Pharmapedia

CHALLENGES ENCOUNTERED BY PHARMA PROJECT MANAGER

ABOUT AUTHOR
Purva Gupta.
IIHMR, New Delhi.
purvagupta456@gmail.com

New Domain: This problem arises when organisation has not handled similar project earlier and stake holders have no prior experience on the project.

New Technology / Challenging Technology: Selected Project involves use of new technology or new equipment or specially trained staff may pose delay in completion of task, thereby project.

AN APPROVAL TO MANUFACTURE AND SALE THE COPY OF INNOVATOR PRODUCT IN THE US MARKET

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ABOUT AUTHORS
MUNISH THAKUR*,  Dr. ANUPAMA SETIA, Ms. NEETU.
DEPARTMENT OF PHARMACEUTICAL MANAGEMENT &
 DRUG REGULATORY AFFAIRS,
JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA).
munish.thakur98@gmail.com

ABSTRACT
The drug designated for production has to be manufactured in compliance with Current Good Manufacturing Practices (cGMP) following USFDA requirements, EU Directive or International Conference on Harmonization (ICH) Guidelines or Regulatory Authority of respective country. Regulatory authorities bear the responsibility to conduct inspections on pharmaceutical manufacturing plants to ensure they follows cGMP guidelines so that the drug manufactured is safe and effective. A quality system has to be set up such that the drug is manufactured in accordance with approved procedures. A drug is not permitted for sale until the marketing application for the new drug has been reviewed and approved by regulatory authorities. Extensive dossiers are provided to the authorities to demonstrate the safety, potency, efficacy and purity of the drug. After the drug has been approved and marketed, there is continuous monitoring of the safety and performance of the drug to ensure that it is prescribed correctly and adverse events (side effects) are investigated. The United States Food and Drugs Administration (FDA) has one of the most comprehensive and transparent regulatory systems in the world. In US Common Technical Document (CTD) format and most recently its electronic version-the electronic Common Technical Document (eCTD) format is used for submission of dossiers. Inclusion of a paragraph IV certification permits the Applicant to file its ANDA 4 years after the approval of a new chemical entity that is 1 year before the actual expiry of the 5 years exclusivity. In case patent exists that claims the drug, drug product, or method of use, the applicant is requested to file a patent certification with regards to the patent status. The different types of patent certifications are discussed. This project work elucidates US FDA’s previous interpretations of the statute regarding 180 days exclusivity and latest amendments in the current guidance. Information considered helpful in the compilation of different CTD modules 1, 2, 3, and 5 is discussed. Electronic submission in eCTD format is outlined.

Nobel to Artimsisinin discoverer will surely encourage research in natural products

Amit Gangwal
MPharm., PhD.,
gangwal.amit@gmail.com

This has been made possible by years of honest research in Ayurvedic formulae and therefore people are getting results. This is not a small success, looking at the no of years, Patanjali has been in market and it’s whopping turnover.

The Nobel Prize in Physiology or Medicine has been awarded 106 times to 210 Nobel Laureates between 1901 and 2015, as per the information depicted on nobelprize.org/nobel_prizes/medicine/ laureates/. It further reads-The Nobel Prize in Physiology or Medicine 2015 was divided, one half jointly to William C. Campbell and Satoshi Ōmura "for their discoveries concerning a novel therapy against infections caused by roundworm parasites" and the other half to Youyou Tu "for her discoveries concerning a novel therapy against Malaria".

Challenges of Packaging and Labeling in the Pharma Industry

A recent study carried out by Pharma IQ has shed some light on some very common problems pharmaceutical companies face in the field of Packaging and Labeling. Companies already know their internal challenges, but are often unaware of the global trend of recurring issues and solutions to overcoming them. This is because the strict rules and regulations of packaging quality control in pharma, are not only strict, but also vary across different parts of the world.

Are pharmacists and colleges ready for a big change?

ABOUT AUTHOR
Amit Gangwal
gangwal.amit@gmail.com

Perhaps for the first time in the history of pharmaceutical sciences (from view point of academicians, graduating pharmacy students and other stake holders) things are appearing (not confirmed) vibrant and auguring well looking at future. This has been made possible by the recent notification in Gazette of India. Though I could not construe the meaning what is being interpreted by many on social platforms and few newspapers have also published the same. The newspapers’ shots I am sharing here for better understanding of readers and other stake holders. This interpretation of certain people on social media has also been opposed by Indian Medical Association (IMA). IMA said the notification by government does not empowers or entitles registered pharmacists to practice as qualified MBBS.

Dangerous facts behind Expired Medicine Usage

The term "expired" indicates that has come to its end. People hate expired medicine to be waste. To save money and avoid a trip to the doctor for a new prescription, many people do take expired drugs.

The expiration date indicated the date the manufacturer guarantees the full potency and safety of the drug. At the time of the medication expiry date, the drug must be at least 90% of the original potency under proper storage conditions. Drug's potency begins to reduce from the moment it is manufactured; it is not in anyway spontaneous after the expiry date. Expiration date doesn’t really indicate a point at which the medication is no longer effective or has become unsafe to use. Once the expiration date has passed there is no guarantee that an expired medicine will be safe and effective.

Generic drug prescription: Possible issues, impacts and consequences

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ABOUT AUTHOR
Shashank Chaturvedi
Department of Pharmaceutics
Invertis Institute of Pharmacy,
Invertis University, Bareilly, U.P
shashank.c@invertis.org

ABSTRACT
The generic drug and branded drug is a confusing concept, and is a matter of serious concern for the pharmaceutical sector after the imposition of the rule that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs. The generic drug should be bioequivalent before they can be prescribed as an alternative from their branded counterparts. The possible impacts over the Pharmaceutical Sector should be assessed before implementing this mammoth decision.

GOODS AND SERVICES TAX (GST) in Indian Pharmaceutical and Its Impact on Industry

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ABOUT AUTHOR
Neha Bala, Naresh Mali
*
Institute of Health Management Research, Jaipur
Rajasthan,  India
malinaresh888@gmail.com

“GST will be the best example of co-operative federalism. Together we will take India to new heights of progress. We continue to work with all parties and states to introduce a system that benefits all Indians and promotes a vibrant and unified national market. This reform will promote ‘Make in India,’ help exports and thus boost employment while providing enhanced revenue.” — Prime Minister of India, Mr. Narendra Modi, 3rd August 2016

Demonetisation of notes and Indian pharmaceutical industry

  • Posted on: 3 April 2017
  • By: admin

After the demonetisation of 500 and 1000 rupees notes, numerous sectors are being affected and hopefully we all have been affected with that. Also Global banks and rating agencies have downgraded India’s growth in the wake of demonetisation of high level. Current year’s GDP rate has been slowed down to 6.5. But Pharmaceutical industries are growing with good margin. Even shares of pharmaceutical industries are rating higher.

AFTERSHAVE: A TRUTH BEHIND ICONIC FRAGRANCE

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Dhrubo Jyoti Sen
Department of Pharmaceutical Chemistry, Shri Sarvajanik Pharmacy College, Gujarat Technological University, Arvind Baug, Mehsana-384001, Gujarat, India
dhrubosen69@yahoo.com

ABSTRACT:
Aftershave is an important part of a man’s daily lifestyle routine. After shave is a liquid product applied to skin after shaving. It contains an antiseptic agent such as denatured alcohol, stearate/citrate or witch hazel to prevent infection of cuts, as well as to act as an astringent to reduce skin irritation. Menthol is used in some varieties as well to numb damaged skin and it is an ingredient that shaving cream manufacturers have started including in their formulations, too. Aftershave with alcohol usually causes an immediate burning sensation when applying it post-shave, with effects sometimes lasting several minutes, but most commonly only for seconds. For this reason, a market consisting of highly differentiated products has been created—some using alcohols, some not. Some aftershaves use fragrance or essential oil to enhance scent. Moisturizers—natural and artificial, are often touted as able to soften the skin. Rinse your face and neck with cool water next to help close up your pores before you apply the aftershave. Do not apply aftershave immediately after you have finished shaving since doing so might make your skin sore or irritated. Pat your face and neck dry gently with a towel. As you shave, feel free to keep applying shaving cream. When you're done shaving, wash the area generously with lots of warm water. When you shave, shower in warm water first to soften skin, then lubricate with a shaving cream or lotion, never dry shave. Assure you use a clean, sharp, razor and shave in the direction of hair growth. Once shaven those hair follicles are open, clean area well and apply a gently aftershave lotion or aloe vera gel. Keywords: Cologne, Moisturizer, Humectant, Denatured alcohol, Polyquaternium-10, Allantoin, Styptic

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