Universally, drug availability is divided into 3 categories based on the novelty and level of risk as per the USFDA (Pacifici and Bain, 2018). Drug availability is a rising issue in the Indian pharmaceutical market. These drugs comprise of:
- New drugs (drugs that were never been approved before).
- Generics (copy of a branded drug).
- Over the counter (OTC) drugs (can be purchased without a prescription).
Indian pharmaceutical market predominately comprises of generic drugs (70% revenue share) with lesser OTC drugs (21% revenue share) and a very few patented drugs (9% revenue share). In the next few years, the generic drug segment in India is envisioned to grow further, along with the off-patenting of many drugs in the US and other nations (IBEF, 2017). The pharmaceutical sector of India is readily moving into biologics including biosimilars and bio-betters but will take at least a decade to become a global competitor. However, the Indian Government has boosted the biosimilar market by providing funding to local players for its development. This move by the Government of India predicts to attract global leaders of biosimilars.
Status of commercial drugs available in India
According to the list by National List of Essential Medicines, (2015), a member of the pharma regulatory body of India, CDSCO has enlisted a few allergies based drug types that are legally available in India. These comprise of;
- non-steroidal anti-inflammatory medicines,
- antiallergics and medicines used in anaphylaxis,
- antidotes and other substances used in poisoning and,
- antineoplastic/ immunosuppressives and medicines used in palliative care.
Likewise, the Central Drugs Standard Control Organization (CDSCO) in 2018 approved 25 new forms of drugs, but none of them was allergy based drugs. In India, anti-allergic, antipyretics and antidotes all together hold the lowest share in the market (approx. 5%), as compared to other agents. On the other hand, allergic cases (approx. 30% for asthma and allergic rhinitis) in India are continuously growing. This, however, must make a way for the antiallergic agents to prevail in the Indian pharmaceutical market at present. Furthermore, growth in the segment of gastrointestinal agents remains expected on account of increasing research in this area (IBEF, 2017). However, the research and development of new anti-allergic drugs remain poor causing the lack of approval of new drugs in India.
The poor drug availability in India
In spite of being a developing country, India is a global hub of generic drugs. However, drugs are available at a higher price relative to that in the developing nations at the same economic level (Selvaraj et al., 2010). On the other hand, it remains acclaimed by several studies that there remains limited access to essential medicines particularly antipyretics and immunosuppressives in India (Prinja et al., 2015, Selvaraj et al., 2010). A strong correlation between antiallergic-availability and deaths due to asthma and allergic rhinitis remain reported.
It has also been found that across the hospital and private-sector retail pharmacies, the mean availability of essential medicines mainly anti-allergics, analgesics, and non-steroidal medicines (70%) was less than the WHO availability target (80%) (Faruqui et al., 2019). These studies imply that there is a need for streamlining public-sector and private-sector medicine procurement and supply systems to meet the demands of drug availability. Similarly, Prinja et al., (2015) also found poor availability of anti-allergic and anti-hypertensives in public health facilities of Northern India. More than 60% of the anti-allergic, anti-spasmodics and anti-hypertensives remain unavailable due to out of stock conditions.
Reasons for the poor drug availability in India
Availability of drugs remains greatly affected by drug utilization which, in turn, influenced by a variety of socio-economic factors (Jain et al., 2015; Bhaduri and Kipgen, 2018). These comprise of;
- sales without prescription,
- unaffordable drug prices,
- increasing population, changes in demographics and in the health status of a population,
- changes in health policies and programmes,
- lack of continuation and frequent changes in the regulation of new drugs’ approval,
- dependence upon regulatory knowledge acquired from other nations,
- poor level of consciousness in the decision-making process and,
- the paucity of correspondence with larger institutional settings.
In developing countries, especially India millions of deaths remain reported per year as a consequence of acute respiratory infections, malaria, tuberculosis and diarrhoea. Essential medicines can actually help rescue such therapeutic conditions. This necessitates access to essential medicines so that these disease-related mortalities can be avoided.
Scope of improvement of drug availability in India
The drug development programme was initiated by the Department of Science and Technology (DST), Government of India during 1994-95. It was developed to promote collaborative R&D in the pharmaceutical sector. Even though it has not been effective, but with the rise in relaxation of FDI in the pharma sector, the chance of promoting collaborative R&D is high. Recently, clinical trial regulations in India have relaxed to speed up the process of drug approval. Therefore, there will be no need to conduct phase III clinical trials or new drugs if have been already been approved in the European Union, US, UK, Canada, Australia or Japan. Some of the favourable factors driving foreign direct investment (FDI) in the Indian pharmaceutical market are:
- Increasing export value,
- increase in the number of hospitals and patient-pool,
- lower cost of production and,
- ample and cheaper availability of a skilled workforce.
The Indian pharma industry is being seen flourishing in the near future, as the industry is paved with opportunities. Establishment of chemical hubs and new R&D clusters has promised to promote research in the coming years. This would help to boost the nation’s economic environment and will also help India become a leader in pharmaceutical manufacturing. Together these factors act to draw the attention of more foreign investors towards the pharmaceutical sector of India. This, in effect, would ameliorate India’s relationships with other nations with whom scopes of promoting business are foreseen.
- BHADURI, S. & KIPGEN, T. 2018. ‘New Drugs’ Approvals in India: An Institutional Perspective. Science, Technology and Society, 23, 444-462.
- CDSCO. 2018. National List of Essential Medicines 2015. Available at: http://cdsco.nic.in/writereaddata/nlem-2015/nlem,%202015.pdf
- FARUQUI, N., MARTINIUK, A., SHARMA, A., SHARMA, C., RATHORE, B., ARORA, R. S. & JOSHI, R. 2019. Evaluating access to essential medicines for treating childhood cancers: a medicines availability, price and affordability study in New Delhi, India. BMJ Global Health, 4, e001379.
- IBEF (2018). Pharmaceuticals. Available at: https://www.ibef.org/download/Pharmaceuticals-March-2018.pdf.
- JAIN, S., UPADHYAYA, P., GOYAL, J., KUMAR, A., JAIN, P., SETH, V. & MOGHE, V. V. 2015. A systematic review of prescription pattern monitoring studies and their effectiveness in promoting rational use of medicines. Perspectives in clinical research, 6, 86.
- National List of Essential Medicines. 2015. List of approved drugs.
Available at: http://cdsco.nic.in/writereaddata/nlem-2015/nlem,%202015.pdf.
- PACIFICI, E. & BAIN, S. 2018. An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco, Academic Press.
- PRINJA, S., BAHUGUNA, P., TRIPATHY, J. P. & KUMAR, R. 2015. Availability of medicines in public sector health facilities of two North Indian States. BMC Pharmacology and Toxicology, 16, 43.
- SELVARAJ, S., CHOKSHI, M., HASAN, H. & KUMAR, P. 2010. Improving governance and accountability in India’s Medicine supply system. Draft Report Submitted to Results for Development Institute. New Delhi: Public Health Foundation of India.