Several controversial nutraceutical products, now being marketed as food supplements by some of the prominent pharma companies, will have to be withdrawn from the market and should be sold as drugs as the DTAB sub-committee, which analysed these products, has recommended that these products shall be classified as drugs.
Ferradol by Pfizer; Revital by Ranbaxy Laboratories; Beneficial capsules, CSN capsules and DSN capsules by Shreya Life Sciences, A to Z by Alkem Laboratories; Kidvit Z drops by Ceza Formulations; and Resource Diabetic and Resource Renal by Drytech Process are some of the products which have been examined by the sub-committee.
“Committee examined the ingredients present in the product. Committee noted that some ingredients present in the product fall under the range as prescribed under schedule-V of Drugs and Cosmetics Rules, 1945 either in prophylactic or in a therapeutic dose. The Committee recommended that the product shall be classified as drug,” the sub-committee in its recommendation said.
The sub-committee was constituted during the 68th meeting of the DTAB held on February 16, 2015 for analysing the component of ingredients of each products and its effect on the human body if consumed as a food and come to the conclusion whether the products would fall under the classification of the Drugs and Cosmetics Act, 1940 or under the Prevention of Food Adulteration Act as food as per directions of the High Court of Patna in the matter of CWJC of 2425 of 2006.
Dr. G. B. Gupta, vice-chancellor, Ayush and Health Sciences University of Chhattisgarh; Prof. M. D. Karvekar, Bangalore; O. S. Sadhawani, controlling authority & joint commissioner, FDA, Maharashtra; Dr. S. K. Sharma, Prof. & head, department of medicines, AIIMS, New Delhi; Dr. A. K. Gadpayle, medical superintendent, Dr. RML Hospital, New Delhi; Dr. Hansraj, Cons. & Prof. department of medicines, RML Hospital, New Delhi; Dr. M. K. Daga, director & Prof., department of medicines, Maulana Azad Medical College, New Delhi; and Dr. V. G. Somani, joint drugs controller (India), CDSCO, HQ, FDA Bhawan, New Delhi were the members of the sub-committee.
The sub-committee also discussed each product as per directions of the High Court of Patna and gave its recommendations.
The DTAB in its 70th meeting held on August 18, 2015 deliberated the recommendations of the sub-committee. After detailed deliberations, the DTAB accepted the report, however, recommended that the report of the sub-committee may be put on the website of CDSCO for comments from the public within one month of its uploading. The comments shall then be further examined by the sub- committee and then put up to DTAB.
The CDSCO has now put the sub-committee recommendations on the public domain and has sought suggestions and comments from the stakeholders within one month.