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.
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.
It includes the standards with which the imported, manufactured, sold or stocked drugs should comply.
SCHEDULES TO THE RULES
|Proforma for the application for the licences, issue and renewal of licences, for sending memoranda under the act
|Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories or other government laboratories
|List of biological and immunological products, antibiotics, ophthalmic, lotions, ointments and all products for parenteral use
|List 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
|Exemptions 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
|List of poisons for which labelling and other requirements were to be complied with
|List of poisons substances under Ayurvedic, Siddha and Unani systems of medicine
|Requirements for operation and functioning of blood banks and/or preparation of blood products
|Special provisions applicable for the production, testing, storage, labelling and packing of bacterial and viral vaccines, antisera, diagnostic agents etc.
|Details of standards for surgical dressings.
|Details of standards of umbilical tapes
|Details of standards for ophthalmic preparations
|List of substances that required to be used under only medical supervision and which are to be labelled accordingly
|List of substances that should be sold by retailers only on prescription of registered medical practitioner
|List of disease or ailments which a drug may not purport to prevent or cure
|List of drugs that are exempted from certain provisions related to manufacture
|Good laboratory practices (GLP) and requirements of premises and equipment
|Good Manufacturing Practice (GMP) requirements of factory premises, plants and equipment’s
|Requirements of factory premises for manufacturing of homeopathic preparations
|Requirements of factory premises for manufacturing of cosmetics
|Requirements of factory premises for manufacturing of medical devices
|List of minimum equipment’s for efficient running of a pharmacy
|Standard for disinfectant fluids
|Life period of the drugs
|Pack size of drugs
|Part I- List of dyes, colours and pigments permitted in cosmetics and soaps
Part II- List of colours permitted in soaps
|Standards for condoms of rubber latex and other mechanical contraceptives
|Standards for medical devices
|Standards for cosmetics
|Requirement of factory premises and hygienic condition for Ayurvedic (including Sidha) and Unani drugs
|Particulars to be shown in manufacturing, raw material and analytical record of the drugs
|Particulars to be shown in manufacturing, raw material and analytical record of the cosmetics
|Standard for patent or proprietary medicines
|Drugs marketed under generic name only
|Names of narcotic and psychotropic drugs for which special control measure have been laid dawn
|Requirements 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.