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Dear Saxena ji,
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A transfer order on May 10, 2005, cut short A Ramakrishnan's crusade against sub-standard food and drugs and malpractices by companies like Johnson and Johnson. The outgoing commissioner, Food and Drug Administration (fda), Maharashtra, talks to nidhi jamwal about his efforts to ensure safer products
How were your 10 months at fda?
It was a great learning experience! The subjects were new, but I took the initiative every regulator should take, to understand them. I met people in the field before questioning the companies.
Of fda's many important decisions last year, the crucial one was about gutkha, which contains magnesium carbonate and is manufactured in contravention of Prevention of Food Adulteration Act, 1954 (pfa). The Central Committee for Food Standards has recommended a ban on gutkha to the Union ministry of health and family welfare (mohfw).
What triggered the baby oil campaign?
fda got complaints from many consumers about baby skin rash with use of specific baby oils. Bureau of Indian Standards (bis) regulates only baby soap and powder, so we tested various baby oil brands in our lab. Tests revealed liquid paraffin content. In the us, multinationals (mncs) mention ingredients on labels, but in India nobody bothers to disclose that baby oils contain paraffin! We have given companies 90 days to get central clearance, or drop 'baby' and 'massage' from their products.
Why are our regulations so weak?
Amendments nullify laws like pfa and the Drugs and Cosmetics Act (dca), 1940. Earlier, proprietary food manufacturers had to get labels approved, mention percentage of ingredients. Now even percentage doesn't have to be revealed. How can regulators test them?
But abroad, MNCs print information on the label. Why not in India?
It's not mandatory here. The central government can issue basic guidelines to states. But that's not happening, not even with medicine standards. By law, any medicine that is not as per pharmacopoeia, has to have clinical trials, but there are no guidelines for the tests. No committees validate proprietary medicines. India's nearly 36 drug controllers have become mere licence issuers.
You issued notices to cosmetics firms
In the absence of standards, it's a free-for-all. Companies bend rules; even bis committees comprise mncs. Can Fair and Lovely or vitamin capsules stand up to scientific scrutiny? Deo soaps claim to be anti-bacterial, but are neither deo nor medicated. Total fatty matter in Lifebuoy was reduced from a required 60-70 per cent to 48 per cent.
Ayurvedic products also use chemicals
I issued a notice to No Marks for using soap noodles -- basically chemicals. Selling ayurvedic products requires no special license and manufacturing licenses require no validation -- a Delhi manufacturer can get a licence from an ayurveda controller in Assam and then sell all over without regulations. Ayurvedic drug testing is not established and central guidelines for testing are not available. In the name of proprietary ayurvedic drugs, all kinds of ingredients are added to prepare 'medicine'. Even big companies flout the law. Himalaya ' ayurvedic' oil is 96 per cent mineral oil.
And lab testing of food and drugs?
The government has allowed umpteen manufacturers, but has no system to test products for efficacy and stability. Licence fee is as low as Rs 100. Nor is industry serious. Why can't food companies, whose turnover runs into Rs 30,000 crore, set up a good lab for Rs 20 crore? Fake lab reports are another problem. 14 people died in Nashik due to argemone oil, found by fda to be contaminated. But the manufacturer got a second sample tested from a lab in Mysore and got a clean chit. Such is the integrity of labs. No one is accountable.
Can't the Centre issue notifications?
The Centre wants power but no accountability. Government and industry work in tandem. When we found branded coconut oils were paraffin-based -- 96 per cent Parachute 'coconut' hair oil is paraffin -- a sub-committee chaired by me moved to delete the word coconut and its picture from containers. But Dabur stalled the move -- this is the kind of clout industry has. Laws are modified to suit mncs.
Nutraceuticals are popular now
India permits only food and drugs, no nutraceuticals, unlike the us with its dietary supplements where manufacturers have to declare nutraceutical content, clinical trials and health studies. But in India, as drugs mean price regulations, these conveniently become food, requiring no test or licence. Studies by the Indian Council for Medical Research show that unmonitored nutraceuticals can be dangerous for health. I have informed Customs that if anyone imports food supplements with therapeutic claims, then it should be imported only as a drug, until a new legislation is put into place.