International guidelines and regulatory bodies

Links to important international guidelines and regulatory bodies


WHO (Medicines)

WHO guidelines on medicines policy, intellectual property rights, financing & supply management, quality & safety, selection & rational use of medicines, technical co-operation and traditional medicines.

WHO sites

WHO guidelines on all areas relevant to health of people all over.

ICH

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) guidelines defining quality, safety, efficacy & related aspects for developing and registering new medicinal products in Europe, Japan and the United States

OECD

Organization for Economic Collaboration and Development including 30 member countries covers economic and social issues in areas of health care.

EMEA

European Medicines Agency (EMEA), a decentralised body of the European Union headquartered in London, prescribes guidelines for inspections and general reporting and all aspects of human & veterinary medicines in the European Union.

US FDA

Regulations, guidelines, notifications, news and communications from US Food and Drug Administration.

TGA

Specifications regulating medicines, medical devices, blood, tissues & chemicals, issued by Therapeutic Goods Administration, the Australian regulatory body.

South Africa

The department of Health, South Africa.

WTO

News, resources, documents and publications of the World Trade Organization (WTO), the global international organization dealing with the rules of trade between nations.

Codex Alimentarius

Collection of international food standards and guidelines for processed, semi–processed and raw foods, adopted by the Codex Alimentarius Commission under the Joint FAO / WHO Food Standards Programme.

MHRA

News, warnings, information and publications of Medicines and Healthcare products Regulatory Agency (MHRA), responsible for ensuring efficacy and safety of medicines and medical devices in the UK.

Health Canada

Advisories, warnings, recalls, reports, publications, activities, legislations and guidelines from Health Canada, the Federal Department responsible for health related issues in Canada.

Thai FDA

Thai Food and Drug Administration laws and regulations with respect to drugs, food, cosmetics and narcotics.

HSA, Singapore

Health Sciences Authority (HSA), the regulatory body of Singapore.

DOH, Philippines

The Department of Health, Philippines.

Medsafe,

New Zealand

Medsafe, New Zealand Medicines and Medical Devices Safety Authority.

NPCB, Malaysia

Regulatory information, news and publications of National Pharmaceutical Control Bureau, Malaysia.

DGMP, Belgium

Guidelines and useful information to ensure safety, efficacy and quality of medicines, issued by Directorate-General Medicinal Products, Belgium.

BfArM, Germany

Licensing and registration guidelines for medicinal products laid down by Federal Institute for Drugs and Medical Devices, Germany

SwissMedic

Swiss regulatory agency for therapeutic products.

MPA, Sweden

Regulatory and surveillance guidelines issued by Medical Products Agency, Sweden.

NAFDAC, Nigeria

News, regulations and guidelines issued by The National agency for Food Administration and Control (NAFDAC), Nigeria.

Vernier Caliper

How to use and read a vernier caliper？


An ordinary vernier caliper has jaws you can place around an object, and on the other side jaws made to fit inside an object. These secondary jaws are for measuring the inside diameter of an object. Also, a stiff bar extends from the caliper as you open it that can be used to measure depth.


The basic steps are as follows:



1. Preparation to take the measurement, loosen the locking screw and move the slider to check if the vernier scale works properly. Before measuring, do make sure the caliper reads 0 when fully closed. If the reading is not 0, adjust the caliper’s jaws until you get a 0 reading. If you can’t adjust the caliper, you will have to remember to add to subtract the correct offset from your final reading. Clean the measuring surfaces of both vernier caliper and the object, then you can take the measurement.



2. Close the jaws lightly on the item which you want to measure. If you are measuring something round, be sure the axis of the part is perpendicular to the caliper. Namely, make sure you are measuring the full diameter. An ordinary caliper has jaws you can place around an object, and on the other side jaws made to fit inside an object. These secondary jaws are for measuring the inside diameter of an object. Also, a stiff bar extends from the caliper as you open it that can be used to measure depth.



3. How to read the measured value:


1), Read the centimeter mark on the fixed scale to the left of the 0-mark on the vernier scale. (10mm on the fixed caliper)

2). Find the millimeter mark on the fixed scale that is just to the left of the 0-mark on the vernier scale. (6mm on the fixed caliper)

3). Look along the ten marks on the vernier scale and the millimeter marks on the adjacent fixed scale, until you find the two that most nearly line up. (0.25mm on the vernier scale)

4). To get the correct reading, simply add this found digit to your previous reading. (10mm + 6mm + 0.25mm= 16.25 mm)

4.Maintenance



Clean the surface of the vernier caliper with dry and clean cloth (or soaked with cleaning oil) and stock in a dry environment if it stands idle for a long time.

Digital Vernier Caliperse:

Least count:


The least count of any measuring equipment is the smallest quantity that can be measured accurately using that instrument.Thus Least Count indicates the degree of accuracy of measurement that can be achieved by the measuring instrument.



The Vernier scale consists of a main scale graduated in centimeters and millimeters. On the Vernier scale 0.9 cm is divided into ten equal parts. The least count or the smallest reading which you can get with the instrument can be calculated as under:


Least count = one main scale (MS) division - one vernier scale (VS) division.

= 1 mm - 0.09 mm

= 0.1 mm

= 0.01 cm


The least count of the vernier =  Value of  the smallest division on MS/Total number of divisions on VS
                                                     =  1 mm/ 10 = 0.1 cm/10 = 0.01 cm

Stability Zones

Leading UK pharmaceutical corporations, 2002(Link for contacts)

Leading UK pharmaceutical corporations, 2002
1. GlaxoSmithKline2. Pfizer3. Astra Zeneca4. Merk & Co5. Wyeth6. Novartis7. Aventis Pharma8. Pharmacia Ltd9. Roche10. Lilly11. Sanofi-Synthelabo12. Bristol-Myers Squibb13. Johnson & Johnson14. Boehringer Ingelheim15. Novo Nordisk16. Abbott17. Bayer18. Schering Plough19. Schering Ag20. Lundbeck

All company contacts available in this link:
http://www.allaboutmedicalsales.com/dir/top20_pharma_companies.html#Top

Pharmaceuticals Industries in India

Capsule

Capsule:
In the manufacture of pharmaceuticals, encapsulation refers to a range of techniques used to enclose medicines in a relatively stable shell known as a capsule, allowing them to, for example, be taken orally or be used as suppositories.
The two main types of capsules are: Hard-shelled capsules, which are normally used for dry, powdered ingredients or miniature pellets or tablets; Soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or suspended in oil.

Capsule Sizes:

Capsule Locking Mechanism:

Dosage form

A dosage form (DF) is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others. Notably, the route of administration (ROA) for drug delivery is dependent on the dosage form of the substance in question.

Various dosage forms may exist for a single particular drug, since different medical conditions can warrant different routes of administration. For example, persistent nausea and emesis or vomiting may make it difficult to use an oral dosage form, and in such a case, it may be necessary to utilize an alternate route such as inhalational, buccal, sublingual, nasal, suppository, or parenteral instead.

Indian Regulations & Guidelines:

Indian Regulations & Guidelines:
CDSCO
Central Drugs Standard Control Organization (CDSCO), Ministry of Health & Family Welfare, Government of India provides general information about drug regulatory requirements in India.
NPPA
Drugs (Price Control) Order 1995 and other orders enforced by National Pharmaceutical Pricing Authority (NPPA), Government of India. View the list of drugs under price control here.....
D & C Act, 1940
The Drugs & Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs in India.
Schedule M
Schedule Mof the D&C Act specifies the general and specific requirements for factory premises and materials, plant and equipment and minimum recommended areas for basic installation for certain categories of drugs.
Schedule T
Schedule T of the D&C Act prescribes GMP specifications for manufacture of Ayurvedic, Siddha and Unani medicines.
Schedule Y
The clinical trials legislative requirements are guided by specifications of Schedule Yof The D&C Act.
GCP guidelines
The Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects. These GCP guidelines are essentially based on Declaration of Helsinki, WHO guidelines and ICH requirements for good clinical practice.
The Pharmacy Act,1948
The Pharmacy Act, 1948 is meant to regulate the profession of Pharmacy in India.
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954
The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 provides to control the advertisements regarding drugs; it prohibits the advertising of remedies alleged to possess magic qualities.
The Narcotic Drugs and Psychotropic Substances Act, 1985
The Narcotic Drugs and Psychotropic Substances Act, 1985 is an act concerned with control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.

The Indian pharmaceutical industry

“The Indian pharmaceutical industry is a success story providing employment for millions and ensuring that essential drugs at affordable prices are available to the vast population of this sub-continent.”
The Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology. A highly organized sector, the Indian Pharma Industry is estimated to be worth $ 4.5 billion, growing at about 8 to 9 percent annually. It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured. From simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made indigenously.

What is Pharma Industry?

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications.Pharmaceutical companies can deal in generic and/or brand medications. They are subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs.