A brief idea aboutbpharmaceutical regulatory environment in US, UK and India

1. Overview of Regulatory EnvironmentOverview of Regulatory Environment
in USA, Europe & Indiain USA, Europe & India
Dijo Mathew JohnDijo Mathew John
Pharm.D Post BaccalaureatePharm.D Post Baccalaureate

2. Need For Therapeutic Good RegulationNeed For Therapeutic Good Regulation
 Protect health and safety of population.
 By ensuring the safety, quality and efficacy of therapeutic
goods covered under the scope of regulation.

3. Clinical Research Regulation in USAClinical Research Regulation in USA

4. Food & Drug AdministrationFood & Drug Administration
 The US FDA is a scientific, regulatory and public
health agency under the United States Department
of Health and Human Services.
 It is led by the Commissioner of Food and Drugs,
appointed by the President with the advice and
consent of the Senate.
 Comprised of several offices and centers.

5. Primary Responsibility of FDAPrimary Responsibility of FDA
 For protecting and promoting public health through the
regulation and supervision of food safety, tobacco
products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines,
biopharmaceuticals, blood transfusions, medical devices,
electromagnetic radiation emitting devices (ERED),
veterinary products and cosmetics.

6.  Agency scientists evaluate applications for new human drugs
and biologics, complex medical devices, food and color
additives, infant formulas and animal drugs.
 The FDA monitors the manufacture, import, transport, storage
and sale of about $1 trillion worth of products annually.

7. Centre for Drug Evaluation and ResearchCentre for Drug Evaluation and Research
(CDER)(CDER)
CDER is one of the centers of US FDA that
Reviews NDAs and ANDAs for their safety and efficacy
manages US cGMP regulations for pharmaceutical
manufacturing
Review advertising and promotion of drugs
collects and analyses safety data about pharmaceuticals that
are already on the market.

8. Selected regulations and guidance
for drug studies
 Code of Federal Regulations (CFR)
 CFR Title 21: clinical trials related regulations. (revised
frequently and published yearly):
 Part 11: Electronic records
 Part 50: Protection of human subjects
 Part 54: Financial disclosure by clinical investigators
 Part 56: Institutional Review Boards
 Part 312: Investigational new drug application
 Part 314: Applications for FDA approval to market a new drug

9. New Drug Approval Process at FDA
1. Sponsor/FDA Meetings (Pre-IND)
2. Submission of IND to FDA
3. Sponsor/FDA Meetings (End of Phase 2)
4. Accelerated Drug Review
5. Parallel Track
6. Clinical Hold Decision
7. Notification to Sponsor (i.e for deficiencies)
8. Sponsor/FDA Meetings (Pre-NDA)
9. New Drug Application
10. Final Meetings with Sponsor
11. Permission for marketing
12. Post marketing review

11. Clinical Research Regulation in Europe – TheClinical Research Regulation in Europe – The
European Agency for the Evaluation ofEuropean Agency for the Evaluation of
Medicinal Products (EMEA)Medicinal Products (EMEA)
 Decentralized scientific body of the European Union
 Protection and promotion of public and animal health through
the evaluation and supervision of medicines for human and
veterinary use.
 Scientific opinions of the agency are prepared by 3 committees:
 CPMP: medicines for human use
 CVMP: veterinary medicines
 COMP: designation of orphan medicines for rare diseases

12. Clinical Research Regulation in UK – Medicines &Clinical Research Regulation in UK – Medicines &
Healthcare products Regulatory Agency (MHRA)Healthcare products Regulatory Agency (MHRA)
 MHRA – competent authority of authority for the medical
devices and the Licensing Authority for pharmaceuticals
advised by Committee on Safety of Medicines (CSM)

13. Key Activities of MHRA
 Regulating medical devices.
 Licensing of medicines before marketing and subsequent
variations.
 Regulation of clinical trials.
 Operating adverse incident reporting system for medical devices.
 Issuing safety warning.
 Responsibility for reporting, assessment and communications of
defective medicines.

14.  Monitoring of medicines and acting on safety concerns after
marketing.
 Evaluating medical devices to inform purchasing and encourage safe
use.
 Managing the General Practice Research Database (GPRD).
 Setting quality standards for drug substances through the ‘British
Pharmacopoeia’.
 Providing advice and guidance on medicines and medical devices.

15. Drug Regulatory System in IndiaDrug Regulatory System in India
 Health is in concurrent list of Indian Constitution
 It is governed by both central and state governments

16. Clinical Research Regulation in India –Clinical Research Regulation in India –
Drug Controller General of India (DCGI)Drug Controller General of India (DCGI)
 Legislation is enforced by Central Govt (Dept of Chemicals
and Fertilizers, Ministry of Chemicals and Petrochemicals).
 Drug Controller General of India (DCGI) under Central drug
Standard Control Organization (CDSCO) has prime
responsibility for regulating Clinical trials in India.
 DCGI: matters related to product approval and standards,
clinical trials, introduction of new drugs and import licenses
for new drugs.

17.  Approvals for setting up manufacturing facilities, obtaining
licenses to sell and stock drugs are provided by the State
Governments.
 2 drug organizations to exercise control over drugs:
 Central Drug Standard Control Organization (CDSCO)
 State Drug Control Organizations

20. Central Drug Standard Control OrganizationCentral Drug Standard Control Organization
((CDSCOCDSCO))
 Controlling the quality of imported drugs.
 Co-ordinating the activities of the States and advising them
on matters relating to the uniform administration of the Act
in the country.
 Laying down Rules and ancillary provisions of Drugs
Control and standards of drugs.
 Controlling the quality of drugs moving in inter-state
commerce jointly with Drug Control Organizations.
 Granting approval to ‘New Drugs’ proposed to be imported
or manufactured in the country.
 Controlling the quality of drugs which are exported.
 Arranging meetings of 2 statutory bodies, DTAB and DCC .

21.  Drugs Technical Advisory Board (DTAB): Technical
experts and advises the Central and State Governments on
all technical matters arising out of the enforcement of
drug control.
 Drug Consultative Committee (DCC): To ensure that the
Drug Control measures are enforced uniformly in all
States.
 Genetic Engineering Approval Committee (GEAC):
authority to approve rDNA pharmaceutical products.
Assess the bio-safety/environmental product.

24. Clinical Trials Guidelines in IndiaClinical Trials Guidelines in India
The guidelines that govern the conduct of Clinical
trials in India include:
• Schedule Y of Drugs and Cosmetics Act, 1940.
• Ethical Guidelines for Biomedical Research on
Human Subjects, 2000.
• Good Clinical Practices, 2001.

26. Schedule Y of Drugs and Cosmetics Act, 1940Schedule Y of Drugs and Cosmetics Act, 1940
Requirement and guidelines on clinical trials for
import and manufacture of new drug in India.
Recommendations for carrying out Clinical Trials in
India:
• The clinical trials required to be carried out in the country
before a new drug is approved for marketing depend on the
status of the drug in other countries.
• Phase III trials are usually required for the drugs which are
already approved/marketed in the country of origin.

27. If the drug is not approved/marketed, trials are
generally allowed to be initiated at one phase earlier
to the phases of trials in other countries.
For new drug substances (IND) discovered in other
countries phase I trials are not usually allowed to be
initiated in India, unless phase I data from other
countries are available.
If the drug is of unmet therapeutic need, such trials
may be permitted even in the absence of phase I data
from other countries.

28. For new drugs having potential for use in children,
permission for clinical trials in the pediatric age
group is normally given after phase III trials in adults
are completed.
However, if the drug is of value primarily in a disease
of children, early trials in the pediatric age group may
be allowed.

29. CDSCO

30. Application Requirements
 Application for permission to conduct clinical
trials is made to the office of DCGI in Form 44.
 Permission to import drug may be obtained by
applying in Form 12 for a test license.
 Permission to carry out clinical trials with a new
drug is issued in Form 11 along with a test license

31. Data requirements under schedule YData requirements under schedule Y

34. Thankyou…