India's Medical Device Regulations May Change In 2015

India’s ministry of health has proposed amendments to the country’s medical device and pharmaceutical laws that will be submitted to parliament for approval in 2015. The draft changes have been publicly released for comments. The new legislation was developed to more closely align India’s regulations with the European Medical Device Directives.

The medical device market in India is one of the largest markets in Asia, and it continues to grow rapidly. A middle class that is increasing, along with increased health awareness and government initiatives, have some observers predicting double digit growth over the next several years. To foster this growth, India’s regulatory body, the Central Drugs Standards Control Organization (CDSCO), has proposed several initiatives. The goal of these changes is to develop a more formal and transparent market authorization process for medical device manufacturers that wish to access the Indian market.

Recently, India’s health ministry, the Department of Health and Family Welfare, released a proposed draft of the Drugs and Cosmetics (Amendment) Bill, according to a recent blog post from the Emergo Group. The ministry plans to bring the changes before parliament in 2015 and has publicly disclosed the draft document so that stakeholders from industry, government, and even the general public can provide comments. The proposed changes include updates to the definitions of medical devices, as well as in vitro diagnostic products. The updates are designed to bring existing definitions more closely in line with those established by the European Medical Device Directives.  

In addition to updating definitions, the new legislation is designed to make the requirements for device importation more explicit and systematic, according to the Emergo Group. Similar changes are also planned for the manufacturing, sales, and distribution of medical devices. Clinical trials for medical devices will also be subject to changes with the new legislation, as the regulatory requirements will be more detailed and thorough in this regard. To help with technical and administrative issues that may arise from central and state Indian governments, a Medical Devices Technical Advisory Board is also being established.

CDSCO recently announced its 2015 regulatory initiatives, which include standards of accreditation for clinical trials, investigators, and ethics committees, according to the Emergo Group. To improve submission of clinical trial applications for drugs and medical devices, implementation of an online system is also planned.

In other efforts to align India’s regulatory requirements with the international environment, CDSCO also recently proposed changes to the country’s good manufacturing practices. The new standards were designed to closely match ISO 13485, which may streamline the approval of devices.