Clinical trials for medical devices to be made mandatory

The government has decided to have properly-documented government-approved clinical trials for medical devices before their introduction in India.

The Central Drug Standards Control Organisation (CDSCO) has come out with an order clarifying that clinical trial for medical devices would follow the same process as obeyed 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 its July 3 order, the regulator, however, recognises the fact that there is no concept of conducting phase-I clinical trial to assess the safety and tolerability of medical devices.
Six days later, CDSCO came out with another order listing 14 categories of medical devices, which would be considered as drugs and require regulation.

The categories include disposable hypodermic syringes and needles, cardiac stents, drug eluting stents, catheters, bone cements, heart valve, intra-ocular lenses, intra-venous cannulae, orthopaedic implants and internal prosthetic replacements. All of them were notified as drugs between 1989 and 2005.

After the two orders were issued, representatives from the medical device industry and business lobby groups are meeting officials at the CDSCO and Health Ministry to seek more clarifications on what this means for the industry.

“We are seeking clarifications from the government as the orders are not adding any value to what is known,” Vibhav Garg, a senior official at Boston Scientific, a prominent medical device company, told Deccan Herald.

There are as many as 14,000 different types of medical devices ranging from bandage and hypodermic needles to pacemakers and stents.

The industry is pushing for a new chapter in the Drugs and Cosmetics Act, arguing that medical devices are different from drugs and need different standards of regulation.

Indian medical device market currently stands at $3 billion but was growing exponentially. More than 75 per cent of medical devices used in India are imported as there are no indigenous base for manufacturing these devices.

The medical device industry came under the regulator’s scanner in the wake of the 2005 controversy involving J J Hospital in Mumbai, which was using imported Axxion stents for heart patients without any approval from the Centre.

Those drug-eluting stents were not permitted for use in the country of origin, the Netherlands.