Dec 14, 2019
Food or drug? Government to take a call soon
NEW DELHI: Is a multivitamin preparation a drug or just plain old food? And what about pick-me-ups like Revital or supplements like Ferradol? Given the confusing proliferation of products, the government is looking to arrive at an answer by changing the regulatory framework.
It appears the solution will be broadly along these lines: If the ingredients of a particular product are below that determined as the daily dosage, or 1RDA (Recommended Dietary Allowance), then it will be deemed ‘food’ and regulated by the Food Safety and Standards Act (FSSA), according to people with knowledge of the matter and documents that ET has seen. Anything above that will be a ‘drug’ and regulated under the Drugs and Cosmetics (D&C) Act. 1RDA is defined as the level of nutrients to be consumed daily to meet all the requirements of a healthy individual. At a recent meeting between the Drug Controller General of India (DCGI) and the FSSAI, which administers the FSSA, it was decided that multivitamin preparations containing vitamins in a strength lower than 1RDA would be excluded from the D&C Act. The Act will be amended so that vitamins and minerals below 1RDA for prophylactic purpose are deleted from Schedule V.
“Prophylactic levels of vitamins and minerals equal to or less than 1 RDA as specified by ICMR, may be regulated under FSSA and its rules,” FSSAI told the DCGI in a November 21letter, asking it to make the necessary amendments in the D&C Act.
Most companies prefer to position their products as health supplements under the FSSA to avoid the more onerous D&C Act regime, which could also invite price controls. The ambiguity stems from multivitamin preparations being covered by both the D&C Act and by the FSSA. Taking advantage of this overlap, companies had started seeking approval of the Food Safety and Standards Authority of India (FSSAI) to circumvent price controls and tighter regulation. “There is an apparent regulatory overlap of FSSA and D&C Act since multivitamin composition of certain products are, in fact, used for both prevention of diseases as well as providing health benefits,” said a senior government official on condition of anonymity.
For example, Abbott’s product Limcee Plus, which was approved by FSSAI in January 2018 in the health supplement category, costs Rs 60 for a strip of 15 tablets. On the other hand, its chewable vitamin tablet Limcee, on the national list of essential medicines since 2013, costs Rs 14 for a strip of 15 tablets. The company says Limcee Plus contains amino acids and thus doesn’t just target patients who suffer from vitamin C deficiency.
The DCGI and FSSAI had earlier this year approached the Indian Council of Medical Research (ICMR) to review prophylactic doses mentioned under Schedule V and Schedule K of the D&C Act vis-a-vis the doses prescribed under the FSSA with an intent to avoid confusion.
VACB finds Food Safety staff-hoteliers nexus
Officers reluctant to register complaints, violations never reach trial stage
The Vigilance and Anti-Corruption Bureau (VACB) on Friday said endemic corruption in the Food Safety wing had brought the State to the brink of a public health crisis.
The agency, which conducted a surprise inspection of Food Safety offices in the State, said that inspectors accepted bribes and rarely sent food samples collected from outlets for chemical examination. They appeared reluctant to register complaints from the public or record them in registers and give acknowledgement receipts to petitioners. Citizens who sought information on action taken on their appeals were turned away harshly.
Director General, VACB, Anil Kanth had ordered the inspections code-named Operation Jeevan after a family was laid low recently consuming stale food from a popular latenight eatery here.
Investigators said that Food Safety inspectors routinely buried damning food safety analysis reports to save favoured hoteliers in exchange of sizeable backhander payments.
In many cases, food safety officials did little to remove banned food products from supermarket shelves.
The agency said corrupt officials ensured that food safety violation never reached the trial stage. They saved the accused by letting them off with minor fines.
Records fudged
Food safety officials who detected persons responsible for food contamination rarely prosecuted them. They fudged records and accepted bribes to protect the offenders.
In many cases, officials laid down a smokescreen by conducting make-believe inspections at predictable places and timings.
They often saved violators by insulating them from criminal prosecution and restored the food permits secretly days after they annulled them publicly.
In Varkala, the VACB found that inspectors had only sent eight out of the 101 stale food samples seized from various outlets for food safety tests.
The office had taken no action on 23 complaints received from tourists about food sold in the tourist resort area.
In Thiruvananthapuram, the VACB found that the Assistant Commissioner, Food Safety, had taken no action on 78 complaints. The situation was the same in food safety offices in other districts.
An investigator said hoteliers paid food safety inspectors to inform them earlier about food safety raids.
FSSAI mulls cattlefeed norms to curb animal food contamination
Animal feed and fodder are turning out to be a major source of contaminant of foods of animal origin - The Hindu
For now, feed/fodder to conform to BIS standards
The Food Safety and Standards Authority of India (FSSAI) is looking at bringing in standards for animal feed so as to curb contaminants, pesticides and heavy metals finding their way into foods of animal origin through feed and fodder.
Till the time these regulations are finalised, the FSSAI has directed that cattlefeed materials must conform to norms set by the Bureau of Indian Standards (BIS).
Six-month breather
“In order to address the issue on an interim basis, it has been decided that commercial feeds/feed materials intended for food producing animals shall comply with the relevant BIS standards and shall not be manufactured, imported, distributed and sold except under the Bureau of Indian Standards certification,” the directive said. Stakeholders have been given six months to comply with the directive, which will come into force in June.
Noting that animal feed and fodder are turning out to be a major source of contaminants of foods of animal origin, it said, “regulatory control to ensure quality and safety of animal feed and silage is urgently needed.”
According to the findings of the National Milk and Quality Survey, 2018, traces of contaminants such as Aflatoxin M1 have been found not just in raw milk supplied by unorganised players but also in processed milk supplied by organised players; feed and fodder are the cuiprit. The food safety authority had said that the presence of Aflatoxin M1 residues beyond permissible limits in processed milk is a serious concern.
In its action plan for safe and quality milk and milk products, the FSSAI believes that “regulatory values or recommendations through legislation can limit animal exposure through feed ingestion against the presence of residues of mycotoxins in animal-derived products.”
The regulator has also said that it will be putting in systemic efforts to improve animal husbandry practices to address safety and quality concerns over milk.
The FSSAI, in collaboration with the Ministry of Animal Husbandry, Dairying and Fisheries along with the National Dairy Development Board, will work towards enhancing awareness on improved animal husbandry and farm practices among small dairy farmers.
FSSAI inks MoU with Nasscom to prevent food wastage
New Delhi, Dec 13 (KNN) Food Safety and Standards Authority of India (FSSAI) has signed a Memorandum of Understanding (MoU) with Nasscom foundation to develop an app and set up a 24×7 helpline number to connect donors with surplus eatables with food distribution organisations.
“India will soon have access to a common help-line and a mobile application ‘Food Donation in India’ to donate food to the needy. FSSAI and NASSCOM Foundation have signed a MoU today to jointly build a technology platform for Food Donation in India,” FSSAI said in a statement.
The platform will also facilitate registration of surplus food distribution organisations, and initially, the network of 81 such organizations across PAN India, known as the Indian Food Sharing Alliance (IFSA) will be a part of this platform, it said. The solution, FSSAI said, will provide an easy accessible platform that will cater to different stakeholders like food businesses, hoteliers, caterers, individuals etc and facilitate food donations in any part of the country.
FSSAI CEO Pawan Agarwal said that this would definitely provide a recognition to the organisations involved in surplus food distribution and would help in reducing the wastage of food in the country through food donation.
On the other hand, Ashok Pamidi, CEO, Nasscom Foundation said the collaboration is a significant step in the direction of leveraging tech for solutions and the foundation hopes more such engagements in future.
Visible food safety violations to attract spot fine from now on
Visible violations by Food Business Operators (FBOs) are expected to see a decline with the Food Safety and Standards Authority of India (FSSAI) all set to start levying spot fines.
As per a new directive, Designated Officers of the FSSAI in each district can now impose spot fine on FBOs who are found with certain visible violations.
While violation for the first and second time attracts fine, repetition of the same violation for a third time will attract a higher amount of fine and cancellation of the registration certificate issued by the food regulator.
The spot fine is also expected to have an impact on the sale of banned products like gutka as seizure of any such item for a third time will attract cancellation of registration certificate and a spot fine of ₹ 25,000, the highest fine among all violations.
K. Tamilselvan, Designated Officer of FSSAI for Coimbatore, said that the spot fine system was expected to have a deterrent effect on FBOs that repeatedly flouted food safety norms.
“The new directive empowers Designated Officers to levy spot fine when a food is found containing extraneous matter, FBOs failing to comply with directions of food safety officers, unhygienic or unsanitary processing or manufacturing and sale of food items,” he said.
FBOs, who are slapped with a spot fine, will have to pay the amount at the treasury and food safety officers cannot collect the penalty as cash. If the FBOs fail to pay the penalty within the stipulated time, the Designated Officer can suspend the registration certificate of the FBO until the penalty is paid.
According to Dr. Tamilselvan, misbranding, label violations, possession of banned food products and adulteration in certain food items are among the common visible violations found in Coimbatore.
“The spot fine applies to the possession of banned food item like gutka when the seized quantity is less than that of the sample quantity. Sample quantity means the quantity required to lift four separate samples of the same item for laboratory analysis. Now, even if a vendor is found with two or three sachets of different gutka, spot fine can be levied,” he explained.
Stating that levy of spot fine would have a deterrent effect on violators, Coimbatore-based lawyer and consumer rights activist V.P. Sarathi said that the food safety officers should also strictly implement other provisions of the FSSAI Act to bring down other violations by FBOs.
Citing an incident wherein he found worm in a packaged drinking water a year ago, sample of which was subsequently found “unfit for human consumption” in a laboratory analysis, Mr. Sarathi said that the food regulator only served a ‘caution notice’ to the manufacturer.
“Such offences should have seen a logical end of prosecution by the court and heavy fine should have been imposed on the violator,” he opined.
A meat stall owner with whom spoke to said that the spot fine would not affect traders, who sold quality meat to customers, but would help buyers understand those who sold sub-standard items.
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