Food vendors get more time for registration

Buckling under the pressure from the Union Health Ministry, the top food regulator has, instead of penalising the defaulters, once again extended the February 4, deadline by next six months for food vendors and businessmen for mandatory registration and licensing.

The move followed tepid response to the Food Safety and Standards Authority of India (FSSAI) drive with just 19 lakh out of around five crore food operators and vendors coming forward for mandatory registration by February 4, 2014. Similarly, just around five lakh businessmen engaged in the food business have been issued licence so far against the target of 50 lakh. Just a month ago, the FSSAI had warned to penalise the defaulters and made clear that no extension will be allowed. However, response has been utterly poor despite three extensions.

A look at the Government data shows that the States have failed miserably to cover all the food operators under its registration and licencing drive within the deadline of February 4. Maharashtra is the only State which has registered highest food business operators followed by Tamil Nadu and Madhya Pradesh. (See box) When asked, AK Panda, Joint Secretary in the Health Ministry blamed the States for failing to create awareness among the food business operators. “Moreover, it is not easy task to cover each and every food operator in the country like ours,” he said adding that more time has been given to the vendors to register with the Government. The first deadline was August 4, 2012, that is one year after the implementation of the FSS (Licencing & Registration of Food Businesses) Regulations, 2011. It was extended again by six months to February 4, 2013, and then to February 4, 2014. 

The FSS Act makes it mandatory for every FBO having a turnover Rs 12 lakh to obtain a licence and those below Rs 12 lakh to get themselves registered. This implies that excepting big eateries all FBOs, from road-side sellers to vegetable vendors and from milkman to caterers, all need to be registered. As per the Act, all FBOs must maintain a record of the inventory of raw food, stored food, water, food and air testing and pest control regimes.

USFDA talks tough on lapses in quality standards

Summary

Several Indian pharma companies, including Wockhardt have come under FDA fire because of alleged serious shortcomings in their quality standards.

Margaret A Hamburg, Commissioner, US Food and Drug Administration (USFDA), has sent a strong message to pharma companies supplying drugs to the US market. Hamburg, who is on a nine-day visit to India says companies must ensure that their products are safe and “significant lapses in quality” by some companies operating in the US and around the world “is unacceptable”. 

An industry representative present during the interaction with Hamburg told The Indian Express, that the USFDA has made it amply clear that there would be no leniency in quality controls, and approvals for Indian drugs would be given only after they satisfy their quality, efficacy and safety standards. 

Hamburg’s visit to India is the first by a USFDA commissioner. The visit comes after the US drug regulator prohibited Ranbaxy from supplying drugs and raw materials from its Toansa plant to the US market. USFDA cited ‘lack of good manufacturing practices’ at Ranbaxy’s fourth plant. 

Several Indian pharma companies, including Wockhardt have come under FDA fire because of alleged serious shortcomings in their production and quality standards. 

After a series of meetings with the Indian regulator Drug Controller General of India (DGCI) and the industry, Hamburg, in a blog written on February 14, said that while the FDA will address the challenges faced by Indian companies in terms of approval times for generic drugs, “in recent years the FDA has identified significant lapses in quality by some companies operating in the US and around the world”. 

“As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable,” she wrote. 

She also indicated that in future, the number of inspections may go up, as it is required under the US Generic Drug User Fee Act. 

Despite her tough stance, the visit, according to industry, has “generated a lot of much-needed goodwill”, especially at a time when the industry has been going through a tough time in the US market due to regulatory issues. 

“It is a very positive development. It is important to engage and open up a dialogue between the regulators to dislodge certain myths and perceptions that have tainted the Indian pharma sector. She made some very positive statements about her willingness to help the industry in overcoming certain compliance challenges and to work with the DCGI in terms of capacity,” said Kiran Mazumdar Shaw, chairman and managing director of Biocon. She added that it is high time for Indian regulators to engage with the USFDA on key issues and collaborate as equal partners. 

A senior executive of a pharma major said, on condition of anonymity, that while Hamburg expressed the philosophy and expectations of the FDA, “the fact that she spent so much time in India is indeed a positive for us. FDA has assured us that it will help us in understanding its expectations much better”.