Businessmen in this sector have demanded separate laws for prime quality control and proper keep watch over of all kinds of medical gadgets, equipment and diagnostic re-agents to make sure upper medical services for the folks of the country.
Device importers say the government’s regulatory corporate Directorate of Drug Control (DGDA) is harassing and arbitrary throughout the name of registration. They’ve to do various problems to get registration. At the an identical time, Bangladeshi businessmen wish to pay 65,000 taka, where they’ve to pay 10 dollars to get registered throughout the neighboring country India, there are also complications. Then again bearing in mind the folks of the country, the registration process will have to be more uncomplicated. In such circumstances, explicit individual regulations could also be the solution.
The businessmen made the ones requires at a press conference organized underneath the banner of the Medical Device Traders Association at Jahur Hossain Chowdhury Hall of the National Press Club on Thursday (January 23).
At the moment, Aminul Islam Khan (Abu), Fundamental Secretary of Diagnostic Re-Agent and Equipment Traders Association of Bangladesh gave a keynote take care of. Besides, Atiqur Rahman, Vice President of Bangladesh Medical Equipments and Sanatorium Equipment Dealers and MFRS Association, President of BMA Bhavan Retailer Householders Welfare Association said. Riazul Islam and Fundamental Secretary of Bangladesh Medical Equipment Importers and Suppliers Association Arshedul Alam Pulak.
Aminul Islam said, ‘Medical gadgets and diagnostic materials and re-agents throughout the medical system of Bangladesh are completely relying on imports. For a long time, we’ve were given been importing and supplying diagnostic equipment, gear and reagents to the public and private medical colleges, hospitals and diagnostic amenities of the country with recognition. In keeping with the Drug Act of 1940 and the Keep watch over Ordinance of 1980, medical gadgets used outdoor the human body and diagnostic re-agents don’t appear to be defined as drugs, so a permit was once required to import the ones products. In recent years, the government has enacted the Medicine and Cosmetics Act-2023 by way of canceling that ordinance.
He said, by way of this Act, registration of medical gadgets and reagents has been made necessary. Besides, the elements of regulations is also clearly mentioned. We want separate registration rules and up-to-date regulations to be framed accordingly. For this serve as, a Medical Device Professional Committee can also be formed with folks of business associations, representatives of client diagnostic and well being facility owner associations and similar execs.
Aminul Islam said that the recipe used throughout the preparation of substances will have to be registered for approval. Then again since 95% of medical gadgets are import dependent, this recipe approval process is completely unreasonable. Our imported gadgets are US-FDA or CA & ISO certified. Nevertheless need to submit free sale certificate. This yet again will have to be attested from the Bangladesh Embassy, which takes time. On account of which the normal import process is hampered and at the back of agenda.
This importer said, “We want exemption from the prevailing Medicine and Cosmetics Act and separate laws as an alternative.” Besides simplifying the registration process, we name for that the registration rate be better from Tk 1,000 to Tk 15,000 in keeping with the category. If the ones are carried out, the affected individual’s research rate will decrease.
These days, Atiqur Rahman said, ‘We’re being cheated during the law of substances and cosmetics. In the past days, we’ve were given cooperated by way of bringing rapid re-agents to handle corona epidemic and dengue epidemic. So why will have to we be sure that underneath this law? It’s to not point out that DGDA is scammed throughout the name of registration. My name for is 100,000 pieces, on the other hand they’re allowing 20,000. On account of the ones reasons fake gadgets are getting into the country by way of baggage occasions. So there’s a need for separate laws to offer cheap and easy services.’
Every other importer Riazul Islam said, ‘Since 2016, we’ve were given been tricky separate laws. Then again we’re puzzled in many ways. Regardless of no longer having medical tool testing options, DGDA requires us to conduct assessments. Regardless of the registration, the tool’s price will building up on account of imposition of various VATs. Which affects the victims.’
mAh/