Last Updated on January 6, 2024 by The Health Master
Even as the deadline set by the Union Health Ministry for submitting objections and suggestions on the draft of the Medical Devices Amendment Rule 2022 ends on March 25, the academic community has raised objections, apart from the industry, alleging that the amendment will pave the way for unqualified people to handle the medical devices industry and business.
A wave of objection has built up in the academic circle in Pune in Maharashtra and it will be spread among all faculty members of pharmaceutical sciences in the higher education sector across the country within days through social media and news media, it is learnt.
Calling the attention of all stakeholders of pharmacy, Dr. Atmaram Pawar, principal of the Poona College of Pharmacy in Pune, is now engaged in the mission of stirring up pharmacist and academic communities in the country to respond passionately to the draft rules by emailing their objections and suggestions at the earliest.
According to him, with strong opposition from the pharmacist fraternity the government can be forced to withdraw from its decision to issue registration certificates for the 12th class passed persons to buy, stock and sell devices in the field of medical business.
As per the gazette notification of February 9 this year, a person with a university degree, or a 12th class passed person with one year experience in dealing with sale of medical devices can be the competent technical staff to manage and supervise sale of medical devices.
Elaborating his viewpoint with Pharmabiz, Dr. Pawar said he has shared his view with teachers of all pharmacy colleges and their associations in the country, asking them to express their feelings against this draft rule which will, in all respects, foil the attempt of the qualified pharmacists to get into medical devices business.
He claims that since medical devices come under the category of ‘drugs’, they should be handled by registered pharmacists only. However, compromise can be made in the case of medical professionals, but pharmacists are the right competent persons to obtain registration certificates from the regulatory authority.
“When India has a sufficient number of registered pharmacists as competent staff to direct and supervise the business of medical devices, what for unqualified persons are included in the lis ? Every year the pharmacy institutions in the country admit 11 lakh students for various courses which include 3.8 lakh D Pharm, 6.78 B Pharm, 53,000 M Pharm and 3,000 Pharm D.
This shows that the country has more than enough well-educated, trained and skilled human resources in health and pharmacy, similar to those in medical education. Medical devices are categorized under the definition of drugs which means that these devices should be sold under the supervision of a registered pharmacist,” said Dr. Pawar.
The academician wanted the union health ministry not to try to dilute the standards of the country’s health sector and pharmacy sector in the name of promoting ‘Skill India’ initiative.
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