Drugs and Cosmetics Act: New Regulatory Regime for eight medical items

The Ministry of Health and Family Welfare recently notified eight items to be regulated under the Drugs and Cosmetics Act. According to the ministry, this had come into effect on April 1, 2021 under the Medical Devices Rules, 2017 that was enacted in 2017.

What are the new eight medical items?

The new eight medical items that has come under the regulation of Drugs and Cosmetics Act are as follows:

  • Bone Marrow Cell Separator
  • X-Ray machine
  • Dialysis machine
  • PET Equipment
  • Defibrillators
  • MRI Equipment
  • CT Scan Equipment
  • All Implantable Medical Devices

What are the new regulations?

According to the new order, the manufacturers and importers are required to take manufacturing license from Central Licensing Authority or State Licensing Authority.

Earlier Developments

In 2020, the Ministry of Health and Family Welfare announced that the medical equipment will be qualified as “Drugs” under Section 3 of Drugs and Cosmetics Act.

Drugs and Cosmetics Act, 1940

  • It regulates the import, manufacture and distribution of drugs in the country.
  • The main objective of the act is to make sure that the drugs and cosmetics sold in the country are safe.
  • The Drugs Technical Advisory Board is the highest decision-making body in matters related to the technical details of the drugs. The board was constituted under the Drugs and Cosmetics Act, 1940.

Importance of bringing more medical devices under the Drugs and Cosmetics Act

  • The import of medical devices in India is more than 75% of the total medical device sale in the country.
  • By bringing more medical devices under the regulations of Drugs and Cosmetics Act, the Indian companies shall raise their products to International standards.
  • It increases the accountability of the manufacturers and the importers.
  • It provides an assurance of safety to the customers.

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