Mint Explainer: What’s in India’s new drugs and cosmetics bill?

The draft bill proposes stricter regulations for online pharmacies and also seeks to regulate medical devices (Photo: Mint)
The draft bill proposes stricter regulations for online pharmacies and also seeks to regulate medical devices (Photo: Mint)

Summary

  • The Drugs, Medical Devices and Cosmetics Bill, 2023 will replace the 80-year-old Drugs and Cosmetics Act once parliament clears it

The union government is likely to table the Drugs, Medical Devices and Cosmetics Bill, 2023 in the ongoing monsoon session of parliament. Once passed, the legislation will replace the 80-year-old Drugs and Cosmetics Act, 1940 with updated laws and strict regulations for the pharmaceutical sector. The bill also seeks to improve transparency and quality in the drugs and medical-devices sectors. Mint takes a closer look.

What’s in the Drugs, Medical Device and Cosmetic Bill 2023?

The bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics in India. It aims to ensure standards of quality, safety, efficacy, performance and clinical trials of new drugs, and build a transparent regulatory regime that would replace the Drugs and Cosmetics Act, 1940. The bill is yet to be introduced in parliament.

Why did the government want to replace the old law?

The government said it felt the need for a comprehensive legislation as the present act was being updated frequently based on the latest requirement. It said the draft bill was prepared, after consultations with the experts, to keep pace with changing needs, times, technology.

What about online pharmacies?

The union government has proposed stricter regulations for online pharmacies because of rising data-privacy concerns and fraudulent practices. To regulate e-pharmacies, the draft proposes that no person can stock, exhibit, sell, offer for sale, or distribute any drug online without a licence or permission to do so. It also has a separate chapter on regulating the import of cosmetics into India.

Why does the bill have separate chapters on regulating AYUSH products?

The draft bill contains a separate chapter on AYUSH products, proposing for the first time to regulate Sowa Rigpa and homoeopathy. The existing act regulates only Ayurveda, Unani and Siddha drugs and cosmetics. The new law would empower the government to establish central and state drug laboratories to test Ayurveda, Siddha, Sowa Rigpa, Unani and homoeopathy.

Why are industry bodies unsatisfied with the new bill?

Industry stakeholders, particularly, from the medical-device sector, are demanding a separate law to regulate medical devices, as is in most countries. Last month, stakeholders met with the union health & chemical fertiliser minister Mansukh Mandaviya to discuss the matter and asked for the bill to be revised.

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