious Products In Six Districts Mumbai, 21 Sept 2018: The Gujarat Food and Drug Control Administration (FDCA) has recently lodged an FIR against a wholesaler for supplying spurious products in six districts of Gujarat.
Med Specialists Warn About Drug Allergies Aurangabad, 21 Sept 2018: Skin specialists have called for certain measures to be taken by physicians and patients to avoid drug reactions, following an incident of adverse drug reaction in Waluj a few days ago.
WY Tablets Worth 2 Crore Seized In Manipur Imphal, 15 Sept 2018: Contraband drugs worth about Rs 2 crore were seized by the Assam Rifles in Manipur, according to the office of the Inspector General of Assam Rifles, South Sector (IGAR-S). A person transporting the banned goods was subsequently apprehended.
National Injections
6 Shops And Clinics Found Selling Drugs Without Licence Solan, 24 Sept 2018: A team of officials from the Drug Control Administration and police raided 10 premises at Paonta Sahib in Sirmaur on Monday and found at least 6 of them selling drugs without a valid drug license. A case under the relevant sections of the Drugs and Cosmetic Act 1940 has been registered against them.
SHRC Turns Its Attention To Spurious DrugsSrinagar, 20 Sept 2018: Redressing a complaint pending before it since 2013, the Jammu and Kashmir State Human Rights Commission on Thursday directed the state’s drug controller to prepare within six months a scheme for curbing sale and supply of spurious and substandard drugs.
1080 Phensedyl Bottles Seized At Guwahati Station GUWAHATI, 19 SEPT 2018: GRP sleuths seized at least 1080 bottles of banned Phensedyl cough syrup worth Rs 1.79 lakh at Guwahati railway station on Monday. Following the seizure, three persons were arrested and sent to judicial custody.
MoH To Launch ICMED-Plus To Address Regulatory Requirements Of Medical Device Product Compliance Mumbai, 19 Sept 2018: Aimed at creating a voluntary system of compliance for Indian medical device manufacturers, the union health ministry will soon launch Indian Certification for Medical Devices Scheme (ICMED)-plus, a third level of compliance meant to address regulatory requirements for product compliance.
Roorkee Emerging As Hub Of Fake Medicines Roorkee, 17 Sept 2018: For many, Roorkee is a place synonymous with the Indian Institute of Technology and other centres of learning, but of late, the town and adjoining areas have also emerged as a hub of the illegal trade of duplicate medicines which are supplied across most of north India.
IIT Finds Quick Way To Detect Cancer Mumbai, 22 Sept 2018: A research team from IIT-Bombay has developed a system that could help in the detection of cancerous cells that grow inside the body in about a minute. These cells, which are technically difficult to detect in the early stages, can be detected or rather ‘sniffed’ using a direct (label-free) technique called Raman spectroscopy to detect specific substances in single molecular levels. Interestingly, this can be used to monitor air pollution levels or to detect explosives.
Global Injections
Pensioners Warned Not To Mix Statins And Herbal Remedies England, 25 Sept 2018: More than a million pensioners risk worsening their chances of suffering a heart attack or stroke by taking herbal remedies alongside statins and warfarin, researchers have warned. A new study found older people on the life-saving drugs are often also taking three or more herbal supplements.
Role of 'Medicine Experts' to Be Highlighted on World Pharmacists Day SEPTEMBER 24, 2018: World Pharmacists Day is being celebrated Tuesday around the globe. First designated in 2009 by the International Pharmaceutical Federation (FIP) Council in Istanbul, Turkey, the day is being utilized to encourage pharmacists to promote and advocate for their profession.
Counter Antibiotics With Priobiotics
Washington DC, [USA], 16 Sept 2018: A recent study has highlighted that the use of probiotics is directly linked to the reduced need for antibiotic treatment in infants and children.
Pharmacists May Soon Be Able to Tell You the Cheapest Way to Get Prescriptions
A bill backed by President Donald Trump that will allow pharmacists to tell patients about the cheapest way to pay for prescription drugs at the counter won approval in the House of Representatives Tuesday.
How blockchain could eliminate counterfeit medicine- Articles, Chief Data Officer, Innovation Enterprise
Counterfeit medicines are on the rise, killing an estimated 1 million people a year. The World Health Organization (WHO) estimate that around 10% of medicines across the world are counterfeit and that this rate is as high as 30% in some areas of Asia, Latin America and Africa.
Tencent Going for China’s $2.3 Trillion Healthcare Market
Sep 25, 2018 : Tencent partners with Novartis! China’s healthcare market was estimated to be ~$710 billion in 2017, and it’s on track to hit $2.3 trillion by 2030, according to government estimates cited by the People’s Daily newspaper. Tencent (TCEHY) is pursuing this opportunity.
PSM PILL
DOJ Indicts Two Found With 13,000 Counterfeit Pills Made Of Imported Fentanyl From China
September 24, 2018: The Daily Herald in Snohomish County, Washington reported on the seizure of about 10,000 counterfeit oxycodone pills made with fentanyl from a home in the Arlington area and the arrest of two men.
Arizona Substance Abuse Coalition/FDA: ‘Know Your Source’ For Prescription Medication
Doug Herbert, a retired Drug Enforcement Agent and volunteer with the Arizona Substance Abuse Coalition spoke with Arizona’s Fountain Hills Times about the “elephant in the room” that is counterfeit drugs in America.
Frequently Asked Questions
Q: Why Vitamin D is called Sunshine Vitamin?
Ans: Vitamin D is a fat-soluble vitamin that acts as a steroid hormone. Vitamin D influences the bones, intestines, immune and cardiovascular systems, pancreas, muscles, brain, and the control of cell cycles. Vitamin D is unique because it can be made in the skin from exposure to sunlight. Thirty to 90 minutes in the sun will give the average person all the daily vitamin D he/she needs. The key is in the skin’s oils -- a derivative of cholesterol called 7-dehydrocholesterol. When exposed to sunshine, this compound is converted to cholecalciferol – which is then converted to the actual vitamin D, known as: 25-hydroxy-cholecalciferol, or D3. Therefore, Vitamin D is called sunshine vitamin. Read More>>>
SUBSCRIBER'S SYMPTOM
Expert view: Current trends in detection of falsified medicines
Article contributed by Mr.Parmeshwar Rao, Maharashtra
There is global public health concern over the falsification of pharmaceutical products and the extent to which widespread distribution of substandard drugs has developed.
Blog Addicts
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