Govt Kickstarts Makeover of Drug Regulator CDSCO

The Narendra Modi government has kick-started the process to revamp the country’s apex drug and medical device regulator, the Central Drugs Standard Control Organisation (CDSCO), News18.com has learnt.

A long-pending move, the Ministry of Health and Family Welfare was recommended to strengthen the drug regulation agency of India in 2012 by the Parliamentary Standing Committee.

The ministry has now started work on several recommendations that were sought during the last decade. “While the work to strengthen CDSCO was pending, the outbreak of Covid has made it clear that a strong regulatory system is the need of the hour,” said an official involved in the process. “Meetings have begun and now we are firming up an execution plan. Recommendations on strengthening CDSCO and the budget are already in place.”

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As per the recommendations, the regulator will undergo a makeover along with a change of name.

Another official from the health ministry said meetings have commenced and officials are also firming up hiring plans for the agency. “The idea is to create a powerful regulator such as the United States’ Food and Drug Administration (US FDA),” the official said.

Currently, the CDSCO regulates and approves drugs, vaccines, clinical trials, and blood bank licensing. “To discharge duties effectively, CDSCO will be revamped into a one-point agency with vast powers, manpower, and infrastructure similar to the US FDA,” the official added.

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A second official in the ministry said, “The work should ideally start before the end of this year with an objective of completion in the next one to two years.”

What’s On the Cards

As part of the makeover, the government will take steps to establish a training academy, new drug testing laboratories and upgrade the existing central laboratories. It will also start strengthening the state drug regulatory system and create basic infrastructure, and train officials at the state level.

“The government has already started working on new laws for drugs and cosmetics. The previous one was amended several times so that it was full of confusion. The process of strengthening will now be more meaningful with new law in place,” the ministry official quoted previously said.

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In 2020, the chemical and fertiliser minister DV Sadananda Gowda had informed Parliament that the government has approved a proposal to strengthen the drug regulatory system in the country — both at central and state levels — at a total expenditure of Rs 1,750 crore.

“Out of this, Rs 900 crore is for strengthening the central drug regulator structure and Rs 850 crore is for strengthening the drug regulatory system in the states,” he had said.

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