Earlier this week, the Ministry of Health and Family Welfare released a draft National Pharmacy Commission Bill, 2023, inviting comments from the people and stakeholders. The Bill aims to replace the Pharmacy Act of 1948 and the existing Pharmacy Council of India (PCI) with a future-ready National Pharmacy Commission.

A Pharmacy Ethics and Registration Board has also been proposed to maintain a National Pharmacy Register listing details of pharmacy professionals. It may be up for Parliament’s approval in the budget session, which is expected to start in the last week of January.

The Bill aims for two things: to improve access to quality and affordable pharmacy education and ensuring availability of adequate and high-quality pharmacy professionals in the country.

The proposed legislation is in line with recent government efforts to restructure the medical education and healthcare systems for greater quality, accountability and transparency. It had recently replaced the Medical Council of India, the apex statutory body for medical education in the country, with the National Medical Commission and increased seats in medical colleges.

Solutions to improve India's overburdened healthcare system serving 1.4 billion people have kept the focus on infrastructure, availability of qualified doctors and paramedics. The lacunae of the system were brought to light in combating the Covid-19 pandemic.

But scant attention has been paid to the availability of trained pharmacists—a critical agent who contributes to quality healthcare. “One of the biggest challenges in healthcare in India is lack of availability of enough trained pharmacists. They affect the efficiency of public health systems in ensuring availability of good quality medicine,” Maulik Choksi, deputy country director (India) at ACCESS Health International – a global healthcare advocacy group.

“It affects the rational use of medicine contributing to medicine resistance and inappropriate consumption of medicine, where pharmacists in India act as prescribers in many instances and having trained pharmacists can resolve these two biggest challenges health systems in India face,” Choksi said.

The field of pharmacy and pharmacy education has been due for an overhaul with the Pharmacy Act 1948 becoming obsolete over time. Its various provisions need revisiting to match global standards. For instance, diploma holders aren't allowed to practice as per pharmacy education standards worldwide, but they are allowed to in India. When it becomes law, the proposed Bill will align India with global practices.

The Bill pushes for regular, transparent assessments of pharmacy educational institutions. "The (National Pharmacy) Commission shall take all such steps as it may think fit for ensuring coordinated and integrated development of pharmacy education and maintenance of the standards of delivery of services, with periodic revisions, as may be specified by regulations," says the draft bill.

Experts say India needs high quality health personnel with a variety of skills who are adequately distributed in all parts of the country, rural areas in particular. The public health system has a shortage of medical and paramedical personnel.

Health Ministry data says India has 16.86 lakh pharmacist professionals, 34.33 lakh nursing professionals, 13.1 lakh doctors and 5.65 lakh Ayush healthcare professionals. Government estimates show 16% hospitals and healthcare facilities are without a pharmacist. The proposed Bill and the changes it brings about can create a better pool of quality pharmacy professionals.

The abstract of a US study by A Tumkur, PM Muragundid, R Shetty and A Naik titled Pharmaceutical Care: Need of the Hour in India says: "Pharmaceutical care signifies a shift of practice in pharmacy from being drug product-oriented to one that is patient-oriented to achieve definite outcomes that improves patients’ quality of life. In order to achieve pharmaceutical care, pharmacists have to assume the role of caregiver, communicator, decision-maker, researcher and manager, which will help him provide individualised care."

Pharmaceutical care is aimed to achieve rational and evidence-based pharmacotherapy, which is beneficial for the patients and the society. Independent pharmacies in developing nations can play an important role in reducing mortality, providing continuity of care, and improving life expectancy, says the US study.

On the ground, pharmacists agree that it’s time for stricter regulatory mechanisms here and they should go with the times. Pharmacy educational institutions are yet to react to the changes proposed by the Bill on them since it is still at the consultation stage.

That said, there are experts who believe the proposed legislation could have had a broader scope.

“It should have a mix of both, pharmacy education and the profession. The draft bill is more focussed on pharmacy education and does not address the needs of the pharmacy profession on the whole,” Dr BR. Jagashetty, former drug controller of Karnataka.

The Bill proposes to create three boards. These are Pharmacy Education Board, Pharmacy Assessment and Rating Board, and Pharmacy Ethics and Registration Board. All of these boards are led by mainly educationists and government officials.

“There is hardly a representative from the qualified pharmacy profession, representing the state chapter of commission,” Jagashetty said. “For instance, in the draft bill there is no provision for state drug controllers in the board that would leave many problems unaddressed.”

Also, the draft Bill does not mention what kind of action would be taken in case of dispensing certain medicines in the absence of registered pharmacists, which is there in the existing Pharmacy act, the former drug controller of Karnataka said.

“There is a considerable degree of oversight in the bill,” he said.

Choksi agrees with Jagashetty, saying while “the Bill is progressive, there may be other elements that could have been referred to or added.”

“Also, there is a need for revision of the curriculum and implementation plan of the National Pharmacy Commission, and there is not much clarity on this from the bill,” he said. “Unless this happens the effectiveness of the commission needs to be watched carefully.”

To be sure, the bill is at a draft stage and will likely undergo changes as it gets debated by stakeholders before the government pilots it in parliament, likely in the budget session next year.