What is a “new drug”?
A new drug means;
i. a drug, including
active pharmaceutical ingredient or phytopharmaceutical drug, which has
not been used
in the country
to any significant
extent has not
been approved as safe
and efficacious by
Central Licencing Authority
(CLA) i.e. DCG(I) with respect to
its claims; or
ii. a drug approved by the CLA
for certain claims and proposed to be marketed with modified or new claims
including indication, route of administration, dosage and dosage form; or
iii. a fixed dose combination of
two or more drugs, approved by CLA separately for certain claims and proposed
to be combined for the first time in a fixed ratio, or where the
ratio of ingredients
in an approved
combination is proposed
to be changed with certain claims
including indication, route of administration, dosage and dosage form; or
iv. a modified or
sustained release form of a drug or novel drug delivery system of any drug
approved by the Central Licencing Authority; or
v. a vaccine,
r-DNA derived product,
living modified organism,
monoclonal anti- body, stem cell
derived product, gene therapeutic product or xenografts, intended to be used as
drug;
What is a “subsequent new
drug”?
A subsequent new drug means a drug
approved by the Central Licencing Authority for certain claims
and proposed to
be marketed with
modified or new
claims including indication,
route of administration, dosage and dosage form. A subsequent new drug also
includes a new drug already approved in the country.
What is an “orphan drugs”?
An “orphan drug” means a drug intended to treat a
condition which affects not more than 5 lakh persons in India
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