Supreme Court directs High Court to Re-examine the Issue of Fake Pharmacists: Mukesh Kumar vs. State of Bihar (29 November 2022)

Date of the Judgment: 29 November 2022

Citation: (2022) INSC 1750

Judges: M. R. Shah, J., M.M. Sundresh, J.

Can the health of citizens be compromised by allowing unqualified individuals to dispense medicines? The Supreme Court of India recently addressed this critical question in a case concerning the regulation of pharmacies in Bihar. The Court criticized the High Court’s casual disposal of a Public Interest Litigation (PIL) that raised serious concerns about the operation of hospitals and medical stores by unregistered or fake pharmacists. The bench, consisting of Justices M. R. Shah and M.M. Sundresh, found that the High Court did not adequately address the serious allegations made in the PIL.

Case Background

The appellant, Mukesh Kumar, filed a Public Interest Litigation (PIL) before the High Court of Judicature at Patna, raising concerns about the widespread practice of allowing non-registered pharmacists to dispense medicines in government hospitals and private medical stores. The PIL highlighted that even clerks, Auxiliary Nurse Midwives (ANMs), and staff nurses were performing the duties of pharmacists. The petitioner contended that this practice violated the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015, endangering the health of patients. The petitioner also alleged that the Bihar State Pharmacy Council was involved in granting fake and illegal registrations to unqualified individuals.

The petitioner sought directions from the High Court to ensure that only registered pharmacists are allowed to dispense medicines, to implement the Pharmacy Practice Regulations, 2015, and to create necessary posts for pharmacists. Additionally, the petitioner requested an inquiry into the functioning of the Bihar State Pharmacy Council.

Timeline:

Course of Proceedings

The High Court disposed of the PIL after noting that the Bihar State Pharmacy Council had submitted a fact-finding committee report to the State Government. The High Court directed the petitioner to individually verify each case of illegality and bring it to the attention of the Bihar State Pharmacy Council or the State of Bihar. The Supreme Court found this approach to be inadequate, given the serious nature of the allegations and the potential impact on public health. The Supreme Court noted that the High Court failed to exercise its powers under Article 226 of the Constitution of India.

Legal Framework

The Supreme Court referred to the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015, emphasizing the duty of the Pharmacy Council and the State Government to ensure that hospitals and medical stores are run only by registered pharmacists. The Pharmacy Act, 1948, aims to regulate the profession of pharmacy, ensuring that only qualified individuals handle the dispensing of medicines. The Pharmacy Practice Regulations, 2015, further detail the responsibilities and standards expected of pharmacists. The court highlighted that these regulations are in place to safeguard public health and prevent the misuse of medicines.

The Supreme Court noted that the High Court’s casual approach overlooked the core issue: the potential harm to public health caused by the operation of medical facilities by unqualified personnel. The Court stressed that the State Government and the Bihar State Pharmacy Council cannot be allowed to compromise the health and lives of citizens.

Arguments

The appellant argued that the High Court erred in dismissing the PIL without addressing the substantive issues raised. The appellant contended that the practice of allowing non-pharmacists to dispense medicines was a clear violation of the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015. The appellant also submitted that the Bihar State Pharmacy Council was failing in its duty to regulate the profession and was allegedly involved in granting fake registrations. The appellant emphasized the potential harm to public health caused by these practices.

The respondents, the State of Bihar and the Bihar State Pharmacy Council, submitted that a fact-finding committee had been constituted and its report was forwarded to the State Government. However, they did not provide any detailed information on the actions taken to address the allegations of fake pharmacists or the operation of medical facilities without registered pharmacists.

Issues Framed by the Supreme Court

The Supreme Court did not explicitly frame issues in a separate section. However, the following issues were implicit in the Court’s analysis:

• Whether the High Court was justified in disposing of the PIL in a casual manner.
• Whether the State of Bihar and the Bihar State Pharmacy Council have taken adequate steps to prevent the operation of hospitals and medical stores by fake or unregistered pharmacists.
• Whether the Pharmacy Practice Regulations, 2015, are being followed in the State of Bihar.

Treatment of the Issue by the Court

The following table demonstrates as to how the Court decided the issues

Authorities

The Supreme Court primarily relied on the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015. The court underscored the importance of these legal provisions in ensuring that only registered pharmacists dispense medicines and that the health of citizens is protected. The court noted that the High Court failed to appreciate the gravity of the situation and the potential harm to public health.

Judgment

How each submission made by the Parties was treated by the Court?

How each authority was viewed by the Court?

The Court relied on Pharmacy Act, 1948* to underscore the importance of having registered pharmacists and the Pharmacy Practice Regulations, 2015* to highlight the duty of the Pharmacy Council and the State Government to adhere to these regulations. The court emphasized that the High Court failed to appreciate the gravity of the situation and the potential harm to public health.

What weighed in the mind of the Court?

The Supreme Court was deeply concerned about the potential harm to public health caused by the operation of hospitals and medical stores by unqualified individuals. The Court emphasized the duty of the State Government and the Bihar State Pharmacy Council to ensure that only registered pharmacists are allowed to dispense medicines. The Court was also critical of the High Court’s casual approach to the PIL, which raised serious allegations of fake pharmacists and violations of the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015.

Logical Reasoning:

The Court considered the potential for harm to public health as a primary reason for its decision. The Court noted that the High Court’s casual disposal of the PIL was inadequate, especially given the serious allegations of fake pharmacists and violations of the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015. The Supreme Court emphasized that the State Government and the Bihar State Pharmacy Council cannot be allowed to compromise the health and lives of citizens. The Court also considered the lack of concrete action by the State and the Council to address the allegations of fake pharmacists or the operation of medical facilities without registered pharmacists. The Court highlighted the need for accountability and directed the High Court to inquire into these allegations.

The Supreme Court stated, “The manner in which the High Court has disposed of the public interest litigation – writ petition ventilating the very serious grievances touching the health and life of the citizen is disapproved.” The Court also noted, “The State Government and the Bihar State Pharmacy Council cannot be permitted to play with the health and life of the citizen.” Additionally, the Court remarked, “The High Court has failed to exercise the powers vested in it under Article 226 of the Constitution of India.”

Key Takeaways

• The Supreme Court has emphasized the importance of having registered pharmacists in hospitals and medical stores.
• State Governments and Pharmacy Councils have a duty to ensure compliance with the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015.
• Public Interest Litigations concerning public health issues must be addressed seriously by the High Courts.
• The Supreme Court is willing to intervene in cases where High Courts fail to exercise their powers under Article 226 of the Constitution of India.

Directions

The Supreme Court quashed the High Court’s judgment and remanded the matter back to the High Court. The High Court was directed to consider the writ petition afresh after calling for detailed reports from the State of Bihar and the Bihar State Pharmacy Council on the following:

• How many government hospitals/hospitals/medical stores/private hospitals are being run either by fake pharmacists or without registered pharmacists.
• Whether any action has been taken by the State Government on the fact-finding committee report submitted by the Bihar State Pharmacy Council.
• Whether there are any fake pharmacists as alleged in the writ petition.
• Any action taken by the State Government or by the Bihar State Pharmacy Council against such fake pharmacists.
• Whether the Pharmacy Practice Regulations, 2015, are being followed in the entire State of Bihar.

The High Court was directed to take up the matter within four weeks from the date of the order.

Development of Law

The ratio decidendi of this case is that High Courts must take public interest litigations concerning public health seriously and must not dispose of them in a casual manner. The Supreme Court has reiterated the importance of strict adherence to the Pharmacy Act, 1948, and the Pharmacy Practice Regulations, 2015, and has emphasized the duty of the State Government and the Pharmacy Council to ensure that hospitals and medical stores are run only by registered pharmacists. This decision reinforces the judiciary’s commitment to protecting public health and ensuring accountability in the healthcare sector.

Conclusion

The Supreme Court’s decision in Mukesh Kumar vs. State of Bihar is a significant step towards ensuring the proper regulation of pharmacies and the protection of public health. By remanding the matter to the High Court with specific directions, the Supreme Court has emphasized the need for accountability and transparency in the healthcare sector. This judgment serves as a reminder that the health of citizens cannot be compromised and that legal frameworks must be strictly enforced to prevent the misuse of medicines by unqualified personnel.