How many schedules are in the Drug and Cosmetic Act?
It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y. Different type of forms is also given for the different type of approvals from drug authorities.
What are the schedule to the body and Cosmetic Act?
Schedules are the set of provisions for classifications of drugs, forms, fees, standards, requirements and regulations related to drugs and cosmetics under Drug and Cosmetic Act, 1940 and Rules, 1945. Here drugs includes pharmaceutical, Ayurvedic (including siddha), unani and tibb system of medicines, homeopathy etc.
Which are the acts and rules that regulate manufacturing export and clinical research of drugs and cosmetics in India?
The Drugs and Cosmetics Act 1940 (DCA) and the Drugs and Cosmetic Rules 1945 (DCR) regulate the manufacture, sale, import, export and clinical research of drugs and cosmetics.
What is pharmacy schedule?
Scheduling is a national classification system that controls how medicines and poisons are made available to the public. Medicines and poisons are classified into Schedules according to the level of regulatory control over the availability of the medicine or poison required to protect public health and safety.
What is the schedule N?
[See Rule 64(1)] List of minimum equipment for the efficient runninig of a pharmacy: Entrance. The front of a pharmacy shall bear an inscription “Pharmacy” in front.
What are Schedule M drugs?
Schedule M is a part of Drug and Cosmetic act 1940. It is GMP for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.
What is a schedule 4r?
Schedule 4 Appendix D These drugs are referred to as “prescribed restricted substances” under the Poisons and Therapeutic Goods Regulation 2002 (NSW) and are listed in Appendix D of the Regulation. Drugs included in Appendix D include benzodiazepines, anabolic steroids, gabapentinoids and opiates.
What are schedule K drugs?
Schedule K consists of those drugs that are exempted from Chapter IV of the Drugs and Cosmetics Act, 1945 which deals with manufacture, sale and distribution of drugs and cosmetics. Because of this advancement in drug manufacturing area, “ready to consume” drugs in various dosage forms are easily available.