Pharmaceutical Jurisprudence- Schedules To The Rules

Introduction

Schedules to the Rules are the part of drugs and cosmetics act of India. The drugs and cosmetics act was passed in 1940. This act regulate the import, manufacture, distribution and sale of drugs and cosmetics. This act also control over the manufacture, sale and distribution of Ayurvedic, Siddha, Unani and homeopathic medicines. We will see Schedules to the Rules in this article.

SCHEDULES TO THE ACT

There are two Schedules to the Act.

First schedule

It includes the list of names of books under Ayurvedic, Siddha and Unani systems that are used for different formulations according to the provisions of the Act. There are a total 57 Ayurveda, 30 Siddha and 13 Unani books listed in the schedule.

Second schedule

It includes the standards with which the imported, manufactured, sold or stocked drugs should comply.

SCHEDULES TO THE RULES

A

 

Proforma for the application for the licences, issue and renewal of licences, for sending memoranda under the act
BFees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories or other government laboratories
CList of biological and immunological products, antibiotics, ophthalmic, lotions, ointments and all products for parenteral use
C IList of other special products like digitalis, adrenaline, antibiotics, vitamins, liver extract preparations and sterile disposable devices whose import, sale manufacture and distribution are governed by special provisions
DExemptions that have been granted to drugs and importers of drugs from complying with the requirements of import of the drugs and also the condition for such exemptions
EList of poisons for which labelling and other requirements were to be complied with
E IList of poisons substances under Ayurvedic, Siddha and Unani systems of medicine
FRequirements for operation and functioning of blood banks and/or preparation of blood products
F IISpecial provisions applicable for the production, testing, storage, labelling and packing of bacterial and viral vaccines, antisera, diagnostic agents etc.
F IIDetails of standards for surgical dressings.
F3Details of standards of umbilical tapes
FFDetails of standards for ophthalmic preparations
GList of substances that required to be used under only medical supervision and which are to be labelled accordingly
HList of substances that should be sold by retailers only on prescription of registered medical practitioner
JList of disease or ailments which a drug may not purport to prevent or cure
KList of drugs that are exempted from certain provisions related to manufacture
L IGood laboratory practices (GLP) and requirements of premises and equipment
MGood Manufacturing Practice (GMP) requirements of factory premises, plants and equipment’s
M IRequirements of factory premises for manufacturing of homeopathic preparations
M IIRequirements of factory premises for manufacturing of cosmetics
M IIIRequirements of factory premises for manufacturing of medical devices
NList of minimum equipment’s for efficient running of a pharmacy
OStandard for disinfectant fluids
PLife period of the drugs
P IPack size of drugs
QPart I- List of dyes, colours and pigments permitted in cosmetics and soaps

Part II- List of colours permitted in soaps

RStandards for condoms of rubber latex and other mechanical contraceptives
R IStandards for medical devices
SStandards for cosmetics
TRequirement of factory premises and hygienic condition for Ayurvedic (including Sidha) and Unani drugs
UParticulars to be shown in manufacturing, raw material and analytical record of the drugs
U IParticulars to be shown in manufacturing, raw material and analytical record of the cosmetics
VStandard for patent or proprietary medicines
WDrugs marketed under generic name only
XNames of narcotic and psychotropic drugs for which special control measure have been laid dawn
YRequirements and guidelines on clinical trials for import and manufacture of the new drugs

 

Frequently asked questions

What is schedule H in pharmacy act?

Schedule H in pharmacy act is a list of substances that should be sold by retailers ‘only on prescription’ of registered medical practitioner.

What is schedule J in pharmacy?

Schedule J in pharmacy act is a list of disease or ailments which a drug may not purport to prevent or cure.

What is schedule Y drugs?

Schedule Y provides requirements and guidelines on clinical trials for import and manufacture of the new drugs.

What is schedule M?

Schedule M gives outline for Good Manufacturing Practice (GMP) requirements of factory premises, plants and equipment’s.

What is schedule W?

Schedule W deals with drugs marketed under generic name only.

 

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