Oct 31, 2019
Govt considers single US FDA-like regulator for food, drugs and medical devices
The move is aimed at streamlining regulatory structure while ensuring transparency, effective monitoring as well as ease of doing business.
At present, both medicines and medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO), whereas food along with nutraceuticals are monitored by the Food Safety and Standards Authority of India (FSSAI). Both CDSCO and FSSAI heads report to a joint secretary in the health ministry.
Government think-tank NITI Aayog has floated a proposal suggesting a separate third vertical for regulating medical devices similar to CDSCO and FSSAI. It has also recommended that instead of reporting to a JS, all the three verticals can be supervised by FDA India head who will be an IAS officer of the rank of additional secretary in the health ministry, official sources said.
“NITI Aayog’s suggestion has found favour with the PMO and is likely to be implemented soon,” a senior official told TOI.
“It is important to restructure the regulators because while much of these are pharmaceutical products or products concerning the health of people, they are different in their making, design, technology, usage as well as marketing and distribution. It is unfair to regulate medical devices as medicines. At the same time, it is important to have somebody overseeing them from a health perspective,” the official said.
The NITI Aayog’s proposal has also been endorsed by industry which says the move will be in line with international standards and procedures and therefore, will help ease regulatory approvals for Indian companies in other countries.
All the three sectors – pharmaceuticals, medical devices and food – are fast growing industries in the country with rapidly increasing consumption of such products. The Indian drug manufacturing industry – which clocked a local annual sales of over Rs 1,36,000 crore – is also the third largest export revenue churner. The medical devices industry, currently pegged at around $7 billion in India, is rapidly growing and projected to touch $50 billion by 2025. The Indian food market, valued at $39.71 billion, is also one of the fastest growing industries in the country.
“An overarching body like FDA India will help enhance the brand value and establish a credibility by way of uniformity. It is often difficult and sometimes even embarrassing for us in other regulated markets to seek clearances for our products because they are certified by authorities or organisations with no global recognition,” a medical device manufacturer said.
The Aayog has also been pushing for a separate law or Act to regulate medical devices. The proposal for the bill also recommends a separate regulatory authority for medical devices and an overarching body headed by health ministry. The proposal is in final stages of discussion with an inter-ministerial note circulated to different ministries.
Food safety officials begin streamlining sale of oil
After reports on loose sale of oil emerged, food safety officials have begun streamlining manufacture and sales of oil used for lighting. While oil for lighting should not be made where edible oil is manufactured, many units still violate the rule, officials said.
It is difficult to differentiate between the two varieties by the way it is packed which, the officials say, is done intentionally to make a killing. While the packing is similar to edible oil with misleading pictures, often a mention is made in the packet that it is meant for only lighting.
“This is written in English which is a deliberate to mislead people,” designated officer for food safety, Madurai district Dr M Somasundaram said.
To end the illegal practice, the officials have introduced a common colour to differentiate lighting oil from cooking oil. Only violet colour should be used on packing with a wording not less than 10 mm height mentioning that the oil is not meant for cooking.
FSSAI has recently implemented Blissful Hygienic Offering to God (BHOG) to ensures a list of pooja items used in temple are edible, as the products go into ‘abishekam’ and people consume it after the pooja. The list of items includes lighting oil, honey, sucrose syrup, camphor, incense sticks, fragrance oil, kunkum, ghee and holy ash.
Telangana scores low in food safety, termed ‘weak state’
Hyderabad: Telangana has been described as a ‘weak state’ when it comes to food safety. The Food Safety and Standards Authority of India (FSSAI) has given India’s youngest state a total score of 40 out of 100 in the state food safety index report.
Telangana received poor marks in various categories. In human resources and institutional data, it got seven out of 20 marks. In compliance, it got 14 out of 30, in food testing-infrastructure and surveillance, it received 15 out of 20, in training and capacity building, it got four out of 10 and in consumer empowerment, it got zero out of 20 marks.
Telangana is among the 24 states that have been bracketed as ‘weak states’. Jharkhand got 33 marks, Lakshadweep 22, Mizoram 36, Nagaland 39 and Sikkim received 37 marks. Neighbouring Andhra Pradesh did comparatively better with 57 out of 100. With 84 out of 100, Goa topped the list of states, followed by Kerala and Tamil Nadu.
Having been bracketed among weak states, which have a score of less than 60 and needing a push in food safety, authorities in Telangana have started implementing measures to improve the ranking. “We are positive that our ranking and scores will improve soon. Among the most important measures we have taken include training hotel workers in cleanliness and preservation of food, use of gloves and regular health check-ups,” K Shankar, director of food safety.
According to Shankar, 2,500 hotel workers in Hyderabad and districts like Warangal have been trained on various aspects of food safety. Additionally, vegetable oil manufacturers are being urged to produce fortified oils which will be rich in vitamins. They can display ‘K+’ label on their products to show the oil has been fortified. The food index report was released in June.
Indian sweetmeats have expiry dates too
Did you know traditional Indian sweets have different spans of shelf life like packaged food products? For instance, khoya burfi has a shorter shelf life than the boondi laddoo.
According to a guidance note on traditional Indian milk products released by Food Safety and Standards Authority of India (FSSAI), the shelf life of Indian sweets depends on the kind of ingredients used in them. It is the responsibility of packaged food manufacturers to clearly mention the date of manufacturing and ‘best before’ or ‘use by’ date on the labels.
Mandatory labelling
"In case of pre-packaged milk products, the list of ingredients and the date of manufacturing and best before or use by date should be mentioned as prescribed under the FSS (Packaging and Labelling) Regulations, 2011," FSSAI stated in its guidance note.
Even in the case of non-packaged or loose sweets, the food safety authority recommends that the container or tray display information including whether the food item contains oil, ghee or vansapati.
Shelf life
So what needs to be consumed on the day of purchase? FSSAI says Kalakand and its variants such as Butterscotch Kalakand and Chocolate Kalakand should be kept at room temperature and consumed the same day.
Milk products and Bengali sweets should be stored in the refrigerator and consumed within two days, it adds. They include sweets such as badam milk, rasgulla, rasamalai, shahitoast, rajbhog among others.
Sweets that are made in khoya format besides certain variants of laddoo should be consumed within four days. So traditional Indian sweets such as milk cake, mathura peda, milk/pista/coconut burfi, and boondi laddoo should not be eaten after fourth day.
Durable sweetmeats
What can be stored and consumed for a longer duration? Sweets that contain ghee and dry fruits can be consumed within seven days, according to FSSAI. This include kaju katli, ghewar, shakkar para, and dryfruit/aata/besan laddoo.
Take a look at the complete list of sweets and their shelf life by FSSAI
So make sure you don't eat traditional sweets past their shelf life and ask the sweets vendors for information on date of manufacturing.
Milk in India is certainly not as safe as the food regulator claims
The recent report released by FSSAI about its milk survey shows many glaring discrepancies
The apex food regulator of the country — Food Safety and Standards Authority of India (FSSAI) — released its final report of the National Milk Safety and Quality Survey (NMSQS) on October 18 this year and gave a clean chit to milk available in India as being ‘largely safe’.
A close look at the report however suggests otherwise. It clearly shows that a substantial proportion of milk samples, particularly processed milk, is unsafe for consumption and it chooses not to inform consumers about these brands of processed milk. It also does not provide important information pertaining to antibiotics in milk.
As stated in the report, FSSAI had collected milk samples (both raw and processed) from local dairy farms, vendors, retail shops, milk mandis, and processing units across all states and Union Territories of India.
These milk samples were subjected to tests for quality and safety. Quality tests included those for fat and Solids-Not-Fat (SNF). Safety was evaluated based on the presence of adulterants and contaminants. Twelve adulterants (such as urea, sugar, maltodextrin, etc) and three categories of contaminants (aflatoxin M1, antibiotics, and pesticides) were evaluated.
An in-depth look at the data on unsafe milk samples show that over 10 per cent of the processed milk samples (271 out of 2,607) in the country are found unsafe due to presence of contaminants such as aflatoxin M1, antibiotics, and pesticides above the tolerance limits set by FSSAI.
In other words, one in 10 packets of the milk bought by consumers could be unsafe. Apart from processed milk samples, 4.8 per cent of raw milk samples (185 out of 3825) were found to be non-compliant for safety.
It is worrying and intriguing as to how contaminants continue to remain in processed milk, in higher probability, despite having undergone several levels of processing and checks by the organised sector.
“The message from the central food regulator is confusing. The report suggests otherwise. Sadly, milk does not appear to be as safe as it is being communicated”, says Amit Khurana, director of the programme on food safety and toxins, Centre for Science and Environment (CSE).
By not informing about the brands of samples found unsafe, the report has left consumers clueless and does not help them make an informed choice. Moreover, it is unclear if this is about few national-level brands or multiple local brands.
Since long-term exposure to aflatoxin M1 can cause cancer and presence of antibiotics in foods has linkages to antimicrobial resistance (AMR), a global public health threat, it is important that a correct message about milk safety should have been communicated to the public. This is particularly important as milk is a staple in most Indian households, especially those with children.
The results clearly show that presence of unsafe milk is a country-wide problem, unlike what is said in the report that “the problem is restricted to a few pockets and in some states”. Unsafe milk was reported from 21 states and two Union Territories (see ‘State of the states’).
The question of antibiotics
Antibiotics in milk are a big concern as out of the three contaminants, antibiotic residues in milk can be attributed to their deliberate use in dairy production. Moreover, unsafe levels of antibiotics that were detected in 77 samples from 13 states and two Union Territories, suggesting that the problem is widespread; particularly for the processed milk sector (40 out of 77 were of processed milk).
On the other hand, out of the 37 raw samples, 20 were from Madhya Pradesh, making it more of a state-level issue and not a pan-India scenario.
“Antibiotic residues in milk from across the country are a big concern. To contain antibiotic resistance, antibiotics must not be allowed to be misused in the dairy sector. They should not be used for non-therapeutic purpose and those which are critically important for humans should be regulated,” adds Khurana.
The report does not provide necessary information related to antibiotics in milk. It does not tell us which antibiotics were found at unsafe levels. It also does not inform about samples with antibiotics present but within limits set. There is no mention of levels of antibiotics found, so one does not know if antibiotic residues found were just above or many times higher than the limits set.
It is unclear whether only classes of antibiotics (beta-lactams, sulfonamides, quinolones, tetracyclines) were tested or individual antibiotics belonging to these classes were also tested.
The report also mentions that 93 antibiotics and veterinary drugs were tested according to the Food Safety and Standards (Contaminants, Toxins and Residues) regulation. But the actual number of antibiotics tested could be less as only 29 are antibiotics in the list mentioned in the regulation.
Moreover, it can be inferred from the report that veterinary drugs were not tested at all. Further, apart from the four classes, there are several antibiotics for which standards have been set by the FSSAI but not tested like Streptomycin, Neomycin, Apramycin, and Colistin (which was banned in July 2019 but was allowed to be used at the time of survey).
But most importantly, antibiotics which are commonly used in the dairy sector but their upper limits are not set so far, are not included in this survey like Gentamycin and Amikacin. Else, the number of unsafe samples would have been more.
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