Every year 25th of September is celebrated as World Pharmacists Day to pay tributes to pharmacists for the role they play in improving global health and to encourage the role and activities of pharmacist in improving health in every part of the world. The pharmacy profession has a significant misunderstanding - Pharmacy or Farmacy, which creates confusion about whether it is related to medicines or farming. However, in recent years, the pharmacy profession has gained remarkable prominence as a choice of career.
Indian pharmaceutical industry has positioned itself as a global platform, primarily as a supplier of high-quality generics and low-cost vaccines. India is known as the world's Generic Pharmacy as it supplies generic medications to more than 200 nations and accounts for 20 per cent of worldwide supply by manufacturing 60,000 different generic brands. Like other regulatory countries, India also implemented criteria of bioequivalence testing for generics with initial list of 139 drug molecules in 2020. India is the only country outside the US with approximately 741 US FDA approved manufacturing locations and about 4500 ANDA (generic) market authorizations. Its 55 per cent of exports are to highly regulated countries due to licensed sites from US, WHO, and European regulatory organizations. 90 per cent of WHO pre-qualified medicinal compounds and 70 per cent of WHO vaccination requirements are sourced from India. Despite producing 500 or more active pharmaceutical molecules and accounting for 20 per cent of the global supply, India is heavily reliant on bulk drug imports. Over the last decade, Indian pharma sector has risen consistently at a CAGR of 9.43 per cent, and it now ranks third in the world in terms of volume of output. Its output in 2020-21 is Rs. 4,27,109 crore, whereas it has regularly earned a trade surplus.
During the Covid-19, India proved its ability to address domestic as well as international difficulties. In addition to meeting domestic medicine demands of vaccinations, Remdesivir, Tocilizumab, Favipiravir, and others, India supplied hydroxychloroquine to 120 countries, vaccines to 96 countries, and paracetamol to 20 countries. However, obtaining drug molecules, its key starting materials (KSM), and excipients from the outside world, particularly China, proved costlier and difficult. Taking note of the lesson, India has launched the Development of Pharmaceutical Industry Scheme to strengthen the pharmacy sector, with the goal of achieving self-sufficiency and reducing reliance on drug molecule imports. Production Linked Incentive (PLI) scheme was also implemented in 2020 to promote bulk drug production and KSMs. The total financial outlay is of Rs. 6,940 crore with actual investment of Rs. 775 crore till December 2021. A 'Scheme for Promotion of Bulk Drug Park' also promotes the development of world-class infrastructural facilities. The scheme's overall financial outlay is Rs. 3,000 crore, with financial support up to 90 per cent of the project cost. To upgrade MSMEs to GMP standards of the regulated markets, a scheme known as the 'Pharmaceutical Technology Upgradation Assistance Scheme' provides loans with interest rates ranging from 5-6 per cent. 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. Pharmaceutical is a prominent source of FDI and 100 per cent FDI is allowed under automatic route in Greenfield projects for creating complete facility for pharmaceuticals as well as in medical devices. Medical equipment is a promising field for the Indian pharma industry. As India imports over 80 per cent of medical devices, however it has been demonstrating its presence in the sector over the last five years, as evidenced by exports of $ 1,016 million in 2020-21. Inclusion of medical devices under the definition of drug and the establishment of particular regulatory standards for them under the D&C Act are milestone steps in this direction.
India has well-established drug distribution networks, with approximately 60,000 wholesale and eight lakh retail pharmacies, with chain pharmacies gaining attention in recent years. The drug law, enacted 8 decades ago, insists the sale of medicines under the direct supervision of a pharmacist, which has been a stronger point in the dispensing of quality medications. India introduced the Janaushadhi scheme in 2008 with the goal of increasing access to affordable medicines. It has grown dramatically under ‘Pradhanmatri Bharatiya Janushadhi Pariyojana (PMBJP) from 240 PMBJP centres in 2015 to 8640 centres in December 2021, with sales of Rs. 665.83 crore in 2020-21. In this way, India is not only on its way to earning Atmanirbhar status but also to gaining global pharmacy esteem.
Qualified and skilled human resource is backbone for growth of any profession. With the aim, in the 1930s, India established B. Pharm education to strengthen pharma sector. According to the Pharmacy Council of India, there are 3,680 pharmacy institutes in India now, with 11 lakh students and 80,840 faculty. The related statistics are as follows:
D. Pharm: 2883 colleges, 3.5 lakh students.
B. Pharm: 2085 colleges, 6 lakh students.
M. Pharm: 874 colleges, 70,000 students.
Pharm. D: 286 colleges, 51,480 students.
Pharm. D. PB: 145 colleges, 1,450 students.
About 30 per cent of colleges have PhD facilities. Number of aspirants 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 taluka level. The Govt has also established 7 national institutes - NIPER, the first of which was established in Mohali in 1998.
Despite of all these positive developments in field of pharmacy, India still has a long way to go, to became top global leader. The latest pandemic reveals that there is ample opportunity to scientifically promote Indian system of healing, Ayurveda. On the one hand, India is known as the world's generic pharmacy, where the term "generic" means little more than "cheaper." There should be an open discussion on the quality of generic drugs for export and domestic usage. It is great that India has introduced bioequivalence testing of generic medications; however, the concept needs to be familiarized with the medical community and the general public. Concerning the cost of medicines, it is reasonable to pose questions from both sides: why are branded medicines so expensive, despite the fact that they are not the result of original research or patented products? And how is it possible to make a low-cost medicine at a fraction of the cost of a branded counterpart? Though it is legally required to sell drugs under the direct supervision of a pharmacist, how does an internet pharmacy avoid the law?
When it comes to human resources, the availability of D Pharm education is scarce on the world map, but in recent years the course has received a brisk reaction in our country. On the other side, we are not giving higher quality Pharm D programmes they deserve. The topic of National Education Policy is a flexible and holistic curriculum; therefore, the Pharmacy Council of India should reconsider the current 'one nation, one syllabus' concept.
To summarise, while moving forward in capturing the global pharma market, we must also work to enhance the quality of medications and pharma graduates to provide better healthcare.
(Author is principal of Poona College of Pharmacy)
|