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Quality assurance of biological products is central to India's good distribution practices guidelines.


Pharmaceutical Technology
Volume 37, Issue 2

In October 2012, India's Central Drugs Standard Control Organization (CDSCO) released its official guidelines on good distribution practices (GDP) for biological products (1). This move was timely, considering that India's biologics industry is becoming a key player in the global biopharmaceutical market.


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Currently, the country's biopharmaceutical industry is valued at $2 billion a year with 20 companies producing biosimilars and 50 products available in the domestic market, according to a report by ABLE-PwC (Association of Biotechnology Led Enterprises-PricewaterhouseCoopers), published in 2010 (2). Factors such as a rise in demand, lower costs, availability of skilled talent base, higher purchasing power, and a growing population contributed to the development of biologics manufacturing in India. Many companies, in fact, have jumped on the biologics bandwagon. In January 2012, California-based Spectrum Pharmaceuticals joined hands with Viropro to develop a follow-on version of Roche and Biogen Idec's rituximab. Pfizer also finalized a deal with Bangalore-based Biocon to commercialize four insulin products in October 2010.

In a bid to ensure quality and standards, the GDP guidelines for biological products request that all parties "assist in ensuring the quality and identity of the biological products during all aspects of the distribution process." Anjan Sen, director of Deloitte Touche Tohmatsu India, said, "Clearly, this calls for collaboration and cooperation among multitude of bodies (including pharmaceutical companies and logistics providers) to ensure that the quality of biopharmaceutical products is not compromised. It also aims to pave a way for the creation of an effective and robust distribution channel that will drive the growth of the sector."

Sen added, "These guidelines will open up new business opportunities for logistics providers to specialize in biopharmaceutical supply chain and tap growing industry needs. Additionally, they will have to invest time in training employees and maintaining quality checks. Pharmaceutical companies, on the other hand, will have to deploy additional resources to monitor the supply chain and maintain quality standards. They will also have to take additional steps to prevent counterfeiting."

Emphasis is also placed on temperature control during biologics distribution whereby validated temperature control systems must be in place to ensure ideal transport conditions. Temperature control is particularly sensitive in the case of complex-molecule biologics that are manufactured through complex microbial cultures. It is imperative for biopharmaceutical companies to invest in their supply chains and processes to ensure proper quality and efficacy of these products.


IMPORTANT FACTS
Many local companies possess little knowledge of the cold-chain market and the required temperature for shipping of drugs. However, due to the rise in exports of vaccines in recent years, India's cold-chain market is picking up. Globalization processes and the entry of multinational companies (MNCs) on Indian soil have also sped up market growth. As a result, domestic companies are now gaining awareness of the cold-chain market.

Dealing with temperature-sensitive pharmaceutical items is particularly challenging in India because of its hot climate and accessibility to remote areas. Therefore, pharmaceutical companies have to source for logistics providers who possess state-of-the-art cold-chain processes. For example, FedEx has a cold-chain air solution that combines temperature-controlled shipping and a compliant audit trail of packages.

Inevitably, the GDP guidelines will have significant impact on business approaches and operations of all key stakeholders. Srinath Manda, program manager of transportation and logistics practice at Frost and Sullivan, said, "Pharmaceutical companies have to come up with standardized processes and infrastructure across their supply chain that may not be possible if unorganized logistics providers are employed in transportation and storage activities as the latter lack resources to build complex cold-chain infrastructure. Hence, pharmaceutical companies would need to increasingly employ organized logistics service providers with cold-chain capabilities." He further added, "In addition, they have to ensure that the same standard practices are employed throughout their distribution channel participants to the retail delivery of their goods as this would reduce the scope for pilferage and adulteration of products within the supply chain. Logistics providers will also be encouraged to build standardized and nationwide cold-chain networks eligible to serve the industry. They will also see the need to improve their capabilities and raise performance standards to meet the safe handling of products as defined in the guidelines."

On the whole, the pharmaceutical industry is expected to become more quality conscious, according to Vikas Anand, chief operating officer of DHL Supply Chain. However, the implementation of these guidelines is challenging, and regulators will have to ensure that key stakeholders are collaborating and conforming to requisite standards.

—Jane Wan is a freelance writer based in Singapore.

References

1. CDSCO website, "Guidelines on Good Distribution Practices for Biological Products," www.cdsco.nic.in, accessed Jan. 4, 2013.

2. ABLE-PwC report, "The Vision 2020 BioPharma Strategy," http://www.ableindia.in/admin/attachments/reports/reports17_Vision%202020%20Bio%20Pharma%20Strategy%20Report.pdf, accessed Jan. 9, 2013.

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