Medical devices like stents will now be regulated by CDSCO
Medical devices like stents will now be regulated by CDSCO
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New Delhi: The Narendra Modi government is set to hire more than 700 inspectors and technicians with the sole aim to regulate the medical devices sector in India.

The move comes just a month after the Union Ministry of Health and Family Welfare empowered drug regulator Central Drugs Standard Control Organisation (CDSCO) to handle medical devices as well.

Now, the ministry has gained in-principle approval from the finance ministry’s Department of Expenditure for the creation of posts across levels.

The government is acting on a report submitted in April by the Drugs Technical Advisory Board (DTAB) — the country’s highest statutory decision-making body on technical matters related to medicines and medical devices — which advised hiring more inspectors.

“In order to strengthen the medical devices vertical of CDSCO and have adequate capacity for regulating all the medical devices, which are being brought under regulation, ministry had submitted a proposal to the Department of Expenditure to create 754 posts at various levels,” Health Minister Dr Harsh Vardhan told ThePrint.

“The department has agreed, in-principle, to the creation of posts in a phased manner. The matter has been taken up for obtaining its formal approval.”


Also read: Shaken by J&J faulty implants, govt to regulate eight more medical devices


Overriding NITI Aayog’s objections

The government’s policy think-tank, NITI Aayog, had criticised the move to bring medical devices within the CDSCO’s ambit. It proposed a separate regulator for them, citing lack of expertise and absence of laws for regulation of devices.

“Notifying medical devices as ‘drugs’ is an unhealthy way of regulating the segment that is growing by leaps and bounds. It’s a temporary solution,” a senior official at NITI Aayog had told ThePrint earlier. “Clearly, CDSCO lacks the expertise and ecosystem to effectively regulate the sector.”

However, hiring more hands may solve the problem, according to health ministry officials. “This will help us make the regulation more powerful and justified,” an official said.

According to the DTAB proposal, 449 of the 754 officers will be hired to deal with regulatory affairs, including surprise visits and audits at manufacturing sites. They will be responsible for granting and cancelling approvals and trade licences for the import of medical devices.

The other 305 officers will work in laboratories to check the safety and efficacy of devices, and cross-check companies’ claims about their devices and innovations.


Also read: After stents and knee implants, Modi govt wants to control prices of all medical devices


 

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3 Comments Share Your Views

3 COMMENTS

  1. We need to ensure that CDSCO is recruiting only Engineers and Doctors for this post and no pharmacists should be recruited. The pharmacy council is pressurizing CDSCO to include pharmacy as one of the qualification for this recruitment. This move should be stopped.

  2. One more inspector raj means more opportunity to the Babus for rent seeking. Nothing good will come out of such controls and regulations. Breeds more corrupt practices.

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