The role of Indian pharmaceutical and compounding facilities in the world is vital. As per the Department of Industrial Policy and Promotion (DIPP), this sector alone attracted a foreign direct investments (FDI) worth over US$ 960 million between April 2000 and May 2012. As a result of which, the pharmaceutical market in India is one of the fastest growing sectors, next to information technology.
It is expected to touch US $74 billion in sales by 2020 (PricewaterhouseCoopers report). According to Barclays Capital Equity research report on India, healthcare & pharmaceuticals projected a compound annual growth of 15.3% between years 2011-12 to 2013-14. Pharmaceutical Exports Council of India (Pharmexcil) reported 27% growth in India’s exports to drugs, pharmaceuticals and other fine chemicals which cost about US $10.85 billion for the year, which ended March 2012.
The primary responsibility of this industry is to provide consumers the formulation which is prescribed by a medical practitioner in a safe and appropriate way. This enables optimal therapeutic outcomes in response to the use of medications, devices, and other pharmacy related products. In pharmaceutical and other compounding facilities, where drugs and related products are manufactured for public consumption must be maintained appropriately to prevent contaminants in the final products. It is essential to practice sterile techniques for compounding, dispensing, and other pharmacy-related services to reduce the potential risk of infections.
Overlooking the above discussed facts may have dire consequences. For example, in October 2012, a compounding pharmacy located in the New England area was linked to the fungal meningitis that has infected 424 people and caused 31 deaths so far. The Center for Disease Control (CDC) and state health departments estimate that approximately 14,000 patients may have received injections with medication from the three implicated lots of methylprednisolone and nearly 97% have now been contacted for further follow-up. The CDC’s lab has identified a fungus known as Exserohilium rostratum from the clinical specimen obtained from most of the infected patients. However, Aspergillus fumigatous and Cladosporium are also identified from some infected individuals. Interestingly, these two fungi are common in indoor environments, but previously unlinked to this type of infection.
The goal of the pharmaceutical industry is to maintain a high level of quality control and good manufacturing practices (GMP) in order to maximize therapeutic benefits. Ultimately, it is related to the public well-being and improving the quality of life for an individual suffering with health related issues. Improper handling and bad hygiene in pharmaceutical facilities is a common factor for adversely affecting health and environments. Therefore, it is expected that pharmaceutical manufacturers must have the essential knowledge of the industry’s good practices in order to minimize the potential risk of heath and environment related problems. Most manufacturers or companies think that the only way to effectively reduce potential hazards requires substantial investment. However, a structured training program, a potential source of contaminant awareness, environmental monitoring, microbiological surveillance, sterility testing, remedial action and, more importantly, regular compliance oversight is helpful in maintaining pharmacies and other compounding facilities in order to serve the health care needs of society sensibly.
After all good manufacturing practices in Pharmaceutical industry prevent unwanted episodes of health and environment related problems.
Dr. Rajiv R. Sahay is a Certified Indoor Air Quality Professional (CIAQP) and Laboratory Director at the Environmental Diagnostics Laboratory (EDLab) at Pure Air Control Services Inc. in Clearwater, Florida, USA.