How India's food regulator allowed sale of unsafe processed food for years

By 2025, Indians are expected to eat processed food valued at Rs 72 trillion annually, while the revenues of the processed food industry forecast to touch Rs 60 trillion. Between 2012 and 2015, the industry tried to introduce nearly 4,500 products with completely new formulations. But, as this two-part series reports, the food safety regime has failed to keep pace with the rapidly growing industry. The first part of the series details recent CAG’s findings on how the authorities allowed the sale of food proven to be dangerous.

In December 2013, the Food Safety and Standards Authority of India (FSSAI), which is responsible for ensuring that the food sold in the country is safe for consumers, granted permission to a company called Pushpam Foods and Beverages to sell an energy drink called Restless Ginseng.

Just under a year later, scientists at the food safety authority gave senior officials a piece of information that is well-recognised in the rest of the world: that caffeine and ginseng, the two key ingredients in Restless Ginseng, make for a dangerous cocktail that could increase heart rate and blood pressure.

It took the authority seven months to react. It was only in June 2015 that it withdrew the no-objection certificate given to the company to sell the product. For a year and a half, the company was able to manufacture and sell a harmful product. Despite the authority’s action, Pushpam Foods continues to promote the drink on its website. The food safety authority has evidently failed to check whether the product has been withdrawn from the market.

As the Comptroller and Auditor General of India (CAG) pointed out in a recent report, had the authority followed its own guidelines framed in 2011, products such as Restless Ginseng would not have been put in the market in the first place.

The guidelines required food firms to provide scientific evidence that their product is safe. Only after the authority’s scientists were satisfied was the product to be allowed into the market.

Diluting guidelines

Restless Ginseng was not an exception. Starting from 2012, the authority has diluted its regulations, bypassed established protocols and ignored warning from its scientists to allow the sale of more than 800 processed foods with new formulations without assessing their safety. Some of these are still on the market.

The authority enabled this, the CAG noted, by diluting the 2011 guidelines to give temporary one-year no objection certificates to products even before its scientists had examined them.

The dilution goes against the provisions of the Food Safety and Standards Act, 2006, mandating that only scientific panels can decide if a food product or food type is safe to consume.

The bureaucrats heading the authority can issue licences for food business operators to sell a product only after the scientists have approved it as safe.

Proprietary foods

Restless Ginseng is one of hundreds of products that are sold as proprietary or novel foods – new formulations of processed food products for which safety standards do not exist in the 2006 Food Safety and Standards Act that applies to all packaged foods. The 2011 guidelines were formulated to regulate such foods.

Among these foods that do not have pre-set safety standards under the law are energy drinks, salted snacks, noodles, soups and pasta. Also in this category are nutraceuticals — dietary supplements such as multivitamins that may improve health but do not treat a medical condition. Though such supplements might be sold by chemists, they are categorised as food, not medicine. By 2020, the nutraceutical industry in India alone is expected to grow to Rs 260 billion, according to the Drug Marketing and Manufacturing Association.

CAG’s findings

When the CAG did a test audit of 50 proprietary food products approved for sale to consumers between 2012 and 2014, it found that even the diluted regulations were not followed. In many cases, the authority did not send the product for scientific assessment even after giving it the temporary no-objection certificate. By April 2015, a note written by the authority’s chief executive in May 2015 shows, it had issued such certificates to over a thousand products but sent only 200 of them for testing.

In the case of at least four products, the authority continued to allow sale for up to 47 months after the scientists rejected them as unsafe. For some products, the authority did not cancel the no-objection certificates in time. Sometimes when it did cancel the certificate, it allowed the sales licence for the product to stand.

A timeline of events

Pre-2006:  Several laws were in force to regulate food. No law governed proprietary food

2006:  Food Safety and Standards Acts enacted

2011:  Regulations to implement food law brought in. No rules for foods that do not have standards, called proprietary and novel foods

2012:  Food authority issues guidelines for proprietary foods requiring scientific assessment

2013:  The authority dilutes these guidelines, allows sale even before scientific assessment

Jun 2014:  The Bombay HC declares the guidelines illegal on procedural grounds

Aug 2014:  The Prime Minister's Office orders scientific assessment for proprietary food to be done away with

May 2015:  Food safety authority CEO writes against such dilution

Aug 2015:  The Supreme Court upholds the Bombay High Court order. Government stops issuing new licenses but allows the existing licenses to continue

Jan 2016:  In the name of 'public health’, food authority drafts and implements new regulations before they are formally notified. Does away with the need of scientific assessment of propriety food. Allows food firms to self-attest their safety

The CAG highlighted the case of a company called Chemical International that had received a no-objection certificate to sell a mushroom-based nutraceutical in August 2012. A month later, the authority’s scientists asked for the product to be banned as the company had not submitted clinical data about its claimed health benefits. But the authority did not cancel the licence for the product.

In August 2013, the safety authority gave a company called Surya Herbal a licence to sell Sunova Spirulina tablet. But since the company did not provide scientific evidence of the tablet’s safety, the scientific panel cancelled the no objection certificate in August 2014. Yet, the company continued to carry the licence to sell the tablet till December 2017. It still promotes Spirulina tablets on its website, though it could not be ascertained if this is the same product that has been banned. The authority does not require companies to disclose such details on their websites.

Licence raj

In 27 of the 50 cases audited by the CAG, the authority’s product approval unit had recommended referring the items to its scientific panels for assessment. But this was not done. Instead, the authority issued no-objection certificates to all the products.

Restless Ginseng is probably not the only potentially harmful energy drink that the authority has allowed. The CAG said it was likely other companies besides Pushpam continue to sell drinks with the same dangerous concoction of ginseng and caffeine.

The authority has also granted the approvals arbitrarily. In January 2013, it allowed the Indian biotech company Biocon to market its nutraceutical tablet S-Adenosyl Methionine but denied permission to Sun Pharmaceutical Industries to sell the same product in August that year. Although Biocon’s product approval was withdrawn about a year later, the company continues to hold the licence to sell the nutraceutical till May 2020.

This arbitrary clearance system was struck down when challenged before the Bombay High Court and its decision was validated by the Supreme Court in 2015.
 

With the clearance regime banned by the courts, the sale of proprietary food products should have stopped until a new system was put in place. But, the CAG found, a month after the judgement of the Bombay High Court, the food safety authority issued “blanket instructions” to its licensing authorities to renew or continue all existing licences issued on the basis of the no-objection certificates it had already issued.

“Consequently, FSSAI permitted the indefinite manufacture, distribution, sale or import of possibly unsafe foods,” the CAG said. “FSSAI did not take any action after the final orders of the Supreme Court to withdraw these blanket instructions.” Despite this, the food authority, and the Union health and family welfare ministry which oversees it, have been dismissive of the CAG’s report. The main thrust of their defence is that it is old news and a new set of regulations has been put in place starting 2016.

Pawan Kumar Agarwal, the chief executive officer of the FSSAI, reiterated this to Scroll.in. “Product approval [under the guidelines the courts have done away with] is a thing of the past,” he said. “Why don’t you write a forward-looking article? The CAG report is not based on facts.” But the new regulations promise to be worse, shows an investigation by Scroll.in, which found new evidence that had escaped even the CAG. The details will be reported in the second part of this series.

In arrangement with Scroll.in