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| (L-R) Dr RK Sanghavi, Chairman, Nutraceutical Subcommittee, IDMA; S Veeramana, President, IDMA; Ganesh Kamath, Director, Vital Neutraciticals; Daara Patel, Secretary General, IDMA; Sandeep Gupta, Vice Chairman, Neutraceutical Subcommittee, IDMA; Dheeraj Nair, Legal Expert |
Indian Drug Manufacturers’ Association (IDMA) recently called a press meet to discuss the implications of the June 30 Mumbai High Court judgement which quashed an advisory issued last May by the Food Safety and Standards Authority (FSSAI) for prior product approvals (PA) of dietary food and health supplements already licensed and existing in the market under the erstwhile Food Adulteration Act.
Giving more details, Dr RK Sanghavi, Chairman, Nutraceutical Subcommittee and SV Veeramani, President, IDMA explained that the June 30 judgement ruled that the May 11, 2013 advisory ‘has no force of law and is not within the ambit and scope of the power conferred on FSSAI under the provisions of the FSS Act, the Rules and the Regulations framed thereunder.’
The discontinuing of the PA system allows unhindered manufacturing of nutraceuticals, with hopes that the sector achieves a CAGR of 18 per cent.
Daara B Patel, Secretary General, IDMA informed the gathering that IDMA had explored all the alternative possibilities to resolve the issue and support the manufacturers. However, nothing seemed to have worked and even getting appointments to meet the authorities and explain the problems in greater details was difficult. IDMA and some of its aggrieved and affected members ultimately decided to file a suit in the Bombay High Court.
Nutraceuticals have gained importance as the focus has shifted from replenishing nutrients to fight deficiency diseases to the current trend to combat to use dietary food and health supplements to check proliferation of chronic diseases against which there is limited or nil options in modern systems of medicine. Some examples include the use of nutraceuticals like glucosamine and collagen for joints, omega-3 for heart, diabetes, coenzyme Q10 for heart.
This trend gave a boost to the nutraceutical sector in India in the early 1990s but this scenario changed when the Food Safety Standards Act of 2006 was implemented which required each product (even those already being consumed) to apply to the central licensing authority for approval.
This system was contrary to global regulations for this class of products, and besides the approval was subject to bias in view of no established guidelines set to objectively assess the nutraceuticals. As a result, there were large-scale rejections of products, including those already being consumed.
This move drew protests from manufacturers of dietary food and health supplements. According to a report by the Confederation of All India Traders (CAIT), “…the enforcement of this Act in the present form, it will lead to the closure of over 17 lakh Indian food industries and will force unemployment on over 20 million people.”
The FSSAI claimed that the PA system was introduced for the safety of consumers; however, sources at IDMA point out that there is no such requirement for the same category of products in most regulated markets such as US. Any new ingredient included for the first time in a product in the country, and not mentioned in Codex needs to undergo ‘ingredient approval’. Hence, the FSS Act has already provided a mechanism to ensure safe consumption of products.
Manufacturers of nutraceutical products and IDMA personnel met the relevant FSSAI officials to explain the flaws in the PA system and emphasise upon focusing on the ‘ingredient approval’ system but in vain. As a logical outcome Vital Neutraceutical, one such affected company, and IDMA approached the Mumbai High Court, vide writ petition 2746 of 2013, for seeking relief and deliverance which resulted in the judgement of June 30 which vindicates their stance.
Speakers at the meet clarified that this judgement meant that product-wise approval for proprietary food (nutraceuticals) was never required and now cannot be demanded or enforced. The judgement is applicable for not only the existing ones but all such manufacturers.
EP News Bureau – Mumbai
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