PHARMACY REGULATIONS & QUALITY ISSUES
Pharmacy education in India is regulated by 2 organizations:
The Pharmacy Council of India (PCI), under the Pharmacy Act of 1948, and
The All India Council for Technical Education (AICTE), which was established under the AICTE Act of 1987.
📢 As mentioned previously, the PCI makes regulations regarding the minimum standard of education required for qualification as a pharmacist. It is responsible for registration of persons fulfilling the prescribed eligibility criteria (minimum D.Pharm) and issuing a license permitting them to practice in an Indian state. Registration activity is decentralized and the state pharmacy councils are responsible for registering pharmacists in their respective states. Thus, the PCI regulates the D.Pharm program and the recently introduced PharmD program. The B.Pharm program needs to be recognized by the PCI for the qualifications to be accepted for registration purpose only. The PCI has no jurisdiction over M.Pharm and other higher-level degree programs.
📢 Pharmacy education at all levels excluding the PharmD is regulated by the AICTE and all these programs must be approved by it. The AICTE is primarily responsible for planning, formulating, and maintaining norms and standards in technical education, which include pharmacy. Besides the Pharmacy Act, pharmacy practice is also governed by the Drugs and Cosmetics Act of 1940, which stipulates the manufacture, distribution, and sale of drugs. Currently, there are no regulatory body and regulatory control for clinical pharmacy practice.
🔉 The AICTE is also responsible for quality assurance of pharmacy programs (D.Pharm, B.Pharm and M.Pharm) through accreditation by National Board of Accreditation (NBA) constituted by the AICTE. However, only 8% of pharmacy programs have been accredited.
Accreditation is voluntary and also a stringent process; thus, few institutions have applied for accreditation on their own. The voluntary accreditation seems to serve little purpose for any of its stakeholders. Unlike other countries, the current regulations do not require any continuing education to maintain licensure once they are conferred. In addition, registered pharmacists do not have any established norms on competencies or standards of services. There is no categorization of practicing and non-practicing pharmacists.
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