AHMEDABAD: Drug-makers in Gujarat have objected to a few provisions in the new food safety act that have brought manufacturing of health supplements under central licensing. The Food Safety and Standards Act, 2006, prepared by the Union Health ministry, was implemented in 2011 and drug makers, many of whom also make food supplements, say they are feeling the heat. Small units engaged in making these products particularly object to a non-refundable fee of Rs 25,000 for obtaining a mandatory no-objection certificate (NOC) valid for one year. "For small-sized companies, it would be a huge expense," says Chirag Doshi, chairman of Indian Drug Manufacturers' Association's Gujarat Chapter.
Various high courts have issued 17 stay orders on provisions of the act after the industry challenged them. Most cases have been filed by food and general industry associations from Tamil Nadu and only three stay orders have been vacated so far.
Sections 50 to 65 of the Act stipulate penalty for manufacturing and selling sub-standard food, misbranded items and misleading advertisements. The units fear return to the license raj where government officials tend to get unreasonable.
"The minimum penalty amount starts from Rs one lakh," says Atul Shah, secretary, Small Scale Indian Drug Manufacturers' Association. "Take the issue of hygiene. It can be easily manipulated by the food inspector as definition of hygiene differs from person to person.
It may increase corruption and harassment," adds Mr Shah who is also the treasurer at IDMA's Gujarat chapter.
Gujarat Chamber of Commerce & Industry ( GCCI), the apex trade and industry body, has already filed a suit and the first hearing is slated for August 23. The Gujarat chapter of IDMA may file a separate suit in Gujarat High Court in the next two weeks.
Doshi says the new Food Act not only has implications on the food industry, but will also direct or indirectly affect the pharmaceutical companies that make the products and chemists who sell them.
Gujarat has the highest number, 41, of USFDA approved plants. The remaining 119 plants are scattered all over the country. The state's pharma industry contributes 40% to national turnover and has a 22% share in Rs 42,263-crore pharmaceutical exports. The stakes are therefore, high in the state.
"We will file the litigation to stop implementation of the new Food Act until there is clarity on provisions affecting the drug industry," says Mr Doshi.
The act covers energy capsules, baby food, body-building drinks and popular health supplements given to growing kids.
It also makes it mandatory for food business operator having annual turnover less than Rs 12 lakh to apply for registration. "This provision is absurd. Even a kirana-wala (neighbourhood grocer) falls within the ambit of this provision," says an IDMA official.
The Food Safety and Standards Authority of India has allowed a six-month extended period for acquiring licenses and registration after only 15% companies complied with the new act.
Various high courts have issued 17 stay orders on provisions of the act after the industry challenged them. Most cases have been filed by food and general industry associations from Tamil Nadu and only three stay orders have been vacated so far.
Sections 50 to 65 of the Act stipulate penalty for manufacturing and selling sub-standard food, misbranded items and misleading advertisements. The units fear return to the license raj where government officials tend to get unreasonable.
"The minimum penalty amount starts from Rs one lakh," says Atul Shah, secretary, Small Scale Indian Drug Manufacturers' Association. "Take the issue of hygiene. It can be easily manipulated by the food inspector as definition of hygiene differs from person to person.
It may increase corruption and harassment," adds Mr Shah who is also the treasurer at IDMA's Gujarat chapter.
Gujarat Chamber of Commerce & Industry ( GCCI), the apex trade and industry body, has already filed a suit and the first hearing is slated for August 23. The Gujarat chapter of IDMA may file a separate suit in Gujarat High Court in the next two weeks.
Doshi says the new Food Act not only has implications on the food industry, but will also direct or indirectly affect the pharmaceutical companies that make the products and chemists who sell them.
Gujarat has the highest number, 41, of USFDA approved plants. The remaining 119 plants are scattered all over the country. The state's pharma industry contributes 40% to national turnover and has a 22% share in Rs 42,263-crore pharmaceutical exports. The stakes are therefore, high in the state.
"We will file the litigation to stop implementation of the new Food Act until there is clarity on provisions affecting the drug industry," says Mr Doshi.
The act covers energy capsules, baby food, body-building drinks and popular health supplements given to growing kids.
It also makes it mandatory for food business operator having annual turnover less than Rs 12 lakh to apply for registration. "This provision is absurd. Even a kirana-wala (neighbourhood grocer) falls within the ambit of this provision," says an IDMA official.
The Food Safety and Standards Authority of India has allowed a six-month extended period for acquiring licenses and registration after only 15% companies complied with the new act.
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