New Opportunities and Challenges in Pharma Education and Business

The pharmacy profession has grown significantly in popularity as a career option in recent years. It is one of the top industries that has made a significant contribution to attracting resources and investments from abroad. Although the positive growth is seen in number of academic institutes, retail, wholesale and chain pharmacy outlets and manufacturing units, the recent regulations and practices are posing various challenges.

 

Since beloved Professor M.L.Schroff considered BSc specialisation in pharmaceutical Chemistry in the 1930s, the number of pharmacy institutes and programmes has increased significantly. The regular B. Pharm. intake of 30 students has increased to 100; the practise component of the 10+2 D.pharm. from 1953 has been re-invented in 2008 as a 6year duration Pharm.D.; and the PG research from the 1940s. in four basic specialisations has now expanded in to applied skills like drug regulation, quality assurance, biotechnology, and industrial pharmacy. According to the pharmacy Council of India, there are 3680 pharmacy institutes in India now, with 11 lakh students and 84858 faculty members. The related statistics is - D. Pharm: 2883 colleges, 3.5 lakh students. B.Pharm.: 2085 colleges, 6 lakh students, M.Pharm: 874 colleges, 70000 students.  Pharm. D.: 286 Colleges, 51480 students, Pharm. D. PB : 145 colleges, 1450 students. About 30 % colleges have PhD facilities. The number of aspirants are increasing every year due to global demand for pharmacy graduates and domestic advancements in pharmacy sector. Pharmacy education that was restricted to metro cities is now getting established at rural places. Despite this, the Government of India has established seven national institutes-NIPER, the first of which was established in Mohali in 1998.

 

The recent surge in PCI inspections has put in to doubt not only the quality of pharmacy education but also the stake holders’ long- term trust and faith. It has raised concerns not only about the SOP for monitoring educational quality in the past, but also about the objective of mega inspection drive in this academic session, regardless of the status of approvals. The discontinuation of a long- standing course or the re-introduction of reduced -Seat courses could be a good problem statement for conducting research on pharmacy education in India. However, how can the delayed admission process be supported? And what about the possibility of reduced enrollment this academic year?

When it comes to human resources, D. Pharm. education is scarce on the global map, but the course has received a brisk response in our country in recent years. We have not only upgraded diploma institutes in to degree institutes, but we have also down- streamed by the proliferation of diploma institutes. There is also recognisable noise from distance PGs and PhDs. On the other hand, we do not give higher-quality Pharm.D. programmes the credit they deserve. Aspirants and parents are baffled about the content and outcome of the six-year programme. Another challenge that has resulted in agitations in a few states is the availability of sufficient clinical data in attached hospitals and  the independence provided by these hospitals to pharm.D interns. Today, pharma graduates are showing an interest  in exploring allied areas such as Al, Data Science, Medical writing, PV, pharmacoeconomics, medical devices, and so on, which are labelled as so on, which are labelled as ‘out of syllabus’ in the existing curriculum. To align with ‘flexible and holistic curriculum’ theme of National Education Policy, the Pharmacy Council of India should reconsider the concept of ‘one nation, one syllabus’.

 

The  Indian pharmaceutical industry has established itself as the world’s Generic Pharmacy, supplying high-quality generic drugs and low-cost vaccines. It supplies generic medications to more than 200 nations and accounts for 20% of worldwide supply by manufacturing 60000 different generic brands. Like other regulatory countries, India also implemented criteria of bioequivalence testing for generic drugs with initial list of 139 drug molecules in 2020. Other than the United States, India is the only country with approximately 741 USFDA- approved manufacturing units and approximately 4346 ANDA (generic) market authorizations, Because of licenced sites from the WHO, and European regulatory organisations, 55% of its exports are to highly regulated countries. India supplies 90% of  WHO-qualified medicinal compounds and 70% of WHO vaccination requirements. The Indian pharmaceutical sector has grown consistently at a CAGR of 9.43% over the last decade, and it now ranks third in the world in terms of output volume. During the COVID pandemic, India demonstrated its capability by meeting domestic vaccine and other medicine demands while also exporting hydroxychloroquine, vaccines, and paracetamol.

 

Despite producing 500 or more pharmacological molecules and accounting for 20% of global supply, India relies heavily on bulk drug imports, which have proven risky and difficult during pandemics. India recently launched the Development of Pharmaceutical Industry Scheme in order to strengthen the pharmacy sector and achieve self-sufficiency while reducing reliance on drug molecule imports. To promote bulk drug production and key starting materials, a production Linked Incentive (PLI) plan and a ‘Scheme for promotion of Bulk Drug Park’ are also in place. To help MSMEs meet GMP standards in the US, WHO, and other regulated markets, the ‘Pharmaceutical Technology Up-gradation Assistance scheme’ offers low interest loans. A sub-scheme called ‘Assistance to Pharmaceutical Industry for Common Facilities’ assists in the creation of common facilities such as pharma research parks, public testing laboratories, effluent treatment plants, and so on. 100% FDI is allowed under automatic route in Greenfield projects for creating complete facility for pharmaceuticals as well as in medical devices. The latest pandemic reveals that there is ample opportunity to scientifically promote our Indian system of healing, Ayurveda. On the contrary, PG admissions for pharmaceutical chemistry and pharmacognosy are declining year which may lead to vanishing of presence of pharmacy graduates in the bulk drug and herbal industry.

 

Medical devices are also a promising area for India’s pharmaceutical industry. The inclusion of medical devices in the definition of Drug, as well as the establishment of specific regulatory standards for them under the Drug and Cosmetic  Acts, are significant first steps in this direction. As of 2020-21,India imports more than 80% of medical devices, with a total value of $6240 USD. Over the last five years, India has demonstrated its presence in. the sector, as evidenced by exports of $1016 million in 2020-21. However, neither pharmacy education nor policymakers have fully recognised the opportunities for pharmacists in the emerging sector.

 

In 2008, India launched the Janaushadhi scheme, with the goal of increasing access to low-cost medications. Under its new name, Pradhanmatri Bharatiya janushadhi Pariyojana (PMBJP), it has grown dramatically, from 240 PMBJP centres in 2015 to 8640 centres in December 2021.On the one hand, India is known as the world’s generic pharmacy, where ‘’generic’’ simply means ‘’cheaper.’’ The quality of generic drugs for export and domestic use should be openly debated. It is wonderful that India has implemented bioequivalence testing for generic medications; however, the concept needs to be introduced to the medical community and the general public, Concerning the cost of medicines, it is reasonable to ask from both sides: why are branded medicines so expensive in India, despite the fact that they are not the original research or patented products? And how can a low-cost medicine be produced at a fraction of the cost of a branded counterpart?

 

The country has well-established drug distribution networks, with approximately 60000 wholesale and eight lakh retail pharmacies, with chain pharmacies gaining attention in recent years. The drug law, which was enacted eight decades ago, allows for the sale of medicines under the direct supervision of a pharmacist, which has been a stronger point in the dispensing of quality medications. Despite the fact that it is legal to sell drugs under the direct supervision of a pharmacist, how does an online pharmacy avoid the law? The lack of a system to identify authentic prescribers as well as medicines, as well as the expulsion of dispensing pharmacists from the online distribution chain, has created challenges for the distribution of fake medicines and their irrational use.

 

On a positive note, India is not only on its way to Atmanirbhar status but also to global pharmacy esteem. Despite all of these positive developments in the field of pharmacy, India still has a long way to go before it can be considered a top global leader. To summarise, as we work to capture the global pharma market, we must also work to improve the quality of  medications and pharma graduates to provide better health care. Existence of several professional associations reflect the strength of the pharmacy profession; however, the above list of issues should be included on their agenda. The 72^ndIPC provided numerous opportunities for interactions among experts and authorities from various fields. Moreover, all the Pharma Power Centres should focus their functioning to empower pharmacy ecosystem.

 

By,

Dr. Atmaram Pawar

Principal, Poona College of Pharmacy,

Bharati Vidyapeeth

 

 

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