Drugs and Cosmetics Act 1940 Current Affairs - 2020

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Medical Devices now to be regulated under Drugs and Cosmetics Act

On February 11, 2020, Ministry of Health and Family Welfare announced that medical devices are to be brought under Drugs and Cosmetics act (DCA). This is to come into effect from April 1, 2020

Highlights

According to the regulation, every product that is used to treat a patient will now be under the ambit of DCA. It includes MRI, CT scan, thermometer, dialysis machines, etc. A list of 37 devices has been included. This includes medical devices used on animals as well.

Drugs and Cosmetics Act

The DCA regulates manufacture, distribution and import of drugs in India. It was passed in 1940. The act was prepared based on the recommendations of Chopra Committee that was constituted in 1930.

The term Drug in the act includes substances and diagnostic devices as well. The act provides guidelines for sale, display, prescription and storage of drugs. The act has so far been amended in 7 times.

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GoI halts online drug sales

The Government of India has halted online sales of drugs as it is working on framing rules to regulate the sector. This has hit the pharmacy sector greatly.

Delhi High Court’s Order

The order of sale prohibition was initiated by the Drugs Controller General of India (DCGI) V.G.Somani. The order has referred to the Delhi High Court judgement pronounced in response to the case filed by Dermatologist Dr Zaheer Ahmed. Delhi High Court order says that the sales of medicines online are in violation of Drugs and Cosmetics act. Therefore, GoI is framing strict guidelines for E-pharmacies.

E-Pharmacy rules

The E-Pharmacy rules are still at draft stage. The draft includes registration of e-pharmacies, protection of privacy of customers, measures to counterfeit unauthorized sales, drugs and expired products. It also includes periodic inspection as referred by the Narcotic Drugs and Psychotropic Substances Act, 1985, verification of registered pharmacists, details of patients and drugs on E-pharmacy portal.

E-Pharmacies claim that their business comply to Information Technology Act, 2000.

Current Market Scenario of E-pharmacy in India

In the present day, retail stores contribute to 99% of medicines sales with E-pharmacy contributing to only 1% of total medicine sales. In February 2019, the DPIIT (Department of Promotion of Industry and Internal Trade) published Draft National E-commerce policy. It includes E-pharmacy guidelines as well. As the industry has a billion-dollar potential, it is important to frame strict guidelines.

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