Updates * What is the National Health Protection Mission (NHPM)? NHPS is a health insurance scheme which seeks to provide insurance coverage to approximately 50 crore people (with focus on 10 crore poor and vulnerable families) of up to 5 lakh rupees per family per year against hospitalization expenses in …
The New Drugs and Clinical Trial Rules, 2019 released by the government seeks to enable faster approvals and to cut down on red tape with respect to the clinical trials in India. It seeks to promote clinical research in India by providing for a predictable, transparent and effective regulation for clinical trials and by guaranteeing faster accessibility of new drugs to the Indian population. Thus it has the potential to reinvigorate the clinical research industry, which was almost on its death bed a few years ago.
This article answers the following questions in an analytical manner.
- What are clinical trials?
- What is the need for clinical trials?
- How Clinical trials are conducted?
- Why is India a popular destination for Clinical trials?
- What is the regulatory mechanism for Clinical Trials in India?
- What are the key Issues regarding Clinical Trials in India?
- What are the measures taken by the government to solve those issues?
- What are the features and significances of the new rules of 2019?
- What are the suggestions to further improve the scenario?
The Ministry of Chemicals & Fertilizers has recently released the Drugs (Prices Control) Amendment Order, 2019 which prescribes that the drugmaker who has brought in an innovative patented drug will be exempt from the price control rules for 5 years from the date of marketing. It is meant to strike the right balance between consumer and producer interests. However, it falls short of addressing certain concerns regarding the drug pricing regulation in India.
Recently, the Lok Sabha has passed the Surrogacy (Regulation) bill, 2016 which prohibits commercial surrogacy and allows only altruistic surrogacy. The bill seeks to protect the rights of the surrogate mother and the child born from surrogacy and promotes ethical surrogacy. However, it falls short of addressing certain key concerns regarding the surrogacy in India.
The Zika virus has hit Jaipur, Rajasthan and it has the risk of spreading to other areas as well. With the number of cases rising steadily, the central government has sent an Indian Council of Medical Research (ICMR) Team to Rajasthan to intensify vector control measures. Notably, a broad range of initiatives are being taken by authorities to control Zika, however, they are being viewed as a delayed response to an epidemic.
A recent investigation revealed that the world’s largest veterinary drug-maker, Zoetis, was selling antibiotics as growth promoters to poultry farmers in India. Zoetis halted such practice in the US since the US prohibited the use of antibiotics as growth-promoters in early 2017…
The Drug Technical Advisory Board (DTAB) in July 2018 has recommended banning 343 “irrational” fixed-dose combination (FDC) drugs.
Oxytocin is also known as the love hormone, is released naturally in human bonding activities
such as childbirth, breastfeeding, and sex. Oxytocin is made in the hypothalamus region of the brain