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Draft medical devices Bill

  • IASbaba
  • July 19, 2022
  • 0
Governance
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In News: Recently Union Health Ministry released a draft of a proposed The Drugs, Medical Devices and Cosmetics Bill, 2022.

  • The Bill replaces the existing The Drugs and Cosmetics Act, 1940, and several sets of Rules by which the industry is currently run.
  • The draft focuses on regulating medical devices as a separate entity, makes provision for fines and imprisonment for injury and death related to clinical trials or investigations, and seeks to regulate e-pharmacies.

Major provisions of the Bill

Regulation:

  • It seeks to regulate e-pharmacies and medical devices and provides for penalties including imprisonment for failing to pay compensation for injury or death during clinical trials for both drugs and medical devices.

Drugs and Cosmetics Act of 1940:

  • For the first time, regulations for conduct of clinical trials for new drugs and medical devices have been brought under the draft New Drugs, Medical Devices and Cosmetics Bill, 2022 which seeks to replace the existing Drugs and Cosmetics Act of 1940.

AYUSH drugs:

  • The draft bill has a separate chapter for AYUSH drugs which proposes to regulate Sowa Rigpa and Homoeopathy for the first time.
  • The existing act regulates Ayurveda, Unani and Siddha drugs and cosmetics.

New definitions:

  • The draft bill introduces various new definitions or provisions like bioequivalence study, bioavailability study, clinical trial, clinical investigation, controlling authority, manufacturer, medical device, new drugs, over the-counter (OTC) drugs, adulterated cosmetics, etc. for more clarity and smooth functioning and implementation.

Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB):

  • It proposes the constitution of a separate Drugs Technical Advisory Board (DTAB) and Medical Devices Technical Advisory Board (MDTAB), comprising experts from various associations to advise the central government in technical matters.

Penalties:

  • The penalties for offences related to import of drugs and cosmetics have been enhanced appropriately.
  • It mentions where any person permitted under sub-section (1) of section 72 fails to provide the required medical management or compensation under section 73, shall be punishable with imprisonment which may extend to one year or with fine which shall not be less than twice the amount of compensation.

Central Licensing Authority:

  • In the interest of public health or extreme urgency of drugs, the central government is empowered to make provisions for Central Licensing Authority to waive the requirement of conducting clinical trials for manufacture or import of new drugs or investigational new drugs in the country.

Compensation:

  • Where a participant during a clinical trial suffers injury or death on account of his participation in such investigation, provision has been made to provide compensation and medical management to such participants.

E-pharmacy:

  • Permission has to be taken to operate an e-pharmacy.
  • 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 by online mode (e-pharmacy) except under and in accordance with a licence or permission issued in such manner as may be prescribed.

Medical device testing centres:

  • Provisions have been incorporated to designate or establish medical device testing centres by the central government for testing and evaluation of medical devices for regulators and industry.

About Drugs and Cosmetics Act, 1940

  • The Act regulates the import, manufacture, and distribution of drugs in India.
  • The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.

Section 3 of the Drugs and Cosmetics Act, 1940:

  • The Central Government, after consultation with the Drugs Technical Advisory Board (DTAB), specifies the devices intended for use in human beings or animals as drugs.

Source: Indian Express

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