Last Updated on November 10, 2025 by The Health Master
Act
The new Drugs, Medical Devices and Cosmetics Act will reportedly be tabled before the Parliament in the upcoming winter session as a new piece of legislation to overhaul the age-old Drugs and Cosmetics Act, 1940, a law that’s been in place since before India has even acquired independence.
With this announcement comes a long overdue momentum for quality control standards in the country and, some would say, a preemptive lawmaking effort for hospitals and pharmacies operating within its borders.
Safety Enhancement
But what does this mean for manufacturers, exporters, and most importantly, consumers?
The goal of the new law is to provide the central drug regulatory body with significant statutory powers which would facilitate government’s ability to hold various holdings legally accountable for incredibly rigorous quality testing and subsequent checks and balances of drugs, medical devices, and cosmetics.
For the Central Drugs Standard Control Organisation (CDSCO), this is a game-changer as products found to be spurious or substandard may run the risk of immediate action that previously had no empirical basis or legal recourse.
Ultimately, should the new law go into effect, accountability will no longer be debatable.
It’s Comprehensive
The Act has been drafted to regulate anything from here on out in a way that transcends simple name changes from the Drugs and Cosmetics Act, 1940.
The 1940 Act could never see the challenges approaching:
- Medical Device Regulation: For the first time, medical devices will be regulated with rules that are relevant. This is a huge boost for any Medical Device Safety Legislation.
- Clinical Trials: There are provisions secured over the integrity of any clinical trials executed across the board.
- Drugs for Rare Diseases: The draft has flexible provisions for nationwide public interest determination where the Central Licensing Authority has discretion to expedite approval for drugs without some pre-clinical and clinical data.
Online Pharmacy License
Perhaps most importantly considering we live in an online age is how this draft bill relates to e-commerce.
It states: “No person shall sell any drug or stock or exhibit stock or distribute any drug by means of an electronic or digital platform except under a license or permission issued by the authority.”
Therefore, while e-commerce options may increase access to drugs, if an entity cannot account for proper standards, they will not be able to conduct business as a functional online pharmacy.
Stronger Advisory Structure
Additionally, no law should be established without secure advice to counsel its implementation.
The new provision creates further advisory bodies to appropriately assess technical issues that require regulatory expertise:
- Medical Devices Technical Advisory Board (MDTAB): A body that’s established anew for all technical issues concerning medical devices in parallel to the existing Drugs Technical Advisory Board (DTAB) for related matters.
- Drugs, Medical Devices and Cosmetics Consultative Committee (DMDCCC): A central body consisting of a DCGI-led agency that will convene every six months at minimum with agenda items focused on cohesion across State and Central Government efforts relative to the new Act.
New Drugs Medical Devices and Cosmetics Act
Q: Why a new Drugs, Medical Devices and Cosmetics Act?
A: The Drugs and Cosmetics Act 1940 is an old Indian Law (pre-Independence) that doesn’t account for modern complexities like high-end medical devices, modern clinical trials, and online pharmacies that have come about in this day and age, especially due to globalization and medical advancement. The new Act is necessary because we need laws that keep up with industry, technology, and necessities to ensure public safety gaps don’t exist among new creations.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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