What is the difference between GSTR1, GSTR2, and GSTR3?

The monthly return to be submitted under GST consists of one return that is to be submitted in three parts:

• GSTR 1
• GSTR 2
• GSTR 3

GSTR-1 is a monthly return where the registered person is required to provide details of the value of outward supplies made by him. Additionally, the return also requires you to provide details of the invoices raised, debit notes and credit notes issued.

GSTR -2 is the part where the registered person provides inward supplies received by him on which he wishes to avail input credit. The details in this return are auto populated from the GSTR 1 filed by other suppliers. In case any additions are to be made, the same shall also be possible.

GSTR -3 is the final return wherein the output liability as per GSTR 1 is set off against input as claimed in GSTR 2 and balance liability, if any, is determined which is to be paid in cash. On payment of balance tax liability and setting off of the same, the final return can be submitted.

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What Is Pharmacovigilance ??

Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.

Drugs and Cosmetics Rules, 1945

The Drugs and Cosmetics Rules, 1945 contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule.^[1] The Rule 67 details the conditions of licenses. The Rule 97 contains the labeling regulations.^[3]

The notable Schedules and their summary:

• Schedule G: Most of these drugs are hormonal preparations.^[4] The drug label must display the text “Caution: It is dangerous to take this preparation except under medical supervision” prominently. Examples of substances under this schedule: Testolactone, Hydroxyurea, Carbutamide, Primidone etc.^[3]
• Schedule H: The drug label must display the texts “Rx” and “Schedule H drug. Warning : To be sold by retail on the prescription of a Registered Medical practitioner only” prominently. It can only be supplied to licensed parties. It cannot be sold without a prescription and only the amount specified in the prescription should be sold. The time and date of prescription must be noted. Examples: androgenic, anabolic, oestrogenic and progestational substances; Alprazolam(Xanax), Hepatitis B vaccine, Ibuprofen, Vasopressin etc.^[3]
  • If a Schedule H drug also comes under the purview of Narcotic Drugs and Psychotropic Substances Act, 1985, it must carry the texts “NRx” and “Schedule H drug. Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.” on the label prominently.
• Schedule X: All the regulations of Schedule H apply. The retailer must keep a copy of the prescription for two years. The drugs must be kept under lock and key. Examples: Secobarbital, Glutethimide etc.^[3]
• Schedule J: Contains a list of various diseases and conditions that cannot be treated under any drug currently in market. No drug may legally claim to treat these diseases.^[3]

Other Schedules and their summary:

• Schedule A: Contains various forms and formats of letters for applications of licensing etc.^[3]
• Schedule B: Contains fees structure for government-run labs.^[3]
• Schedule C: Contains various biological products^[4] and their regulation. Examples: Serums, Adrenaline etc.^[3]
• Schedule E: Contains various poisons^[4] and their regulation. Examples: Sarpa Visha (Snake venom), Parada (Mercury) etc.^[3]
• Schedule F: This contains regulations and standards for running a blood bank.^[3]
  • Schedule F-I: This contains regulations and standards for vaccines.^[3]
  • Schedule F-II: This contains regulations and standards for surgical dressing.^[3]
  • Schedule F-III: This contains regulations and standards for umbilical tapes.^[3]
• Schedule F-F: This contains regulations and standards for ophthalmic ointments and solutions.^[3]
• Schedule K: Contains various substances and drugs and their corresponding regulation.^[3]
• Schedule M: Contains various regulations for manufacturing, premises, waste disposal and equipment.^[3]
• Schedule N: Contains various regulations and requirements for a pharmacy.^[3]
• Schedule O: Contains various regulations and requirements for disinfectant fluids.^[3]
• Schedule P: Contains regulations regarding life period and storage of various drugs.^[3]
  • Schedule P-I: Contains regulations regarding retail package size of various drugs.^[3]
• Schedule Q: Contains a list of permitted dyes and pigments in soap and cosmetics.^[3]
• Schedule R: Contains various regulations and requirements for condoms and other mechanical contraceptives.^[3]
• Schedule S: Lists various cosmetics and toiletries, and directs the manufacturers of cosmetics to conform to the latest Bureau of Indian Standardsrequirements.^[3]
• Schedule T: Contains various regulations and requirements for manufacture of Ayurvedic, Siddha and Unani products.^[3]
• Schedule U: Contains various regulations and requirements for record keeping.^[3]
• Schedule V: Contains standards for drug patents.^[3]
• Schedule Y: Contains requirement and guidelines for clinical trials.^[3]
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What Is an Active Pharmaceutical Ingredient (API)?

The Active Pharmaceutical Ingredient (API) is the part of any drug that produces its effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.

Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs.

Components of Medications

All drugs are made up of two core components: the API, which is the central ingredient, and the excipient, the substance inside the drug that helps deliver the medication to your system. Excipients are chemically inactive substances, such as mineral oil.

For instance, if you have a headache, acetaminophen is the active ingredient, while the liquid in the capsule or the bulk of a pill is the excipient.

Strength of APIs

Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. One brand might use one test, another a different one.

Top API Manufacturers

The leading manufacturer of APIs is TEVA Pharmaceuticals. With over 300 API products, they have the industry’s largest portfolio.

 Another leading manufacturer is Dr. Reddy’s, with more than 60 APIs in use today.

Where are APIs Made?

While many pharmaceutical companies are located in the United States and England, most API manufacturers are overseas. The largest are located in Asia, particularly in India and China. More and more companies are turning to outsourcing to API manufacturers like Dr. Reddy’s to cut costs on expensive equipment, employees, and infrastructure.

GENERIC VERSUS BRAND MEDICATIONS……

What are generic drugs?

A generic drug is a chemically equivalent, lower-cost version of a brand-name drug, costing 30-80% less! A brand-name drug and its generic version must have the same active ingredient, dosage, safety, strength, usage directions, quality, performance and intended use.

Are generic drugs as safe as brand-name drugs?

Yes. Generic and brand-name drugs must meet the exact same standards for effectiveness, safety and quality.

Are generic drugs as strong as brand-name drugs?

Yes. The Food and Drug Administration (FDA) requires generic drugs to have the same quality, strength, purity and stability as their brand-name versions. Generic drugs are thoroughly tested to make sure their performance and ingredients meet the FDA’s standards for equivalency.

Do generics take longer to work?

No. Generic drugs work in your body in the same way and in the same amount of time as brand-name drugs

Are brand-name drugs manufactured in better facilities than generic drugs?

No. Both brand-name and generic drug facilities must meet the same standards; the FDA won’t permit drugs to be made in substandard facilities. The FDA conducts about 3,500 inspections a year to ensure standards are met. In fact, brand-name firms are linked to an estimated 50% of generic drug production. They frequently make generic copies of their own or other brand-name drugs, then sell them with a generic name.

What is the price difference between generic and brand-name drugs?

In 2008, the average price of a brand-name drug was $137.90, while the average generic prescription cost $35.22, according to the National Association of Chain Drug Stores. In addition to the savings on the price difference, there is also a savings on your copayment for using a generic drug over a brand-name drug.

If generic drugs are just as good as brand-name drugs, why do generics cost less?

When a company develops a new drug and submits it for FDA approval, a 20-year patent is issued, preventing other companies from selling the drug during the life of the patent. As a drug patent nears expiration, any drug manufacturer can apply to the FDA to sell its generic version. Because these manufacturers didn’t have the same development costs (such as years of expensive research), they can sell the drug at a discount. Once generics are allowed, the competition keeps the price down. Today, almost half of all prescriptions are filled with generics.

Why do some generic drugs look different from their brand-name versions?

All drugs have inactive ingredients such as dyes, fillers and preservatives. These ingredients often determine the size, shape and color of the drug. Trademark laws do not allow a generic drug to look exactly like its brand-name version. A generic drug must duplicate the active ingredient and it must be equally effective, but the color, shape, and other inactive ingredients may be different.

How do I get generic drugs?

Talk with your doctor and pharmacist. Explain that you want the most effective drug at the best price. Ask your doctor to write prescriptions for generic drugs whenever possible.

What’s the bottom line on generics?

You can use generics with confidence. Although they may look different from their brand-name versions, generics are safe and effective. As always, any medication changes must be discussed with your physician and pharmacist.

Pharmaceutical Approvals

US FDA (United States Food and Drug Administration)
UK’s MHRA (United Kingdom’s Medicines and Health products Regulatory Agency)
TGA Australia (Therapeutic Goods Administration)
MCC South Africa (Medicines Control Council)
ANVISA Brazil (National Health Surveillance Agency)
Health Canada and
GCC DR (Gulf Central Committee for Drug Registration)

21 CFR PART 11

1. Validation of Systems       21 CFR 11.10(A)
2. Accurate Generation of Records             21 CFR 11.10(B)
3. Protection of Records               21 CFR 11.10(C)
4. Limited System Access                21 CFR 11.10(D)
5. Audit Trails                                     21 CFR 11.10(E)
6. Operational System Checks            21 CFR 11.10(F)
7. Authority Checks                                21 CFR 11.10(G)
8. Input Checks                                      21 CFR 11.10(H)
9. Education, Training and Experience              21 CFR 11.10(I)
10. Policies for Using Electronic Signatures          21 CFR 11.10(J)
11. Document Control  21 CFR 11.10(a) 21 CFR 11.10(k)

What is Converged infrastructure ??

Converged infrastructure (CI) is an approach to data center management that seeks to minimize compatibility issues between servers, storage systems and network devices while also reducing costs for cabling, cooling, power and floor space. A converged infrastructure can be implemented with a CI reference architecture, with standalone appliances or with a software driven hyper-converged approach.

With a CI reference architecture approach to converged infrastructure, the vendor provides the customer with pre-tested recommendations for how best to use hardware components in the data center to meet requirements for specific workloads.

With an IT appliance approach to CI, the vendor provides the customer with a single box that houses tightly integrated compute, storage, networkingvirtualization resources from the vendor and perhaps the vendor’s partners. Should the need arise, additional appliances can be purchased and added, a concept known ashorizontal scalability.

With a hyper-converged approach, the vendor abstracts compute, networking and storage resources from the physical hardware, bundling virtualization software with their CI offerings. Hyper-converged vendors may also provide additional functionality for cloud bursting or disaster recovery and allow administrators to manage both physical and virtual infrastructures — whether on-site or in the cloud — in a federated manner with a single pane of glass.

Commonly Used Port Numbers

This is a list of commonly used ports, and does not include all possible ports that may be opened on a server.

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cPanel
	cPanel	2082
	cPanel – SSL	2083
	WHM	2086
	WHM – SSL	2087
	Webmail	2095
	Webmail – SSL	2096
Email
	POP3	110
	POP3 – SSL	995
	IMAP	143
	IMAP – SSL	993
	SMTP	25
	SMTP Alternate	26
	SMTP Alternate	587
	SMTP – SSL	465
Web
	HTTP	80
	SSL	443
	FTP	21
	FTPs	990
	SFTP	22
	SFTP Shared/Reseller Servers	2222
	Webdisk	2077
	Webdisk – SSL	2078
	MySQL	3306
	MSSQL	1433
	SSH	22
	SSH Shared/Reseller Servers	2222
Other
	Plesk Control Panel	8880
	Plesk Control Panel – SSL	8443
	Plesk Linux Webmail	N/A*
	Plesk Windows Webmail (SmarterMail)	9998**
	Virtuozzo	4643
	DotNet Panel	9001
	DotNet Panel Login	80
	RDP (Remote Desktop Protocol)	4489

Horizontal vs. Vertical Markets in Business

Businesses can be placed into two kinds of markets: horizontal and vertical. Both are vital for marketing and company-building purposes. Here are some ways to differentiate horizontal markets from vertical markets and understand how you can use them.

Horizontal markets are:

• Defined by a demographic feature that can be common across different kinds of businesses
• Always broader than vertical markets
• Usually cooperative and seeking joint opportunities
• An opportunity to market to a general audience FOR EG: MICROSOFT OFFICE.

 Vertical markets are:

• A group of businesses that share the same industry
• Always specific and cannot cross industries
• Often competing against each other
• An opportunity to market to a specific audience

Although the two market types are contrasting, businesses can usually be categorized into both horizontal and vertical markets at the same time. For example, a shoe company could market horizontally to the area in which it is located. It could also market vertically to anyone considering a new pair of shoes. A children’s book publishing company can market horizontally to literate people or vertically to children and parents.