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Establishing Best Practices in the Changing World of New Age Pharma

Pharmaceutical industry is one of the largest in the world, with global pharmaceutical market size being an estimated USD 1.4 trillion. With changing dynamics in the world health scenario, 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 USD 55 billion by 2020, Indian pharmaceutical industry is one of the leaders amongst developing countries. Its export to the world in 2017-2018 is estimated to be USD 17.27 billion, and is expected to grow by CAGR 22.4 percent between 2015 and 2020.

Furthermore, presently the Indian pharma sector meets over 50 percent global demands for various vaccines and is the largest generic drugs producer in the world. The global industry is looking towards a shift in focus towards emerging markets, which have a growing role in the pharmaceutical industry. However, with the business and drugs  manufacturing focus shifting towards developing countries, the need to  keep up with quality standards and latest innovations is making industries to redefine best practices in the changing the world of new age pharma.

Increasing focus on quality standards and best practices

With the shift of global pharma towards India, there also are high expectations from Indian manufacturers to adhere to the quality standards and best practices and to keep updated with the evolving trends and new benchmarks. Any perceived or valid nervousness regarding quality standards led to significant measures being initiated which along with other factors resulted in export figures dropping from USD 6488 million in 2015 to USD 2082 million in 2016.

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

Setting the objectives right

To become a leader in 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. Not only will it set the basic benchmark of manufacturing quality within India benefiting Indian consumers, but also it will add to the credibility and international standing of the country as well as open doors for stronger business ties. It needs to be noted here that even countries like Turkey, Iran, South Africa, Ukraine, Romania, Malaysia, Korea, and Indonesia are all PIC/S members while India is not.

Establishing best practices: The need of the time

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, which saw its last amendment years ago, needs to be revised and a more comprehensive act needs to be passed by the government with the larger vision in mind of boosting Indian manufacturing to international standards as a whole. Fortunately, the government is not sitting idle.  The Drugs and Cosmetics (Amendment Bill) 2017 is being drafted and up for discussion in the parliament. It would be fruitful if the bill is drafted keeping in view the International standards that other countries need India to maintain.

Getting the basics right: To begin with, the industry as 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, while emergency system too should be periodically tested to support the operations in case of a major glitch. Focusing on employing skilled staff and investing on their training and growth are important aspects that need due attention. Establishing processes that drive results at par with international standards and regular process reviews is another focus area. Good distribution practices in purchasing, storage, transportation, repackaging and labeling, and documentation and record keeping are needed for efficient supply chain matrix.

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

  • Knowledge and data management. This includes transfer of knowledge across processes and across 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 bench marking 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, and so on
  • Ensuring data integrity. Data integrity primarily is concerned with completeness, accuracy, and consistency of data in its lifecycle and it need to be attributable, legible, contemporaneously recorded, original in nature. Ensuring data integrity is not only important to be in compliance with CGMP, but also is vital in the world of big data to ensure recoverability and searchability, traceability and connectivity. Ensuring data integration also increases the stability and performance of your systems. In light of increasing CGMP violations involving data integrity, this burning issue needs utmost attention
  • Plant hygiene: This is again one of the core quality aspects for any drugs manufacturer. Plant hygiene is of supreme importance because any negligence or leniency compromises the purity of products. Therefore, sources of contamination in any aspects of manufacturing, including personnel, premises, equipment and apparatus, production materials and containers, and products for cleaning and disinfection need to be identified and eliminated through an integrated sanitation program.

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 specially while catering to global markets.

India indeed has a golden opportunity to dominate the global pharma industry first by establishing the best practices and then by upgrading to international standards. The process indeed 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 Author is Sanjeev Gupta, Managing Director, Kusum Group of Companies. – Medical Buyer Bureau

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