Biological tests applied on starting material, intermediate material, etc.
Chemical info like chemical name, code name, dosage forms etc. non-parenteral preparation administration. Schedule C1- Non- injectable products, i.e. Schedule C- Injectable products i.e for parenteral administration. (ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 6 or insects which cause disease in human beings or animals, (iii) all substances intended for use as components of a drug including empty gelatin capsules (iv) such devices* intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board. This marked the start of the FDA approval process in its modern form. 1937 Elixir Sulfanilamide tragedy, in which over 100 people died after using a drug formulated with a toxic, untested solvent. Considering the US was largely spared that tragedy because Dr. Frances Oldham Kelsey of the FDA refused to authorize the medication for market, the 1962 Kefauver-Harris Amendment to the FD&C Act was passed, which represented a "revolution" in FDA regulatory authority. Louis, Missouri.The serum was originally collected from a horse named Jim, who had contracted tetanus. The 1902 Biologics Control Act was put in place after a diphtheria antitoxin-derived from tetanus-contaminated serum-was used to produce a vaccine that caused the deaths of thirteen children in St. In other jurisdictions they are regulated at the state level, or at both state and national levels. In some countries, such as the United States, they are regulated at the national level by a single agency, Like FDA. 
There is thus, increased incidence of self-medication among consumers in day-to-day life This leads to Production and usage of substandard and poor quality drugs with increased fatalities due to them. Easy Availability of drugs:- Number of companies producing Multiple drugs without proper regulations.
Some drugs are sold by the Pharmacies very easily without even a prescription, whereas, for some drugs, prescription is mandatory. Medication use includes Physician Prescription and self- prescribing of drugs, Dispensing, Consumption of drugs.
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