India’s Central Drug Standard Control Organization Releases Drafts of Medical Device Regulatory Applications

India continues to signal that new medical device regulations are on the horizon. On August 4, 2010, the Central Drugs Standard Control Organization (CDSCO) released online a draft of two different medical device-related documents: the “Guidance Document on Common Submission Format for Registration of Medical Devices in India” and the “Requirements for Conducting Clinical Trial(s) of Medical Devices in India.” The CDSCO solicited opinions on these drafts from all readers, and opinions were due on August 25, 2010.

In the “Guidance Document on Common Submission Format for Registration of Medical Devices in India,” there are general instructions on how to apply for medical device registration. The guidance lists the 15 commonly required components, including: a “covering letter” (essentially a signed summary of the application’s purpose and contents), an authorization letter that serves as proof of a local agent, and Form 40 (a standard form that includes information on the device, manufacturing site, fees for registration, and more), Plant Master File, etc. Most of the Indian government issued documents are included as annexes in the guidance.

“Requirements for Conducting Clinical Trial(s) of Medical Devices in India” similarly provides basic instructions on how to apply for clinical trials for medical devices. Most companies will have to include 17 parts in the application. Key forms are included in this guidance. For example, significant technical data will be required for submission, such as design analysis data, biocompatibility data, animal study data (if applicable), and more.

The CDSCO is in charge of the Drug and Cosmetics Act (DCA). Under the DCA, at least 14 categories of medical devices are listed as drugs. There are an additional number of medical devices that are listed as “notified medical devices” in the DCA. The medical devices considered as drugs and the “notified medical devices” are currently regulated under the DCA and require registration.

In recent years, there has been significant discussion on how to begin regulations on the rest of the medical devices in India. Many analysts expect the Ministry of Health and Family Welfare’s bill that would revise the DCA to become the law on medical devices. In this bill, the DCA would include details on the creation of a new organization, currently called the Central Drug Authority (CDA), which would regulate both drugs and medical devices. This bill would lead to a comprehensive four class medical device risk classification system, enforce safety standards, conduct post-marketing surveillance, and more. The CDSCO’s guidances may become the official guidelines if this bill were to become law. The bill is expected to pass within the next few years.