Best practices for new age pharma

The pharmaceutical industry is one of the largest in the world, with global pharmaceutical market size being an estimated $1.4 trillion. With changing dynamics in the world health scenario, the pharmaceutical industry is constantly evolving to address the market challenges, countering pricing and reimbursement barriers, embracing newer technologies and strengthening focus on research and development.

With an estimated market size growth of $55 billion by 2020, the Indian pharmaceutical industry is one of the leaders among developing countries. However, as the focus of business and drugs manufacturing are shifting towards developing countries, the industry is redefining best practices to keep up with quality standards and latest innovations.

Any perceived or valid nervousness regarding quality standards lead to significant measures being initiated which along with other factors resulted in export figures dropping from $6488 million in 2015 to $2082 million in 2016.

Non-adherence to basic international guidelines invites further scrutiny. Till last year, the US Food and Drug Administration (FDA) had sent 42 warning letters to its global drug manufacturers. Nine of those letters were directed at Indian facilities. In light of repeated concerns, USFDA inspection in India has increased by over 20%. Contrarily, India has done significantly well in the developing countries including CIS (Russian Commonwealth) nations, Latin American nations and African countries, who have favoured India for importing pharma products, keeping immediate competitor, China, fairly behind.

To become a leader in the pharmaceutical industry, India needs to have its objectives right. It is increasingly becoming important for countries to be Pharmaceutical Inspection Co-operation Scheme (PIC/S) compliant and Good Manufacturing Practice (GMP) certified. It will set the basic benchmark for manufacturing quality, benefitting Indian consumers, and add to the credibility and international standing. There are some measures that need to be implemented at a policy level and some at the industry level.

Relooking at the law: The Drugs and Cosmetics Act 1940 needs to be revised with a larger vision in mind of boosting Indian manufacturing to international standards. Fortunately, the Drugs and Cosmetics (Amendment Bill) 2017 is being drafted. It would be fruitful if international standards that other countries need India to maintain are kept under consideration.

Getting the basics right: To begin with, the industry as a whole needs to get its basics of manufacturing, packaging, distribution, research and development, pharmacovigilance, testing, documentation, licensing, various certifications and approvals right. Equipment and technology used should be correctly calibrated and reviewed. Focusing on employing skilled staff and investing in their training and growth are important aspects that need due attention.

Upgrading to better standards: Any pharmaceutical enterprise should gradually think of upgrading its verticals to improve operational management, lower the risk, and better product quality. Upgrading the following verticals would be of further help:

• Knowledge and data management: This includes transfer of knowledge across processes and life-cycles. Staff training in documenting and sharing of information as per need is much required. Metrics and performance analysis form a key part in identifying gap areas and avert potential threats.

• Benchmarking: Upgrading to higher standards of benchmarking various verticals is another way to upgrade the overall output capacity and quality. It includes setting the right benchmarks for various aspects such as process performance, quality, supply chain reliability etc.

• Ensuring data integrity: This primarily concerns with completeness, accuracy, and consistency of data in its lifecycle and it needs to be attributable, legible, contemporaneously recorded and original in nature. Ensuring data integrity is not only important to be in compliance with CGMP, but is also vital in the world of big data to ensure recoverability and searchability, traceability and connectivity.

• Plant hygiene: This is of supreme importance because any negligence or leniency compromises the purity of products.

Keep a check on legal and regulatory developments: Needless to say, it is important to be on the right side of the law, with all due compliance, certifications, paperwork, etc in place. One also needs to understand the law of the land, especially while catering to global markets.

India indeed has a golden opportunity to dominate the global pharma industry, first by establishing best practices and then by upgrading to international standards. The process will take time, but government and non-government stakeholders need to come together to pace the process further with maximum possible consensus between all parties.

(The writer is Managing Director, Kusum Group of Companies)