CURRENT AFFAIRS

Detailed explanation-1: -The Health Ministry has proposed expanding the list of devices in eight new categories, under the definition of ‘drugs’ to bring them under the purview of the Drugs and Cosmetics Act, 1940.

Detailed explanation-2: -The draft Bill makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices. There is a new provision for imprisonment, and fine amounting to double the compensation amount if the compensation is not paid.

Detailed explanation-3: -The National Pharmaceuticals Pricing Authority (NPPA) has invoked extraordinary powers under the Paragraph 19 of DPCO, 2013, to put a cap on trade margin of five medical devices - oximeter, glucometer, BP monitor, nebulizer and digital thermometer.

Detailed explanation-4: -909(E), dated 20.12. 2001. The Drugs and Cosmetics Rules, 1945, as amended upto the 1st May, 1979 are contained in the publication of the Ministry of Health and Family Welfare (Department of Health) containing the Drugs and Cosmetics Act, 1940 (P DGHS-61).

Detailed explanation-5: -contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940) are included in the definition of medical devices.