The Prescription: 1st June 2018 Issue
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EDITOR'S EMULSION

Pooja Khaitan

Warm Greetings on yet another edition of The Prescription!

High risk medicines are those medicines that have a high risk of causing significant patient harm or death when used in error. These medicines are available freely in the market without any caution to consumers. In a move to enhance consumer awareness and accountability of pharma companies, the health ministry has made it mandatory for high-risk medicines to carry warnings prominently on drug packs from November 1. Read more on this under PSM India Capsules.

The Government is pressing forward in launching various regulatory policies for the benefit of patients while also launching operations to crack down on illegal manufacturing and import of drugs, especially oxytocin. They are planning regulations for medical devices, amending Drug Schedules to curtail misleading ads, while reconstituting the drug technical advisory board. Catch up with all such drug laws and policies around us under Drug Laws and Policy Injections.

This issue of The Prescription highlights the root cause of the much talked about Nipah infection and the claims by Serum Institute that they can develop the vaccine to fight Nipah if the government asks them to. Read these interesting articles under Pharma and Drug Dopes section.

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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@safemedicinesindia.in

Stay Healthy. Stay Protected.

Pooja Khaitan

Editor-in-Chief,
The Prescription

DOSE OF THE DAY

“The shortcomings can’t go overnight, but with this government, health has taken centre stage. It can now only get better from here.”

Dr. V.K.Paul, Professor
Member, NITI Ayog

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PSM India Capsules

High-Risk Drugs To Carry Warnings Prominently

In a move to enhance consumer awareness and accountability of pharma companies, the health ministry has made it mandatory for high-risk medicines to carry warnings prominently on drug packs from November 1. The new rules will be applicable to medicines such as cancer drugs, narcotics analgesics, sedatives, tranquillisers, steroids and anti-depressants which have either a high risk of side effects or are to be used strictly under medical supervision.

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Drug Laws & Policy Injections
CDSCO Launches Nationwide ‘Special Operations’ To Prevent Illegal Manufacturing And Import Of OxytocinNew Delhi, 25 May 2018: The Central Drugs Standard Control Organisation (CDSCO) has launched ‘special operations’ to crack down on illegal manufacturing and import of oxytocin, a neurotransmitter and peptide hormone widely misused in the dairy and horticulture industry. A letter issued by Drugs Controller General of India (DCGI) Dr S Eswara Reddy in this regard has been sent to all zonal, subzonal and port offices of the CDSCO, it is learnt.Read More
Govt Plans Regulations For Critical Medical Devices Like Pacemaker, X-Ray Machines New Delhi, 24 May 2018: Critical medical devices such as pacemakers, CT scanners and X-ray machines will soon have an assurance of quality, with the government set to regulate their manufacture, import and sale in the country.Read More
MoH To Amend Schedule J Of D&C Rules To Curtail Misleading AdsMumbai, 25 May 2018: The Union health ministry will soon amend Schedule J of the Drugs and Cosmetics Rules, 1945 to prohibit misleading advertisements for the treatment of ailments which are also under the purview of Drugs and Magic Remedies (Objectionable Advertisements) Act (DMR), 1954 and Rules, 1955. Read More
Drugs Controller To Come Out With Vaccine Specific Regulatory PolicyHyderabad, 19 May 2018: The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday. Read More
MoH Reconstitutes Drug Technical Advisory BoardNew Delhi, 23 May 2018: The Union Health Ministry has reconstituted the Drugs Technical Advisory Board (DTAB), the country’s highest drug advisory body on technical matters. Director General of Health Services (DGHS) Dr Promila Gupta is the ex-officio chairman of the newly formed Board constituted under section 5 of the Drugs and Cosmetics Act. Drugs Controller General of India Dr S Eswara Reddy is an ex-officio member. Read More
Health Ministry To Integrate Mobile App For Reporting ADR With Global Regulators To Enhance PharmacovigilanceMumbai, 22 May 2018: Government is planning to integrate its mobile application by the name “ADR PvPI” meant for ADR reporting with global regulatory agencies to enhance pharmacovigilance (PV) for drug quality and patient safety. Read More
DTAB Approves DCGI's Proposal For Introducing Unique Code To Drug Packs To Curtail Spurious Drugs In Domestic MarketMumbai, 22 May 2018: The Drugs Technical Advisory Board (DTAB), the highest decision making body under the Union health ministry on technical matters, has approved Drug Controller General India (DCGI)'s proposal for introducing a unique code on drug packs whether it is bottle, strip or vial to ensure authenticity of the medicine. It will help curb menace of spurious drugs in the domestic market. Read More
Pharma Injections
Pharma Firm Chief Gets NCB SummonsKOLKATA, 22 MAY 2018: The Kolkata zonal unit of Narcotics Control Bureau (NCB) has summoned the director of a wellknown pharmaceutical company on Tuesday to discuss the alleged diversion of a stock of cough syrup to be smuggled to Bangladesh.Read More
Experts Unsure About Root Cause Of Nipah InfectionCHANGAROTH (KOZHIKODE), 21 MAY 2018: Even after it was confirmed that three people had died of Nipah viral infection in Changaroth grama panchayat, 40 km away from Kozhikode city, experts are yet to determine the root cause of the infection. Identifying a colony of bats inside a well in the compound of a house belonging to the family of two of the deceased, has, however, given them a sense of direction.Read More
PDMA Moves Punjab HC Against Joint Inspection Of Pharma Units By CDSCO and State Drug Inspectors Mumbai, 22 May 2018: The Punjab Drug Manufacturers Association (PDMA) has filed a writ petition in Punjab High Court against the Union Health Ministry's Notification No. GSR 1337 (E) dated 27.10. 2017 which allowed joint inspection of pharmaceutical units by Central Drug Standards and Control Organisation (CDSCO) and the state drug inspectors. So far, such inspections were carried out by state drug inspectors alone. Read More
Ranbaxy Whistleblower Petitions PMO To Investigate ‘Illegal’ Drug Approvals NEW DELHI, 21 MAY 2018: Ranbaxy whistleblower Dinesh Thakur has petitioned the Prime Minister’s Office, seeking a commission to investigate the manner in which several potentially irrational medicines have been approved and marketed in India. Read More
Proper Critical Care Training Needed For Paramedics : HC New Delhi, 16 May 2018: The Delhi High Court today stressed the dire need for proper critical care training to paramedics, while hearing a plea by a woman whose mother had died of cardiac arrest due to medical negligence. Read More
SMPMA Urges DCGI To Act Against NSQ Drug Manufacturers As Per DCC Guidelines Mumbai, 17 May 2018: Small and Medium Pharma Manufacturers Association (SMPMA) has urged the Drugs Controller General of India (DCGI) to direct state drug authority to follow Drugs Consultative Committee's (DCC) guidelines for taking action on samples of drugs declared spurious or not of standard quality (NSQ) in the light of enhanced penalties under the Drugs and Cosmetics (Amendment) Act, 2008. 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
Panel Reviewing Safety Of Banned FDC Drugs To  Submit Report In JulyNew Delhi, 24 May 2018: The fate of 349 banned fixed dose combination (FDC) drugs will become clearer in the first week of July, when an expert panel studying the issue presents its report. Read More
Serum Institute Can Develop Vaccine To Fight Nipah If Government Asks For ItPUNE, 24 MAY 2018: Pune-based Serum Institute of India has said that it may look at evaluating a candidate vaccine to combat Nipah virus, and that can be rolled out in three to four years if the country decided to develop the preventive on a priority. Read More
Kerala Health Minister KK Shylaja Orders Probe Into Flawed Blood Test At Medical College Hospital THIRUVANANTHAPURAM, 21 MAY 2018: Health Minister K K Shylaja has ordered an inquiry into the incident in which a laboratory operated by the Kerala Health Research and Welfare Society at the Thiruvananthapuram Medical College Hospital allegedly provided a flawed blood test result. Read More
3 Men From Tamil Nadu Get 10 Years In Assam For Smuggling Phensedyl GUWAHATI, 16 MAY 2018: Three men from Tamil Nadu have been sentenced to 10 years’ rigorous imprisonment in Assam for smuggling Phensedyl, a banned cough syrup with high codeine content. Read More
National Injections
Modicare To Offer 20% Lower Rates Than CGHS Rates NEW DELHI, 24 MAY 2018: In a move likely to set new pricing standards for medical procedures in the country, the government-sponsored National Health Protection Scheme (NHPS), popularly known as Modicare, will offer common treatments such as coronary bypass, knee transplant and C-section at a rate which is around 15-20% lower than Central Government Health Scheme (CGHS), which provides comprehensive medical care to government servants, pensioners and their dependants. Read More
Central High-Level Team: Nipah Virus Disease Is Only A Local Occurrence, Not A Major OutbreakNew Delhi, 24 May 2018: Following directions of the Union Health Minister, Shri J P Nadda, a multi-disciplinary Central Team led by the National Centre for Disease Control (NCDC) is presently in Kerala constantly reviewing the situation of the Nipah Virus Disease.Read More
Misrepresentation during Inspection: 9 Medical Faculty Suspended by Medical Council of India After thorough perusal of the documents by the committee officials, it was found that the doctors had been shown as working at the college before 2006 whereas the college was started in June 2006. Read More
IPC Discusses Strategy With Research Institutions For Using ADR Info For Health Research Mumbai, 18 May 2018: The Indian Pharmacopoeia Commission (IPC) is in talks with health research institutions like Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT) and Council of Scientific and Industrial Research (CSIR) for devising strategies for effective use of adverse drug reactions (ADRs) information for health research in Indian population for patient safety. Read More
Punjab Rejects Haryana's 'Watered Down' Act To Regulate Private Hospitals Chandigarh, 18 May 2018: The Punjab government has decided not to follow Haryana in implementing what Punjab considers a ‘watered down’ version of the Clinical Establishments (Registration and Regulation) Act. Read More
ASSOCHAM Urges Greater Utilisation Of Technology In Pharmaceuticals New Delhi, 11 May 2018: Advanced, affordable and accessible solutions are the only way forward towards intensifying the innovations in the Indian pharmaceutical sector, a top Union Health Ministry official said at an ASSOCHAM event in the national capital. Read More
Global Injections
New Blood Test Can Detect Liver Damage Even Before Symptoms Appear LONDON, 25 MAY 2018: Scientists have developed a quick and robust blood test that can detect liver damage before the symptoms appear. Read More
Antidiabetic Drug Linagliptin Had 313 Adverse Events In 6 Years Seoul, 21 May 2018: Type-2 antidiabetic treatment Linagliptin has had a 7.69 % incidence of abnormal events in the past six years in Korea. Read More

HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs A Notice by the Health and Human Services Department on 05/16/2018
SUMMARY: Through this request for information, HHS seeks comment from interested parties to help shape future policy development and agency action.
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US FDA Names And Shames Drug Makers To Encourage Generic Competition Maryland, 17 May 2018: Pharmaceutical companies that spend billions of dollars to develop new drugs do not want competitors to profit from inexpensive generic copies of blockbuster medicines. To avoid rivals, they fight for patent extensions, seek new uses for old products and, sometimes, prevent generic drug companies from obtaining samples.Read More

WHO Publishes Its First Essential Diagnostics List NEW DELHI, 16 MAY 2018: The World Health Organisation (WHO) has published its first 'essential diagnostics list', a catalogue of tests needed to diagnose the most common conditions as well as a number of global priority diseases.Read More

Future directions in countering antimicrobial resistance The fight against bacteria that are resistant to antibiotics is a crucial element of medical and microbiological research today. The phenomenon of antibiotic resistance itself is a part of the expression of the bacterial genome, and therefore can be expected to emerge in whatever situation antibiotics are used, and to increase with the number of drugs used.Read More

PSM PILL

1,500 Counterfeit Fentanyl Pills Netted In Ohio Bust

May 25, 2018: The U.S. Department of Justice (DOJ) announced indictments against three Summit County, Ohio residents for conspiracy to possess with intent to distribute fentanyl and possession with intent to distribute fentanyl.

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Partnership For Safe Medicines Urges Passage Of The STOP Act To Increase Inspections For Dangerous Synthetic Opioids

WASHINGTON (May 24, 2018) : The Partnership for Safe Medicines (PSM) today urged passage of the Synthetics Trafficking and Overdose Prevention Act of 2017 (S.372), also known as the STOP Act of 2017. The STOP Act addresses the crisis of counterfeit medications made with fentanyl that has swept the nation in the past twenty four months.

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Frequently Asked Questions

Q. If a medicine is used for more than one problem and I only have one of those problems, should I use the medicine?
Ans: It is better to find and use a medicine that treats only the problem (or symptom) you have. If you use a medicine that treats your problem plus other problems you don't have, then you may be using extra medicine you don't need. Over-the-counter medicines can help you feel better, but they can also cause unwanted side effects. Using extra medicine that you don't need to treat your problem increases the chance of unwanted side effects. It is better to choose a medicine that treats only the problem or problems you have. If you and your parent or guardian aren't sure how to choose, ask a pharmacist or a doctor for help.

Q. Why should I read the Warnings section of the Drug Fact label?
Ans: You should read the Warnings section because it explains when the medicine shouldn't be used at all and when you should check with a doctor or pharmacist before using the medicine. The Warnings also tell you how the medicine might make you feel, when you should stop using the medicine, and things you shouldn't do while using the medicine. For example, the Warnings section will tell you to avoid using a medicine if you are allergic to its active ingredient.

Q. What happens if I use too much of an OTC medicine? Can a medicine harm me if I use more than the recommended dose?
Ans: If you use too much of any medicine, tell a grown-up right away. A pharmacist or doctor can tell you and your parent or guardian if you need to get medical help right away. What happens when you use too much of an OTC medicine depends on the type of medicine and how much you used. The correct medicine dose is carefully figured out and approved by the Food and Drug Administration. Using more than the recommended dose may not work better than the recommended dose and it may harm you.

SUBSCRIBER'S SYMPTOM

Govt Planning Unique Codes To Check Menace Of Fake Medicines

Article contributed by by Prof. B.N.Srivastav, Ajmer

New Delhi, 14 May 2018: India’s highest advisory body on drugs will discuss a mechanism to end the menace of fake medicines at a meeting on 16 May. According to the proposal to be discussed at the Drug Technical Advisory Board meeting, consumers will be able to check whether the medicines that they have purchased are genuine by texting a unique code to be printed on the medicine’s package to a number, said two people aware of the matter, both of whom requested anonymity. Read More

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Mr.Rajiv Gujral, Director, Peerless Hospital: Interesting to see your work to educate people of Fake medicines and the health policies. It’s amazing work you are doing. My best wishes are with you.
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