SCHEDULE X PRESCRIPTION DRUG – WARNING To be sold by retail on the prescription of a Registered Medical Practitioner only.
List of schedule X drugs:
- Ketamine hydrochloride
Note: 1. Any stereoisometric form of the substance specified in this Schedule, any salt of the substance and preparation containing such substances are also covered by this Schedule.
2. Preparations containing the above substances are also covered by this Schedule.
Provided, however, preparations containing Meprobamate in combination with other drugs may be exempted by the Licensing Authority specified in clause (b) of rule 21, from the provisions of this Schedule, if satisfactory evidence is adduced that these preparations are not liable to be misused.]
- Substances specified in Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years.
- The supply of drugs specified in Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years.
- The person dispensing a prescription containing a drug specified in Schedule X shall comply with the following requirements in addition to other requirement of these rules: (a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once;
(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions;
(c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed.
- No person dispensing a prescription containing substances specified in Schedule X, may supply any other preparation, whether containing the same substance or not, in lieu thereof.
Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored—
(a) under lock and key in cupboard or drawer reserved solely for the storage of these substances; or
(b) in a part of the premises separated from the remainder of the premises and to which only responsible persons have access;
Supply of Schedule X Drugs:
- The supply of drugs specified in Schedule X shall be recorded at the time of supply in a register (bound and serially page numbered) specially maintained for the purpose and separate pages shall be allotted for each drug.
- The following particulars shall be entered in the said register, namely:–(i) Date of transaction;
(ii) Quantity received, if any, the name and address of the supplier and the number of the relevant licence held by the supplier;
(iii) Name of the drug; (iv) Quantity supplied;
(v) Manufacturer‘s name; (vi) Batch No. or Lot No;
(vii) Name and address of the patient/purchaser;
(viii) Reference Number of the prescription against which supplies were made;
(ix) Bill No and date in respect of purchases and supplies made by him;
(x) Signature of the person under whose supervision the drugs have been supplied.
- No advertisement of the drugs specified in Schedule X shall be made except with the previous sanction of the Central Government
Packings of drugs specified in Schedule X.-
The drugs specified in Schedule X
shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules;
(ii) 300 ml in the case of oral liquid preparations; and (iii) 5 ml in the case of injections:
Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that–
(i) such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.
No sale of any drug by wholesale shall be made to a person not possessing the requisite
[licence to sell, stock or exhibit or offer for sale, or distribute] drugs specified in Schedule X :
Provided that this condition shall not apply to the sale of any drug to – (a) an officer or authority purchasing on behalf of Government;
(b) a hospital, medical, educational or research institution, nursing home, Registered Medical Practitioner for the purpose of supply to its/his patients or manufacturer holding a licence in Form 25-E or 28-B to manufacture the drugs containing drugs included in Schedule X.