Draft Pharmacy Regulations To Include Manner of Holding Enquiry, Imposing Penalty and Preferring Appeal

The Pharmacy Council of India (PCI) has released draft regulations for public comment to address false claims of registration by pharmacy practitioners and to provide for the manner of holding enquiry, imposing penalty and preferring appeal. The PCI is inviting comments on the proposed regulations by August 8, 2024.

It may be recalled that the Jan Vishwas (Amendment of Provisions) Act, 2023, aims to decriminalize minor offenses and streamline enforcement procedures. The PCI, under the Ministry of Health, has created regulations specific to the Act in relation to pharmacists.

Key Points of the Draft Regulations

A new chapter, Part XII, is proposed titled, ‘Manner of Enquiry and Preferring Appeal’.

The process includes:

  1. Initiating an inquiry upon receiving a complaint.
  2. Inspectors conducting the inquiry and submitting a report.
  3. A preliminary review by the Registrar/ Secretary.
  4. Potential dismissal of frivolous complaints.
  5. Issuing a detailed report with evidence for supported complaints.
  6. The President of the State Council acting as the adjudicating officer.
  7. Potential penalties for those found guilty (maximum ₹1 lakh for first offense, ₹2 lakh for subsequent offenses).
  8. Written notification of the decision to all parties involved.
  9. Maintaining detailed records for future reference.
  10. Monitoring compliance with decisions.

Appeals Process

An appeals process is also outlined in the draft regulations:

Appeals can be filed with the President of the Central Council within 45 days of the adjudicating officer’s decision. The appeal must be submitted in writing with supporting documents.

The Central Council will acknowledge receipt and schedule a hearing if the appeal is valid. A written decision will be issued within 90 days of filing the appeal.

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