Politics, Pills and Procurement: The Challenges of Ensuring Drug Quality in Bihar
Rupasinghe, Yoshini Naomi
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AbstractIntroduction: In 2014-6 the National Drug Survey, conducted by the Indian government, identified that 10.02% of drugs in the public sector were substandard. This study examined the challenges of ensuring the quality of drugs procured by public tender in Bihar. In 2010, the Bihar Medical Services and Infrastructure Corporation Limited (BMSICL) was established to serve as Bihar’s drug procurement agency. It drew on a well-regarded model: the Tamil Nadu Medical Services Corporation (TNMSC). However, to date, the BMSICL has struggled to develop the functionality associated with the TNMSC.
Methods: This qualitative case study examined public procurement in Bihar from 2010 to 2017 and drew on thirty in-depth interviews and three field visits. Data was analyzed using a four stage qualitative coding approach, supported by Atlas.ti software. Participants were selected using a purposive, expert sampling strategy. Interviews were conducted with pharmaceutical companies, procurement agencies, regulatory experts, companies and pharmaceutical industry representatives. Field visits were conducted to Patna, Vaishali and Chennai. Interview transcripts, grey literature and field notes were reviewed to identify and analyze patterns and themes. This paper is focused on themes relating to state-level factors in Bihar, which were: corruption and vested interests, technical measures and manufacturer incentives and practices.
Findings: Corruption has made it difficult to establish the operational capacity of the BMSICL and compromised efforts to develop the organization’s credibility. This political environment has undermined the effectiveness of technical measures, such as blacklisting, eligibility criteria and quality-testing. It has also affected the behavior of pharmaceutical companies. Reputable companies producing and supplying high-quality products in other markets, both domestic and international, expressed being disinclined to work with the BMSICL. Some explained that the cost of assuring quality prevented their company being able to successfully compete in public sector tenders. Others were deterred by the perception that doing business in Bihar would invoke a power struggle with existing local players, requiring the payment of kickbacks and senior political support to manage disgruntled stakeholders. Participants also explained that low quality suppliers were adopting fraudulent measures, such as diluting active ingredients in products to lower production costs, bribing regulatory and procurement officials and falsifying documentation. This was viewed as an indication of the weakness of the regulatory system.
Conclusion: The BMSICL struggled to achieve the progress offered by replicating the TNMSC model because Bihar’s political environment, where corruption and vested interests play a significant role, was not supportive of drug quality being prioritized and ensured. It is a case of what Pritchett and Andrews describe as isomorphic mimicry. On paper, the BMSICL had processes that look like those found in functional states. Establishing measures and processes through written documents has been a hallmark of how the agency sought to replicate the TNSMC model. However, implementing measures without fully addressing corruption and vested interests has led to isomorphic mimicry.
Implications for policy makers and donors: For interventions to improve drug quality they need to consider and address issues such as corruption and vested interests. However, donors and policy makers often opt for technical approaches because the complexities of adaptive approaches, which seek to address people’s behaviors and incentives, can compromise the sustainability, risk appetite and relationships of the intervening organization. While the study identified a range of intervention options to support donors and policy makers, two options have been prioritized: a drug inspector enhancement program, and a lab capacity and data improvement program. These options can be framed as technical interventions whilst also providing opportunities to address adaptive aspects of the issue.
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