The Ministry of Health and Family Welfare, Government of India vide Gazette notification nos. S.0.4379(E) to S.0.4706(E) dated 07.09.2018 has prohibited 328 Fixed Dose Combinations (FDCs) for manufacture, sale or distribution with immediate effect under Section 26A of Drugs & Cosmetics Act,1940. It has also restricted six more FDCs subject to certain conditions. The said publication is the continuation of the earlier notification of 10th March 2016 in the Gazette of India prohibiting 344 FDCs. Pursuant to the said notification the matter was appealed by pharmaceutical manufacturers and finally based on the decision of Hon'ble Supreme Court of India in its judgment of December 15, 2017, in Union of India and Anr. v/s Pfizer Ltd. and Ors. Civil Appeal No. 22972 of 2017 (Arising out of SLP (c) No.7061 of 2017), the matter was directed for examination to the Drugs Technical Advisory Board (DTAB) constituted under section 5 of the Drugs and Cosmetics Act, 1940 for providing its report to the Central Government.
After examination DTAB opined that the ingredients of these drugs have no therapeutic rationale and are risky for consumption to human beings. The Central Government has received the similar recommendations by an Expert Committee appointed earlier to examine these FDCs. The Central Government, on the basis of recommendations, has now prohibited the manufacture for sale; sale; and distribution of the notified FDCs for consumption by human beings, in public interest.
FDCs are the combination of two or more active pharmaceutical ingredients in a fixed ratio packed in a single dose. The rationale behind the therapy is primarily patient compliance and to simplify the dosage regimen and therapy. It is expected that this ban could impact the sales figures as FDCs make up a major portion of the overall sales and around 6,000 brands with the market potential of approximately 2500 crore worth are likely to be affected.
The copies of said notifications are available on the website of CDSCO.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.