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Functions
undertaken by
Central Government
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Functions
undertaken by
State Governments
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Laying
down standards of drugs, cosmetics, diagnostics and devices. |
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Licensing
of drug manufacturing and sales establishments. |
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Laying
down regulatory measures, amendments to Acts and Rules. |
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Licensing
of drug testing laboratories. |
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To
regulate market authorization of new drugs. |
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Approval
of drug formulations for manufacture. |
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To
regulate clinical research in India. |
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Monitoring
of quality of Drugs & Cosmetics, manufactured by respective
state units and those marketed in the state. |
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To
approve licenses to manufacture certain categories of
drugs as Central Licence Approving Authority i.e. for
Blood Banks, Large Volume Parenterals and Vaccines &
Sera. |
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Investigation
and prosecution in respect of contravention of legal provisions. |
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To
regulate the standards of imported drugs. |
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Administrative
actions. |
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Work
relating to the Drugs Technical Advisory Board (DTAB)
and Drugs Consultative Committee (DCC).
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Pre-
and post- licensing inspection. |
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Testing
of drugs by Central Drugs Labs. |
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Recall
of sub-standard drugs. |
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Publication
of Indian Pharmacopoeia. |
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Other
Functions |
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Coordinating
the activities of the State Drugs Control Organizations
to achieve uniform administration of the Act; and policy
guidance.
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Guidance
on technical matters.
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Participation
in the WHO GMP certification scheme. |
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Monitoring
adverse drug reactions (ADR). |
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Conducting
training programmes for regulatory officials & Govt.
Analysts. |
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Distribution
of quotas of narcotic drugs for use in medicinal formulations. |
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Screening
of drug formulations available in Indian market. |
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Evaluation/Screening
of applications for granting No Objection Certificates
for export of unapproved/banned drugs. |
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