07-09-2022
Currently different countries have to follow different regulatory requirements for
Regulatory requirements for drug
approval:
Drug Development Teams
DRUG DESCOVERY AND DEVELOPMENT
Some of the rules & guidelines that should be followed
for regulation of drugs in India are:
 Drugs and Cosmetics Act 1940 and its rules 1945
 Narcotic Drugs and Psychotropic Substances -1985
 Drugs Price Control Order 1995
 Consumer Protection Act-1986
 Factories Act-1948
 Law of Contracts (Indian contract Act-1872)
 Monopolistic & Restrictive Trade Practices Act-1969
 ICH GCP Guidelines
approval of new drug.
For Marketing Authorization Application (MAA) : a single regulatory approach is
applicable to various countries is almost a difficult task. Therefore, it is necessary to
have knowledge about regulatory requirement for MAA of each country. Each country
has its own regulatory requirements which have to be satisfied to approve a new drug
in that particular country.
Regulation of Drug Approval Process
Approval of New Drug in India :
If any company in India wants to manufacture or import a new
drug, apply to seek permission from the licensing authority
(DCGI) by filing in Form 44 also submitting the data as given
in Schedule Y of Drugs and Cosmetics Act 1940 and Rules
1945.
 To prove its efficacy and safety in Indian population they
need to conduct clinical trials in accordance with the
guidelines specified in Schedule Y and submit the report of
such clinical trials in specified format.
 The regulations under Drugs and Cosmetics Act 1940 and
its rules 1945, 122A, 122B and 122D describe the
information required for approval of an application to
import or manufacture of new drug for marketing.
Drug Development Teams & Their Responsibilities
The drug development team includes a diverse group of individuals with different
philosophies and approaches to the development process. All team members must work
closely together to ensure that a drug is both safe and efficacious.
The responsibilities of these project teams include –
1. Reviewing research results from experiments conducted by any of the various
scientific disciplines.
2. Integrating new research results with previously generated data.
3. Planning research studies to further characterize a drug candidate.
4. Preparing a detailed drug development plan, including designation of key points or
development milestones, generating a timeline for completion, and defining the
critical path.
5. Monitoring the status of research studies to ensure that they are being conducted
according to the timeline and critical path in the development plan and, if appropriate,
modifying the plan as new information becomes available.
6. Comparing research results and development status and timelines with drug
candidates under development by competitors.
7. Conducting appropriate market surveys to ensure that the development of a drug
candidate is economically justified and continues to meet a medical need.
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