The components of the pharmaceutical business constitute three main clusters. These comprise:
- regulatory and legal and,
- marketing clusters (Ashton, 2008).
These three clusters together help in the growth and development of any pharmaceutical company. The manufacturing cluster is more associated with research and development, clinical trials, and mass production of newly developed products.
Regulatory and legal, on the other hand, looks after the legal issues and aspects of the company. They form the most important part of the pharmaceutical business . Lastly, the marketing cluster is associated directly toward increasing sales and revenue generation.
Manufacturing cluster is an important part of the pharmaceutical business
The first and foremost component is raw material (bulk drug) procurement of raw material in pharmaceuticals. It is being carried out through many methods such as tenders, competitive negotiations and even direct procurement. The aim of the manufacturing step is to give quality drugs at a lower cost as required by the customers (WHO, 2002). Chemical composition formation or formulation of the drug involves the preparation of the drug that is stable as well as acceptable.
Furthermore, drug processing or drug synthesis is an industrial-scale production of pharmaceutical drugs. The process of drug synthesis
- powder blending,
- milling, granulation,
- Holt melt extrusion and,
- tablet pressing and others (Gibson, 2016).
The regulatory and legal cluster of the pharmaceutical business
This cluster is based on the looking after the regulations and legal aspects of the drugs being developed or manufactured. This cluster makes sure that the company is following the laws and regulation of drug development. Quality control check of the drugs and its efficacy is the foremost step in drug manufacturing. Drug filing is another regulatory requirement and an important component of the legal cluster. It involves applications for approval by the regulatory body such as national (Central Drugs Standard Control Organization) and international (
The regulatory cluster is also respcnsible to look after the clinical trial acts for any company developing a new drug. Good manufacturing and testing practices are also looked after by the regulatory and legal cluster of the pharmaceutical industry (Lee et al., 2015). Good manufacturing practices (GMP), good clinical practices (GCP) and good laboratory practices (GLP) are all part of the responsibilities of the regulatory cluster. This cluster is also responsible to see that patenting of new drugs and pharmaceutical compounds are withing reguulations and legally protected.
The marketing cluster of the pharmaceutical business
The marketing cluster too plays a major role in the pharmaceutical business of operations. It is responsible for the sales and marketing of pharmaceutical compounds and strategies to tackle competitors. The cluster targets a diverse population of consumers on the basis of classification of the pharmaceuticals drugs (Torjesen, 2015). They are also responsible for evaluating the costs and prices of prescription drug and make sure that the consumer demands are met accordingly. This cluster is also responsible to influence advertisements, doctors, hospital administration, and community (Bhutada, Rollins, & Perri, 2017).
- Ashton, W. (2008). Understanding the organization of industrial ecosystems: A social network approach. Journal of Industrial Ecology, 12(1), 34-51.
- Bhutada, N. S., Rollins, B. L., & Perri III, M. (2017). Impact of animated spokes-characters in print direct-to-consumer prescription drug advertising: An Elaboration Likelihood Model Approach. Health communication, 32(4), 391-400.
- Feldman, R., & Frondorf, E. (2016). Drug wars: a new generation of generic pharmaceutical delay. Harv. J. on Legis., 53, 499.
- Gibson, M. (Ed.). (2016). Pharmaceutical preformulation and formulation: a practical guide from candidate drug selection to commercial dosage form. CRC Press.
- Lee, S. L., Saluja, B., García-Arieta, A., Santos, G. M. L., Li, Y., Lu, S., … & Purandare, S. (2015). Regulatory considerations for approval of generic inhalation drug products in the US, EU, Brazil, China, and India. AAPS J, 17(5), 1285-1304.
- Torjesen, I. (2015). Drug development: the journey of a medicine from lab to shelf. Pharmaceutical Journal.
- WHO. (2002). Practical Guidelines on Pharmaceutical Procurement for Countries with Small Procurement Agencies. Available at: http://apps.who.int/medicinedocs/pdf/h2999e/h2999e.pdf.