What Is FDA

1. What is FDA? Elaborate on the roles of FDA.
The Food and Drug Administration is a federal agency of the United States
Department of Health and Human Services.
The Food and Drug Administration is responsible for protecting the public
health by ensuring the safety, efficacy, and security of human and
veterinary drugs, biological products, and medical devices; and by ensuring
the safety of the nation's food supply, cosmetics, and products that emit
radiation.
FDA also has responsibility for regulating the manufacturing, marketing,

and distribution of tobacco products to protect the public health and to
reduce tobacco use by minors.
FDA is responsible for advancing the public health by helping to speed

innovations that make medical products more effective, safer, and more
affordable and by helping the public get the accurate, science-based
information they need to use medical products and foods to maintain and
improve their health.
FDA also plays a significant role in the Nation's counterterrorism capability.

FDA fulfills this responsibility by ensuring the security of the food supply
and by fostering development of medical products to respond to deliberate
and naturally emerging public health threats.
The FDA regulates a wide range of products, including foods (except for
aspects of some meat, poultry and egg products, which are regulated by the
U.S. Department of Agriculture); human and veterinary drugs; vaccines and
other biological products; medical devices intended for human use;
radiation-emitting electronic products; cosmetics; dietary supplements,
and tobacco products.
FDA is responsible for
● Protecting the public health by assuring that foods (except for meat
from livestock, poultry and some egg products which are regulated
by the U.S. Department of Agriculture) are safe, wholesome,
sanitary and properly labeled; ensuring that human and veterinary
drugs, and vaccines and other biological products and medical
devices intended for human use are safe and effective
● Protecting the public from electronic product radiation
● Assuring cosmetics and dietary supplements are safe and properly
labeled
● Regulating tobacco products
● Advancing the public health by helping to speed product
innovations
FDA's responsibilities extend to the 50 United States, the District of

Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and
other U.S. territories and possessions.
2. Mention 10 important amendments brought in drug regulation.
On September 27, 2007, President George W. Bush signed into law H.R.
3580, the Food and Drug Administration Amendments Act of 2007. This
new law represents a very significant addition to FDA authority. Among
the many components of the law, the Prescription Drug User Fee Act
(PDUFA) and the Medical Device User Fee and Modernization Act
(MDUFMA) have been reauthorized and expanded. These programs will
ensure that FDA staff have the additional resources needed to conduct the
complex and comprehensive reviews necessary to new drugs and devices.
Two other important laws were reauthorized: the Best Pharmaceuticals for
Children Act (BPCA) and the Pediatric Research Equity Act (PREA). Both of
these are designed to encourage more research into, and more
development of, treatments for children.
1941
Insulin Amendment requires FDA to test and certify purity and potency of
this life saving drug for diabetes
1945
Penicillin Amendment requires FDA testing and certification of safety and
effectiveness of all penicillin products. Later amendments extended this
requirement to all antibiotics. In 1983 such control was found no longer
needed and was abolished.
1948
Miller Amendment affirms that the Federal Food, Drug, and Cosmetic Act
applies to goods regulated by the Agency that have been transported from
one state to another and have reached the consumer.
1951
Durham-Humphrey Amendment defines the kinds of drugs that cannot

be safely used without medical supervision and restricts their sale to
prescription by a licensed practitioner.
1960
Color Additive Amendment enacted, requiring manufacturers to establish

the safety of color additives in foods, drugs and cosmetics. The Delaney
proviso prohibits the approval of any color additive shown to induce cancer
in humans or animals.
1962
Kefauver-Harris Drug Amendments passed to ensure drug efficacy

and greater drug safety.
1965
Drug Abuse Control Amendments are enacted to deal with problems

caused by abuse of depressants, stimulants and hallucinogens.
1968
Animal Drug Amendments place all regulation of new animal drugs under
one section of the Food, Drug, and Cosmetic Act-Section 512-making
approval of animal drugs and medicated feeds more efficient.
1976
Vitamins and Minerals Amendments ("Proxmire Amendments") stop
FDA from establishing standards limiting potency of vitamins and minerals
in food supplements or regulating them as drugs based solely on potency.
3. Write a note on Indian Drug & Cosmetic Act.
● The Drugs and Cosmetics (Amendment) Bill, 2013 was introduced in

the Rajya Sabha on August 29, 2013. The Bill amends the Drugs and
Cosmetics Act, 1940 and changes the name of the Act to the Drugs,
Cosmetics and Medical Devices Act, 1940.
● The Bill proposes changes in the regulation of the import, export,
manufacture, distribution and sale of drugs, cosmetics and medical
devices and to ensure safety, efficacy, quality and conduct of clinical
trials.
● The definition of drugs is changed to include new drugs that are (i)
not in significant use in India and are not recognised as effective and
safe by the Drugs Controller General of India (DCGI);(ii) approved by
the DCGI for certain claims but are being marketed with
modified/new claims; (iii) a fixed dose combination of two or more
drugs, which are individually approved but are being combined for
the first time in a fixed/changed ratio; and (iv) all vaccines,
Recombinant Deoxyribonucleic Acid derived products, Living
Modified Organisms, stem cells, gene therapeutic products etc. which
are intended to be used as drugs.
● Under the Act, medical devices were covered under the definition of
drugs. The Bill changes this by adding a definition of medical devices
to include any instrument, implant, material or other article,
including the software, intended to be used specially for human
beings or animals for the specific purposes of diagnosis, prevention,
treatment or alleviation of any disease or, injury, modification of the
body’s anatomy and sustaining life.
● Clinical trials are defined in relation to drugs, cosmetics and medical,
and involve their systematic study with the objective of determining
their safety, efficacy, performance or tolerance. Anyone initiating a
clinical trial has to register with the Central Drug Authority (CDA)
and get approval from an Ethics Committee registered with it. The
Bill creates provisions for the medical treatment and compensation
in case of injury or death of a person during participation in a clinical
trial or due to it.
● The Central Government shall establish a CDA to subsume the
existing Central Drugs Standards Control Organisation. The CDA will
be composed of representatives from the Ministries of Health and
Family Welfare, Law, Commerce and Industry, Science and
Technology, Chemicals and Fertilisers, DCGI, Indian Council of
Medical Research, Directorate General of Health Services, and other
experts nominated by the central government, including those from
state licensing authorities.
● The CDA shall among others, specify guidelines, structures and
requirements for the effective functioning of the central and state
licensing authorities; review, suspend or cancel any licence or
permission issued by them; and decide on disputes between two or
more state licensing authorities relating to the provisions of the Act
and rules and regulations made under it
● The DCGI is the central licensing authority that has the power to
issue, renew, suspend or cancel licences for import, export or
manufacture of drugs, cosmetics or medical devices or permission for
conducting clinical trials. The DCGI also has the sole power to issue
licenses for the manufacture, sale, and export of 17 categories of
drugs.
● The Bill constitutes the Medical Devices Technical Advisory Board
and the Drugs Technical Advisory Board to advise the central and
state governments and the CDA on technical matters pertaining to
medical devices, and drugs.
● In order to ensure standard quality of drugs, cosmetics, and medical
devices, the Bill specifies conditions under which they will be
considered misbranded, adulterated, and spurious and specifies
penalties and offences for the same.
4. What is GMP? Explain the GMP set by WHO for a pharma &
biopharma company.
Good manufacturing practices (GMP) are the practices required in order to conform to the
guidelines recommended by agencies that control the authorization and licensing of the
manufacture and sale of food and beverages, cosmetics,pharmaceutical products,dietary
supplements,and medical devices. These guidelines provide minimum requirements that a
manufacturer must meet to assure that their products are consistently high in quality, from
batch to batch, for their intended use.
Current cGMPs for compliance in pharmaceuticals

Current Good Manufacturing Practices (cGMP) for compliance in pharmaceuticals
are built on the same lines as many other of the FDA's guidelines, in the sense that it
too, offers broad and general GMP guidelines that pharmaceutical companies have
to comply with. The core philosophy that these cGMPs for compliance in
pharmaceuticals are stated in bold: "Quality should be built into the product, and
testing alone cannot be relied on to ensure product quality". All the ensuing cGMPs
flow from this dictum.
These are the current GMP compliance requirements for pharmaceuticals (some of
these guidelines overlap with those for medical devices)

Basic Guidelines in GMP for biopharma industries
1. Hygiene: Facility must maintain a clean and hygienic manufacturing area.
2. Controlled Environment: To prevent cross contamination of one product from another
drug or particulate matter.
3. Defined Manufacturing process: Manufacturing processes are controlled and changes
are to be evaluated.
4. Instructions and procedures are written in clear and unambiguous language.
5. Operators are to be trained to carry out and document their work and procedures.
6. Records are to be maintained manually or by instruments and all steps are to be
documented.
7. Proper labeling and distribution system should be in place.
8. A system should be available for recalling any batch or supply.
9. Complaints about marketed drugs should be examined; the causes of quality defects
investigated and appropriate measures to prevent recurrence should be undertaken.
10. Practices are recommended with the goal of safeguarding the health of patients.• GMP
guidelines are not prescriptive instructions on how to manufacture products. • They are a
series of general principles that must be observed during manufacturing. • When a
company is setting up its quality program and manufacturing process, there may be
many ways it can fulfil GMP requirements. • It is the company's responsibility to
determine the most effective and efficient quality process.
5. A. What is the importance of preservation & packaging of drugs?

B. What are the different methods by which therapeutic proteins are
preserved & packed?
A.
Packaging, storage and preservation:
It is important to choose the type of packaging that provides a good protection to the
drugs.Usually leaves and herbs material are baled with power balers into a solid compact mass
that are sewn into a burlap cover.Drug that are likely to deteriorate from absorbed moisture (e . g
. Digitalis, ergot) are packed in moisture proof cans. Gums, resins and extracts are shipped in
barrels and boxes. Proper storage and preservation are important factors in maintaining a high
degree of quality of the drug.
37 Hard–packed bales, barks and resinous drugs usually absorb little moisture. But leaf herb
and root drugs that are not well packed tend to absorb moisture which reaches 10 – 30 % the
weight of the drug.Excessive moisture not only increases the weight of the drug, thus reducing
the percentage of active constituents, but also favors enzymatic activity and facilitates fungal
growth.Light adversely affects drugs that are highly colored rendering them unattractive and
possible causing undesirable changes in constituents. The oxygen of the air increases oxidation
of the constituents of drugs, especially when enzyme oxidase is present. Therefore, the
warehouse should be cool, dark and well ventilated with dry air.
B.
6. Natural sources of drugs are plants,animals,microbes & minerals.
Justify your answer.

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1. What is FDA? Elaborate on the roles of FDA.

FDA also has responsibility for regulating the manufacturing, marketing,

FDA is responsible for advancing the public health by helping to speed

FDA also plays a significant role in the Nation's counterterrorism capability.

FDA is responsible for

FDA's responsibilities extend to the 50 United States, the District of

2. Mention 10 important amendments brought in drug regulation.

Durham-Humphrey Amendment defines the kinds of drugs that cannot

Color Additive Amendment enacted, requiring manufacturers to establish

Kefauver-Harris Drug Amendments passed to ensure drug efficacy

Drug Abuse Control Amendments are enacted to deal with problems

3. Write a note on Indian Drug & Cosmetic Act.

● The Drugs and Cosmetics (Amendment) Bill, 2013 was introduced in

Current cGMPs for compliance in pharmaceuticals

5. A. What is the importance of preservation & packaging of drugs?

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