The Pharmacy Council of India (PCI) has issued a formal communication regarding the implementation of recently amended provisions of the Pharmacy Act, 1948, as revised under the Jan Vishwas (Amendment of Provisions) Act, 2023.
The letter, dated June 19, 2025 was addressed to all State Governments, Union Territories, including their Principal Secretaries and Health Secretaries, as well as to State Pharmacy Councils. The letter confirms that the amendments to Sections 26A, 41, 42, and 43 of the Pharmacy Act have been formally notified in the Gazette of India, Extraordinary Part III-Section 4, No. 426, dated June 13, 2025.
The communication was signed by the Registrar-cum-Secretary of the Pharmacy Council of India (PCI), urging all concerned authorities to ensure timely action and implementation of the revised regulations.
Background: Strengthening Legal and Ethical Oversight
The amendments to the Pharmacy Act were introduced as part of the broader Jan Vishwas (Amendment of Provisions) Act, 2023, which aims to promote ease of compliance, reduce regulatory burden, and foster trust between citizens and the government. The Act proposes rationalization and decriminalization of minor offenses across several central laws, including the Pharmacy Act.
However, in the case of pharmacy regulation, the revisions go beyond just procedural convenience.
What Do The New Regulations Cover?
The regulations lay out detailed procedures for the handling of complaints, conducting inquiries, and appealing penalties imposed on violators of the Act. This marks the first time such a structured adjudication mechanism has been codified for the pharmacy profession in India.
Key provisions of the regulations include:
1. Lodging a Complaint
Any individual may file a complaint using Form-I, submitted via electronic means, speed post, or in person.
The complaint must specify details such as time, place, nature of contravention, evidence, and pecuniary impact.
2. Inquiry Process
Upon receiving a complaint, the Adjudicating Officer will issue a Show Cause Notice (Form-II) to the respondent, granting at least 7 days to reply.
If grounds exist for proceeding, the officer will conduct a formal inquiry, where the respondent may appear personally or via an authorized representative.
The respondent may furnish documents and a counter statement (Form-III).
The inquiry must be concluded within six months, and orders, if any, must be in writing, dated, signed, and reasoned.
The Bharatiya Sakshya Adhiniyam, 2023 (Evidence Act) need not be strictly followed, offering procedural flexibility.
3. Appeals
Aggrieved persons may file an appeal within 45 days using Form-IV, extendable on reasonable grounds.
Appeals are heard by the Appellate Authority, namely the President of the Central Council.
A decision must be made within 90 days, and the authority may call for original inquiry records before pronouncing judgment.
4. Orders and Penalties
All penalties imposed will be credited to the account of the respective State Pharmacy Council.
All orders must be duly dated, signed, and communicated to both the complainant and the respondent free of charge.
Access to Regulations and Compliance
The PCI has confirmed that the full text of the regulations is publicly accessible on the Council’s website under the ‘Rules/Regulations & Syllabus’ section. All stakeholders, including institutions, regulatory bodies, and practicing professionals, are encouraged to review the document carefully and initiate the necessary steps for compliance.
