Turning to India for Dietary Supplement Innovation

For a long time, the categories natural products, dietary supplements, or herbal products were considered synonymous to “SAFE”. However, in the past few years, increasing awareness and the market competition has made end users challenge this safety.

Be it regulators, investors or the end consumers, everyone requests reliable data, i.e. credible research to justify the claims that back the product. Manufacturers are now not only trying to establish themselves in this crowded market but are also focusing on providing “that special touch” to their products.

When the word “innovative” was used, emphasis was laid not only on cost effective, but other factors as well.  Quality and timelines topped the list. In scenarios like these, “Clinically Proven” claims are attracting the attention on most labels.

The top companies in the healthcare industry also agree that they can no longer rely on just having a good marketing strategy. A bridge has to be developed between innovative research and effective marketing. This in turn can make a company’s marketing much stronger and effective.

Clinical Research - The Revenue Generating Innovative Step

Right from development, to commercialization, clinical research is an arduous, time-consuming and a highly regulated process. The expertise required at every step right from protocol writing and project management, to data management, statistics and the regulations are so crucial that most manufacturers resort to and completely rely on outsourcing. Just as big as the word looks, Clinical Research consists of combinations of elements such as e confidentiality, reliability and moving up to productivity. When choosing an outsourcing partner, the sponsors have to carefully weigh their pros and cons. This is especially true in the case of natural products and the dietary supplement industry.

The news headlines and the recent paradigm shift in the approach of the FDA and the FTC toward non-substantiated claims has shaken up the roots of the dietary supplement industry. The promise of the FTC to prevent fraudulent, deceptive and unfair business practices has made them take some stringent steps. In scenarios like these, not only are the millions of dollars for research going down the drain, but the manufacturers end up in a pickle when the FTC calms them down with little or no authentic data to substantiate these claims.

In atrocious cases such as that of the dietary supplement, Seasilver, where claims were made that it is clinically proven to treat and cure approximately 650 diseases, the U.S. Court of Appeals ordered the defendants to pay a hefty almost $120 million in fines (Decision available from the FTC Web site).

Another product where the FDA intervened was for the marketers of the 7-day Miracle Cleanse Program in which one of the defendants appeared as the “Health Man” in nationally televised infomercials. Claims such as people using the product were cured of skin and breast cancer within weeks without treatment or surgery were blatantly made. Other claims including “Clinically Proven” for other diseases made this scenario even worse. Eventually, a penalty of almost $15 million was levied, which was later suspended due to the defendant’s inability to pay. However, the ban from any type of infomercials remained applicable.

Questions were raised by the industry such as, if there is so much legitimacy about these regulations then what makes it difficult for manufacturers to generate the required data? Is it the lack of awareness? Is the nonchalant attitude? Or are there budgetary restrictions involved?

Evidence has clearly stated that the research carried out by local hospitals or universities cannot suffice the need of the hour. Regulators always demand authentic research that has involved quality research from step one. The quality level required is very much in par with the well established and trusted pharmaceutical quality. When it comes to the most trusted guidelines in this sector, International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) standards definitely top the list.

Universities and hospitals have a well-qualified staff: however the lack of training and the expertise for the stringent regulations remains a matter of concern. A lot of money is invested in research carried out in these institutions, but the level of the research is now being challenged. The tests can be called as human research, but the tag of “clinically proven” will always be tough to achieve on the labels. 


ICH-GCP guidelines are well defined and precise. However, the amount of documentation at every level ends up making it an expensive process. The  man hours required for training, documentation, quality control and other detailed processes is what makes it expensive. The initial investments look so high that companies find it difficult to analyze their risk-benefit ratio.

Costs for Clinical Trials are Sky High – Fact or Hype?

With the ever increasing competition and the huge number of players in the nutraceutical industry, one can find an effective solution easily. All we need is to define the problem well. The market has a good range to offer in terms of small to big-size CROs. The range is not just in terms of quality, but it also covers costs. If the search is made in the right direction, budget suiting clinical trials with complete regulations are achievable.

Searching in the Right Direction

India, the land of diversities has emerged in leaps and bounds over the last few decades. It has emerged as the attractive destination for clinical trials because of its genetically diverse population of over one billion people. This population has not been exposed to an array of medicines, although they do have myriad diseases that make India an ultimate choice for originating scientific investigations.

The number of English speaking qualified and well-trained investigators for ICH-GCP, differentiates the good from the bad. Furthermore, the highly developed IT and data collection capability that has no language barrier, has made India the ideal choice for outsourcing.The inexpensive labor and low infrastructure cost of conducting trials in India has proven to reduce total trial costs by as much as 60% as compared to the local universities and CROs in USA.

The past few years, have brought about a definitive transformation in India’s regulatory system after the Government of India upgraded Schedule Y of the Drugs and Cosmetics Act of India, in 2005. This is the equivalent of the sections of the Code of Federal regulations applicable to the FDA, thus comparing it closely with U.S. and ICH standards.  These modifications eased a number of regulatory barriers to performing clinical trials in India. 


The following are a few examples:

• Formalized the definition and conduct of clinical trials
• Specified the responsibilities of the sponsor, the investigators, and the Ethics Committees
• Developed guidelines and procedures for importing products for clinical trials
• Instituted required compliance with GCP
• Specified the requirements for informed consent
• Defined the structure, content and formats of clinical study reports
• Increased protection for intellectual property
  
  

This new direction also resulted in formation of many training centers and certification courses dedicated to clinical research. India began contributing immensely in providing qualified and trained human resources for clinical research.

The number of professionals being trained annually for project management, data management, statistics, and medical writing, is contributing to the high quality of work that India now provides. These professionals possess the experience necessary for innovative study design that makes a huge contribution to cost cutting and patient recruitment strategies to avoid bottle necks in recruitment. Such experience contributes to the timely completion of the trials.

It was estimated that in 2005, only 1% of global clinical trials were conducted in India. The contribution in 2009 is estimated at 3% and is rapidly growing. To meet this demand, India has a substantial capacity consisting of about 300 universities, 162 medical colleges, over 5,000 hospitals with more than 870,000 hospital beds, 700,000 medical professionals and over 500,000 doctors. With this pool medical experts, India is set to accept the status of being the “Hub for Clinical Trials.”

Companies that are investing millions of dollars in research trials need to reduce costs and the time it takes to complete research, thus bringing ingredients and products to market faster.  To bridge this gap, India is ready to be the strategic destination to improve quality of research as well as quality of life.

Ms. Mansi Ahuja is a Business Development Manager with Vedic Lifesciences in Mumbai, India. The company is Clinical and Pre-Clinical contract research organization having conducted the largest amount of studies in Nutraceutical and Dietary Supplements. She may be contacted at +91-(0)22-42172300-10 or by email at vedic@vediclifesciences.com