On February 15, 2019, the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers issued six draft Quality Control Orders (QCOs)1, after consulting with the Bureau of Indian Standards (BIS) to ensure safety and effectiveness of these medical devices:
- Medical Electrical Equipment (Quality Control) Order, 2018
- Sphygmomanometers (Quality Control) Order, 2018
- Clinical Electrical Thermometers (Quality Control) Order, 2018
- Blood Glucose Monitoring System (Quality Control ) Order, 2018
- Gloves (Quality Control) Order, 2018
- Surgical Blades (Quality Control) Order, 2018
The QCOs, drafted using powers vested under sub-sections (1) and (2) of Section 16 read with Section 17 and sub-section 3 of the Bureau of Standards Act, 2016 ('BIS Act'), are open for stakeholders' comments/ suggestions till 15th April 2019.
The QCOs also propose:
- Compulsory use of Standard Mark for Goods or articles specified in the QCOs shall conform to the corresponding Indian Standard given therein and shall bear the Standard Mark under a license from the BIS Regulations, 2018. The draft QCOs also suggest that nothing in these Orders shall apply in relation to goods or articles meant for export, which conform to any specification required by the foreign buyer.
- The BIS shall be the certifying and enforcing authority for the goods/articles specified in QCOs. In addition, an officer not below the rank of General Manager, Distinct Industries Center in Department of Industries of the State Government shall also be the enforcing authority.
- Any person who contravenes the provisions of this Order shall be punishable under the provisions of the BIS Act. The latest version of Indian Standards including the amendments issued thereof, as published and notified by the Bureau from time to time, shall be applicable from the date as notified by the Bureau.
The draft orders, once finalized will make BIS the certifying and enforcing authority for these medical devices. However, making voluntary ISI marking mandatory for only few medicals devices instead of regulating all medical devices will not offer imperative solution to medical device sector.
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