Medical Devices Clinical Trials in India
For conducting the medical devices clinical trials, government has set certain standards regulations. The following clarifications are required to conduct the medical devices clinical trials in India:
- Under the provisions of drugs and cosmetics rules, for registration of medical devices in India, a certificate for free sale issued by the Health Ministry/National regulatory Authority is required.
- Approval for manufacture and free sale from the regulatory authorities of the respective countries is to be submitted like USFDA/TGA Australia/Health Canada/ Ministry of Health, Labour and Welfare Japan or CE Certification is to be submitted.
- For conducting a clinical trial of a device already in use in another country, trial record of 100 days is required to be submitted to the regulatory authorities of India.
- Any change that may involve change in design/ change in composition, or any other change in the medical device requires approval by DCGI.
Clinical trials of medical devices must be in compliance with the Food and Drug Administration (FDA) informed consent and Institutional Review Board (IRB) regulations. Requirements for carrying out clinical trials of medical devices were enacted in US as a part of Medical Device Amendments of 1976 and the Safe Medical Devices Act of 1990.
Indian market for Medical Device Clinical Trials:
India serves a promising market for clinical trials of medical devices. The accelerating graph for GNP is a proof for this. Market for medical device trials turned over about USD 12.60 million in 2004 and is expected to reach USD 1.7 billion in 2010.
There is a demand of foreign involvement in India for high quality medical equipments. The driving factors for this demand are:
- Need for equipments for plastic surgery.
- Cancer diagnosis.
- Medical imaging.
- Economic growth.
- A developed industry and investment in health infrastructure.
Secondly, the National health policy aims to increase and upgrade health care facilities, while the duties on medical equipments have been reduced.
Thirdly, most medical devices do not require duties.
Moreover, the private hospitals are always ready to invest on the best and expensive equipments for their patients.
Medical Devices Clinical Trials Regulation Update:
As of now, medical devices are not yet regulated in India. With the proposal of forming a new regulatory authority, government also desires to have a separate division for medical devices also. The current regulations on medical devices are not very strong and contain many deficiencies.
In India, devices such as metered-dose inhalers, disposable hypodermic needles and syringes, intrauterine devices,in vitro diagnostic kits for HIV, diagnostic x-ray equipment, disposable perfusion sets, sterilized sutures and ligatures, metered-dose inhalers, and other such devices have been regulated till now.
Some of the devices are also categorized under drugs and hence fall under Drug and Cosmetic Act (DCA) in notification S.O. 1468(E). DCGI issued new guidelines for import and manufacture of medical devices on March 1, 2006. Ten devices were categorized under drugs according to DCGI.The ten devices were:
- cardiac stents
- drug-eluting stents
- catheters
- intraocular lenses
- IV cannulae
- bone cements
- heart valves
- scalp vein sets
- orthopedic implants
- internal prosthetic replacements
As a result of efforts put up by the Indian government, a new pharmaceutical policy has been proposed which focuses to place the critical and expensive medical devices under an affordable pricing system. According to this policy, medical devices must be of cost that is affordable also by the low income group patients. There is a lot of controversy on this proposal as the critics believe that the lowering in prices will have more of negative effects than positive as according to them, this will lead to the companies to lower their R&D budgets and avoid Indian market.
