News Feature | July 17, 2014

India's CDSCO Clarifies Device Trial Requirements, Categories

By Nick Otto


India’s Central Drugs Standard Control Organization (CDSCO) issued notices last week clarifying several categories and regulatory requirements for devices that would be regulated under the same requirements that drugs face via India’s Drugs and Cosmetics Act of 1940.

CDSCO’s first order says clinical trials for medical devices would follow the same process used in the clinical trials of new drugs and vaccines with regard to the accreditation of investigators, selection of sites, and approval by the Ethics Committee.

In the July 3 order, the regulator recognized the fact that there is no concept of conducting a Phase I clinical trial to assess the safety and tolerability of medical devices. Still, the procedure for clinical trial approval is similar to that of trials for news drugs and vaccines.

Six days later, a second order was released listing 14 devices categories that fall within the definition of “devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board,” as noted under section 3(b)(iv) of the act.

The 14 categories include:

  • Disposable hypodermic syringes
  • Disposable hypodermic needles
  • Disposable perfusion sets
  • In vitro diagnostics for HIV, HbsAg, and HCV
  • Cardiac stents
  • Drug eluting stents
  • Catheters
  • Ontra ocular lenses
  • IV cannulae
  • Bone cements
  • Heart valves
  • Scalp vein sets
  • Orthopedic implants
  • Internal prosthetic replacements

The medical device regulatory landscape in India has been difficult to navigate with a lack of clear guidelines for industry to follow, but in recent years the Ministry of Health and Family Welfare, along with CDSCO have taken several steps to further clarify what is expected of industry, and to help clear some of the more difficult hurdles.

CDSCO outlined last month compensation formulas for trial-related deaths, with payouts ranging from nearly $7,000 to about $124,000 in most situations. The formula still must be approved by the Supreme Court.

The Indian parliament also late last year introduced new legislation to update the Drugs and Cosmetics Act that included a separate framework to regulate devices, but many industry experts had expected the bill to fizzle before the recent Parliamentary elections as other, more prominent bills focused on jobs and inflation.

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