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Pharmacists Oppose Health Ministry’s Draft Amendment To MDR-2017 Allowing Class 12th Pass Outs To Sell Medical Devices

Scores of pharmacists have opposed the Union ministry of health and family welfare’s draft amendment to Medical Devices Rules, 2017 allowing non pharmacists who are just class 12th pass outs to stock and sell medical devices, saying that it will have detrimental impact on public health.

As per the draft amendment issued by the ministry on February 9, 2022, Rule 87(A) will be inserted after the Rule 87 in Medical Devices Rules (MDR), 2017 containing details of competent technical staff under whose direction and supervision the sales activity of medical device shall be undertaken and such staff holds a degree of a recognized university or a registered pharmacist or has passed intermediate examination or its equivalent examination from a recognized board with the oneyear experience in dealing with sale of medical devices.

Earlier diploma in pharmacy was mandatory for those who have passed class 12th exam to sell or stock medical devices including in-vitro diagnostics.

Taking exception to the health ministry’s draft amendment, Kailash Tandale, president of Maharashtra Registered Pharmacists Association (MRPA) said “The ministry’s decision to allow class 12th pass outs without having D Pharma to sell or stock medical devices puts public health at risk. It could also hurt the job prospects of pharmacists.”

There is no dearth of pharmacists in the country. Currently, scores of pharmacists in the country are jobless. The recent draft amendment will add to their woes, said Tandale.

By allowing non pharmacists to sell or stock the most sophisticated items like blood products and stents, the government is playing with people's lives, he added.

MRPA requested the health ministry to roll back the draft amendment doing away with the requirement of pharmacy qualification to sell medical devices and in-vitro diagnostic medical devices after class 12th. date : February 16, 2022

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