B. Pharm. Final Year, Sem:- VII, INDUSTRIAL PHARMACY-II, Unit 3 chapter 3 regulatory affairs, As per PCI Syllabus

1. IP-II,
Unit- III,
Regulatory Affairs
Mr. Audumbar Mali,
Asst. Professor,
Sahyadri College of Pharmacy, Methwade.

2. Contents:-
# Introduction,
# Historical overview of RA,
# Responsibilities of RA,
# Regulatory Authorities,
# Role of RA department.

3. • Pharmaceutical & Clinical Research Industry most
regulated among all the industries.
• Every drug before getting market approval must
undergo clinical trials to ensure its Safety,
Efficacy & Quality.
• Standards are set by regulatory
authorities.
• RA department acts as a crucial link between
company, products & regulatory authorities.
Introduction
3

4. What isDRA??
• Unique mix of science and management to achieve a
commercially important goal.
• It touches everything relating to drugs from the
development manufacture and marketing.
• RA takes care of
 Design = Development Plan
 Co-ordination = Writing/
reviewing, supervising
 Construction = Assembling&
Submission management
4

5. .
It is a dynamic and challenging field in the
pharmaceutical industry.
It is an link between the competent authority
and an applicant (company) to manage life
cycle of the products.
In present regulatory scenario, company
requires experts in regulatory activities to
manage the product life cycle.
RA experts are qualified professionals to
provide right solution to the technical
problems under the light of laws and

6. .
Historical overview of RA:-
The drug industry in India was at very primitive
stage till 20 th century. Most of the drug; Were
imported from foreign countries.
(a) 1900-1960:
Government passed the Poisons Act, 1919 to check
and hold the control on cheap drugs available in
market. This Act helps in the administered
possession of substance or sale of substances as
specified as poison. It also stated the safe and
protected custody of the poisons, packaging and
labeling of poisons, maximum quantity to be sold
and inspection as well as examination of the poison
sold by vendor during the year.

7. The Poisons Act was followed by The
Dangerous Drugs Act, 1930 which
includes the regulation of cultivation,
manufacturing, possession and trade
of opium.
In 1985, Dangerous Drugs Act, 1930
and Opium Act, 1878 was revoked by
passing of the Narcotics and
Psychotropic Substances Act.

8. Following acts and rules were passed during this era:
# Drugs and Cosmetics Act, 1940: This act regulates the
manufacturing, distribution, import and sale of allopathic,
homeopathic, unani and siddha drugs.
# Drugs and Cosmetics Rules, 1945: This act regulates
manufacture of Ayurvedic drugs for sale only, and not for
consumption and use or possession.
# Pharmacy Act, 1948: This law was amended in 1986 and
it generally controls and regulates the profession of
pharmacy in India.

9. # Drugs and Magic Remedies (Objectionable
Advertisements) Rule, 1955: This rule regulates the
advertisement of drugs in India.
# Drugs Prices Control Order, 1955 (DPCO) (under
the essential commodities Act): DPCO was further
amended in 1995. As per this rule, government has
a jurisdiction to review and fix maximum sale price
for bulk drugs as well as formulation.
(b) 1960-1970:
The Indian Pharmaceutical industry was not mature
enough and major market share was dominated by
MNC and very few Indian manufacturers were in
competition.

10. Focus on pure research and development was very
little because of deficiency of patent protection. The
low availability and high drug price is because majority
shares depend upon the high drug import.
(c) 1970-1980: Government took control for the
medicines regulation and issued few acts and rules.
# Indian Patent Act 1970 (which came in force on 20
April 1972 and replaced Indian Patents and Designs Act
of 1911): It serves as the basis for patent protection in
India.

11. Under this Act product patent was not allowed but the
process and method of manufacturing of Drug
substance was allowed to get the patent
Drug prices capped: Drug Prices Control Order (DPCO)
was introduced to control the high price against
consumers.
(d) 1980-1990: The Indian industry has started
investing in process development of API and created
production infrastructure for the same.
(e) 1990-2000:- A rapid expansion in domestic market
has observed in pharmaceutical industry. The
companies have started entering into Research and
Development.

12. (f) 2000-2010: 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: Indian Government
brought out the Patents (Amendment) Ordinance, 2004 to
address the issues relating to the patent in the country
which was later replaced by the Indian Patent
(Amendment) Act, 2005. The new Act brought some
crucial changes on the legal regime of patent protection
so as to address patent issues in technology, chemicals
and pharmaceuticals sectors.

13. Compulsory Licenses: Such Iicenses 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”.
Few names are given below:
# Drugs and Cosmetics (First Amendment)
Rules. 2011: It mandates registration of Clinical
Research Organization (CRO) for conducting
Clinical Trials (CT).

14. # Clinical Trial Registry-India (CTRI): It
has been set up by the ICMR's (Indian
Council
of Medical Research) National Institute of
Medicai Statistics (NIMS).
# Pharmacovigilance Program of India
(PvPI): The Central Drugs Standard
Control Organization (CDSCO) has
launched Pharmacovigilance programme
to assure drugs safety to Indian patients.

15. • Lifecycle management ranges from
Drug Discovery post-marketing stage of the
process.
• From Drug development to commercialization, each
step is regulated.
Scope
1
5

16. Responsibilities ofRA
professional
• Keep up-to-date about international
legislation, guidelines and customer practices.
• Update with company's product range.
• Compliance of company's productwith
current regulations
• Impart training to R&D, Pilot plant, ADL on
current regulatory requirements
• Formulate regulatory submission strategies.
6

17. • Prepare IMPD, DMF, ANDA, MAA, Dossiers
amendments & supplements etc as per
regional guidelines, submit them to
regulatory authorities in a specified time
frame
• Monitor progress of all registration
Responsibilities ofRA
professional [Contd…]
7
submissions

18. • Respond to queries as they arise and ensure
that registration/approvals are granted
without delay.
• Handle regulatory and customer inspections,
review audit reports and compliance
• Arranges consultations and meetings
between the firm and government
regulatory agencies
Responsibilities ofRA
professional [Contd…]
8

19. 9
• Company success
depends on reduction of
time taken for a drug to
reach market.
• Inadequate reporting of
data may prevent a
timely positive
evaluation of a
marketing application
• Proper conduct of RA
activities is therefore
of considerable
economic importance
for the company.
NO DMF/
DOSSIER NO REGISTRATION
NO SALE
Importance ofRA

20. Regulatory Agencies

21. Country Name of Regulatory Authority Website
USA Food and Drug Administration www.fda.gov
[FDA]
Europe European Directorate for the
Quality of Medicines and
Healthcare (EDQM)
www.edqm.eu
European Medicines Agency (EMA) www.ema.europa.eu
Heads of Agencies for the European
Union
http://www.hma.eu/ 21

22. Country Name of Regulatory Authority Website
Japan
UK
Ministry of Health, Labour and
Welfare (MHLW)
www.mhlw.go.jp/english
Pharmaceuticals and Medical Devices
Agency (PMDA) www.pmda.go.jp/english/
Medicines and Healthcare products
Regulatory Agency (MHRA)
www.mhra.gov.uk
India Central Drugs Standard Control
Organization.
www.cdsco.nic.in
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23. HowtoKeepUpWiththeConstantly
Changing RegulatoryLandscape?
 Monitor Agency’s
websites
 Subscribe to relevant
journals, newsletters
 Get daily e-mails
from regulatory
websites, commercial
information provider
websites
 Attend relevant
conferences/advis
ory meetings
 Talk to colleagues
and consultants
 Employ a
regulatory
information
database In-house
or Paid
 Joining
information blogs
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24. Roles of Regulatory Affairs Experts
Regulatory Affairs plays a crucial role in the
pharmaceutical industry and is involved in all stages
of drug development and also after drug approval
and marketing.
Pharmaceutical companies use all the data
accumulated during discovery and development
stages in order to register the drug and thus market
the drug.
Throughout the development stages,
pharmaceutical companies have to abide by an
array of strict rules and guidelines in order to ensure
safety and efficacy of the drug in humans.

25. In this highly regulated environment, regulatory affairs
plays a critical role not only as the interface with health
agencies and as a link between different departments
in the company but also as the leading department to
provide strategic advice on extremely difficult decisions
through the life of a drug.
Regulatory professionals keep working with the
authorities and different departments within the
company in order to meet regulatory commitments
with the health authorities.
Regulatory experts also ensures the maintenance of the
marketing licence and leads life cycle extension
activities such as broadening the indication of the drug,
change of formulation, changes in the dosage etc..