Emerging markets: comparing India and China as the future R&D hubs for the pharmaceutical industry
pharmafile | November 16, 2011 | Feature | Research and Development |
The pharmaceutical industry is expanding worldwide. For the last few years, the emerging markets that offer the dynamics of growth in research and development and marketing are Brazil, Russia, India, China, Africa and the Middle East. However, the markets in China and India have registered high growth rates in terms of sales and marketing, though the growth rates in other Asian markets such as Singapore, South Korea, Taiwan, Malaysia, Thailand and Indonesia are equally impressive. Both India and China have been compared head-to-head as the future research and development hubs for the pharmaceutical industry.
The key drivers for India and China to hold the most opportunity for the pharmaceutical industry are low costs, qualified staff and extensive production and research units. Drivers of growth are the growing population in India and China, as well as the larger number of people with markedly higher demand for medicines. With economic growth and liberalization across all the sectors, there is a considerable increase in middle-class households with surplus money at their disposal leading to improved health consciousness that contributes significantly to the growth of the pharmaceutical industry.
Both India and China have come a long way with regards to streamlining their regulatory environments including the implementation of the New Patent Law in India in 2005. Indian pharmaceutical companies are now refocusing on in-house new drug development, contract research and manufacturing services (CRAMS) for western drug makers. In the drug development spheres, India has implemented Good Clinical Practices (GCP) by amending the Schedule Y of the Drugs and Cosmetics Act in line with ICH GCP and is recently in the process of implementing guidance documents to specify the general requirements for approval of clinical trial under different categories of New Drugs viz. Investigational New Drugs, New drugs substances, additional strength, additional indication, modified release form etc. Indian regulatory authorities are in constant touch with USFDA and Canadian FDA authorities to improve the Indian standards and have undertaken several initiatives including strengthening the inspection mechanism.
China’s regulatory authority, State of Drug and Food Administration (SFDA), has also seen many positive changes in their regulatory mechanism. China has initiated improvement in their GCP, GLP, and GMP which have reached a similar level of standards as those in the ICH environment. In spite of these changes, challenges still exist due to a complicated regulatory approval process and longer approval timelines. Language is a barrier in the conduct of international standard clinical trials. Standard of care or medical practice due to racial variation may necessitate proper attention in protocol design, which may be slightly different than the western Caucasian world. In order to improve the quality of research, the SFDA has put in place a qualification process for the investigator sites thus limiting the qualified investigators and increasing competition for patients and site resources.
The pharmaceutical industry in India is highly recognized globally for its success in the generics business. The pharma industry in India has set new heights in the fields of production, development, manufacturing and research due to low cost manufacturing facilities, educated and skilled manpower and cost effective labor force among others. The domestic pharma market is likely to reach US$20 billion by 2015.
China has a well-established leadership in providing other biopharmas with basic intermediaries, APIs and bulk drugs. It is acknowledged as a low-price leader, even when compared to other emerging countries. Media reports estimated that China’s pharmaceutical market was $40 billion in 2010 and projected to grow up to $93 billion by 2015 which will be 9% of the global pharmaceutical market.
While looking for outsourcing destinations, many pharmaceutical companies focused on the emerging countries such as India and China due to huge population, disease spread, improved regulatory mechanisms and availability of qualified resources. India and China offer significant cost effectiveness due to easy fast patient recruitment which is supported by the huge patient pool not exposed to any or many medications. The cost for trial related tests and procedures are comparatively cheaper than in the USA or Europe. The per patient cost, i.e. the investigator fees, are less due to comparatively low cost of living and base salary.
India and China present challenges for the pharmaceutical industry in working with subjects with illiteracy, poverty and cultural phenomenon. There is always a conflict of ethics vis-Ã -vis natural justice while recruiting above subjects to meet the recruitment target. The administration of consent process is a challenge and that necessitates a specific skill. More training for the investigators is needed, especially when administering for placebo controlled trials. India, being a vast country with multiple languages, translation and validations for patient information, consent documents and quality of life questionnaires are issues. China offers further larger magnitude as almost all documents for clinical trials / labels for the marketing of products should be translated in local languages. Pharmaceutical industry gives special attention while dealing with special populations with racial or genetic differentiators than the normal Caucasian population.
Creating public awareness is key for the growth of the pharmaceutical industry in emerging markets. It is a joint responsibility of the pharmaceutical and contract research companies, regulators, and national and international bodies to jointly spread awareness amongst the public. The media in the emerging markets like India and China are very active and should play a constructive role in a sensitive market.
By: Umakanta Sahoo, MBA, PhD – executive director, Asia-Pacific, Chiltern
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