CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 3
Abstract
The medical technology sector in India valued at approximately $ 10 billion in 2015 at end consumer prices and is growing at 10-12 percent annually. Currently, the Indian medical devices industry represents just over 2 percent of the global medical device market. With such immense potential, some of the challenges that this industry faced with lack of framework. India’s medical device sector was greeted by a breakthrough announcement during union budget speech in 2017. India’s finance minister declared that the government would formulate new norms, ‘harmonized with international rules’, for the medical devices sector. Post which Ministry of Health and Family Welfare released a media statement that it had notified the Medical Device Rules 2017 on Jan 31st, which would be enforceable from January 2018. These new medical device rules would attract more foreign investment and reduce prices of medical devices. This positive policy push for the development of the domestic medical device market will potentially bring more devices under its ambit, the new medical rules will bring in a huge wave of relief to consumers, protecting their right to access high quality and safe products. As the fastest growing healthcare market in the world, the government can further take several measures to create a conducive environment to consolidate the growth of the medical devices sector with regularly advising new guidances. The recent notification on essential principles for safety and performance of medical device, risk based classification with list of medical devices and in-vitro diagnostics, notified bodies auditing the firms demonstrates the favorable environment for manufacturing of medical devices nurturing growth and innovation in the country.
Authors and Affiliations
Pratibha Chauhan, Rahul Chauhan
Keywords
Related Articles
- EP ID EP326759
- DOI 10.22270/ijdra.v5i3.203
- Views 115
- Downloads 0
A STUDY ON HEAMPHILUS INFLUANZAE TYPE B DISEASE CAUSING ANTIGENS: AN APPROACH OF EPITOPE PREDICTION, ANTIGENICITY AND IMMUNOGENICITY PREDICTION
Vaccines work by mimicking disease agents and stimulating the immune system which in turn builds a defence mechanism against the disease causing agents. Some of the vaccines contain a part of the disease causing agents w...
CLINICAL TRIAL IN INDIA: RISE AND FALL
Fight with the disease is the ever evolving frontier for human beings. Discovery of new drugs and devices through clinical research are the armory to help in the fight with the affliction of mankind. Clinical trials, tes...
Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review
Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient t...
QbD APPROACH FOR STABILITY INDICATING HPLC METHOD FOR DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN COMBINED DOSAGE FORM
The present paper reports a highly selective, sensitive and robust stability indicating RP-HPLC method using QbD approach, developed and validated for determination of Artemether and Lumefantrine in combined dosage form....
FORMULATION DEVELOPMENT AND IN VITRO EVALUATION OF FLOATING TABLETS OF LAFUTIDINE BY EMPLOYING EFFERVESCENT TECHNOLOGY
In the present research work gastro retentive floating matrix formulation of Lafutidine by using various polymers were developed. Initially analytical method development was done for the drug molecule. Absorption maxima...