Clinical Trials of New Drugs: The Union Health Ministry has taken a big decision regarding foreign medicines. Now if a medicine is successful in clinical trials conducted in the US, UK, Australia, Japan, Canada and European Union and gets approval for use from the Drug Regulatory Authority there, then this medicine will be able to come directly to the Indian market. For this, separate trials will not have to be done in India. For this, Rule 101 of the New Drug and Clinical Trial Rule 2019 has been changed. With this decision of the government, medicines for serious diseases will be able to come to India soon.
The Union Health Ministry believes that the Indian companies were eagerly waiting for this decision of the government. Also, this will make medicines for serious diseases easily available. Health Ministry officials claim that this decision of the government will save the resources that were spent in the regulatory process of medicines and they can be used for some other work. It is also being claimed that the Indian pharmaceutical industry is moving from volume to value, for which this step of the government will prove to be a milestone.
The government has claimed that any medicine that comes to India from abroad will be suitable for Indian geographical conditions. Along with this, any new and better medicine being made will get approval in India with immediate effect. According to sources in the Health Ministry, medicines coming from UK, US, Australia, Japan, Canada and EU countries will not have to undergo domestic clinical trials. If any medicine has already undergone clinical trials in that country, then it will not need to be tried again in India. It is claimed that doing so will greatly facilitate the use and resources of medicines.
There will be benefit in many diseases
The Health Ministry claims that this decision of the Central Government can benefit Orphan Drugs for rare diseases, Gene and cellular therapy products, New drugs used in pandemic situation, New drugs having significant therapeutic advance over the current standard of care.
There will also be facility for research
According to sources in the Union Health Ministry, this decision of the government will greatly help in research on medicines in India. It is being claimed that Indian companies had to wait for foreign medicines for many medicines. Especially, they had to wait for medicines for serious diseases, which include cancer and rare diseases. If such medicines are easily available in India, then research will be easy and its indigenous version can be made as soon as possible.
Medicines will also be cheaper
According to sources, this decision will also make medicines easily available. Especially medicines for serious diseases require special permission to be used in India. Such medicines will be easily available in India. Along with this, if India has an agreement with foreign companies, then the foreign company will have an agreement with Indian companies for the medicines and its production will also be done in India. Due to this, these medicines can become very cheap.
The medicine will arrive in a short time
According to sources in the Union Health Ministry, earlier when any patented medicine was brought to India, then clinical trials of that medicine were conducted here. It used to take about 5 to 20 years for the medicine to go through this process. Now there is no need to wait for long. Now if any new medicine gets approval in these countries, then it will also be directly available in the Indian market.
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Tags: health, india news, Lifestyle
FIRST PUBLISHED : August 8, 2024, 14:46 IST