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Note : This
product information is intended only for residents of the
India. Taj Pharmaceuticals Limited, medicines
help to treat and prevent a range of conditions—from the
most common to the most
challenging—for people around the world.
Information for Health Care Professionals
*** Please consult local Prescribing
Information for any product before use. This website is an
international information resource for healthcare
professionals with an interest in disease management. This
website is not intended to replace the advice of a
qualified healthcare professional. Above brand is a
trademark of the Taj group of companies (Taj
Pharmaceuticals Limited).
SCHEDULE IV CONTROLLED SUBSTANCES : Controlled Substances Import
and Export Act
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER II - IMPORT AND EXPORT
"Placement on schedules; findings required Schedule IV
substances are those that have the following findings:The drug
or other substance has a low potential for abuse relative to the
drugs or other substances in schedule III. The drug or other
substance has a currently accepted medical use in treatment in
the United StatesAbuse of the drug or other substance may lead
to limited physical dependence or psychological dependence
relative to the drugs or other substances in schedule
III.Control measures are similar to Schedule III. Prescriptions
for Schedule IV drugs may be refilled up to five times within a
six-month period. A prescription for controlled substances in
Schedules III, IV, and V issued by a practitioner, may be
communicated either orally, in writing, or by facsimile to the
pharmacist, and may be refilled if so authorized on the
prescription or by call-in. DRUGS IN THIS SCHEDULE
INCLUDE:Benzodiazepines, such as ALPRAZOLAM (Xanax),
chlordiazepoxide (Librium), clonazepam (Klonopin), diazepam
(Valium), and Lorazepam (Ativan), as well as:temazepam (Restoril)
(note that some states require specially coded prescriptions for
temazepam) flunitrazepam (Rohypnol) (note that flunitrazepam is
not used medically in the United States). The
benzodiazepine-like Z-drugs: zolpidem (Ambien), zopiclone (Imovane),
eszopiclone (Lunesta), and zaleplon (Sonata) (zopiclone is not
commercially available in the U.S.) Chloral hydrate, a
sedative-hypnotic, Long-acting barbiturates such as
phenobarbitalSome partial agonist opioid analgesics, such as
pentazocine (Talwin) The stimulant-like drug modafinil (sold in
the U.S. as Provigil) as well as its (R)-enantiomer armodafinil
(sold in the U.S. as Nuvigil)
Difenoxin, an antidiarrheal drug, such as when combined with
atropine (Motofen) (difenoxin is 2–3 times more potent than
diphenoxylate, the active ingredient in Lomotil, which is in
Schedule V)
Tramadol (Ultram) / Carisoprodol (Soma) has become a Schedule IV
medication as of 11 January 2012.
Section 1000 [951 note] Short Title
This title may be cited as the "Controlled Substances Import and
Export Act.'' EXPORT IS SUBJECTED TO NOC (Narcotic Drugs Import
and Export Act) INDIA.
Export/ Import
ANY NARCOTIC DRUGS OR PSYCHOTROPIC SUBSTANCES CAN BE IMPORTED
INTO/ EXPORTED OUT OF INDIA SUBJECT TO RULE 53 AND RULE 53-A OF
THE NDPS RULES, 1985.
The import of - (i) opium, concentrate of poppy straw, and (ii)
morphine, codeine, thebaine, and their salts is prohibited save
by the Government Opium Factory under the provision of Rule 54
of the NDPS Rules, 1985. The import into and export out of India
of any narcotic drugs or psychotropic substances specified in
Schedule I is prohibited under the provision of Rule 53 of the
NDPS Rules, 1985. The export of any narcotic drugs or
psychotropic substances or preparations containing any of such
narcotic drugs or psychotropic substances specified in Schedule
II shall be prohibited to the countries or to the region of
such country specified therein under the provision of Rule 53-A
of the NDPS Rules, 1985.The manufacture of psychotropic
substances specified in Schedule III can be allowed for export
purpose only under the provision of Rule 65(1) of the NDPS
Rules, 1985. The import of psychotropic substances specified in
Schedule III may be allowed for test/ analysis purpose as well
as for re-export purpose. The export out of / import into India
of a select number of Precursor Chemicals is exercised by the
Narcotics Commissioner in accordance with Directorate General of
Foreign Trade (DGFT) notification and Administrative Control.
ANY COMPANY/APPLICANT DESIROUS OF OBTAINING NO OBJECTION
CERTIFICATE FOR EXPORT OF NOTIFIED PRECURSOR CHEMICALS ARE
REQUIRED TO APPLY TO THE NARCOTICS COMMISSIONER. (UNDER RULES
FROM CENTRAL BUREAU OF NARCOTICS, GOVERNMENT OF INDIA)
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