Last Updated on 08/08/2024 by wccexam Desk
The Drug Controller General of India has taken a big decision regarding foreign medicines. The Drug Controller General has abolished the requirement of local clinical trials for many foreign medicines and drugs. So now foreign medicines will be able to get permission for use directly on applying for use in the Indian market. For this, they will not need to present the study of any clinical trial conducted in India.
Under the new Rule 101, countries like the US, UK, European Union, Japan, Australia, Canada have been allowed to consider exemption of local clinical trials for approval of new drugs as per Chapter 10 and to allow clinical trials under Chapter 5. Therefore, if a successful clinical trial of a drug is conducted in the US, UK, Japan, Australia, Canada and EU and these drugs get permission from the regulators of those countries, then such medicines will not require clinical trials in India.
Official sources in the Directorate General of Health Services said that currently many drugs approved by regulatory authorities like the US, UK and European Union are not available in India due to regulatory issues under the Drugs and Cosmetics Act. Because local clinical trials are required before these drugs are allowed for use in the Indian market.
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Why was this step taken?
This step has been taken because the government feels that there is a delay in the launch of many life-saving drugs in India. These categories of drugs have been proposed for exemption from clinical trials in India.
– Medicines for rare diseases
– Gene and Cellular Therapy Products
-New medicines to be used in pandemic situation
– New drugs used for special defense purposes
The decision will be helpful in reducing public procurement prices
Official sources said that now the most in-demand and new medicines that will help in the treatment of diseases like cancer as well as rare diseases like spinal muscular atrophy will be available in India quickly. This decision will help in reducing the prices of public procurement under schemes like state governments, Directorate General of Health Services and Ayushman Bharat. For example, a drug for breast cancer type-3 which is not available in India will now be available in the market after quick approval of market use authorization. This has cleared the way for bringing these medicines to India easily from only selected countries.
Demand for weight loss drugs on the rise
Demand for weight loss drugs is growing among wealthy Indians. So drugs like Ozempic from Denmark’s Novo Nordisk and Monjaro from the US’ Eli Lilly are illegally entering Indian pharmacies, bypassing regulatory checks. The US drug regulator approved Ozempic for the treatment of diabetes in 2017, while a high-dose version under the brand Wegovy was approved in 2021 for the treatment of obesity. While Monjaro, approved for diabetes, is often used off-label for weight loss, both these drugs are not available in India after being recommended by doctors to treat obese patients.
Source (PTI) (NDTV) (HINDUSTANTIMES)