Sem 7 Drug Registration

Drug Registration And Approval
Process
By
DR. Suwarna S Bobde
Assistant Professor
Department Of Pharmaceutics
P.E.S Rajaram & Tarabai Bandekar College Of Pharmacy
Farmagudi-Ponda. Goa
DRUG APPROVAL PROCESS IN USA
• The Food and Drug Administration (FDA) is responsible for
protecting and promoting public health. Like general drug
approval process, FDA’s new drug approval process is also
accomplished in two phases:
-clinical trials (CT) and
- new drug application (NDA) approval
• FDA approval process begins only after submission of
investigational new drug (IND) application.
• The IND application should provide high quality preclinical
data to justify the testing of the drug in humans.
• Almost 85% of drugs are subjected to clinical trials, for which
IND applications are filed.
CLINICAL TRIALS
• PHASE I
• The next step is phase I clinical trials (1-3 years) on human subjects
(~100).
• The drug’s safety profile and pharmacokinetics of drug are focused in
this phase.
• PHASE II
• Trials (2 years) are performed if the drug successfully passes phase I.
• To evaluate dosage, broad efficacy and additional safety in people
(~300).
• If evidence of effectiveness is shown in phase II, phase III studies (3-
4 years) begins.
• PHASE III
• These phase III concerns more about safety and effectiveness of drug
from data of different populations, dosages and its combination with
other drugs in several hundred to about 3,000 peoples
NEW DRUG APPLICATION
• A new drug application (NDA) can be filed only when

-the drug successfully passes all three phases of clinical trials
and
-includes all animal and human data,
-data analyses,
-pharmacokinetics of drug and
-its manufacturing and proposed labelling.
• The preclinical, clinical reports and risk-benefit analysis
(product’s beneficial effects outweigh its possible harmful
effects) are reviewed at the Center for Drug Evaluation and
Research by a team of scientists.
• Generally approval of an NDA is granted within two years (on
an average).
• However, this process can be completed from two months to
several years.
• The innovating company is allowed to market the drug after
the approval of an NDA and is considered to be in Phase IV
trials.
• PHASE IV
• In this phase, new areas, uses or new populations, long-term
effects, and how participants respond to different dosages are
explored
Drug Aproval Process In India
• The Drug and Cosmetic Act 1940 and Rules 1945 were
passed by the India's parliament to regulate the
import, manufacture, distribution and sale of drugs
and cosmetics.
• The Central Drugs Standard Control Organization
(CDSCO), and the office of its leader, the Drugs
Controller General (India) [DCGI] was established.
• In 1988, the Indian government added Schedule Y to
the Drug and Cosmetics Rules 1945.
• Schedule Y provides the guidelines and requirements
for clinical trials, which was further revised in 2005 to
bring it at par with internationally accepted procedure.
• The changes includes, establishing definitions for
Phase I-IV trials and clear responsibilities for
investigators and sponsors
• The clinical trials were further divided into two categories in 2006.
• In one category (category A) clinical trials can be conducted in
other markets with competent and mature regulatory systems
whereas the remaining ones fall in to another category (category B)
Other than A.
• Clinical trials of category A (approved in the U.S., Britain,
Switzerland, Australia, Canada, Germany, South Africa, Japan and
European Union) are eligible for fast tracking in India, and are likely
to be approved within eight weeks.
• The clinical trials of category B are under more scrutiny, and
approve within 16 to 18 weeks.
• An application to conduct clinical trials in India should be submitted
along with the data of chemistry, manufacturing, control and animal
studies to DCGI.
• The date regarding the trial protocol, investigator's brochures, and
informed consent documents should also be attached.
• A copy of the application must be submitted to the ethical
committee and the clinical trials are conducted only after approval
of DCGI and ethical committee.
• To determine the maximum tolerated dose in humans,
adverse reactions, etc. on healthy human volunteers,
Phase I clinical trials are conducted.
• The therapeutic uses and effective dose ranges are
determined in Phase II trials in 10-12 patients at each
dose level.
• The confirmatory trials (Phase III) are conducted to
generate data regarding the efficacy and safety of the
drug in ~ 100 patients (in 3-4 centers) to confirm
efficacy and safety claims.
• Phase III trials should be conducted on a minimum of
500 patients spread across 10-15 centers, If the new
drug substance is not marketed in any other country.
• The new drug registration (using form # 44 along with
full pre-clinical and clinical testing information) is
applied after the completion of clinical trials.
• The application can be reviewed in a range of
about 12-18 months.
• Figure 9 represents the new drug approval
process of India.
• After the NDA approval, when a company is
allowed to distribute and market the product,
it is considered to be in Phase IV trials, in
which new uses or new populations, long-
term effects, etc. are explored
THANK YOU

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Drug Registration And Approval

• A new drug application (NDA) can be filed only when

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