Schedule H1
Definition
Forty-six substances notified by the 2013 amendment (Drugs and Cosmetics Fourth Amendment Rules, 2013, GSR 588(E) dated 30 August 2013, in force from 1 March 2014), covering antibiotics, anti-TB drugs and habit-forming preparations. Pharmacist must maintain a separate register for three years and retain a copy of the prescription.
- Year of amendment
- 2014
- Record retention period
- Three years
- Regulatory rule
- Rule 65(11A) of Drugs and Cosmetics Rules 1945
Common questions
What drugs fall under Schedule H1?+
Schedule H1 includes 46 substances notified in a 2014 amendment, primarily antibiotics, anti-TB drugs, and habit-forming preparations. Specific drugs in this category are alprazolam, nitrazepam, and zolpidem, which are tranquilizers, sedatives, and hypnotics.
What record-keeping rules apply to Schedule H1 drugs?+
Pharmacists and chemists must maintain a separate register for three years with prescriber and patient details. A copy of the original prescription must also be retained for the same period.
Which laws govern Schedule H1 in India?+
Schedule H1 is regulated under the Drugs and Cosmetics Rules 1945, specifically Rule 65(11A), within the broader framework of the Drugs and Cosmetics Act.
Related terms
- Barbiturate
- Cyclic ureide derivative of barbituric acid. Potentiates GABA-A. Sub-classed by duration of action: long (phenobarbital), intermediate (amobarbital), short (secobarbital, pentobarbital) and ultrashort...
- Benzodiazepine
- Fused benzene plus seven-member diazepine ring. Allosteric modulator of GABA-A at the alpha-gamma interface. Reversed by flumazenil.
- CDSCO
- Central Drugs Standard Control Organization, headquartered in Delhi, headed by the Drugs Controller General of India (DCGI). The federal regulator under the...
- Drugs and Cosmetics Act 1940
- Central statute governing the import, manufacture, sale and distribution of drugs and cosmetics in India. Read with the Drugs and Cosmetics Rules...
- FPN Reagent
- Ferric chloride, perchloric acid and nitric acid mixture. Red to orange-red colour with phenothiazines (chlorpromazine and relatives). Screen of choice for major...
- NDPS Act 1985
- India's Narcotic Drugs and Psychotropic Substances Act 1985, the primary statute governing drug offences, establishing small and commercial quantity thresholds that determine...
- Poison Act 1919
- Seventeen-section central statute empowering state governments to notify substances as 'poisons' and to license their sale, possession and import. Still in force.
- Schedule H
- List of prescription drugs under the 1945 Rules; sold only on a registered medical practitioner's prescription. Includes most antibiotics, sedatives, antipsychotics and...
- Schedule X
- Psychotropic substances and narcotics notified under the 1945 Rules. Stored under double lock, register retained for two years, copy of prescription retained.
- Sedative-Hypnotic
- CNS depressant. Sedative dose calms (anxiolysis); hypnotic dose induces sleep; higher doses cause anaesthesia, respiratory depression and death.
- Tranquillizer
- Older umbrella term. Minor tranquillizers (benzodiazepines) treat anxiety. Major tranquillizers (phenothiazines, butyrophenones) are antipsychotics.
- Z-Drug
- Non-benzodiazepine hypnotic (zolpidem, zopiclone, eszopiclone) that binds the alpha-1 subunit of GABA-A selectively. Same date-rape and stupefying-robbery potential as the BZDs.
Explained in these topics
- Indian Poison Laws: Poison Act 1919 and Drugs and Cosmetics ActForty-six substances notified by the 2013 amendment (Drugs and Cosmetics Fourth Amendment Rules, 2013, GSR 588(E) dated 30 August 2013, in force from 1 March 2...
- Tranquillizers, Sedatives and Hypnotics: Forensic AnalysisDrugs and Cosmetics Rules 1945, Rule 65(11A). Subset of Schedule H that requires the chemist to keep a separate register for three years with prescriber and pa...