One of the promises Finance Minister Arun Jaitley made in his budget speech on February 1 was to formulate a new rule to regulate medical devices.
The assurance came while he was talking about the budgetary measures the government was taking to help 'the poor and the underprivileged'. Jaitley claimed that the new rule will be internationally harmonised and hence attract investments to India. This, (and he probably meant local manufacturing), will reduce the cost of devices to the customer, including the poor.
The very next day, health ministry put out the new rule on its website. The ministry was in fact ready with the law, as it had notified a medical device regulation draft in October 2016, and sought public comments. The final rule was notified in the official gazette on January 31, though the public announcement happened after the budget.
Will the 250-page, all new, medical device rule help achieve the twin objectives - harmonised standards and low cost - Jaitley had targeted? The initial reaction from the industry seems to be mixed. While there is close to unanimity in the way regulatory standard setting has been proposed, the global medical technology firms and their local counterparts are not equally impressive with the measures meant towards 'cost reduction'.
The international medical device firms Medical Device Industry is also disappointed that there's nothing to penalise pseudo Manufacturing by making country of origin as a labelling requirement and ban on second hand imports of Medical equipment to safeguard patient from non calibrated equipment.
The domestic industry representatives believe that the new rule has nothing to encourage local manufacturing. Instead, it may result in India becoming a safe place for second hand imports, in the guise of making affordable devices available, they fear.
THE NEW RULE
One of the major complaints of the medical device suppliers, all these years, has been the absence of a regulatory and quality testing mechanism, that was distinctively different from the one existed for drugs and pharmaceuticals. The point they tried to make was that these two categories were entirely different and medical devices itself was a term used for a wide range of electrical and mechanical products. Their long standing demand was to have a certification mechanism that was similar to what exists in other countries, especially advanced economies. The Medical Devices Rules 2017 has addressed that problem. The new set of rules, which will come in force in the next 12 months, has been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.
Medical devices will, under the new rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the rules.
The ministry claims that the new rules have many unique features. "It will be for the first time that there will be no requirement of periodic renewal of licences. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered", an official statement said. " The issuance of licences for Class A medical devices on the basis of self-certification coupled with a system of checks and balances for ensuring compliance is a departure from the inspection based regulatory regime. Risk based audit of manufacturing units will be carried out to assess conformance with standards and quality parameters. These rules envisage creation of a robust eco-system for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators".
"There is nothing (in the rule) to penalise pseudo manufacturing by making country of origin as a labelling requirement and ban on second hand imports of medical equipment to safeguard patient from non calibrated equipment", Rajiv Nath, MD of Hindustan Syringes and the forum coordinator of Association of Indian Medical Device Industry says. The Medical Technology Association of India, a rival lobby group which represents global firms was not critical. "This is a reflection of the growing and clear understanding of the International interconnectedness of this sector and the importance of the global technology, investments and best practices for its progress", the association said in a statement.
Since the implementation of the new rule is a year away, it is too early to predict its impact on the cost of medical devices. That does not mean that the government should avoid further stakeholder consultations. Patient safety and affordability are both important. And that is what Jaitley has promised.