IMPORTANT POINTS
Section 26A provides additional power governed by its own terms which must be exercised in public interest.
There is no explicit requirement in section 26A to consult the DTAB.
While reading down a provision to make it constitutionally valid, words cannot be added as a matter of constitutional doctrine. Words can only be added if literal interpretation of the Section leads to an absurd result.

Headnote:(a) Drugs and Cosmetics Act, 1940 – Section 26A – A without prejudice provision – Means section 26A provides additional power governed by its own terms – Satisfaction of Central Government on three factors – The power must be exercised in public interest. (Para 15, 23, 24)
       (b) Drugs and Cosmetics Act, 1940 – Section 26A – Must be read with the whole Act – So read, no explicit requirement to consult the DTAB – Held, Parliament deliberately did not mandate prior consultation with DTAB u/s 26A. (Para 16, 17)
       1994 Supp (1) SCC 160 – Distinguished
       (c) Drugs and Cosmetics Act, 1940 – Section 5 – DTAB being advisory body, its advice would be desirable in exercise of section 26A – However, not doing so would not vitiate exercise of power u/s 26A. (Para 20)
       (d) Interpretation of statute – Amendment – 1982 Amendment in Drugs Act making changes in many sections including inserting section 26A – Requirement of consultation/advice of DTAB made mandatory in many sections – Section 26A not referring to DTAB – Such omission held to be deliberate. (Para 21)
       (e) Drugs and Cosmetics Act, 1940 – Sections 7A, 5, 33C and 33D – Contention that section 7A making section 5 inapplicable to Ayurvedic, Siddha and Unani drugs makes it applicable to all other drugs rejected – Constitution of a separate technical advisory board u/s 33C and a separate consultative committee for Ayurvedic, Siddha and Unani drugs u/s 33D – Held, section 7A simply affirms that DTAB set up u/s 5 will apply to all drugs except Ayurvedic, Siddha or Unani medicines – Maxim “expressio unius est exclusio alterius” cannot apply. (Para 22)
       (1977) 4 SCC 608; (1972) 2 SCC 560 – Relied upon
       (f) Interpretation of statute – Reading down – While reading down a provision to make it constitutionally valid, words cannot be added as a matter of constitutional doctrine – Moreover, words can only be added if literal interpretation of the Section leads to an absurd result – Cassius omissus. (Para 25, 27)
       (2016) 7 SCC 703 – Relied upon
       Writ Petition Nos.21933 and 25442 of 2011 (Mad); (2014) 5 Kant LJ 440 – Approved
       Facts of the case:
       These appeals and transfer petitions relate to the interpretation of Section 26A of the Drugs and Cosmetics Act, 1940.
       The learned single Judge of the Delhi High Court, differing from the views of Karnataka and Madras High Courts 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.
       Finding of the Court:
       There is no explicit requirement in section 26A to consult the DTAB.
       Result: Appeals and transfer petitions disposed of.

JUDGMENT :

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 59th 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.

4. With the approval of the Ministry of Health and Family Welfare, the CDSCO constituted 10 different Committees for examination of the said applications which were received on 3.2.2014. As the said Committees could examine only about 295 applications, on 16.9.2014, the Ministry of Health and Family Welfare constituted a Committee under the Chairmanship of Professor C.K. Kokate, Vice Chancellor of KLE University, Belgaum, Karnataka for examining the safety and efficacy as per the following terms of reference:

a. Those FDCs which are considered grossly irrational/unsafe based on pharmacokinetic and pharmacodynamic interaction, dosage compatibilities of FDCs vis-a-vis that of single ingredients present in the FDC and available literature/evidence.

b. Those FDCs which the Committee

Click Here to Read the rest of this document

2017 Supreme(SC) 1205

Cases Referred (6)