Recently, both Houses of Parliament in India passed the Pharmacy (Amendment) Bill 2023. This amendment is expected to bring-in changes in regulating the pharmacy profession viz Jammu and Kashmir. The present governing law, the Pharmacy Act 1948, regulates the pharmacy profession and the formation of Pharmacy Councils. The new amendment is the outcome of the Jammu and Kashmir reorganization in 2019. A similar amendment was carried out in 1959 to take care of the pharmacists affected by the partition and reorganization of the State in 1956. However, the administration’s apathy for amending the pharmacy law to address concerns has been due since 1948. Has the current Act served the purpose of contemporary India? An amendment was carried out in 1976 from Burma, Sri Lanka and Uganda. The article will explore the developments concerning Pharmacy Law, touching upon the new amendment.
Overview of the Pharmacy Act of 1948
The primary objective of the Pharmacy Act is to regulate the education and practice of Pharmacy in India. It strives to ensure that pharmacists meet specific standards of education and professional conduct, contributing to delivering safe and effective healthcare services. The various bodies and essential areas related to the Act are-
Pharmacy Council of India (PCI) under Section 3 of the Act establishes the Pharmacy Council of India (PCI), a statutory body responsible for overseeing and controlling the Pharmacy profession at the national level and maintaining the minimum standards for pharmacy education in India.
State Pharmacy Councils (SPCs) under Section 19 of the Act permit the formation of State Pharmacy Councils (SPCs) in each state and union territory. SPCs are tasked with registering and regulating pharmacists at the state level, ensuring that local needs and standards are met.
Registration of Pharmacists: Chapter 4 of the Pharmacy Act mandates that individuals aspiring to practice as pharmacists must register with their respective State Pharmacy Councils. This registration process verifies that pharmacists have met the necessary educational and professional requirements, maintaining the quality and competency of the workforce.
Education and Training:
Section 10 of the Act specifies minimum qualifications and standards for the education and training of pharmacists in India. It includes requirements for pharmacy schools and colleges, promoting the development of high-quality pharmacy education institutions.
Code of Ethics: The Act incorporates a code of ethics for pharmacists, outlining the ethical standards they must uphold in their professional practice. This code governs their interactions with patients, physicians, and the public, ensuring professionalism.
Inspections and Disciplinary Actions: The Act under section 16 empowers PCI and SPCs to inspect and regulate pharmacy institutions and take disciplinary actions against pharmacists who violate the code of ethics or practice below the prescribed standards.
Promotion of Quality Healthcare: Through these regulations, the Pharmacy Act promotes quality healthcare in India by ensuring pharmacists are qualified and adhere to professional standards. It ultimately benefits the health and well-being of the population.
Identifying the Registered Pharmacist
- Dress Code: The Registered pharmacist shall be formally dressed according to the code. A clean white overall coat/apron with a badge displaying the name and registration number of the pharmacist is to be worn.
- Display: Registered pharmacists under law shall display as suffix to their names only recognized pharmacy qualifications/degrees or such certificates/diplomas and memberships/honours which confer professional knowledge or recognize any exemplary qualification/achievements.
- Owner of the Pharmacy: The name of the owner of the pharmacy business shall be reflected at or near the main entrance of each premises in which the business is being carried on.
- Dispensing as per the prescription of Registered Medical Practitioner only: Every registered pharmacist shall dispense only those medicines as prescribed by the Registered Medical Practitioner and shall not substitute the dispense only those medicines as prescribed by the Registered Medical Practitioner.
- The pharmacist does not have the power to substitute the medication.
- A person having qualifications in another system of pharmacy is not allowed to practice the modern system of pharmacy in any form. For renewal of registration, the pharmacist shall attend a minimum of 2 refresher courses in the pharmacy of a minimum of one-day duration, each in a span of 5 years, organized by any one of the following bodies.
No person other than a Registered Pharmacist shall compound, prepare, mix, dispense or supply any medicine on the prescription of a Registered Medical Practitioner (Schedule H & X drugs);
Important Precedence on Pharmacy Law
In the case of Pharmacy Council of India v. Dr. SK Toshniwal Educational Trusts Vidarbha Institute of Pharmacy, the Supreme Court reaffirmed the significance of the Pharmacy Act, particularly concerning the recognition of pharmacy education degrees and diplomas. The court ruled that the Act takes precedence in matters related to pharmacy education, emphasizing the importance of having specialized individuals, experts in pharmaceuticals, pharmacy, and related subjects, as members of the Pharmacy Council of India.
The Hon’ble High Court of Kerala allowed the writ petition vide common judgement/order dated. 23.8.2017 and upheld the provisions of section 42 of the Pharmacy Act, 1948 and held “No person other than a Registered Pharmacist can dispense the medicine.”
The Supreme Court held in a recent judgment raising a paramount concern that the hospitals, dispensaries, and medical stores running in the absence of unregistered pharmacists or by fake chemists will ultimately affect the health of citizens” (Press Trust of India. (2022 December 1). People’s health affected by hospitals, medical stores run by fake pharmacists: SC. Kashmir Reader). The right to health is already recognized as a fundamental right. The bench comprising of justices of the Supreme Court, M. R Shah and MM Sundresh, noticed the gap in the judgment passed by the Patna High Court. They were setting aside the order passed by the high court on a plea by pharmacist Mukesh Kumar. The petitioner is seeking directions from authorities concerned not to allow anyone other than a registered pharmacist to operate for compounding, preparing, mixing or dispensing any medicine on the prescription of any medical practitioner. The bench held that the Hon’ble Court passed the order without investigating the grievances raised. The high court disposed of the writ petition in a “most casual manner” just by noting that the Bihar State Pharmacy Council had submitted that the fact-finding committee was constituted, and they forwarded its report to the state government.
“Running the hospitals/dispensaries in absence of any registered pharmacist and/or running such hospitals by fake pharmacist and even running the medical stores by fake pharmacist and without even any pharmacist will ultimately affect the health of the citizen. The State Government and the Bihar State Pharmacy Council cannot be permitted to play with the health and life of the citizen,” the bench said.
Obsolete Provisions
The Karnataka State Registered Pharmacists Association (KSRPA) is insisting on replacing the Pharmacy Act, of 1948 with the National Pharmacy Commission Act 2022. in a communication to the Union government, KSRPA president Ashokswamy Heroor. The out-of-date Pharmacy Act has also brought about the deterioration of the standards of education. There is no uniformity either in the syllabus or in the examination standards, which vary from State to State, he said. PCI is in no position to regulate the present degree and post-graduation courses, which are also seen to be discontinued in most colleges. Some relevant observations about the obsolete clauses of the Pharmacy Act (Ramesh et al.. (2023, May 28). Bizz Buzz. Bizz Buzz)
- It requires a mere diploma to run as a pharmacist in India. In the global context, it is only in India that a diploma holder can work as a registered pharmacist. All over the world, a pharmacist is a graduate eligible to work in an approved pharmacy, lending credence to the highly critical profession. In the wake of globalization, India is still waiting to make the change. There is a growing demand that registration should be allowed only upon graduation in pharmacy (B Pharm) from a recognized university and submitting the degree certificate.
- It was also suggested that to strengthen the efficiency of the pharmacy council, the central council should take on board representatives from the Central Drugs Standard Control Organisation (CDSCO), the National Pharmaceutical Pricing Authority (NPPA) and the Indian Pharmacopoeia Commission (IPC).
- The Pharmacy Council of India has finalised that the exit exam of Diploma in Pharmacy candidates will be implemented from the 2022-2023 batch of the D.Pharm course. The objective of the exam is to ensure that a candidate applying for registration has undergone necessary education and a comprehensive practical training programme in the Diploma in Pharmacy (D.Pharm) course.
- There is demand for increasing penalty for dispensing medicines by unqualified pharmacists. There should be increase from the existing Rs. 1,000 to a minimum of Rs. 10,000 and imprisonment for such contravention should be increased to two years from the existing six months.
- There is no responsible authority to redress these grievances of the Registered Pharmacists.
- Community pharmacists, who play a vital role in the National Health Programmes as seen during Covid times, are on the verge of extinction due to the lack of support by the state and central pharmacy councils and government authorities, he said.
Present Amendment
The implementation of the Jammu and Kashmir Reorganization Act, 2019 led to the repealing of various Acts applicable in the erstwhile State of Jammu and Kashmir, including the Jammu and Kashmir Pharmacy Act, Samvat, 2011, which regulated the profession of Pharmacy in the State. Consequently, the Jammu and Kashmir Pharmacy Council was re-constituted, and the Pharmacy Act 1948 was adopted in the Union territory of Jammu and Kashmir vide Statutory Order with MHA introducing section 32C in the Pharmacy Act, 1948. It is pertinent to mention that it was never actually amended in the Pharmacy Act 1948 but remained a part of the Statutory Order dated 5-10-2020. Similarly, the Pharmacy Act 1948 was adopted in the Union Territory of Ladakh vide Statutory Order.
This notification created an ambiguity as it did not mention whether the person possessing an approved qualification (medical assistant/pharmacist) under the Jammu and Kashmir Pharmacy Act, Samvat, 2011 (1955 A.D.) but could not be registered/ did not apply earlier due to some reason has an opportunity to be registered and whether the students who were undergoing an approved course leading to an approved qualification (medical assistant/pharmacists) for registration under the Jammu and Kashmir Pharmacy Act, Samvat, 2011 (1955 A.D.) at the time of enactment of the Jammu and Kashmir Re-organisation Act, 2019 and have acquired the said approved qualification (medical assistant/pharmacist) can be considered for registration. Hence, arose the need for amendment of section 32C of the Pharmacy Act. 1948.
Newly appointed DCGI Rajeev Singh Raghuvanshi (Thacker, T. (2023, March 17). All medicines to be sold under the supervision of pharmacist mandates DCGI. The Economic Times. ) has re-emphasised the role of regulators by stating that state drug controllers shall ensure that pharmacists should be physically present in the medical stores and that medicines must be sold under their direct supervision in all the retail pharmacies. How far the same is implemented across India is subject to the tightening of law enforcement by the regulators.
International Development
The United States Food and Drug Administration, the administrative body through the Office of the Commissioner 2020, took action along with the Indian Government to Protect Consumers From Illicit Medical Products by first bilateral enforcement protected American Consumers by stopping approximately 500 shipments of illicit and potentially dangerous, unapproved prescription drugs.
There is a growing demand and need to replace the current Pharmacy Act in India. The Union Health Ministry constituted a Sixteen-member expert committee to review pharmacy education and to restructure the Pharmacy Council of India. The committee will be Chaired by Dr Y K Gupta, President of All India Institute of Medical Sciences (AIIMS) Jammu and Bhopal. It will make recommendations for restructuring of the PCI. There is a need for a potent regulator and laws to meet the current standards to raise the bar of the profession. The issue of spurious drugs or substitution of the drug is not unheard of in India. India awaits to see the new change.
About the author
EDITOR & AUTHOR - Adv. Jyoti Srivastava
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