The efforts by the central drug authority to regulate manufacturing, import and sales of medical devices, notified as drugs under the Drugs &Cosmetics Act and Rules, by revising the Schedule M-III of the Act is in limbo, as an expert committee set up to review the required rules and public comments on the draft guidelines under the Schedule has not come to any conclusion even after an year of formation of the committee.
The Central Drugs Standard Control Organisation (CDSCO) has invited public comments on the draft guidelines approved by the Drug Technical Advisory Board (DTAB) in mid 2009, to revise Schedule M-III regulating the devices notified as drugs under the Act . An expert committee was set up under the chairmanship of Dr Satyanarayana, a scientist with the Indian Council of Medical Research (ICMR) to review the rules of the D&C Act, 1940, and to study the comments for the revised Schedule M-III in September, 2009.
Only three to four meetings were held from the inception of the expert committee, and even the last meeting conducted almost six month ago, in February 2010, has not come to any conclusion, according to an industry member with the committee. The committee was proposed to submit its report by December, 2009.
“The committee was expected to take up the necessary amendments in the rules and to study the comments submitted by various parties of interest on the revised Schedule M III guidelines. The committee has not met in the past six months even after our repeated reminders on the urgency to finalise the regulations,”said Rajiv Nath, forum coordinator, AIMED and a member with the expert committee.
The norms could be strengthened or tightened to bring in quality in manufacturing, import and sales of the devices only after drawing the outline of the medical devices regulation and the implementation of revised Schedule M-III considered as an initial step to bring in such regulations. However, the government has now payed heed to the demand of the industry to bring in some guidance forms for application procedures and similar matters, which is a positive step for the industry, he added.
The DTAB has recommended the guidelines for medical devices by categorizing them into four classes – A, B, C and D considering the risk level and intended use of the product and has published it as draft guideline inviting public comments. While the Low risk devices falls under Class A, low to moderate risk devices like hypodermic needles and suction equipment are categorised under Class B while moderate to high risk equipment like bone fixation plate are classified as Class C. Class D consists of the high risk devices like heart valves and implantable defibrillator.
The DTAB has also recommended strict implementation of Indian Conformity Assessment Certificate (ICAC) for the medical devices manufactured, imported and marketed on Indian market. The Central Licensing Approval Authority (CLAA) was assigned to adapt the classification rules and to review every device specification considering the diverse nature of the devices and the technological progress in the field, for the classification.