Prevalence of Medical and Surgical Devices in Bangladesh
Md. Abdur Razzaq
The Use of Medical and surgical devices in saving lives is a significantly important in global practice. Regulatory control over the same is of utmost importance because of their direct exposure to circulatory system during treatment procedure. Quality standard has to be ensured on priority basis in the interest of safe and effective treatment.
In conformity with the guidelines of the Global Harmonized Task Force (GHFT), DGDA, Bangladesh has presented the nation “Registration Guidelines for Medical Device, Bangladesh 2015” which is considered to be a milestone in the history of regulatory system of medical devices in the country. As an eye opener, the guidelines will create awareness among concerned all regarding regulatory obligations required for protection of greater health care interest. This is more significant for Bangladesh because, we are still dependent on foreign sources for almost 90% national requirement of medical and surgical devices. The guidelines will also encourage stake holders to strive for achieving self-reliance in this ﬁeld of unexplored market through creating local manufacturing facilities. It is expected that strict adherence to the guidelines will also discourage inﬁltration of unsafe devices causing unwanted hazards to public health.
We respectfully recall generosity of the Ministry of Health and Family Welfare for undertaking such a people-friendly initiative through DGDA considering greater health care interest of the country.
Considering consumer welfare interest of common people, DGDA, through a directive dated 10th February, 2016, has re-emphasized concerned all, to print maximum retail price (MRP) on the unit package of all locally manufactured and imported medical and surgical devices as a matter of mandatory requirement.
Tremendous prospect exists for Bangladeshi entrepreneurs to explore the huge market occupied by foreign companies, through generating local manufacturing facilities. Different market studies reveal that significant growth will take place in the global health care devices market including Bangladesh during decades to come.
Before 1992, there was no medical & surgical device manufacturer in Bangladesh. In 1992, Opso Saline Ltd. initiated local manufacture of disposable syringe in Bangladesh. But for a wide range of medical and surgical devices, yet we remained import dependent.
In the year 1999, JMI emerged as a joint venture enterprise with South Korea for production of versatile forms of global standard medical and surgical devices. Beside fulfilling the national requirement of disposable syringes, JMI ventured for pioneering Auto Disable (AD) syringe manufacture under technical collaboration with Star Syringe Ltd., UK, the discoverer of WHO recommended brand, ‘K1 Auto Disable Syringe’. This venture has successfully fulfilled the AD Syringe requirement of EPI for national vaccination program of the government and that of DGFP for the purpose of administering injectable contraceptives.
After successful launching of AD syringe in Bangladesh, JMI was inspired to advance further for introduction of newer medical devices like, IV Cannula, Latex free IV infusion set, Blood Transfusion Set, Scalp Vain Set, Suction Catheter, Urine Drainage Bag, First Aid Bandage and First Aid Box for the first time in the country. The company is now capable enough to meet the national requirement of above mentioned products from its own manufacturing source. Products like Surgical Suture, Gloves, Vacuum Blood Collection Tube, Alcohol Prep Pad, Blood Lancet, Insulin Pen Needle, Micro Burette Set, etc. are in progress of manufacture and marketing by JMI.
A revolutionary venture of JMI Group is, launching of Blood Tubing Set, an important device for Haemodialysis, through local production by its sister concern, ‘Nipro-JMI Company Ltd‘, a joined venture project with Nipro Corporation of Japan, one of the globally reputed health care products manufacturers. This product, manufactured in Bangladesh, is now exported to fourteen countries of Asia, Africa, Europe, and Latin America. Registration process is in progress for export of the same to eighteen more countries of the world.
JMI Group has developed following two backward linkage industries to facilitate smooth production of healthcare devices of self and other manufacturers:
1. JMI Hospital Requisite Mfg. Ltd. (JHRML)- for production of essential components of medical devices.
2. JMI Industrial Gas Ltd.- for mixing of Ethylene Oxide (E0) and CO2 gas in different proportion depending upon customer requirements for sterilization purpose of life saving healthcare products.
In conformity with the national policy of the movement of Bangladesh, JMI prefers to create employment opportunity for our female population. Currently, almost 2000 female workforce are employed in different healthcare device manufacturing units of JMI Group. The company is trying to enhance volume of female employment in its ongoing healthcare projects and also in the projects to be undertaken in near future.
It is to be noted here that beside Opso and JMI, nine other companies were given registration by DGDA till 2015, out of which four companies have already discontinued operation.
JMI, including other manufacturers, is striving to develop entrepreneurship for local production of many more essential medical devices that we import from outside at the cost of hard-earned foreign currency. But prevalence of following relevant impediments/constraints needs to be resolved to encourage local stake holders:
* Inadequate data bank regarding medical devices
* Unauthorized inflow of medical devices
* Mis-declaration of HS code for tax evading
* Inadequate regulatory guidelines and control
* Availability of devices at questionable price and qualities
* Lack of overall awareness regarding quality requirement of medical devices
* Availability of products from unauthentic sources
* Absence of cash incentive for export as availed by exporters of our competitive countries
* Inadequate support and favors from relevant authorities toward stake holders
National Benefits of Developing Local Entrepreneurship:
* Save hard-earned foreign currency
* Create employment opportunity, particularly for women
* Develop manufacturing know-how and skills of local people
* Earn self-reliance and get rid of foreign dependence
* Create opportunity to explore global markets and earn foreign currency
* Ensure our national health safety
Newer entrepreneurs should be encouraged to take the challenge of exploring the huge market potential by creating local manufacturing facilities for production of desired health care products.
In view of above, we are optimistic enough, concerned all would come forward with whole-hearted support and cooperation to materialize the greater need of becoming self-reliant in the ﬁeld of medical and surgical devices required for our national health care interest.
Md. Abdur Razzaq, one of the distinguished business personalities and the Managing Director of JMI GROUP. The JMI Group is one of the world renowned and diversified global conglomerates of 32 companies with more than 7,000 highly dedicated and educated workforces particularly in the healthcare services.