Industry calls for separate regulation of medical devices
While the country’s Health Minister Anbumani Ramadoss announced recently that the government was having a re-look at the drug policy in the country and was working towards establishing quality standards, for which it has already introduced the Drugs and Cosmetics (Amendment) Bill, 2007 in order to facilitate setting up of a Central Drugs Authority and introduce centralized licensing for manufacture of drugs.
The inclusion of medical devices as a part of the overall description of drugs has drawn serious concerns from the medical devices industry. It has been suggested that medical equipment / medical devices be added as a independent definition and be defined as per the Global Harmonization Task Force to include any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used alone or in combination, for human beings for one or more of the specified purposes.
There is also a need for separate provisions for the regulation of medical devices since they cannot be clubbed with provisions relating to drugs and cosmetics in view of the completely different characteristic of devices and equipments as compared to drugs and cosmetics.
The Government of India is proposing to set-up the Medical Devices Regulatory Authority of India (MDRA). The MDRA would be expected to formulate appropriate guidelines to be a national certifying and regulatory agency in India for medical equipment and devices. In this connection, it is very important to ensure that there is not regulatory overlap for the medical devices industry.
The Draft Medical Device Regulation Bill 2006, and the proposed MDRA is based on tenets of European Medical Device Directive, which is largely accepted even by the Global Harmonization Task Force (GHTF) recommendations.
The proposed constitution of the Central Drugs Authority of India and Drugs Consultative Committee also needs to be reconsidered to increase the maximum number of members to include representatives from all fields including manufacturers of drugs, cosmetics and medical devices who can understand and analyze the points from the industry specific perspective.
Healthcare vouchers for the underserved
The financially-weaker section of the society may hope to get better healthcare facilities from privately-run hospitals in the future. The government is planning to issue healthcare vouchers to the poor who could use it as a currency in private hospitals. Hospitals, in turn, would get full refund from either the government or accredited insurance companies.
Some states like Uttar Pradesh and Jharkhand have already tried this successfully in pilot projects. Haryana, Karnataka and Kerala too have tried public-private partnership and insurance schemes to provide healthcare access to people. Private hospitals and insurance companies will be accredited with the government for this purpose. The proposal is part of a blueprint for healthcare reforms outlined in the eleventh five year plan.
The government’s target is to lower the cost of healthcare for the tax payers as well as to increase access to quality care for the poor. As per the latest official data, Indians spend about 6% of their consumption expenditure on health care. Families’ out-of-pocket expenditure on healthcare accounts for about 72% of the total health expenditure incurred in the country. Consumers end up spending heavily for private healthcare as government spending in healthcare remains below 1% of the GDP.