Several Bills Related To Pharma May Get Through The Ongoing Monsoon Session Of Parliament

Bengaluru : Six bills including Drugs, Medical Devices and Cosmetics Bill, Biological Diversity Bill, National Dental Commission Bill, National Nursing and Midwifery Commission Bill and National Research Foundation Bill are expected to be passed in this ongoing session of Parliament.

Union government has sent the tentative list of government legislative businesses expected to be taken up during the monsoon session of Parliament which commenced on July 20, 2023 and will be in session till August 11, 2023.

The Drugs, Medical Devices and Cosmetics Bill 2023 seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. The focus of this bill is to ensure the medicine and medical devices quality, safety, efficacy, performance and clinical trials of new drugs and medical device. Beside, the Bill seeks clinical performance evaluation of new in-vitro diagnostic medical devices including Ayush medicine, medical devices and cosmetics with the objective of the highest possible regulatory standards, ensure a transparent regulatory regime and to repeal the archaic Act. The status of this Bill is that it is for introduction, consideration and passing.

The National Dental Bill 2023 seeks for setting up a National Dental Commission and repeal the Dentists Act 1948. The motion proposed is for its consideration and to be cleared.

The National Nursing and Midwifery Commission Bill 2023 seeks to set up a National Nursing and Midwifery Commission (NNMC) and to repeal the Indian Nursing Council Act 1947. This Bill too according to the Joint Committees is set for introduction, consideration ad passing.

The National Research Foundation Bill 2023 seeks to establish a National Research Foundation and repeal the SERB which is the Science and Engineering Research Board Act, 2008. This bill is scheduled for introduction and passing.

The Biological Diversity (Amendment) Bill 2022 as reported by the Joint Committee was introduced on December 16, 2021. The amendment report of the joint committee was presented to both the houses of Parliament which has proposed for consideration and passing.

The Forest (Conservation) Amendment Bill 2023 was introduced in the Lok Sabha on March 29, 2023. The Bill was referred to the Joint Committee of the houses with the instruction that this needed to be cleared in the first week of the next session which is currently on. The motion passed to consider passing of this after the report of the Joint Committee is presented to the Lok Sabha.

In the case of the DNA Technology Bill (Use and Application) regulation which was introduced in the Parliament on July 8, 2019 is seen to have an issue. This is despite the report of the standing committee on Science and Technology, Environment, Forests and Climate Change was laid on the table of Lok Sabha on February 2021 the motion proposed was for withdrawal.

According to sources, all these bills are critical for the growth and sustenance of the lifesciences sector which covers pharma, biotech, environmental sciences and forestry that is key for medicinal plants. The global economic crisis has led difficult revenue generation which has been detrimental to the growth of the sector.

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