BP702T_IP_UNIT-III_Regulatory affairs Part I.pdf

Amity Institute of Pharmacy
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UNIT-III
Regulatory Affairs
Presented By
Dr. Vikas Pandey
Associate Professor
Amity Institute of Pharmacy,
Amity University Madhya Pradesh
Gwalior, Madhya Pradesh
BP 702 T
Industrial Pharmacy-II (Theory)

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Introduction,
Historical overview of Regulatory Affairs,
Regulatory authorities,
Role of Regulatory affairs department,
Responsibility of Regulatory Affairs Professionals
Contents

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• high-quality,
• safe and
• effective
All drugs must meet 3 standards

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Regulatory affairs is a profession developed from the desire of
governments to protect public health by controlling the safety and efficacy
of products in areas including
 pharmaceuticals,
veterinary medicines,
medical devices,
pesticides,
agrochemicals,
cosmetics and
complementary medicines, and
by the companies responsible for the discovery, testing, manufacture and
marketing of these products wanting
to ensure that they supply products that are safe and make a worthwhile
contribution to public health and welfare.
What is regulatory affairs?

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A new class of professionals emerged to handle these
regulatory matters for companies.
TOPRA, established in 1978, is a professional membership
organisation to represent and support these professionals.
Address: 6th Floor, 3 Harbour Exchange Square, London
E14 9GE, United Kingdom
It behaves as the link between the regulatory authority and
the project team, and is the passage for communication with
the regulatory authority as it move forwards, target to
providing that project plan correctly predicts what the
regulatory authority will require before approving the product.
What is regulatory affairs?

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Keeping track of the ever-changing legislation in all the
regions in which a company wishes to distribute its products
Advising on legal and scientific restraints and requirements
Collecting, collating and evaluating scientific data
Presenting registration documents to regulatory agencies
Carrying out any subsequent negotiations necessary to
obtain or maintain marketing authorisation for the products
concerned
Giving strategic and technical advice at the highest level in
their companies, making an important contribution both
commercially and scientifically to the success of a
development programme and the company as a whole.
The role of the regulatory professional

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 Helping the company avoid problems caused by badly kept
records, inappropriate scientific thinking or poor presentation
of data.
 Additionally, the regulatory affairs department will often take
part in the development of product marketing concepts and is
commonly required to approve packaging and advertising
before it is used commercially.
 Professionals must combine knowledge of the business,
legal and pharmaceutical industries to determine if regulations
are being followed and, in many cases, form the link between
pharma companies and regulatory authorities, such as the
Food and Drugs Agency (FDA) and the European Union (EU)
The role of the regulatory professional

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During 1950s, multiple tragedies i.e., sulfanilamide elixir, vaccine tragedy
and thalidomide tragedy have resulted in substantial increase of
legislations for drug products quality, safety and efficacy.
This has also resulted into stricter norms for Marketing Authorization
(MA) and Good Manufacturing Practices (GMPs).
To understand the chronological development of the modern era of
pharmaceutical industry and regulatory framework, we will glance through
the historical evolution of regulations in USA, and India.
Historical overview of Regulatory Affairs

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During the early 18th century, chemical manufacturing factories had
started establishing and the first large scale manufacturing of glycerin
started during 1818-1840.
In the USA, the root of modern pharmaceutical industry was borne
during Mexican- American war 1846-1848.
The American troops had suffered due to import of spurious medication
for Malaria, Cholera, Dysentery, Yellow Fever and that had brought federal
government into action for creation of Custom Laboratories.
Import Drugs Act of 1848 - The first law - controlled import of medicines
As per this law, it was mandatory to inspect imported drugs for quality
and purity at the entry of port.

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To define the quality and purity of drug, federal government recognized
United States Pharmacopoeia (USP) as an official compendium.
 Though United States Pharmacopoeia Committee (USPC) was
established in 1820, it was non-government body till Import Drugs Act of
1848.
 Import Drugs Act of 1848: Objective: Creating system for standards,
quality control and national formulary.
At the start of the nineteenth century, new legislations for medicines
control started coming into effect due to multiple tragedies worldwide.
This was the era when ancient traditions of manufacturing and
distribution of drugs evolved into the modern highly organized
pharmaceutical industry and controlled system of Drug Regulatory Affairs
(DRA).

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Almost five decades after issuance of Import Drugs Act of 1848,
vaccines tragedy happened in 1901.
This was ended up with the death of 14 children in November 1901
Simultaneously, smallpox vaccine administered was found contaminated
and resulted into nine more death in Camden, New Jersey.
The Biologics Control Act of 1902 was the result of the vaccine tragedy.
 The federal government took steps for controlling adulteration or
misbranding of foods, drugs, medicines, liquors.
With this law toxic colors and preservatives like borax, sulphuric acid,
formaldehyde, copper sulphate were banned for usage in food and drugs.

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The Food and Drugs Act of 1906
This law made mandatory labelling of ingredients and its content for
drugs i.e., alcohol, cocaine, heroin, morphine, opium.
This was the first wide ranging, national legislation on food and
medicines safety
The Federal Food and Drugs Act 1906 was starting point for eventual
creation of Food and Drug Administration (FDA)
Originally The Bureau of Chemistry was used to regulate food safety,
however in 1927, it was reorganized into the Bureau of Chemistry and
Soils and Food, Drug and Insecticide Administration.
In 1930, the current Food and Drug Administration (FDA) came into
effect after shortening of earlier organization.
Since the root of FDA was born in 1906, FDA still celebrates 1906 as its
establishment year.

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Food, Drug and Cosmetic Act of 1938
Sulfanilamide Elixir tragedy raised concern about the safety of drug
products.
In 1938, more than 100 people were died due to diethylene glycol (highly
toxic solvent) utilized for mixing Sulfanilamide drug.
Consequently, the law was enacted as Food, Drug and Cosmetic Act of
1938 to oversee safety of medicine.
With this law, pre-marketing approval of all new drugs was made
mandatory and proof for scientific safety study was asked by FDA.
 This law also mandated the directions for safe use.

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Historical overview of
Regulatory Affairs -
INDIA

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The drug industry in India was at very primitive stage till 20th Century.
Most of the drugs were imported from foreign countries.
Post First World War (28 Jul 1914 – 11 Nov 1918), the demand for drugs
had increased tremendously and that led to the cheap & substandard
drugs into the market
1900-1960:
Poisons Act 1919 : To control cheap drugs in market.
 This Act regulates possession of substance or sale of substances as specified
as poison.
It also specifies the safe custody of the poisons, labeling and packaging of
poisons, maximum quantity to be sold and inspection as well as examination of the
poison sold by vendor during the year.
The Poisons Act was followed by The Dangerous Drugs Act 1930. This act
regulates the opium plant cultivation, manufacture and possession of opium, its
import, export, transship and sell of opium.
Historical overview of Regulatory Affairs - INDIA

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 Drugs and Cosmetics Act, 1940: Regulate the import, manufacture,
distribute and sale of drugs. This act covers allopathic, homeopathic,
Unani and Siddha drugs.
 Drugs and Cosmetics Rules, 1945: The rules under the Drugs and
Cosmetics Act regulate only manufacture of Ayurvedic drugs for sale, and
not for consumption, use or possession.
 Pharmacy Act, 1948: This law was amended lastly in 1986 and it
regulates the pharmacy profession of India.
 Drugs and Magic Remedies (Objectionable Advertisements) Rules,
1955: These rules control the drug advertisement in India.
 Drugs Prices Control Order, 1955 (DPCO) (under the essential commodities
Act): DPCO was further amended in 1995. Under this rule, government may review
and fix maximum sale price for bulk drugs as well as formulation.
Historical of Regulatory Affairs – INDIA (1900-1960)

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 The market share was dominated by multinational companies and very
few Indian manufacturers were present.
The Indian Pharmaceutical Industry was in an early stage of growth.
 Focus for pure research and development was very little due to lack of
patent protection.
Due to very high import dependency on drugs, the cost of drugs was
very high as well as market availability was comparatively low.
History of Regulatory Affairs – INDIA (1960-1970)

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 Indian Patent Act 1970: It serves as the basis for patent protection in
India. Based on this, only process and method of manufacture of Drug
substance was allowed to get the patent. Product patent was not allowed
under this act.
Indian Patent Act of 1970 came into force from April 20, 1972.
This new act replaced the Indian Patents and Designs Act of 1911.
 Drug prices capped: Drug Prices Control Order (DPCO) was introduced
to control the high price against consumers.
 Local companies begin to make an impact: Since the product patent was
allowed by Indian Patent Act 1970; local companies began manufacturing products/ drugs
using different manufacturing process by reverse engineering.
Due to these new drugs were available cheaply as well as many more substitute drugs
were available in the market against costly imported new drugs.
This has resulted in increase the exports to countries like Russia, Africa, China, and South
America.

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The industry has started investing in API process development and
created production infrastructure.
Government has also issued export incentives.
The Narcotic Drugs and Psychotropic Substances Act, 1985 was issued
which regulates the operation of narcotic drugs and substances.

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The pharmaceutical industry has observed a rapid expansion of
domestic market and during same era globalization happened.
The companies have entered into research activity.
India joined Paris Cooperation Treaty (PCT) in 1999 and implemented
product patent effective from Jan 1, 2005.
The Patent Cooperation Treaty (PCT) is an international patent law treaty,
concluded in 1970.
It provides a unified procedure for filing patent applications to protect
inventions in each of its contracting states.

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This period is considered to be the Innovation and Research era.
During these years, innovative research activity, patenting of the drugs
formula, process, indication as well as merger of companies was started.
 Patent Amendment Act 2005: With this act, provision for Black Box
Application made, as per that if patent application is filed before Jan 1,
2005, then under the transit provision of Trade Related aspects of
Intellectual Property Rights (TRIPS), manufacturer can market this product
post 2005 without infringing product patent, if manufacturer has made
significant investment in manufacturing of the product, produced and
marketed on or before Jan 1, 2005.

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 Compulsory Licenses:
Such licenses can be granted for manufacture and export of the drug
products “to any country having insufficient or no manufacturing capacity,
for the said product, to address public health problems”.
 Herbal preparations having medicinal values can be patented under
new amended law.
Major regulatory changes in terms of marketing authorization process as
well guidelines have come into effect. Few to name are as below:
Drugs and Cosmetics (First Amendment) Rules, 2011
Clinical Trial Registry- India (CTRI)
Pharmacovigilance Programme of India (PvPI)
Guidance documents

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Pharmacovigilance (PV) is the science and activities relating to the
detection, assessment, understanding and prevention of adverse effects
or any other medicine/vaccine related problem.
 All medicines and vaccines undergo rigorous testing for safety and
efficacy through clinical trials before they are authorized for use.
The goals of PV:
•Identify previously unknown adverse effects
•Recognize changes in the frequency or severity of known adverse effects
•Assess a drugs risk/benefit to determine if action is required to improve safety
•Ensure the accuracy of information communicated to healthcare professionals
and patients, and to ensure information contained in patient information
leaflets (PILs) is up to date

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 Pharmacovigilance Week from 17th September to 23rd September 2024
Theme of 4th National Pharmacovigilance Week in 2024 was
"Building an ADR Reporting Culture for Patient Safety"

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Regulatory authorities
INTERNATIONAL ORGANIZATIONS
World Health Organization (WHO)
Pan American Health Organization (PAHO)
World Trade Organization (WTO)
International Conference on Harmonization (ICH)
World Intellectual Property Organization (WIPO)
Every country has its own regulatory authority, which is responsible to enforce the
rules and regulations and issue guidelines for drug development, licensing,
registration, manufacturing, marketing and labeling of pharmaceutical products.

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Major Regulatory Agencies World Wide
Country Name of Regulatory Authority
USA Food and Drug Administration (FDA)
UK Medicines and Healthcare Products Regulatory Agency (MHRA)
Australia Therapeutic Goods Administration (TGA)
India Central Drug Standard Control Organization (CDSCO)
Canada Health Canada
China State Food and Drug Administration
Europe European Medicines Agency (EMEA)

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Regulatory authorities act as a guardian that ensures the safety, efficacy
and quality of drugs available to the public, to identify the strengths and
weaknesses of drug regulation and to propose strategies to improve drug
regulation.
They also play a vital role to ensure and increase regulatory
implementation in non-regulated parts of the world for safety of people
residing there.
The international regulatory organizations play essential role in all
aspects of pharmaceutical regulations related to drug product registration,
manufacturing, distribution, price control, marketing, research and
development, and intellectual property protection.
Common Scope of Such Organizations

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 To promote public health and protect the public from harmful and
dubious drugs,
 To establish proper legalization covering all products with a medicinal
claim and all relevant pharmaceutical activities, whether carried out by the
public or the private sector.
 To increase worldwide regulatory growth to ensure safety of people.
The major challenges of these regulatory bodies

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Central Drug Standard
Control Organization
(CDSCO)

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The CDSCO is the Central Drug Authority for discharging functions
assigned to the Central Government under the Drugs and Cosmetics Act,
1940.
CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and
seven laboratories under its control.
 Headquarter : New Delhi
Major functions of CDSCO:
 Regulatory control over the import of drugs, approval of new drugs and clinical
trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical
Advisory Board (DTAB), approval of certain licenses as Central License Approving
Authority is exercised by the CDSCO headquarters.
Central Drug Standard Control Organization (CDSCO)

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Regulatory control over the import of drugs, approval of new drugs and
clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs
Technical Advisory Board (DTAB), approval of certain licenses as Central
License Approving Authority is exercised by the CDSCO headquarters.
Further CDSCO along with state regulators, is jointly responsible for grant
of licenses of certain specialized categories of critical Drugs such as blood
and blood products, I. V. Fluids, Vaccine and Sera.
 Under the Drugs and Cosmetics Act, CDSCO is responsible for
 Approval of Drugs,
Conduct of Clinical Trials,
 Laying down the standards for Drugs,
Control over the quality of imported Drugs in the country and
Coordination of the activities of State Drug Control Organizations
by providing expert advice with a view of bring about the uniformity
in the enforcement of the Drugs and Cosmetics Act.
Major functions of CDSCO

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Central Drug Standard Control Organization (CDSCO)

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The organization chart (CDSCO)

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World Health Organization
(WHO)
WHO headquarters, Geneva

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 As of January 2021, the WHO has 194 member states
 The WHO employs 7,000 people in 149 countries and regions to carry
out its principles.
 In support of the principle of a tobacco-free work environment, the WHO
does not recruit cigarette smokers.
The organization has previously instigated the Framework Convention
on Tobacco Control in 2003.

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 WHO Country Office for India is headquartered in Delhi
 WHO is the United Nations’ specialized agency for Health.
It is an inter-governmental organization and works in collaboration with
its member states usually through the Ministries of Health.
The WHO is responsible for providing leadership on global health
matters, shaping the health research agenda, setting norms and
standards, articulating evidence-based policy options, providing technical
support to countries and monitoring and assessing health trends.
India became a party to the WHO Constitution on 12 January 1948.
The first session of the WHO Regional Committee for South-East Asia
was held on 4-5 October 1948 in the office of the Indian Minister of Health.
It was inaugurated by Pandit Jawaharlal Nehru, Prime Minister of India and
was addressed by the WHO Director-General, Dr Brock Chisholm.
India is a Member State of the WHO South East Asia Region.

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providing leadership on matters critical to health and engaging in
partnerships where joint action is needed;
shaping the research agenda and stimulating the generation, translation
and dissemination of valuable knowledge;
setting norms and standards and promoting and monitoring their
implementation;
articulating ethical and evidence-based policy options;
providing technical support, catalysing change, and building sustainable
institutional capacity; and
monitoring the health situation and assessing health trends.
Six core functions of WHO

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Regional offices of WHO
Region Headquarters
Africa
Brazzaville, Republic of the
Congo
Europe Copenhagen, Denmark
South-East Asia New Delhi, India
Eastern Mediterranean Cairo, Egypt
Western Pacific Manila, the Philippines
The Americas Washington, D.C., United States

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Map of the WHO's regional offices and their respective
operating regions

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Four strategic priorities of WHO in India

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The WHO India Country Cooperation Strategy 2019–2023: The
four strategic priorities
UHC: Universal health coverage
NCD: Noncommunicable Diseases
IHR International Health Regulations
IHIP Integrated Health Information Platform
AMR Antimicrobial resistance

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https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/ele
ments/download_file_division.jsp?num_id=MTIwMTE=
List of Drugs, Medical Devices, Vaccine and Cosmetics
declared as Spurious/Adulterated/Misbranded for the
Month of August-2024

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https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/ele
ments/download_file_division.jsp?num_id=MTA1MTU=
List of Drugs, Medical Devices and Cosmetics declared as
Not of Standard Quality/Spurious/Adulterated/Misbranded
for the Month of AUGUST – 2023

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