Multi-vitamins and health supplements may soon come under regulatory scanner. The Central drug regulator – Drugs Controller General of India – has set up an expert committee to validate information provided by companies on labels of such products. As of now, a list of 10 popular products, which includes Revital, Ferradol and A to Z, have been drawn for testing, sources said.
“The current list has been drawn based on the popularity of products in the market or their sales,” an official said. The committee has started sampling, after which tests and audit will be conducted.
The move comes in the wake of increasing consumption of these products as well as more number of multi-vitamins and supplements entering the market. “Some of these products are very popular and expensive. It is, therefore, important to ensure that they deliver what they promise,” the official said.
With rising awareness about health and fitness and changing lifestyle, India’s nutraceuticals market is expected to cross $6.1 billion by 2020 from the current level of $2.8 billion growing at compound annual growth rate (CAGR) of about 17%, according to a latest study jointly conducted by Assocham and RNCOS.
The mandate of the eight-member committee includes evaluating claims made on the packaging of these products and checking ingredients and their strengths as per the declarations made on the label. The committee will also define specific norms based on which a product would be differentiated as a drug or a food product.
Sources said the move is also expected to help government tap those products which contain medicine formulation with a tweaked combination to circumvent price control and other stringent regulatory norms that are applicable on pharmaceuticals.
“Companies would often make minute changes by adding a supplement or removing an ingredient from a medicine formulation to qualify as a nutraceutical or a food supplement, which does not fall under the Drugs and Cosmetics Act and therefore not under price regulation,” the official said.
Though most of these multi-vitamins and health supplements qualify as over-the-counter, often they are also being pushed through doctors. “Because of their exorbitant price, companies make a huge margin on these products which is then spent on their promotion and brand building,” another official explained.
The government has tried to plug this loophole in the past also. The National Pharmaceutical Pricing Authority, which regulates prices of medicines, has also written to DCGI and the health ministry several times to address this gap.