Miscellaneous Articles

Pharmaceutical Regulatory Agencies and Organizations around the World: Scope and Challenges in Drug Development

About Authors:
Geetanjali Sengar*, Pranab Tripathy

Drug Regulatory Affairs Dept.
Belco Pharma, 515, Modern Industrial Estate,
Bahadurgarh-124507(Haryana), India.
*geetanjali.sengar@gmail.com, geetanjalisengar87@gmail.com

ABSTRACT:
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, regulatory agencies are being established in various countries across the globe. Regulatory agencies and organizations play a vital role to meet the requirements of legal procedures related to drug development process in a country.

In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products. USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory  agencies and organizations established in respective countries.

Express Test and Nanovision Scan of Fiberglass Using a Nanoindenter

About Authors:
*Kaumudi Singh, Shrishti Saroha
IIMT, Uttar Pradesh, India
*kaumudisingh.info@gmail.com

Abstract
In this research work we actually try to determine elastic modulous and hardness of a fiberglass of a car .this is done by AFM-like scan and in this thermoplastic has shown elastic modulous 7.40 and hardness 0.43 and fiberglass shows 76.69 and hardness 7.90. In this article we concluded that fibre glass is more beneficial than thermoplastic,hence fiberglass are good for tranportation  of pharmaceuticles as I concluded.also as fibreglass is made up of glass it is inert with active ingredients also.

Must Read Article: PHARMA, JOURNEY TO……. JAIL

About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years, retired from own Industry,
Founder President of M.P.Pharmacy Graduates’ Association,
President: M.P.Pharmaceutical Manufacturers’ Organisation,
Founder President : M.P. Small Scale Drug Manufacturers’ Association,
President Indian Pharmaceutical Association, M.P. State Branch, Indore,
Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”
(Email: sharda_jollo@yahoo.co.in)

Quality of Pharmaceuticals has been a concern of the World Health Organisation (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO constitution which sites as one of the organisation’s functions that it should develop, establish and promote International standards with respect to food, biological, pharmaceuticals and similar products.

Campbell (US FDA) was the first leading architect of the present Federal Food, Drug and Cosmetics Act passed in 1938. He differed sharply with ‘Willey’ in his belief that Court proceedings were not the only proper way to secure compliance.

Leveraging Information Technology to combat menace of Counterfeit Drugs

About Author:
R. Hemalatha*
Sunder Deep Pharmacy College,

* latha.hema2004@gmail.com

Counterfeit drugs which are able to penetrate everywhere, are causing huge social and economic costs besides undermining the confidence of the common man on health care system, there is urgent need to combat the problem.
Many methods were developed till date to combat the problem such as holograms and Active/covert systems such as RFID, Taggants and 2D-encryption but still the counterfeiters are able to emulate and circumvent them. However, this problem can be successfully tackled by leveraging the now-a-days omnipresent ICT tools. By making presence of these tools mandatory by all manufacturing units and chemists and by educating people about this ubiquitous menace, this problem can be minimized.

GOOD DOCUMENTATION PRACTICE IN PHARMACEUTICALS

About Author:
Arif Khan,
Malhotra college of pharmacy
Bhopal, MP
RGPV Bhopal, India

 

Abstract
Document is any written statement or proof of any activity in pharmaceuticals. Documentations are to define the manufacturers system of information & control, to minimize the risk of misinterpretation & errors inherent in oral or casually written communication, to provide unambiguous procedures to be followed to provide confirmation of performance, to allow calculations to be checked & to allow tracing of batch history. Documents are a mirror to show actual image of any pharmaceutical company. Documents and products are produced in pharmaceuticals but regulatory bodies are interested to see documents first. Different documents can describe the different activity in pharma and its actual image. Various documents are producing by pharma company would be discussed below. Due to the importance given to documentation in pharma “good documentation practices” is required. Good documentation is a systematic procedure of preparation, checking, verifying, issuing, storing and reviewing of any documents. Batch record is an important document kept along with reserve sample until one year of expiry of the product, and final products are release only after proper review of BMR, even after testing of Product from QC, product would not be released without review and completing of BMR and other documents .every activity should be available written form as SOPs is a requirements of GMP. Control of document is also an important part of GDP to reduce error and misuses of any documents. Master copy for all activity should be prepared such as SOPs started from Draft copy and finalizes after checking and reviewing and Approved by QA documentation. Final copy should be printed as Master copy and stamped as “master copy” by red ink. A photocopy of master copy should be issued to concern department with stamped “control copy”. A record should be maintained for issuing any documents with sign & date. Every document should have effective date, review date and revision no.

Burning issue - Present status of Pharmaceutical Industries

“Recent acquisition of Indian generic drug companies by MNCs has increased fears that the price of low-cost generic drugs will rise in India. The buy-outs will reduce domestic availability of many essential medicines; point out an internal assessment of the health ministry, Government of India. It is ironic that despite India supplying quality generic drugs around the world, the country has concerns about sufficient domestic drug supply and vaccines security. With the increasing acquisition of Indian companies by overseas drug corporations, there is a pressing need to rethink India’s drug strategy”. This statement was released by government of India before few months. Now what global honchos think about India?

View - There is no hope for the perfect research work

Research is an important tool for the human society. It is used to demystify the unsolved enigma of the nature. Homo sapiens are the most intelligent creature who has ever dominated the earth by his Intellectual reasoning and capacity. As we are living in 21st century which is known as modern age. So it is vital to do research to discard the age-old hypothesis and to establish clear/concise conceptions about a particular issue which can makes our lives safer in the planet.

NEED OF PHARMACOECONOMICS IN INDIAN HEALTH CARE SYSTEM: A BRIEF REVIEW

About Authors:
Hinchagri S S 1*, Halakatti P K2,  Devar S B2, Biradar B S2, Kankanwadi S K2, Patil S D2
1. HKES’s College of Pharmacy, Sedam Road, Gulbarga, Karnataka, India
2. HSK College of Pharmacy, BVVS’s Campus, Bagalkot, Karnataka, India

*shivanand.hinchageri95@gmail.com

Abstract:
In India, nearly 3.1 million households below the poverty line and those are unaffordable for private health care. Cost of medicines are growing constantly as new medicines are marketed and are under patent law, preference of drug therapy over invasive therapy, and the irrational drug prescription. In a developing country like India 85% of total health expenditure is financed by house-hold, out-of–pocket expenditure. The proportion of insurance in health-care financing in India is very low. Many poor people frequently face a choice between buying medicines or buying food or other necessities due to limited resources and high pricing of drug. So medicine prices do matter. The main objective of study is to show the importance of pharmacoeconomic evaluation in Indian health care. Methods to be used for pharmacoeconomic evaluation are Cost-effectiveness analysis, Cost minimization analysis, Cost-benefit analysis and Cost-utility analysis. Review of pharmacoeconomic evaluation sample studies shows the pharmacoeconomics became more important 1. To find the optimal therapy at the lowest price. 2. Numerous drug alternatives and empowered consumers also fuel the need for economic evaluations of pharmaceutical products. 3. The use of economic evaluations of alternative healthcare outcomes. 4. Healthcare resources are not easily accessible and affordable to many patients; therefore pharmacoeconomic evaluations play an important role in the allocation of these resources. The study concludes that in India the pharmacoeconomic evaluation is essential to optimal therapy at lowest price, alternative treatment plans, which help the poor and middle class Indians to obtain well health care services.

COLOURING AGENTS USED IN FOOD PRODUCTS

Abstract
Food colourants have been much important in food product manufacturing. Food and color additives are strictly studied, regulated and monitored. Federal regulations require evidence that each substance is safe at its intended level of use before it may be added to foods. Furthermore, all additives are subject to ongoing safety review as scientific understanding and methods of testing continue to improve. A color additive is any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color. FDA is responsible for regulating all color additives to ensure that foods containing color additives are safe to eat, contain only approved ingredients and are accurately labeled. Certified colors are synthetically produced (or human made) and used widely because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues. Color is added to food for one or more of the following reasons:
(1) to replace color lost during processing,
(2) to enhance color already present,
(3) to minimize batch-tobatch variations, and
(4) to color otherwise uncolored food.

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