R.F.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 Such FDCs can pose significant risks to persons and need to be withdrawn immediately in that human lives can be at risk.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)). The DCG(I), in turn, had requested all States/Union Territories Drug Controllers to ask concerned manufacturers in their respective States/Union Territories to prove the safety and efficacy of such FDC licenses issued prior to 1.10.2012, without due approval of the DCG(I), within a period of 18 months, failing which such FDCs would be considered for being prohibited, both qua manufacture and marketing in the country. On 5.7.2013, the DCG(I) vide its communication to the State Drug Controllers asked manufacturers to make applications as per the procedure prescribed within this 18 month period. We have been informed that a large number of applications were received from the manufacturers within the 18 month period for 2911 products, which had to be subjected to examination.;