Food Safety & Standards Authority of India (FSSAI) has issued various advisories from time to time. Amongst these was an advisory of May 11, 2013, which provided guidelines and procedure to obtain ‘Product Approval’ for all food products whose standards were not specified under the Act (‘proprietary foods’).
The Bombay High Court on August 1, 2014, ruled that the Advisory on product approval “did not have force of law” and was beyond its powers as provided by the Food Safety & Standards Act, 2006. FSSAI challenged this order before the Supreme Court. The apex court held that the Bombay High Court was correct and its decision did not require any interference.
The industry was deeply concerned with the Product Approval mechanism inasmuch as, amongst others, it was a multi-layered time-consuming process, lacked transparency and stalled innovation. The product approval is a mechanism that does not exist even in any developed country.
Post the Supreme Court decision, there could be possible implications on proprietary foods in India. Will it be correct to say that FSSAI has been rendered toothless by the apex court? The answer is negative. The Act provides clear and sufficient powers to FSSAI to regulate the safety of food in India.
Powers to FSSAI under the Act
○ Licensing or registration of food business operators (FBOs)
○ Prescribe limits for food additives, crop contaminants, pesticide residue, heavy metals and so on
○ Search, inspect, collect, collate, analyse and examine the safety of the samples of any food product being sold to the consumers
○ Frame Regulations with respect to proprietary foods and its standards
○ Issue improvement notices where food does not comply with the provisions of licence or a particular licence
○ Prohibit a food article or a process or premises or equipment, which carried a health risk
○ Pass emergency prohibition orders for any food which carries a health risk
○ Launch prosecution against FBOs for not complying with the provisions of the Act
While the Act provides powers to FSSAI, it also casts simultaneous self-regulatory obligations on the FBOs as well. Some of these self-regulatory obligations are Not to commence operations without licence or registration; Comply with the labelling requirements for all food articles, including proprietary food and neutraceuticals; Comply with the Regulations with respect to the particular food article; Not to make misleading claims about the food articles; and Ensure additives are within the permissible limits provided under the Act and Regulations.
Partnership between industry and FSSAI
The essence of the Act contemplates continued partnership between the industry (comprising various food manufacturers) and FSSAI. Hence, it is very important that FSSAI and FBOs work in tandem to properly implement the intention behind the Act. These provisions are similar to the provisions of various food laws in developed nations, where the regulators effectively ensure the safety and quality of food by working in partnership with the industry and by regular surveillance. The concept of a cumbersome mechanism like Product Approval is completely alien to these nations.
Being a responsible association of various conscientious manufacturers throughout India, IDMA and its members are open to work closely with FSSAI to ensure better implementation of the provisions of the Act.
Following the judgement of Supreme Court, IDMA (Indian Drug Manufacturers’ Association) looks forward to meet the health minister and health secretary for co-operation and way forward to create harmony and also to request to include 2-3 members of IDMA in the stakeholders’ representation meetings to work on policies and regulations which shall enable to strike a balance keeping the interest of all stakeholders of the sector, interest and safety of consumers and meeting the objectives of regulators.
Interaction with chairperson
Before the week of judgement, IDMA representatives along with chairman Dr R K Sanghavi and myself, VC of Nutraceutical & Health Supplements Committee, also met Ashish Bahuguna who recently took charge as chairperson at FSSAI. He had a very transparent and healthy long interaction with IDMA representatives and expressed his interest to uplift the entire system of FSSAI and bring harmony between the industry and regulator by striking the balance without compromising public interest and safety.
IDMA, during its meeting with the chairperson, updated him about its earlier meetings with the ministry and its very last meeting about 8-10 weeks back with health secretary Bhanu Pratap Sharma who had promised to bring the FSSR 2015 pending since 2011 (draft regulations on nutraceuticals, nutritionals, functional foods, novel foods and health food supplements) for stakeholders’ comments and after seeking such comments to deliberate through internal evaluation in legislative manner and process and then take to Parliament at the earliest. The health secretary during such a meeting mentioned that his objective was to keep the balance interest, which would enable cut down the interface with the authority by bringing such dynamic regulations and create self-regulation infrastructure in the country and in tandem with global practices.
Meanwhile, being the common associate, I am trying my best to deliberate discussions with various associations and trade bodies’ leaders to bring common voice and meet objectives of all the stakeholders without compromising the affairs of public interest and safety, which he believes is equal responsibilities and accountabilities. This process of meeting various association leaders will be completed over two weeks and meeting various scientists, experts and technical stalwarts to bring in the wisdom, which will enable to arrest the instability of the industry.
Growth and innovation
IDMA and the industry are very hopeful that the government, health ministry and the new chairperson under leadership of PM Narendra Modi will set the momentum of growth and innovation in the healthcare & food industry and who would uplift the trust and transparency between the stakeholders and regulator without compromising on public interest and safety and accomplishing the objectives of Make In India, which will shine on the global map.
Meanwhile, IDMA experts are working on mega nutraceuticals and health/food supplements conference which are long pending and shall be announced soon and may take place in September and are keen to invite the health minister, health secretary, chairperson of FSSAI Ashish Bahuguna, special chief guest, scientists and technical experts from leading institutes and research centres, industry experts, trade leaders, industry CEOs and most importantly, all its members and various stakeholders.
