Skip to main content

Expansion of Testing of IVD for Clinical chemistry at NIB

The National Institute of Biologicals(NIB), Noida is an autonomous body under the Ministry of Health and Welfare, GOI. The function of NIB is to assist CDSCO and other similar government bodies dealing with topics in the purview of the health sector of India.

As mentioned in a recent notification, following a change in the Medical Device Rules, 2014. NIB has now been assigned extra responsibilities with the testing of IVD devices for clinical chemistry reagent kits.

This expansion of testing has been made under the provisions of the sub-rule(2) rule 4 of the Medical Device Rules, 2017. These rules also specify the guideline for medical device registration in India.

Earlier the NIB was assigned with the responsibility of testing of five in-vitro diagnostic devices which included:
     Diagnostic kits for human immunodeficiency virus
     Hepatitis B surface antigen
     Hepatitis C virus
     Blood grouping reagents
     Glucose test strips fully automated analyser based glucose reagents

Under the new Medical Device Rules, 2017(w.e.f 1st January 2018), 247 IVD’s under the provisions of the sub-rule(2), rule 4 of these rules were added to this list.

Furthermore, in a latest notification, 42 newly notified clinical chemistry reagent kits have also been added to this list. The NIB will be responsible for the quality control testing of some of these newly notified products

What are Clinical Chemistry Reagent Kits

These kits comprise of reagents that are used in the testing of samples to obtain results in the form of a medical report. These reagent kits are the backbone of medical laboratories. Moreover, these reagent kits also fall under the purview of the medical equipment registration as per the rules.


Popular posts from this blog

India Cosmetics Market Competition Forecast & Opportunities

The Indian cosmetics sector is consistently growing since last few years. Based on Goldstein research, the value of this sector was USD 11.16 billion in the year 2017 and is estimated to increase at a CAGR of 5.91% in coming years. Moreover, the surge in the number of cosmetic product registrations and cosmetic import registrations in India backs this fact even firmly. Along with this, it is further estimated that annually the vend sale of cosmetics is growing in a range of 15-20% with domestic demand as one of the rapidly growing sectors worldwide. In the last 5 years, it has grown by 60%.

The cosmetics industry is influenced by the increasing personal(not reusable) income of people, who are becoming more aware of body aesthetics along with high demand for herbal products. People nowadays are steeply inclined towards herbal products. A sector of cosmetics growing at 15% annually. Consumers have now become highly aware about all the side effects that may arise by using products with ha…

How Safe Are Your Cosmetics? Products Containing Toxic Chemicals Sold As Beauty-Care Items

The cosmetic market in India is booming because of the increasing demand for varied personal care products among the youth. But these particular sectors are simply operating without much safety and regulations, thereby giving way to various concerns among public health advocates. In the present situation, most of the personal care products like hair care products, skincare products, fragrances, bathing products, etc come under the regulation of the Drugs and Cosmetics Act, and they are not at all adequate as per some of the industry experts. Towards the end of the year 2018, the health ministry had given a regulatory framework for the cosmetic products known as "Cosmetic Rules 2018" but it remains unattainable. There are large numbers of cosmetic product that contains several toxic chemicals and are sold in the market without any regulations. The new regulations that were proposed under the D&C Act contains about 169 sections but only seven of them are for cosmetic produc…