Summary: Extending the deadline for re-classification of these devices as drugs will prevent putting up the unnecessary burden on manufacturers and authorities regarding the drug license registration process.
In pursuance sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics
Act, 1940 (23 of 1940), the government recently amended a previous notification from the Ministry of Health &Family Welfare. The amendment is concerned with the extension of timeline of several medical devices as ‘drugs’. Where the effective date of implementation has been extended for a period of one year and will come into effect from 1stof January 2021.
The devices being considered for extension of the timeline under this notification include:
● Glucometer
● Nebulizer
● BP Monitoring Devices
● Digital Thermometer
The principal notification was published in the Gazette of India Extraordinary, Part II, Section 3, Sub-section (ii) vide number S.O. 5980(E), dated the 3rd of December, 2018.
Why was this step taken by the government
The medical device market in India is not very strictly regulated. As medical devices are guarded by more lenient regulations for clinical trials and approval (especially Class I and Class II devices), the market has become crowded by substandard products. Not to mention the level of duplicity which is quite profound at certain levels.
At the moment, only 23 medical devices have been classified as drugs in India. But with the growing scope and need of medical devices in the ever-expanding Indian health sector. More and more devices shall be brought under this category to improve citizen safety.
The government’s goal is to ensure that the quality of medical devices being sold in the Indian market shall be proper and soundly regulated by rules and regulations.
Medical devices now being classified as drugs will have to be mandatorily registered by CDSCO and provide detailed information about its manufacture and use. Moreover, bringing devices under the category of drugs will allow the authorities to properly regulate their price and quality standards.
What does the industry think?
Stakeholders in the medical device manufacturing and marketing sector are viewing this new regulation as a positive step. Since regulating more medical devices will help enhance their quality and the credibility of the manufacturing company.
However, the stakeholders are demanding for a separate act specially formulated for medical devices, since the regulation procedure for drugs is quite stringent at the moment.
