Drugs Marketers to be held liable for quality of drugs and other regulatory non-compliances followed by manufacturer
The Ministry of Health and Family Welfare vide its notification dated 11th February, 2020, notifies the Drugs and Cosmetics (Amendment) Rules, 2020 which mandates that the name of the marketer of the drug and address shall be shown in the drug packet.
Ministry of Health and Family Welfare notifies medical equipment used on humans or animals as ‘drugs’
The Ministry of Health and Family Welfare in its notification dated 11th February 2020 has notified certain medical equipment used on humans or animals as “drugs” under Section 3 of the Drugs and Cosmetics Act, which shall be in effect from April 1, 2020.
Medical devices which are notified as drugs to be mandatorily registered under The Medical Devices Amendment Rules, 2020
Medical devices which has been notified as “Drug “ shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organization.
Prohibition and increased punishment for advertisements falsely claiming to increase height, fairness and cure disorders
the draft Drugs and Magic Remedies (Objectionable Advertisements) (DMR) (Amendment) Bill, 2020 proposes to clearly define ‘advertisement’ and ‘disorders’ covered under the ambit of the act and prescribes increased punishment for deceptive advertisement. The ministry has invited suggestions and objections to the proposal.
DGFT Prohibits the export of personal protective equipment.
The Directorate General of Foreign Trade in its Notification dated 31st January, 2020, has banned the export of all varieties of personal protection effective from date of publication of the order.
MOHFW notifies import of oxytocin reference standards exclusively for test and analysis.
The Ministry of Health and Family Welfare vide notification dated 27th January, 2020, issued amendment to the Drugs and Cosmetics Act, 1940 by which the Oxytocin reference standards is permitted to be imported exclusively for the purpose of test and analysis.
Medical devices notified by health ministry shall be considered as drugs till 1st April 2020.
The Ministry has extended the timeline for taking effect of the notification according to which the list of devices that was notified has to to be considered as ‘drugs’, to 1st April 2021.
Ministry of health and family welfare has issued a advisory on rational use of antibiotics to limit anti-microbial resistance
The Central Drugs Standard Control Organisation(CDSCO) on 23rd December 2019 has issued a notification advising the Stakeholders to take steps in rational use of antibiotics to adhere to the mission of use of medicines appropriately to safe guard the rights, safety and well-being of the patients. following the National Action Plan on AMR (“NAP- AMR) issued by Ministry of health and family welfare.
Madhya Pradesh Clinical Establishments (Registration & Regulation) Bill, 2019, proposes to repeal the existing Madhya Pradesh Upcharyagriha Tatha Rujopchar Samabandi Sthapnaye (Registrikaran Tatha Anugyapan) Adhiniyam, 1973
The State Government of Madhya Pradesh has issued the Madhya Pradesh Clinical Establishments (Registration & Regulation) Bill, 2019 which seeks to repeal the existing Madhya Pradesh Upcharyagriha Tatha Rujopchar Samabandi Sthapnaye (Registrikaran Tatha Anugyapan) Adhiniyam, 1973, in order to provide for the registration and regulation of clinical establishments in the state.
Clinics operating as an Independent entity or as part of an establishment shall apply for certificate under the amended Haryana Clinical Establishments Rules
Clinics in Haryana need to obtain permanent certificate by applying to the authority in person or by post or through web based online facility with the necessary information filled and with evidence of having met the requirements of minimum standards for the particular category of clinical establishment in a form prescribed by the National Council (available at www.clinicalestablishment.gov.in) along with a fee of two thousand rupees.
