Nutraceuticals are gaining acceptance due to their ability to address several diseases, however, several questions pertaining to their regulatory framework remain unanswered. It was this aspect that the 4th International Conference on Nutraceuticals, which was held here on Tuesday, considered prominently.
Organised by the Federation of Indian Chambers of Commerce & Industry (FICCI) and Health, Foods and Dietary Supplements Association (HADSA), the conference was scheduled to be inaugurated by Satej Patil, minister of state, food and drug administration, however, since he was unable to attend, it was thrown open by Mahesh Zagade, commissioner, FDA, Maharashtra.
The event began with welcome address by Piya Singh, director, FICCI, followed by Zagade’s address. He highlighted how nutraceuticals were at a transitional phase, “Citizens understand drug or food, nutraceuticals are still at nascent stage and beyond common man’s understanding.”
He hoped, the conference would, “Go a long way in raising such issues which address regulations at state and national levels.” He added, “The entire globe should be a market for nutraceuticals and not India alone.”
He urged the audience to, “Come forward with complaints, if any. The government body would provide them with assistance. Maharashtra is open to new ventures but people should be willing to come forward and make suggestions or lodge complaints, which nobody does.”
The session began with Dr Vaibhav Kulkarni, head, regulatory affairs, Abbott Nutrition Technologies Ltd, giving an insight into the perspective of regulations. He spoke about a law soon to be implemented by the FSSAI regarding product approval.
“Prior to this law no product approval was required to a food that’s not standardised under any regulation. They just needed to adhere to the list. But post-implementation, product approval for new ingredients would be mandatory,” he pointed out.
He added that all proprietary foods would have to go through the approval process. “This created chaos in the industry since products existing for 15-20 years would also be required to get an approval.”
He informed that at present there were 7,000 applications pending for approval, after much delay FSSAI gave February 2013 as the period when they would get licence. He made a suggestion as to how FSSAI needed to come out with a list of additives which were safe and could be used in goods making it simpler for companies, manufacturers to make products.
He said, “Product approval should not be necessary if it contained ingredients previously used and additives that were permitted.”
The next speaker was Dr Gert Krabichler, head, global regulatory affairs, global R&D / department, Merck Consumer Healthcare Holding GmbH. He spoke about the EU regulations regarding product approval. He informed about health claims and explained the regulation process as far as EU was concerned.
Continuing on same grounds, next speaker Prabodh Halde, head, technical regulatory Affairs, Marico, spoke about Nutraceuticals laws by FSSAI. He said, “People want to manufacture drug by obtaining the label of nutraceutical.”
He said that the distance between drug and food was narrowing. Due to this, clarification on regulations was required. He also informed that every manufacturer would require an NOC to make product. “If there is an additive that’s not approved in India, they can prove that it’s safely used elsewhere and gain the NOC. For manufacturers who are adding new additives altogether would have to first go through an approval by the scientific panel that would assess the risk and analyse the additive which could take months,” he observed.
Other prominent speakers included Rajnit Puranik, CEO, Shree Dhootapapeshwar Ltd, who spoke about ‘What the industries need from the regulatory authorities.’ According to him, licensing authorities do not apply Ayush syntax while giving a licence. He said, “We need the authorities to have a better understanding of Ayush, traditional medicine and for what it stands. Regulation laws put for implementation lead to senseless litigation.” Munesh Khanna, senior partner, Grant Thornton; and Baidyanath Mishra, head, regulatory affairs, Natural Remedies Pvt. Ltd; also participated.
It was this aspect that the 4th International Conference on Nutraceuticals, which was held here on Tuesday, considered prominently.
Organised by the Federation of Indian Chambers of Commerce & Industry (FICCI) and Health, Foods and Dietary Supplements Association (HADSA), the conference was scheduled to be inaugurated by Satej Patil, minister of state, food and drug administration, however, since he was unable to attend, it was thrown open by Mahesh Zagade, commissioner, FDA, Maharashtra.
The event began with welcome address by Piya Singh, director, FICCI, followed by Zagade’s address. He highlighted how nutraceuticals were at a transitional phase, “Citizens understand drug or food, nutraceuticals are still at nascent stage and beyond common man’s understanding.”
He hoped, the conference would, “Go a long way in raising such issues which address regulations at state and national levels.” He added, “The entire globe should be a market for nutraceuticals and not India alone.”
He urged the audience to, “Come forward with complaints, if any. The government body would provide them with assistance. Maharashtra is open to new ventures but people should be willing to come forward and make suggestions or lodge complaints, which nobody does.”
The session began with Dr Vaibhav Kulkarni, head, regulatory affairs, Abbott Nutrition Technologies Ltd, giving an insight into the perspective of regulations. He spoke about a law soon to be implemented by the FSSAI regarding product approval.
“Prior to this law no product approval was required to a food that’s not standardised under any regulation. They just needed to adhere to the list. But post-implementation, product approval for new ingredients would be mandatory,” he pointed out.
He added that all proprietary foods would have to go through the approval process. “This created chaos in the industry since products existing for 15-20 years would also be required to get an approval.”
He informed that at present there were 7,000 applications pending for approval, after much delay FSSAI gave February 2013 as the period when they would get licence. He made a suggestion as to how FSSAI needed to come out with a list of additives which were safe and could be used in goods making it simpler for companies, manufacturers to make products.
He said, “Product approval should not be necessary if it contained ingredients previously used and additives that were permitted.”
The next speaker was Dr Gert Krabichler, head, global regulatory affairs, global R&D / department, Merck Consumer Healthcare Holding GmbH. He spoke about the EU regulations regarding product approval. He informed about health claims and explained the regulation process as far as EU was concerned.
Continuing on same grounds, next speaker Prabodh Halde, head, technical regulatory Affairs, Marico, spoke about Nutraceuticals laws by FSSAI. He said, “People want to manufacture drug by obtaining the label of nutraceutical.”
He said that the distance between drug and food was narrowing. Due to this, clarification on regulations was required. He also informed that every manufacturer would require an NOC to make product. “If there is an additive that’s not approved in India, they can prove that it’s safely used elsewhere and gain the NOC. For manufacturers who are adding new additives altogether would have to first go through an approval by the scientific panel that would assess the risk and analyse the additive which could take months,” he observed.
Other prominent speakers included Rajnit Puranik, CEO, Shree Dhootapapeshwar Ltd, who spoke about ‘What the industries need from the regulatory authorities.’ According to him, licensing authorities do not apply Ayush syntax while giving a licence. He said, “We need the authorities to have a better understanding of Ayush, traditional medicine and for what it stands. Regulation laws put for implementation lead to senseless litigation.” Munesh Khanna, senior partner, Grant Thornton; and Baidyanath Mishra, head, regulatory affairs, Natural Remedies Pvt. Ltd; also participated.
