What is a schedule Y?
Schedule Y defines the clinical trials as the requirements and guidelines for import and manufacture of new drugs for sale or for clinical trials. It describes the details of application process for conducting clinical trials; responsibilities of the sponsor, investigators and the Independent Ethics Committee.
What amendments are in Schedule Y?
The recent amendments in schedule Y are
- Introduction of Rule 122DAB – Specifying the procedures for payment of compensation to the subjects of the trial in cases of injury or death.
- Introduction of Rule 122DAC – Specifying various conditions for conduct and inspection of clinical trials.
When did Schedule Y begin?
Schedule Y of Drugs and Cosmetics Act came into force in 1988 and established the regulatory guidelines for clinical trial (CT) permission.
What is Schedule F drug?
Examples: Sarpa Visha (Snake venom), Parada (Mercury) etc. Schedule F: This contains regulations and standards for running a blood bank. Schedule F-I: This contains regulations and standards for vaccines. Schedule F-II: This contains regulations and standards for surgical dressing.
What is Schedule Z?
The revised Schedule Z deals with the requirements to undertake clinical trials for ASU drugs which the industry claims is a highly unreasonable demand made by the government, threatening to wipe out the industry completely by maiming its growth perspective.
What is Schedule N drug?
Schedule N: Contains various regulations and requirements for a pharmacy. Schedule O: Contains various regulations and requirements for disinfectant fluids. Schedule P: Contains regulations regarding life period and storage of various drugs.
What is Schedule D drugs?
(See rule 21 (d) and rule 24 A) Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India.
What is a Schedule M drug?
Schedule M is titled “Good Manufacturing Practices And Requirements Of Premises, Plant And Equipment For Pharmaceutical Products”. It specify GMP requirements for premises such as buildings, air conditioning, waste management, sanitation of workers, record keeping, etc for pharmaceutical products.
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.
What are Schedule 10 drugs?
Schedule 10: Substances of such danger to health as to warrant prohibition of sale, supply and use. Schedule 10 was known as Appendix C until the introduction of the Poisons Standard 2015. It includes substances of such danger to health as to warrant prohibition of sale, supply and use.
What is the schedule M?
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.
How much is a 1945 wheat penny worth?
USA Coin Book Estimated Value of 1945-S Lincoln Wheat Penny is Worth $0.11 in Average Condition and can be Worth $0.94 to $2.22 or more in Uncirculated (MS+) Mint Condition. Click here to Learn How to use Coin Price Charts .
What kind of pennies were made in 1943?
Unusual Pennies: 1 In 1943, pennies were made of zinc-coated steel because copper was needed during World War II. 2 At the beginning of 1943, a limited number of copper pennies were struck by mistake. 3 In honor of the Mint’s 225th anniversary in 2017, pennies made in Philadelphia had a “P” mint mark for the first time.
When did the Liberty go off the Penny?
Liberty stayed on the penny for more than 60 years. In 1857, the coin got smaller and the metal composition changed to 88% copper and 12% nickel. With these changes came new designs. In 1857 and 1858 the new coins featured a flying eagle on the obverse and a wreath on the reverse.
How much is a 1948 wheat penny worth?
The Melt Value shown below is how Valuable the Coin’s Metal is Worth (bare minimum value of coin). Click here to see the Melt Value of every US Coin. Pictures are of coin up for sale.