Health and Tech: Drugs and Cosmetics Act – 1940 to be replaced

The comprehensive new Bill, which will replace obsolete laws of Drugs and Cosmetics Act, 1940, has updated existing laws aimed at accommodating changed requirements and adaptation of new technology

The Drugs and Cosmetics Act, the pre-Independence legislation enacted 83 years ago in 1940, to regulate import, manufacture and sale of drugs, is all set to be replaced by a modern legislation, which is more in tune with the changing needs and modern technology in medicine.

Titled ‘New Drugs, Medical Devices and Cosmetics Bill, 2023’, the proposed new legislation is widely being expected to be tabled in the ongoing monsoon session of the Parliament session.

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The comprehensive new Bill, which will replace obsolete laws of Drugs and Cosmetics Act, 1940, has updated existing laws aimed at accommodating changed requirements and adaptation of new technology. The work to review Drugs and Cosmetics Rules, 1945, started way back in 2016 and was completed recently.

The Bill essentially will regulate the import, manufacture, distribution and retailing of drugs, medical devices and even cosmetics. The ‘New Drugs, Medical Devices and Cosmetics Bill, 2023′ also seeks to regulate online pharmacies, which have been a major bone of contention between traditional pharmacy retailers (medical shops) and those involved in sale of medicines through online mode.

On the issue of sale of online drugs and medical devices, the draft of the new Bill, which has been uploaded on the Ministry of Health and Family Welfare (MOHFW) website, makes its intention to regulate the sector clear.

“No person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug/medical device by online mode except under and in accordance with a licence or permission issued in such manner as may be prescribed. Licence or permission is required to be obtained from the licensing authority, except under and in accordance with such licence or permission subject to such exemptions and conditions and in such form and manner as may be prescribed,” it reads.

Apart from online retailing of drugs and medical devices, the new Bill is also proposing to regulate clinical trials and investigations of medical devices and drugs, including AYUSH drugs, medical devices and cosmetics. “The objective is to ensure highest possible regulatory standards and a transparent regulatory regime and to repeal the Drugs and Cosmetics Act, 1940,” the draft bill said.

e-Pharmacies

While online pharmacies started operating in 2014-15, they came to limelight during the Covid-19 pandemic when people started ordering online in a big way due to lockdowns. While the online pharmacies have started to flourish, the traditional medical shop owners started protesting the lack of legislation to regulate such enterprises.

Sector observers point out that online sale of medicines and medical devices must be regulated because of the genuine fears of misuse, lack of data privacy of online customers, the risk of online prescriptions fuelling a possible opioid crisis through excessive unwanted use of prescription drugs.

Apart from lack of strong regulatory framework, another major challenge for e-pharmacies is data security and threat of cyber attacks, as they have to deal with highly personal data of customers. A security breach would expose the valuable data of lakhs of customers to unscrupulous elements.