Indian Government to Amend Schedule V of Drugs and Cosmetics Act to clear confusion between the vitamins and Drugs

The government of India is mulling over to amend the schedule V of the Drugs and Cosmetics Act, 1940 to clear the confusion between the dietary supplements, multivitamins and drugs. However, the submission made by the industry says that vitamins are supposed to be included both in health and nutritional supplements only if they are within the recommended dietary allowance (RDA) stipulated by ICMR.

Currently, Schedule V under the Drugs and  Cosmetics Act covers proprietary medicines and patented drugs. Schedule V stipulates standards for patents or proprietary medicines containing vitamins for prophylactic, therapeutics and paediatric use. According to the standards, it should contain the vitamins in required amounts.

To classify products as nutraceutical or drug, a high-level committee of experts from CDSCO and FSSAI was set up. This committee was formed to get the clarity regarding the labelling of products. They were supposed to understand whether the labelling on products is a marketing gimmick or is done as per the requirements for its intended use.

According to a senior CDSCO official, the regulatory authorities want a science-based evaluation on the matter that is taking time. The industry says that, if vitamins are removed from health supplements, it will have far-reaching effects on the health of the consumers, The submissions recommend that vitamins should be allowed both in food as well as drug a, depending on the dosages employed.”


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