Dr. K Madan Gopal
In a speech at a recent conference, Shri Mansukh Mandaviya, the Union Minister for Health and Family Welfare, praised the Indian pharmaceutical industry for its tenacity and ability to distribute drugs to 150 countries during the pandemic. India, regarded as the Pharmacy of the World and a major producer of generic medications, has attracted attention worldwide for addressing both its domestic needs and those of numerous other countries. With ambitions to leapfrog from the current global position of 14 to the top 10 in terms of value by 2030, India’s pharmaceutical industry deems these aspirations realistic. However, the pharma industry and its regulators face a severe challenge in combating the menace of spurious and substandard drugs.
Cough and cold medications produced by an Indian pharmaceutical business were implicated in the tragedy in the Gambia last year. Several instances of businesses failing to comply with regulatory requirements have occurred during the last two years. The country’s reputation has been damaged, and the entire sector has been impacted. However, major pharmaceutical firms ensure that the highest quality standards are met. India provided drugs and vaccines to numerous nations during COVID, and there were no complaints regarding the quality of the products. The Indian pharmaceutical industry must continually invest in raising quality standards as it grows internationally to live up to its promise of being a trustworthy and high-quality supplier of medications globally. Maintaining trust, reliability, and efficacy requires focusing on innovation, which accounts for 2/3rd of the global pharmaceutical market. In summary, quality remains the highest priority for India, with patient centricity as a fundamental principle.
The Menace of Substandard Drugs: Making quality non-negotiable, prioritizing patient safety, and requiring zero tolerance for unapproved medications are all essential requirements. The sector must place a high priority on quality to earn credibility and confidence. It is essential to establish reliable and smooth data management solutions to alleviate worries about the reliability of the data; continuous investment in upgrading quality standards is necessary to pass regulatory scrutiny. India’s pharmaceutical industry, during the COVID-19 pandemic, emerged as a reliable supplier of drugs and vaccines worldwide, upholding its reputation by maintaining quality benchmarks. In the pharmaceutical sector, quality control increases manufacturing effectiveness, promotes public safety, maintains medicine consistency, shields drug manufacturers from bad press, and reduces pharma firm liability.
Quality Ensures Patient Safety and Continuous Investment in Quality: Indian pharma companies deserve credit for regularly upgrading their quality standards through workforce upskilling, digitization, and capability building. However, quality should not be solely the responsibility of a few companies. Acknowledging this, the government has recently launched three critical schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI) to enhance the quality standards of MSMEs. These schemes encourage MSMEs to adopt global best practices, upgrade technologies, and provide credit for facility improvements. The Skill Development Council of India has initiated to launch Good Manufacturing Practice Training Programs, which intend to improve quality control. With the most significant number of accredited manufacturing facilities outside of the US, India, a major exporter of generic drugs and vaccines, must go all out to ensure that the quality of its products is uncompromised. Sustaining the tag of the Pharmacy of the World relies on delivering high-quality and affordable products that enable maximum patient access, thereby reducing the global disease burden.
Moving Forward: The pharma industry must embed a quality culture throughout its entire chain of operations, encompassing the procurement of raw materials, supply chain management, infrastructure development, production processes, workforce training, and management systems. While pharma companies bear the responsibility of maintaining the quality of their products, it is imperative for other stakeholders, including regulatory bodies, policymakers, and healthcare drivers, to contribute through collaborative efforts.
The Indian pharma industry must consider quality the driving force behind its ambitions to ascend the global value chain. The industry must constantly reinvent itself, placing quality at the core of all operations to build and enhance trust among patients in India and worldwide. With a target market size of $130 billion by 2030, quality is the linchpin for achieving sustained growth.
To ensure quality control in the pharma industry, all drug makers must undertake comprehensive measures to guarantee their medicines’ purity, safety, and regulatory compliance. Addressing the policies governing the sterility, functioning, and production of pharma products is crucial. By doing so, pharma companies can continue to thrive and maintain competitiveness in a fiercely competitive global landscape.
Moreover, boasting the most significant number of accredited manufacturing facilities outside the US, India has a unique advantage as a major exporter of generic drugs and vaccines. By embracing and implementing global best practices, collaborating with international partners, and actively seeking knowledge exchange, the industry can further elevate its quality standards and solidify its position in the global market.
In conclusion, the Indian pharma industry’s path to achieving its ambitious goal of a $130 billion market size by 2030 hinges on prioritizing quality control across all facets of its operations. As the industry forges ahead, it must keep quality at the forefront of its endeavors. Collaborative efforts among stakeholders, including regulatory bodies, policymakers, and healthcare drivers, will foster a quality culture and drive positive change. By reinforcing the importance of quality control, implementing global best practices, and fostering partnerships with international counterparts, the Indian pharma industry will solidify its position as a global leader in delivering safe, effective, and reliable healthcare solutions.
(The author was a former Senior. Consultant – Health with NITI Aayog and currently working as Advisor- Public Health Administration National Health Systems Resource Centre- MoHFW, GOI. Views expressed are personal and do not reflect the official position or policy of the FinancialExpress.com.)