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What is a new drug?

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Dr KK Aggarwal    03 February 2018

  1. What is a new drug? A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.
  2. "Theres some cholesterol-lowering effect from curcumin, and some cholesterol-lowering effect from phytosterols, but if you combine them together its a synergistic effect. Its beyond what you expect from the two compounds separately," said Professor Garg, University of Newcastle.
  3. New research published in the journal Aging finds a compound that stops cancer cells from spreading by starving them of vitamin B-2. The findings may revolutionize traditional chemotherapy. Diphenyleneiodonium chloride (DPI) reduced over 90% of the energy produced in the cells mitochondria by blocking vitamin B-2 — also known as riboflavin — which depleted the cells of energy.
  4. Loperamide is a very, very mild opioid, and like all opioids, it slows down the muscles that send poop through your pipes. But unlike most other opioids, its doesnt affect other parts of the body unless you take a shit-ton. The maximum therapeutic dose is 16 mg per day; people using it either to get high or to chase away withdrawal symptoms will take more than 100 mg. Doses that high can (but dont often) cause "adverse cardiac events."
  5. In Indian regulations, the major class of herbal products are:
  6. a) Classical Ayurveda drugs as mentioned in the authoritative books of Ayurveda system, which are manufactured and named in accordance with the formulations described in the authoritative texts.
  1. b) Patent or Proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine.

None of these classes of herbal medicines come under purview of DCGI as they do not fall into categories of new drugs as per Indian regulations. Hence, DCGI approval is not required for clinical trial of herbal products

 

 Dr KK Aggarwal

 

Padma Shri Awardee Vice President CMAAO Group Editor-in-chief IJCP Publications

President Heart Care Foundation of India

Immediate Past National President IMA

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