www.individual.utoronto.ca/ddubins/BE_Criteria.xls 

click on this link in which u found Bioequivalence criterias as per Respective guidelines.

GLP NOTE

Frequently Asked Questions about Generic Drugs

1. What are generic drugs?
2. Are generic drugs as safe as brand-name drugs?
3. Are generic drugs as strong as brand-name drugs?
4. Do generic drugs take longer to work in the body?
5. Why are generic drugs less expensive?
6. Are brand-name drugs made in more modern facilities than generic drugs?
7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
8. Does every brand-name drug have a generic counterpart?
9. What is the best source of information about generic drugs?

1. What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

back to top

2. Are generic drugs as safe as brand-name drugs?

Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

back to top

3. Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

back to top

4. Do generic drugs take longer to work in the body?

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

back to top

5. Why are generic drugs less expensive?

Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

back to top

6. Are brand-name drugs made in more modern facilities than generic drugs?

No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

back to top

7. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

back to top

8. Does every brand-name drug have a generic counterpart?

No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

back to top

9. What is the best source of information about generic drugs?

Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at http://www.fda.gov/cder/ogd/index.htm for more information.

Defination for QA

Role of quality assurance in clinical research

Q. What is the role of quality assurance (QA) in clinical research?
Lakshmi Prasad Peesapati, Hyderabad

The QA person in a clinical trials responsible for:
• Continued maintenance of a clinical QA System with written standard operating procedures (SOPs)
• Preparation of quality assurance department SOPs
• Conduct of quality reviews of protocols, CRFs and supplemental study documentation
• Quality audits of tables, data listings, and study reports for data management projects
• Conduct internal process audits and external site audits to assess compliance with SOPs, GCP and regulatory requirements
• Coordination and conduct of clinical research training programmes
• Identification of areas for continuous quality improvement and leading the organization in implementing these improvements
• Communication with management about quality issues or problems
•Interfacing with regulatory agency, sponsors and independent internal auditors.
.Q. A group of investigators is planning to initiate a study with combination of marketed products in a new indication for academic purpose. Is it necessary to obtain DCGI and/or EC approval is required?
Suresh Vaghela


As per the definition of Phase IV trial in Indian GCP, this will be considered a trial for a new drug.

Phase IV
After a product has been placed on the market, clinical trials designed to explore new indications, new methods of administration or new combinations, etc. are normally considered as trials for new pharmaceutical products.The Medical Council of India’s (MCI) Code of Ethics Regulations 2002, which covers doctor’s obligations towards various laws, suggests that the doctors have to follow Drugs and Cosmetics Act, 1940 and ICMR guidelines.

The relevant MCI code is:
1.9 Evasion of Legal Restrictions: The physician shall observe the laws of the country in regulating the practice of medicine and shall also not assist others to evade such laws. He should be cooperative in observance and enforcement of sanitary laws and regulations in the interest of public health. A physician should observe the provisions of the State Acts like Drugs and Cosmetics Act, 19407.22 Research:
Clinical drug trials or other research involving patients or volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute misconduct. Consent taken from the patient for trial of drug or therapy, which is not as per the guidelines, shall also be construed as misconduct.It is clear from the above that a doctor conducting clinical research has to follow the ICMR guidelines, and Drugs and Cosmetic Act 1940 and other relevant laws.

Q. How many IEC members should vote for the approval of a Clinical Research Study?
Shiva

This depends on 1) total number of members 2) quorum.Schedule Y recommends the following:

Ethics Committee
1. The number of persons in an Ethics Committee should be at least seven members. Ethics Committee should appoint, from among its members, a Chairperson (who is from outside the institution) and a Member Secretary. Other members should be a mix of medical/non-medical, scientific and non-scientific persons, including lay public, to reflect the different viewpoints.For review of each protocol the quorum of Ethics Committee should be at least 5 members with the following representations:

Q. We are conducting a study with a site which has its own EC. Recently, I was told that the sponsor’s representative cannot attend the EC meeting. If I am not wrong, as per the guidelines, the composition includes the management representative as well as member secretary. Is this correct?
S. Gurunath

No guideline describes specific composition i.e. inclusion of a management representative. The membership as per guidelines describes specific professions e.g. scientific / non-scientific / legal / medical person etc. Unless you are officially a member of the EC in one of the prescribed categories (see Schedule Y), you cannot attend the meetingDr Arun Bhatt is currently, president, ClinInvent Research Pvt Ltd, Mumbai. Readers can send their queries at: arunbhatt@clininvent.com