Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

CDSCO Expanding to Enforce New Clinical Trial Rules in India

Indian regulators are adding staff and resources to the Central Drugs Standard Control Organization (CDSCO) in order to enforce more stringent clinical trial guidelines for medical devices and pharmaceuticals.

According to Outsourcing-Pharma.com, the Indian Ministry of Health and Family Welfare has sought stricter oversight of clinical trials following claims of poor safety controls and violations. More than 1,700 patients have died in clinical trials over the past three years, the website reports, noting that “few” of these deaths were directly related to clinical research.

Six investigations have been conducted into alleged violations of Indian clinical trial regulations since 2008. Actions taken by regulators in response to these incidents have included issuing warning letters, temporary trial suspensions and bans, and suspension of research licenses. Such incidents have involved both domestic and foreign clinical research organizations, physicians and one non-governmental organization.

Outsourcing-Pharma.com quotes Indian Minister of Health and Family Shri Ghulam Nabi Azad as saying the CDSCO’s staff and infrastructure are both being expanded in order to more effectively comply with provisions of the country’s new clinical trial rules.

Markets: IndiaTags: CDSCO, clinical trial management, India, medical device

Author: Stewart EisenhartDate: April 16, 2012

Indian Regulators Moving Ahead with Medical Devices Bill

India’s health ministry plans to push forward its proposed amendments to the country’s Drugs and Cosmetics Act that would separately define and regulate medical devices.

There are currently only 14 medical devices regulated by the Drug Controller General of India (DCGI); amending the Drugs and Cosmetics Act would bring all medical devices under regulation in India. The government’s proposed changes would establish a risk-based classification system for medical devices, as well as clinical trial protocols and conformity assessment procedures.

The Indian health ministry also plans to increase staff and infrastructure at the Central Drugs Standard Control Organization’s (CDSCO) medical device division to support expansion of the government’s regulatory scope.

Although a final version of proposed legislation is reportedly drafted, it remains unknown as to when the health ministry will submit the bill to Parliament for passage.

Markets: IndiaTags: CDSCO, DCGI, India, medical device

Author: Stewart EisenhartDate: December 7, 2011

DCGI to Begin Prescreening Device Registration Applications in India

The Drug Controller General (India) (DCGI) has announced plans to prescreen registration applications for medical devices and pharmaceutical products upon receipt beginning December 1, 2011.

The DCGI prescreening plan is intended to expedite device and drug registration applications by allowing regulatory reviewers to more quickly notify applicants if any required documentation is missing or insufficient. Emergo Group staff in India have learned that DCGI officials will use a checklist to make an initial evaluation of applications and at that point let applicants know if anything is out of sorts rather than sending questions during later stages of the registration process.

All divisions of India’s Central Drugs Standard Control Organization (CDSCO) will implement the prescreening protocol.

Markets: IndiaTags: CDSCO, central drugs standard control organization, DCGI, drug controller general india, India, medical device

Author: Stewart EisenhartDate: November 28, 2011

New DCGI director for India

Dr. V. G. Somani has been named Drug Controller General of India (DCGI) as of October 31, 2011. India’s Ministry of Health and Welfare has appointed him to the position overseeing the country’s medical device market for a three-month period, or until further notice.

Somani succeeds Dr. Surinder Singh, who will take a position at the National Institute of Biologicals. Singh’s tenure had been extended until March 31, 2012, but that timeframe was cut by the Madras High Court earlier this year. India’s health ministry is currently setting up a new process for DCGI selection, which explains the brevity of Somani’s appointment.

Somani previously served as deputy drugs controller for the East Zone in Kolkata.

Tags: DCGI, India, medical device, Singh, Somani

Author: Stewart EisenhartDate: November 1, 2011

Indian Regulators to Expand Coverage of Medical Devices

Following recent meeting of India’s Drug Technical Advisory Board and Drug Consultative Committee, proposals to expand the list of Notified medical devices requiring registration have emerged.

Our sources in India tell us of a proposal to bring 20 new products under the scope of Notified Devices in an effort to provide clarity regarding pacemakers, defibrillators, dental implants, neurological implants, thermometers, blood pressure apparatuses and other devices.

In addition, regulators have proposed bringing more IVD products into the Indian registration process.

We will keep you informed as we learn more.

Markets: IndiaTags: dcci, drug consultative committee, India, medical device

Author: Stewart EisenhartDate: October 18, 2011

India's Medical Device Approvals Stalled

Update: the Madras High Court has ruled in favor of a three-month extension of Dr. Surinder Singh's position as DCG(I); he will have to resign his post on October 31, 2011. The court has also ordered the Indian government to quickly identify a successor to Dr. Singh within that three-month period.

Drugs Control General of India (DCG(I)), the country’s regulatory agency overseeing medical devices and pharmaceuticals, is currently lacking a director, stalling all product approvals until the director’s reappointment.

The Indian government had originally granted a nine-month extension to Dr. Surinder Singh as head of DCG(I), but the Madras High Court has stayed that reappointment until further notice, according to Pharmabiz.com.

Singh may not re-assume his position at DCG(I) until further order from the court; in the meantime, an interim head may be appointed if the case is sent to India’s Supreme Court. The case’s petitioner has argued that the Indian government did not follow all aspects of the Drugs & Cosmetics Acts and Rules in extending Singh’s appointment.

Until resolution of this issue, DCG(I) decisions regarding device approvals are expected to slow significantly.

Markets: IndiaTags: DCG(I), DCGI, India, medical device

Author: Stewart EisenhartDate: July 22, 2011