“The pharma sector has clear cut acts protecting data for the companies. There is no such regulatory framework for Indian companies,” Ganguly said at the Functional Food and Beverages India strategic conference in Mumbai on July 26-27.
Coke concerns
Sunil Adsule, director for scientific and regulatory affairs (India and Southwest Asia) for Coca Cola, agreed, pointing out a new functional product Coca-Cola was launching in India, where the company was very concerned about the product approval process.
“We did raise our concerns to the Food Safety and Standards Authority of India [FSSAI]. The product approval form literally asked us to list the formulation on paper and submit it to them,” he said.
Adding that the FSSAI gave no explanation as to how they would go about protecting their data, Adsule said that the company still “submitted the formulation as per the form in good faith.”
Adsule said the company did as much as it could to protect its IP within the process. “We submitted a legal document to the FSSAI, which said that all the information in that document was only for the purposes of evaluation and not for sharing with any other party.”
Safeguards
Anantha Narayana, former head of herbal research at FMCG major Hindustan Unilever, waded into the debate and said that there are some safeguards to the approval process outside protection via acts.
“In the product approval forms, you can mark that the documents and their contents are confidential. As I understand, the FSSAI is bound by its legal charter to not share your information with any other person,” he said.
Narayana said their legal status as food safety regulators means they are legally bound not to share such information, even if petitioned under India’s much lauded Right to Information Act.
Nestlé's Ganguly said that if the functional food sector wants to replicate the million dollar investments that have resulted in many successful innovations in the pharma sector, a more protective regulatory mechanism was needed.
“Companies make claims based on the effect of nutrients the product contains. If the nutrients are available to others, how will the company that invested in developing the product maintain exclusivity on the claim?”
Dr Sanjeev Ganguly, medical director for South Asia at Nestlé India said that one of the key challenges for the sector is that there are no clear cut data protection acts governing functional foods and beverages in India.
