Last Updated on February 16, 2022 by The Health Master
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 Rule 87 in the Medical Devices Rules (MDR), 2017 containing details of competent technical staff under whose direction and supervision the sales activity of medical devices shall be undertaken, and such staff shall hold a degree of a recognized university or a registered pharmacist or have passed an intermediate examination or its equivalent examination from a recognized board with at least one year of experience in dealing with the sale of medical devices.
An earlier diploma in pharmacy was mandatory for those who had passed the 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.”
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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.
He said there are 3.4 lakh registered pharmacists in Maharashtra and the country has more than 20 lakh registered pharmacists who are sufficient to carry out sale activities of drugs and medical devices pan India.
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.
The draft amendment also made a registration certificate mandatory to sell, stock, exhibit, offer for sale, or distribute a medical device, including in-vitro diagnostic medical devices. The State Licensing Authority (SLA) shall appoint licensing authorities to issue the registration certificate, and any person who intends to sell, stock, exhibit, offer for sale, or distribute a medical device, including in vitro diagnostic medical devices, shall make an application in Form MD-41, which has also been introduced in the draft rules, to the SLA for the grant of the certificate.
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