New Drugs, Medical Devices and Cosmetics Bill, 2022

In News

• Recently, the Union government has proposed the New Drugs, Medical Devices and Cosmetics Bill, 2022.

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.
• Committee:
  • In light of recommendations of the central government and the felt need to have comprehensive legislation, a committee was constituted for framing the New Drugs, Cosmetics and Medical Devices Bill.
• 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.

Issues

• Only in rules: Currently all these provisions are there in the Rules but now it has been proposed in the bill.
• No penalty provision: in the existing rules there is no provision to impose penalties such imprisonment on the erring firms or persons for failure to provide compensation to trial participants in the clinical trial for both drugs and medical devices.
• No separate definition: In the existing Act, medical devices are treated as drugs and there is no separate definition of medical devices.
• Many do not have a licence and just sell drugs that are available with other licensed stockists.

Way Forward

• International practices: Separate chapters for medical devices will give distinct treatment to it in line with international practices to boost quality, consumer confidence and expectations of the stakeholders.
• Provisions have been made for risk-based classification of medical devices based on their intended use, risk and vulnerability to the human body.

Source: BS