Miscellaneous Articles

Diabetes is classed as a metabolism disorder. Metabolism refers to the way our bodies used digested food for energy and growth. Most of what we eat is broken down in to glucose. Glucose is a form of sugar in the blood it is the principle source of fuel for our bodies.

When our food is digested the glucose makes its way into our blood stream. Our cell uses the glucose for energy and growth.

About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years,
retired from own Industry (2004),
Founder President of M.P.Pharmacy Graduates’ Association (MPGA),
Ex President: M.P.Pharmaceutical Manufacturers’ Organisation (MPPMO),
Founder President : M.P. Small Scale Drug Manufacturers’ Association (MPSDMA),
Ex President Indian Pharmaceutical Association, M.P. State Branch, Indore (IPA),
Ex Vice Chairman Confederation of Indian Pharmaceutical Industries (SSI) (CIPI)
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)

Article By,
Balbir Negi
GM Regulatory Affairs
SHAH TC Overseas Private Limited, Delhi, INDIA
22 years of industrial Exp,
M.Sc, MBA, Doctor of Science.

Crystallization has the vital role in the pharmaceutical industry as it is started from intermediates separation process and the final manufacture step as active pharmaceutical ingredients (APIs).
Crystallization is a key component of almost all processes in the manufacturing of pharmaceuticals. Whether for purification of intermediates, formation of the product, or prevention of crystallization in amorphous products, crystallization is essential in both processing and development.

Crystallization can be natural or artificial process of formation of solid crystalsprecipitating from a solutionmelts or more rarely deposited directly from a gas.

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.

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.

Should animals be used as research subjects?
Absolutely No Animal Research – Why ?
Animals have rights! Animals surely deserve to live their lives free from suffering and exploitation. Animals are not ours to: eat, wear, experiment on use for entertainment, abuse.

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.

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.

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.