The Drugs and Cosmetics Act was initially passed as a law by the Parliament in 1940. The objective behind this legislation was to ensure that secure drugs are being distributed through a secure channel. This Act came with separate schedules of drugs classified on the basis of the provisions of the Drugs and Cosmetics Rules. Currently, the Second Schedule of the Act only recognizes legally binding standards for drugs, so there are no standards for medical devices and no way to prosecute a manufacturer of medical devices.[1]

The draft proposes the aim to import new definitions to medical devices Which effectively aims to bring ‘medical devices under the Medical devices rule act of 2017; All devices falling under such ambit will be regulated.[2] Apart from medical devices, this Bill also aims to focus on AYUSH products (indigenous medicines) for the purposes of reviewing. It provides for the setting up of a Review Board for AYUSH medicines.

Along with the above, the Draft also specifies about inclusion of E-Pharmacy in order to have them regulated effectively. The concept of E-Pharmacy is a modern advent and was massively successful during the COVID Lockdown when medicines became extremely essential for every household and nobody was allowed to move out of their houses. Hence, it is necessary to effectively regulate such E-Pharmacies as distributors. It was also laid down in the Draft Bill namely E-Pharmacy Rules in 2018 but the same was never enacted. The Draft Bill intends to remedy this gap in regulation by mandating license requirements for the sale of drugs and medical devices through online mode.[3]

With regards to the inclusion of medical devices under the purview of Drugs, Cosmetics and Medical Devices Bill, certain penalties are also specified for ill-use of devices or use of devices without a valid certificate are specified.

The Drugs, Medical Devices, and Cosmetics Consultative Committee (DMDCCC) is a new body for drugs and medical devices. The Drugs Controller General of India chairs this committee, which advises various governments and related parties on matters pertaining to ensuring uniformity in the administration of drugs and medical devices throughout the country.[4]