Hon'ble Judges/Coram:
Rohinton Fali Nariman and Sanjay Kishan Kaul

JUDGMENT

Rohinton Fali Nariman, J.

1. Leave granted.

2. The present appeals and transfer petitions relate to the interpretation of Section 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as "the Drugs Act"). By the impugned judgment of the learned single Judge of the Delhi High Court dated 1.12.2016, the learned single Judge has held that the mandatory condition precedent for the exercise of the power by the Central Government Under Section 26A of the Drugs Act is the prior consultation of the Drugs Technical Advisory Board (DTAB) set up Under Section 5 of the said Act. It must be stated that the learned single Judge differed from judgments of the Karnataka and Madras High Courts in this regard, wherein two other learned single Judges of two other High Courts have held that such consultation with the DTAB is not mandatory before exercise of such power Under Section 26A. Since we are concerned only with this narrow question that has been decided by the learned single Judge of the Delhi High Court, we are not going into any other contentions that have been raised by learned Counsel for the parties.

3. The issue regarding the prevalence of many Fixed Dose Combinations (hereinafter referred to "FDCs") that were flooding the Indian market and had not been tested for efficacy or safety was considered by the Parliamentary Standing Committee on Health and Family Welfare in its 59^th Report in May, 2012. The Standing Committee observed that some of the State Licensing Authorities have issued manufacturing licenses for a very large number of FDCs without prior clearance from the Central Drugs Standard Control Organization (CDSCO). Such FDCs can pose significant risks to persons and need to be withdrawn immediately in that human lives can be at risk. The Committee recommended that a clear and transparent policy may be framed for approving FDCs based on scientific principles, and that, at present, Section 26A of the Drugs Act is adequate to deal with the problem of FDCs not cleared by the CDSCO. Pursuant to the aforesaid report, the Ministry of Health in October, 2012 issued directions to States and Union Territories Under Section 33P of the Drugs Act not to grant licenses to FDCs falling under the definition of "new drugs" and not approved by the Drug Controller General of India (DCG(I)). T........