NEW DELHI: In a major shift in policy to regulate manufacture and sale of health supplements in the country, an inter-ministerial committee has suggested that supplements claiming to cure or mitigate any specific disease should be considered a drug and, therefore, come under the purview of Central Drug Standards Control Organisation (CDSCO).
Currently, all such products come under the purview of Food Safety and Standards Authority of India (FSSAI). The committee, headed by former health secretary Apurva Chandra, has suggested they should be brought under the purview of CDSCO. This would mean more scrutiny of such products before licencing and increased penalty on making false claims about disease-risk reduction.
Main reason why many companies transfer some products from medicine or drug category to dietary supplements category is to escape price regulation. National Pharmaceutical Pricing Authority (NPPA) regulates pricing of drugs and ensures availability of medicines at affordable prices.
While NPPA has the authority to monitor and fix prices of drugs, it cannot take any action if the same drug is re-launched as a food supplement. The recommendation to categorise many health supplements as drugs will, therefore, have an impact on pricing of these products as well, officials said.
Other steps suggested include a separate provision of Good Manufacturing Practices (GMP), establishing a dedicated cell for monitoring of advertisements for such products.