NEW DELHI: It is not easy to introduce a new drug in the market. Before a medicine or vaccine is introduced for public use, pharmaceutical researchers, scientists and doctors do a lot of background work. First, they develop or discover a molecule or active ingredient. Then they check for its efficacy. It is followed by observation on adverse reactions.
Once everything is ok, the new drug is released. Even after release, researchers evaluate the drug.
How long does it take to develop a new drug?It takes about 10 to 12 years to complete the process of developing a new drug. The cost could be between Rs 7,500cr and Rs 15,000cr .
Is there any special relaxation on drug development during pandemics? Yes. During pandemics or new epidemics some of the steps involved in drug development are skipped. This brings down the time to one to two years.
Are there any examples of such relaxations?Yes. During SARS, novel human influenza (swine flu) and Ebola, the vaccine development norms were relaxed. Now, the vaccine for Covid 19 too is expedited.
What is the process of drug development?Basically, there are five stages of drug development and evaluation. They are preclinical trial, clinical trial phase 1, clinical trial phase 2, clinical trial phase 3 and clinical trial phase 4.
What exactly are these stages or phases? 1.Preclinical trial Once an active ingredient or molecule is developed or discovered, its efficacy and safety are evaluated in laboratory (in vitro) and then in animals (in vivo).
2) Clinical trial phase 1 Researchers find out if the new drug or vaccine works (efficacy) in human beings. They also evaluate its safety. They also look into serious side effects, if any. The drug is tested on less than 100 people or volunteers.
3)Clinical trial phase 2 The number of volunteers recruited in drug trials is increased to a several hundreds. Short term side effects are evaluated. Researchers also observe the immune response of the volunteers to the new drug.
4) Clinical trial phase 3 Thousands of volunteers are recruited. The efficacy and safety of the drug is evaluated vis-a-vis people who took the vaccine or drug, and those who did not take it. Safety, efficacy and severe side effects are evaluated. The drug is released into the market.
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Clinical trial phase 4 Post the release of the vaccine or medicine, it is evaluated for safety, efficacy and side effects on a larger population.