Change Is Fine, But Please Ensure Safety

India's ministry of health and family welfare, in response to the long standing demand of medical device industry to delink it from pharmaceutical sector, is apparently moved ahead in this direction and will shortly notify a change in the current drug rules for enabling this de-linkage.

The ministry had already spelled out this in a joint meeting with senior officials representing Central Drug Standards Control Organisation (CDSCO), the drug regulator, and the representatives from the local medical devices industry recently.

The ministry is also looking for getting the Bill passed for amendments in Drugs and Cosmetics Act that governs the regulations for drugs and pharmaceuticals, to include medical devices as a separate section for marketing approvals as well as pricing regulations in the current session of Parliament. The ministry had in fact proposed the draft of the Drugs and Cosmetics (Amendment) Bill, sometime early this year.

The industry has been for long asking the government to differentiate the medical devices from drugs for regulatory as well as pricing requirements as stringent rules that are applied on drug products have been blocking the growth of the devices sector and scare the investors. The other contention from the industry was that the existing drug control officials may not have the expertise to examine and assure the quality of medical devices as these are basically engineering products.

India, one of the largest markets in Asia for medical devices with a rapid annual growth, currently imports at least 70 of the medical devices sold and used in the domestic market. While the local industry is also slowly emerging, domestic manufacturing is still largely revolving around low-end devises. So the relevance of government moving in this direction is mainly in the context of leveraging the emerging medical technology innovation within the country and also to help lifting the local manufacturing to reduce the import dependence.

Currently, medical devices are approved for marketing in the country as per the same regulations applied to drugs and pharmaceuticals for which the standards are laid out in the Drugs and Cosmetics Act. The marketing approvals are also given according to the rules and regulations in this law.

Since majority of these products are currently coming from other markets where they have been in use for some time with approval the respective authorities, Drug Controller General of India rely on the clinical data available from those markets to authorise these products for marketing here.

The medical device market in India is one of the largest markets in Asia, and it continues to grow rapidly. The growth is mainly backed by increased health awareness and spending capacity of people in the country, which is predominantly a private healthcare market.

There were also certain government initiatives earlier to formulate a clear definition for medical devices differentiating for setting standards and testing methods for approving it in the market. Most of the countries across the world, including India's smaller neighbours, have a separate of set of law that defines and authorise a standard medical device used for healthcare delivery and clinical implants.

But, a hurried move like this may not fetch the expected results in this regard or may trigger more risks in the overall context of healthcare delivery in a market where the private provider are already competing for share and there are no government monitoring and control over the quality of services provided by them. The government should also simultaneously set up parallel infrastructure to deal with the newly created segment for implementing the change.

While, the ultimate goal of these changes is to develop a more formal and transparent market authorization process for the benefit of both patients as well as manufacturers, even a small start is a welcome move, sudden relaxation of rules without ensuring the quality of the currently available products may be counter-productive.

Since there are already scary reports from even developed markets on the safety and quality of medical devices including more sensitive products like cardiac stent, it's always wise to go with a more scientific and systematic way rather than rushing for creating a shorter industry impact.