Medical Devices Notified as Drugs 

Medical Devices Notified as Drugs 

Part of: GS Prelims and GS-II – Health

In News:

• With effect from 1st April, 2020, all Medical Devices shall be regulated by the Government as Drugs for quality control and price monitoring.

Key takeaways:

• The Maximum Retail Prices (MPRs) of all the Medical Devices would be monitored by the Government under the provisions of Para 20(1) of the Drugs (Prices Control) Order, 2013.
• This will ensure that no manufacturer/importer increases the MRP of a drug more than 10% of MRP during preceding 12 months, failing which penalty shall be imposed. 

Important value additions:

• National Pharmaceutical Pricing Policy (NPPP) – governs price control.
• Drug Price Control Orders (DPCO) – enforces price control. 
• National Pharmaceutical Pricing Authority (NPPA) – monitors and controls drug prices.
• National Pharmaceutical Pricing Policy-2012 – places a regulatory framework for pricing of drugs.

Miscellaneous 

Azithromycin -Hydroxychloroquine Combination

• The Union Health Ministry has allowed the use of Hydroxychloroquine in combination with Azithromycin under severe conditions. 
• The earlier guidelines which included use of Anti-HIV drugs Ritonavir-Lopinavir in high risk patients, now stand repealed.
• Azithromycin is commonly used as an antibiotic. 
• Hydroxychloroquine (HCQ) is used in treatment of autoimmune diseases such as rheumatoid arthritis. It is also used in treating malaria.
• The azithromycin-hydroxychloroquine combination is part of an upcoming multi-country trial anchored by the World Health Organization to against COVID-19. 

Natuna Islands

• Natuna Islands are within Indonesia’s exclusive economic zone but are also claimed by China.
• Recently, China has sparked a major maritime confrontation with Indonesia near the South China Sea by entering waters along with dozens of Chinese fishing vessels. 

Medical Devices Notified as Drugs

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