PHARMA WISDOM: ACADEMIA

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Showing posts with label ACADEMIA. Show all posts
Showing posts with label ACADEMIA. Show all posts

Monday 15 June 2020

Top 25 Pharmacy Colleges in India || NIRF Ranking for Pharmacy Colleges - 2020

23:43:00 0


Top 25 Pharmacy Colleges in India | NIRF Ranking for Pharmacy Colleges - 2020
The National Institutional Ranking Framework (NIRF) was approved by the MHRD (Minister of Human Resource Development). This framework outlines a methodology to rank institutions across the country. Ranking broadly cover “Teaching, Learning and Resources,” “Research and Professional Practices,” “Graduation Outcomes,” “Outreach and Inclusivity,” and “Perception”.

National Institutional Ranking Framework (NIRF), MHRD has released “India Rankings 2020” of Institutions of Higher Education on 11 June 2020. 

Take a look at the top 25 Institutions of Higher Education in the pharma category.
NIRF Ranking (Pharma category):

1. Jamia Hamdard, New Delhi
2. Panjab University,
Chandigarh
3. NIPER,
Mohali, Punjab
4. Institute of Chemical Technology,
Mumbai, Maharashtra
5. NIPER,
Hyderabad, Telangana
6. Birla Institute of Technology & Science,
Pilani, Rajasthan
7. Manipal College of Pharmaceutical Sciences,
Udupi, Karnataka
8. NIPER, Ahmedabad, Gujarat
9. JSS College of Pharmacy,
Ooty, Tamil Nadu
10. JSS College of Pharmacy,
Mysore, Karnataka
11. NIPER, Guwahati, Assam
12. Annamalai University,
Annamalainagar, Tamil Nadu
13. SVKM's Narsee Monjee Institute of Management Studies,
Mumbai, Maharashtra
14. Maharaja Sayajirao University of Baroda,
Vadodara, Gujarat
15. Amrita Vishwa Vidyapeetham,
Coimbatore, Tamil Nadu
16. Birla Institute of Technology,
Ranchi, Jharkhand
17. Nirma University, Ahmedabad, Gujarat
18. NIPER, Raebareli,
Lucknow, Uttar Pradesh
19. S. R. M. Institute of Science and Technology,
Chennai, Tamil Nadu
20. Banasthali Vidyapith,
Banasthali, Rajasthan
21. Amity University Noida,
Gautam Budh Nagar, Uttar Pradesh
22. Poona College of Pharmacy, Pune,
Maharashtra
23. Punjabi University,
Patiala, Punjab
24. Bombay College of Pharmacy,
Mumbai, Maharashtra
25. Delhi Institute of Pharmaceutical Sciences & Research, New Delhi




Pharma Wisdom congratulates all the institutes 
which participated in NIRF rankings.


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Sunday 25 August 2019

PCI Clears way for Pharm.D holders to become "Clinical Pharmacists"

15:34:00 2

Candidates completing six year Pharm.D course are all set to get recognition as "Clinical Pharmacist" and will get at the drug information centres  in hospitals. The Pharmacy Council of India (PCI) has approved the proposed amendments in the Pharmacy Practice Regulations 2015, for inclusion of the post of Clinical Pharmacists with Qualifications, Duties and Responsibilities.
The Decision was taken in the 107th Meeting of PCI held August, 2019 Recently in New Delhi. 
For Full Information - Click Here

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Saturday 30 June 2018

Retail sale of Controversial Hormone Drug Oxytocin banned from 1st July, 2018

22:23:00 3

Come July 1, Oxytocin, a vital drug, and its formulations, used to stop bleeding during childbirth, will not be freely available for use by doctors.

The manufacture and sale of this drug has been banned for domestic use in the private sector by the government. Import of the drug has also been banned.

Retail or wholesale chemists will not be allowed to stock this drug in their shops in any form or name. The Ministry of Health and Family Welfare has zeroed in on Karnataka Antibiotics & Pharmaceuticals Ltd to manufacture the drug and supply it directly to registered private and public hospitals.

Used to stop bleeding during childbirth, it is allegedly being misused to make cows give more milk; KAPL to be sole supplier

The drug will be available on a demand basis from KAPL after placing an order with the company, a release from the Ministry stated.

“Oxytocin is a life-saving drug in those women who bleed during childbirth or undergo an abortion. There are alternatives like Misoprostol, but the government has restricted its use in private clinics, as they are worried about misuse of Misoprostol in sex-selective abortions,” said Duru Shah, a Mumbai-based doctor.

Not for sale
The Ministry in its statement noted that Oxytocin formulations meant for domestic consumption will be supplied by the manufacturer, i.e. KAPL, to registered hospitals and clinics in public and private sector directly. Oxytocin in any form or name will not be allowed to be sold through retail chemist.
Oxytocin is also used to increase the size of vegetables such as pumpkins, watermelons, eggplants, gourds, and cucumbers.

Previously the High Court of Himachal Pradesh and Shimla had in its judgment on March 15, 2016, titled ‘Court on its own motion’ versus State of Himachal Pradesh and others, observed that there is large-scale clandestine manufacture and sale of the drug Oxytocin leading to its misuse.

The High Courts had also observed that the feasibility of restricting the manufacture of Oxytocin only in public sector companies should be considered.
The matter was considered by the Drugs Technical Advisory Board, a statutory body constituted under the Drugs and Cosmetics Act, 1940.

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Monday 20 March 2017

Pharm.D - IInd Year UNIVERSITY EXAMINATION PREVIOUS QUESTION PAPERS (2012 to 2016) - JNTU HYDERABAD

23:25:00 6

Pharm.D-SECOND YEAR EXAMINATION PREVIOUS QUESTION PAPERS JNTU HYDERABAD

PHARM.D II YEAR QUESTION PAPER - 2012
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Sunday 19 February 2017

How to Open Janaushadhi Medical Store (PMBJK) in your Area - For – Unemployed Pharmacists, Individual Entrepreneurs, Doctors, Registered Medical Practitioners

22:39:00 15

Guidelines for Opening of New Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK) 
For –Unemployed pharmacists, Individual entrepreneurs, Doctors, Registered medical practitioners
Eligibility Criteria 
To open Pradhan Mantri Bhartiya Janaushadhi Kendra: Individual applicants other than doctors and registered medical practitioners should mandatorily be persons having B. Pharma and D. Pharma Degrees. Any organization applying for a PMBJK will have to employ B. Pharma / D. Pharma degree holders and produce proof of the same at the time of submitting applications. In govt hospital premises including medical colleges, the preferred agency would be reputed NGOs/Charitable organizations but individuals would also be eligible.
Requirements for applying for opening new Janaushadhi Medical store (PMBJK) 
·         Own space or hired space (Minimum 120 sq feet) duly supported by proper lease agreement or space allotment letter. Applicant will Page 4 of 20 arrange the space for running the Jan Aushadhi Generic Drug Store & BPPI will have no role for arranging space.
·          Proof of securing a pharmacist with name, Registration with the State Council etc. (or it can be submitted at the time of final approval of JAS).
·          If applicant is under the category of SC, ST and Differently-abled, then proof of SC, ST and Differently-abled certificate from respective authorities.

Guidelines for Opening of Jan Aushadhi Store for different category – Click below Link

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Thursday 15 September 2016

Why GMP? An explanation of Good Manufacturing Practice...!!

14:11:00 3

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.
The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.
In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.
Trained inspectors for the FDA examine facilities around the world, including those facilities that produce the active ingredients and final products. The FDA also reviews consumer and industry complaints filed about the drug, using these reports to identify sites that could benefit from inspection.

About GMP
GMP is a set of regulations that ensures the quality of drugs, medical devices, blood, and some types of food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product.
When discussing current good manufacturing practices, many agencies use the acronym cGMP, with the letter ‘c’ standing for ‘current.’ This nomenclature reminds companies to use the most up-to-date technologies and systems in order to comply with current regulations. Many older GMP practices, specifically those designed to prevent errors, mix-ups and contamination, are now outdated and inadequate.

About Part 210 and 211
21 CFR Part 210 and 211 outline the manufacture, processing, packing, or holding of a drug specifically, although supporting companies and services can benefit by compliance with these standards as well.
Part 210.2 applies to drug products intended for human use and lays out definitions for terms used within the document. Part 211 describes important issues.

Its 11 sub-parts discuss all sections of drug manufacturing operations:
1. General Provision
2. Organization and Personnel
3. Building and Facilities
4. Equipment
5. Control of Components and Drug Product Containers and Closures
6. Production and Process Controls
7. Packaging and Labeling Controls
8. Holding and Distribution
9. Laboratory Controls
10. Records and Reports
11. Returned and Salvaged Drug Product
Each section of code outlines a different GMP activity. 211.22 details the responsibilities of a quality control unit, for example, while 211.25 discusses personnel qualifications, 211.28 deals with sanitation, clothing, protective apparel, hygiene and health habits and 211.34 offers guidelines on working with consultants. Part 1271 subparts C and D describes donor-eligibility and applicable current good tissue practice procedures for owners and operators of establishments engaged in the recovery, donor screening, donor testing and other types of testing, processing, storage, labeling, packaging, or distribution of human cells, tissue samples, and cellular and tissue-based products (HCT/Ps).

What GMP Means for Companies in the Life Sciences Space
GMP regulations address a wide range of production activities, including starting materials, sanitation and cleanliness of the premises, equipment verification, and process validation. GMP regulations even extend into human resources and general offices, offering practice guidelines for record keeping, personnel qualifications, complaints, training, and personal hygiene of staff working in regulated areas. GMP requires documented proof of consistent adherence to established procedures at every step in the production process.

While stringent in their requirement for quality, most GMP regulations are open-ended and flexible in that they allow individual companies the latitude to decide on the best way to implement the controls necessary to achieve the highest quality within each organization. Failure to comply with these regulations may result in regulatory action for the drug and for the company responsible for the failure.

Virtually every person in the United States is affected by the quality of pharmaceuticals. Nearly 70 percent of Americans take a prescription drug, according to Mayo Clinic, and almost half take two. The use of non-prescription or over-the-counter (OTC) drugs and supplements is also widespread. cGMPs are important because consumers cannot easily detect an unsafe or ineffective product simply by looking, smelling or touching it. GMP testing, typically performed on small samples from a batch, ensures that the rest of the batch provides the high quality medication or supplementation desired by these consumers.

What is Good Manufacturing Practices (GMP)?
GMP (Good Manufacturing Practice) is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product.

Quality Assurance / GMP Objectives
Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice.
  • The system of quality assurance appropriate to the manufacture of pharmaceutical products to ensure that:
  • Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP)
  • Production and control operations are clearly specified in a written form and GMP requirements are adopted
  • Managerial responsibilities are clearly specified in job descriptions
  • Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials
  • All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out
  • The finished product is correctly processed and checked, according to the defined procedures
  • Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products
  • Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life
  •  Deviation/complain and recalls are reported, investigated and recorded
  • There is a system for approving changes that may have an impact on product quality
  • Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement

What is GMP in Pharmaceutical Products?
Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types: cross contamination (in particular of unexpected contaminants) and mix-ups (confusion) caused by, for example, false labels being put on containers.

Good Manufacturing Practice is concerned with both production and quality control.

Under GMP:

>All manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications

>Critical steps of manufacturing processes and significant changes to the process are validated;

All necessary facilities for GMP are provided, including

Appropriately qualified and trained personnel Adequate premises and space Suitable equipment and services Appropriate materials, containers and labels Approved procedures and instructions; Suitable storage and transport; Adequate personnel, laboratories and equipment for in-process controls Instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided Operators are trained to carry out procedures correctly Records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; any significant deviations are fully recorded and investigated Records covering manufacture and distribution, which enable the complete tracing history of the batch, are retained in a comprehensible and accessible form Proper storage and distribution of the products minimizes any risk to their quality are in place and documented A system is available to recall any batch of product from sale or supply
  • Complaints about marketed products are examined; the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence
  • no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the relevant authorisations

Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
The basic requirements of Quality control are that:
  • Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;
  • Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control;

Test methods are validated;
  1. Records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated;
  2. The finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled; 
  3. Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;
  4. All batch of product are completely analyzed and approved in accordance with the requirements of the relevant authorization
  5. Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.


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