Articles

ABOUT AUTHORS
Piyush Tripathi*,  Abhishek Arora
GMSCL,
GUJARAT(INDIA)
^*piyushtripathi1992@rediffmail.com

Drug addiction is a serious problem in one country that is known for its culture, traditions & social values all over the world. The country where people commit suicide either because of love affairs or due to drug addiction related issues. Undoubtedly, this writing is talking about India.

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ABOUT AUTHORS
Ms. NEETU*, Dr. ANUPAMA SETIA, Mr. MUNISH THAKUR
*JCDM COLLEGE OF PHARMACY,
SIRSA-HARYANA (INDIA)
^*neetu.kaushal11@gmail.com

ABSTRACT
Abbreviated New Drug Application (ANDA) is an application used for regulatory submission for the authorization of generics drugs and its entry into a brand drug market. Generic drugs are pharmaceutical equivalent to the brand name drugs and distributed without patent protection. Different countries have different requirements for the registration of generic drugs and its own regulatory authority, which are responsible to enforce the rules and regulations, issue the guidelines to regulate the marketing of drugs. Various government agencies in regulating drugs are CDSCO- India, EDQM-Europe, and USFDA-US. Aim of title was to review the generic drug filing and different aspect of obtaining regulatory approval in order to get the marketing authorization in India, Europe & US. Involvement of regulatory in the generic drug development expedites the approval process and they review the queries carefully raised by the regulatory authorities and minimize them. To harmonize the different requirements, CTD format is used for filing the ANDA in respective countries. In this an attempt was made to highlight the difference between the registration requirements for generics drugs in India, Europe & US. The comparison parameters in the generic drug approval among different regions, which gives clear illustration where India lies in its generic drug approval process.

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ABOUT AUTHORS
Narinder Singh*, Surya Prakash Gautam, NeelamKumari,Rupinder Kaur,Manpreetkaur
CT Institute of Pharmaceutical Sciences, Shahpur, Jalandhar, Punjab
^*pharmacist.narinder@gmail.com

ABSTRACT
Virosomes are reconstituted viral envelopes that can fill in as vaccines and as vehicles for cell conveyance of different macromolecules. The prospect of drug delivery and targeting systems utilizing virosomes is an intriguing innovative work field. Since virosomes are biocompatible, biodegradable, non-poisonous and non-autoimmunogenuic; endeavors have been made to use them as antibodies or adjuvants and also conveyance frameworks for drugs and organic for remedial purposes. The achievement of virosomal medicate conveyance relies on upon strategy used to set up the typified bioactive materials and fuse them into the virosomes. Virosome innovation could conceivably be utilized to convey peptides, nucleic acids or, then again qualities and medications like anti-toxins, anticancer agents, and steroids.

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ABOUT AUTHORS
BALVINDER SINGH¹*, PAWAN JALWAL ¹, VIKASH KUMAR RUHIL ², NEHA MINOCHA¹
1.Department of Pharmaceutical Sciences & Research, Baba Mastnath University, Asthal Bohar, Rohtak, Haryana, India
2. P.D.M. College of Pharmacy, Bahadurgarh, Haryana, India
balvindersinghpharmaco@gmail.com

ABSTRACT
B.Pharmacy course is one of the leading professional courses in India. Two types of examinations are prevalent in B.Pharmacy course. One is the sessional examinations for internal evaluation. Second is the semester end/year end examination. Each examination has its own importance. The student should be well prepared for appearing in the examination. Appearing in the B.Pharm. Examination is not only merely science but it requires amalgamation of science and art.

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.

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SHIVANAND *, SAYANTAN MUKHOPADHAYAY
Division of Pharmaceutical Sciences S.G.R.R.I.T.S
Dehradun, Uttarakhand  248001, India.
^*shiva3671@gmail.com

ABSTRACT:
The active pharmaceutical ingredient that is thermolabile and moisture sensitive in nature generally degraded in atmospheric condition and thus have reduced stability and self-life. Lyophilization is one of those techniques which is utilized effectively to improve such critical condition. It is the one of the emerging technology in themodern era, which is effectively involved in the preparation of several antibiotics (e.g., chloramphenicol, doxycycline) and anti-cancer drugs (e.g., doxorubicin, epirubicin). This technique effectively utilized the phenomenon of sublimation to obtained primary dried product followed by removal of excess amount of moisture by modulation of heat. This technique not only improved self-life of thedrug but also provides fast reconstitution and reduced the cost of storage and shipping. Inthis review article principle behind lyophilization, steps involved, formulation aspects, theimportance of lyophilization and detection of the end point in lyophilization along with recent advancementwas explained.

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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.

ABOUT AUTHORS
Tahseen Sameena*1, Prathima Patil1, S.P.Sethy*1
1Department Of Pharmaceutics.
Azad College of Pharmacy
Moinabad-Chilkur Road , Hyderabad- India
* tahseensameena1992@gmail.com
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ABSTRACT: -
The Human Genome Project (HGP) refers to the international 13‐year effort, formally begun in October 1990 and completed in 2003, to discover all the estimated 20,000–25,000 human genes and make them accessible for further biological study. Another goal of this project was to determine the complete sequence of the 3 billion DNA subunits (bases in the human genome). As part of the HGP, parallel studies were carried out on selected model organisms such as the bacterium E.coli and the mouse to help develop the technology and interpret human gene function. The DOE Human Genome Program and the U.S National institute of Health (NIH) National Human Genome Research Institute (NHGRI) together sponsored the U.S.Human Genome Project.”