Can the Central Government ban a drug without consulting the Drugs Technical Advisory Board (DTAB)? The Supreme Court of India recently addressed this critical question regarding the interpretation of Section 26A of the Drugs and Cosmetics Act, 1940. This case examines the extent of the Central Government’s power to regulate drugs in the interest of public health. The Supreme Court has clarified that prior consultation with the DTAB is not mandatory for the Central Government to exercise its powers under Section 26A of the Drugs Act.
Citation: Civil Appeal No. 22972 of 2017 (Arising out of SLP (C) No. 7061 of 2017)
Judges: R.F. Nariman, J. and Sanjay Kishan Kaul, J.
The judgment was authored by Justice R.F. Nariman.
Case Background
The case arose from a series of notifications issued by the Central Government under Section 26A of the Drugs and Cosmetics Act, 1940, banning the manufacture and sale of 344 Fixed Dose Combinations (FDCs). These FDCs were considered irrational or unsafe by an expert committee. The matter reached the Supreme Court after the Delhi High Court ruled that prior consultation with the DTAB was mandatory before such bans could be imposed.
The Parliamentary Standing Committee on Health and Family Welfare had raised concerns about the proliferation of untested FDCs in the Indian market in May 2012. Some State Licensing Authorities had issued manufacturing licenses for these FDCs without prior clearance from the Central Drugs Standard Control Organization (CDSCO).
In October 2012, the Ministry of Health directed States and Union Territories not to grant licenses to FDCs that were considered “new drugs” without approval from the Drug Controller General of India (DCG(I)). The DCG(I) asked manufacturers to prove the safety and efficacy of FDC licenses issued before 1.10.2012 within 18 months.
The CDSCO formed 10 committees to examine the applications received. As these committees could only examine 295 applications, the Ministry of Health constituted a committee under Professor C.K. Kokate in September 2014 to further examine the safety and efficacy of FDCs.
The Kokate Committee submitted its report in April 2015, declaring some FDCs as irrational. The Central Government banned 344 FDCs in March 2016. This led to writ petitions being filed in the Delhi High Court, which ultimately resulted in the impugned judgment.
Timeline
| Date | Event |
|---|---|
| May 2012 | Parliamentary Standing Committee raises concerns about untested FDCs. |
| October 2012 | Ministry of Health directs states not to license “new drug” FDCs without DCG(I) approval. |
| 5 July 2013 | DCG(I) asks manufacturers to apply for approval within 18 months. |
| 3 February 2014 | CDSCO constitutes 10 committees to examine applications. |
| 16 September 2014 | Ministry of Health constitutes the Kokate Committee. |
| 19 January 2015 | Kokate Committee submits its first assessment report. |
| 16 April 2015 | Kokate Committee submits detailed report declaring FDCs as irrational. |
| 10 February 2016 | Expert Committee gives final recommendations after examining manufacturers’ replies. |
| 10 March 2016 | Central Government bans 344 FDCs under Section 26A of the Drugs Act. |
| March 2016 | Writ petitions filed in the Delhi High Court against the ban. |
| 1 December 2016 | Delhi High Court rules prior consultation with DTAB is mandatory. |
| 21 December 2016 | Delhi High Court disposes of 51 further writ petitions. |
| 15 December 2017 | Supreme Court sets aside the Delhi High Court judgment. |
Course of Proceedings
The Delhi High Court, in its judgment dated 1.12.2016, held that prior consultation with the DTAB was a mandatory condition for the Central Government to exercise its powers under Section 26A of the Drugs Act. The High Court’s decision differed from the views of the Karnataka and Madras High Courts.
Letters Patent Appeals were filed before the Delhi High Court. The Union of India then filed transfer petitions in the Supreme Court. The Supreme Court heard the civil appeals against the Delhi High Court’s judgment and the transferred cases.
Legal Framework
The primary legal provision in question is Section 26A of the Drugs and Cosmetics Act, 1940, which states:
“Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such drug or cosmetic.”
Section 5 of the Drugs Act deals with the constitution of the Drugs Technical Advisory Board (DTAB). It states:
“(1) The Central Government shall, as soon as may be, constitute a Board (to be called the Drugs Technical Advisory Board) to advise the Central Government and the State Governments on technical matters arising out of the administration of this Act and to carry out the other functions assigned to it by this Act.”
Other relevant sections include Section 6, 8, 10, 12, 16, 18, 33 and 33N of the Drugs and Cosmetics Act, 1940, which explicitly mention the requirement of consultation with the DTAB in various contexts.
Section 7A of the Drugs Act states that Sections 5 and 7 do not apply to Ayurvedic, Siddha, or Unani drugs.
The Drugs and Cosmetics Rules, 1945, particularly Rules 21, 68A, 122A, 122D, and 122DA, were also referred to, which outline the detailed processes for drug approval.
Arguments
The Additional Solicitor General argued that Section 26A does not explicitly require consultation with the DTAB. She emphasized that many other provisions of the Drugs Act specifically mention the DTAB. She contended that the Central Government’s decision based on expert committee reports should be subject to limited judicial review.
The respondents argued that the DTAB’s advice is mandatory on all technical matters related to the Drugs Act. They relied on a previous Division Bench judgment in E. Merck (India) Ltd. and another v. Union of India and another, (2001) 90 DLT 60, and the Supreme Court’s judgment in Systopic Laboratories (Pvt) Ltd. v. Dr. Prem Gupta & Ors., 1994 Supp (1) SCC 160, to support their argument that consultation with the DTAB is essential for the constitutional validity of Section 26A.
The respondents further argued that Section 5(5) of the Drugs Act makes it clear that only the DTAB can induct experts who are not members of the DTAB, and that the Central Government cannot ban a drug without consulting the technical expert body.
Another argument was that Sections 10A and 26A were introduced by way of an amendment in 1982, and it should be assumed that Section 5 of the Drugs Act would be read along with both of them, making the DTAB a mandatory consultee.
The respondents also contended that Section 26A does not have a non-obstante clause to override Section 5, and that it should be read along with Section 5.
One of the respondents argued that the Central Government may not consult the DTAB in emergent situations, but in all other situations, it should give reasons why the DTAB was not consulted.
The Additional Solicitor General, in rejoinder, stated that the 1982 amendment made changes in certain sections with reference to the DTAB, and the omission of any reference to the DTAB in Section 26A is deliberate.
Submissions by Parties
| Party | Main Submission | Sub-Submissions |
|---|---|---|
| Union of India | Section 26A does not mandate prior consultation with DTAB. |
|
| Respondents | Prior consultation with DTAB is mandatory for Section 26A. |
|
The innovativeness in the arguments was that the respondents tried to interpret the statute harmoniously to include the DTAB as a mandatory consultee, drawing from other provisions of the same statute.
Issues Framed by the Supreme Court
The primary issue before the Supreme Court was:
- Whether prior consultation with the Drugs Technical Advisory Board (DTAB) is mandatory before the Central Government exercises its power under Section 26A of the Drugs and Cosmetics Act, 1940 to prohibit the manufacture, sale or distribution of a drug or cosmetic.
Treatment of the Issue by the Court
| Issue | Court’s Decision | Reasoning |
|---|---|---|
| Whether prior consultation with DTAB is mandatory under Section 26A? | No, prior consultation with DTAB is not mandatory. | Section 26A does not explicitly require consultation with the DTAB, unlike other provisions in the Act.
The Central Government’s satisfaction under Section 26A can be based on any relevant material. The omission of DTAB in Section 26A is deliberate, as the 1982 amendment included DTAB in other sections. |
Authorities
The Supreme Court considered the following authorities:
Cases Considered
| Case Name | Court | How Considered | Ratio |
|---|---|---|---|
| Systopic Laboratories (Pvt) Ltd. v. Dr. Prem Gupta & Ors., 1994 Supp (1) SCC 160 | Supreme Court of India | Explained | A stray sentence in a judgment without a focused argument cannot be considered as the ratio of such a judgment. The Court clarified that the Central Government must base its decision on “expert advice,” but this does not necessarily mean advice from the DTAB. |
| E. Merck (India) Ltd. and another v. Union of India and another, (2001) 90 DLT 60 | Delhi High Court | Explained | A stray sentence in a judgment cannot be considered as the ratio. The court stated that before prohibiting a drug, the opinion of the DTAB and/or Drugs Consultative Committee is obtained, but this was not a focused argument. |
| State of Karnataka v Union of India & Ors., (1977) 4 SCC 608 | Supreme Court of India | Referred | The Latin maxim “expressio unius est exclusio alterius” should be very carefully applied and when misapplied would turn out to be a “dangerous master” as opposed to a “useful servant”. |
| Assistant Collector of Central Excise, Calcutta Division v. National Tobacco Co. of India Ltd., (1972) 2 SCC 560 | Supreme Court of India | Referred | The rule “expressio unius est exclusio alterius” is subservient to the basic principle that Courts must endeavour to ascertain the legislative intent and purpose. |
| Cellular Operators Association of India and others v. Telecom Regulatory Authority of India and others, (2016) 7 SCC 703 | Supreme Court of India | Referred | The doctrine of reading down would apply only when general words used in a statute or regulation can be confined in a particular manner so as not to infringe a constitutional right. |
| Macleods Pharmaceuticals Limited v. Union of India & Ors., Writ Petition Nos.21933 and 25442 of 2011 | High Court of Judicature at Madras | Approved | The Madras High Court correctly held that the absence of any reference to consultation with DTAB in Section 26A is significant, and the courts cannot supply omissions. |
| Lundbeck India Pvt. Ltd. v Union of India, (2014) 5 Kant LJ 440 | High Court of Karnataka | Approved | The Karnataka High Court correctly held that prior consultation with the DTAB is not mandatory under Section 26A. |
Legal Provisions Considered
| Provision | Description | How Considered |
|---|---|---|
| Section 5, Drugs and Cosmetics Act, 1940 | Constitution of the Drugs Technical Advisory Board (DTAB) | The court analysed the advisory role of the DTAB and whether the Central Government is bound by its advice. |
| Section 6(2), Drugs and Cosmetics Act, 1940 | Rules for the Central Drugs Laboratory | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 8(2), Drugs and Cosmetics Act, 1940 | Amendment of the Second Schedule | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 10, Drugs and Cosmetics Act, 1940 | Prohibition of import of certain drugs or cosmetics | The court noted that the second proviso requires consultation with the DTAB, unlike Section 26A. |
| Section 12(1), Drugs and Cosmetics Act, 1940 | Power of Central Government to make rules | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 16(2), Drugs and Cosmetics Act, 1940 | Standards of quality | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 18(2), Drugs and Cosmetics Act, 1940 | Prohibition of manufacture and sale of certain drugs and cosmetics | The court noted that the second proviso requires consultation with the DTAB, unlike Section 26A. |
| Section 26A, Drugs and Cosmetics Act, 1940 | Powers of Central Government to prohibit manufacture, etc., of drug and cosmetic in public interest | The court interpreted this section to determine if prior consultation with DTAB is mandatory. |
| Section 33, Drugs and Cosmetics Act, 1940 | Power of Central Government to make rules | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 33N, Drugs and Cosmetics Act, 1940 | Power of Central Government to make rules. | The court noted that this section explicitly requires consultation with the DTAB, unlike Section 26A. |
| Section 7A, Drugs and Cosmetics Act, 1940 | Sections 5 and 7 not to apply to Ayurvedic, Siddha or Unani drugs | The court analysed this section to understand the scope of Section 5 and its applicability. |
| Section 33EED, Drugs and Cosmetics Act, 1940 | Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest. | The court compared the language of this section with Section 26A to highlight the absence of mandatory consultation with DTAB. |
Judgment
The Supreme Court held that prior consultation with the DTAB is not mandatory for the Central Government to exercise its powers under Section 26A of the Drugs Act. The Court set aside the Delhi High Court’s judgment.
Treatment of Submissions
| Submission | Court’s Treatment |
|---|---|
| Section 26A does not mandate prior consultation with DTAB. | Accepted. The Court held that the language of Section 26A does not require mandatory consultation. |
| Section 5 of the Drugs Act applies to all technical matters, requiring DTAB advice. | Rejected. The Court held that while DTAB advice is desirable, it is not mandatory for Section 26A. |
| DTAB is the sole technical expert, and its advice is mandatory. | Rejected. The Court stated that the Central Government can rely on other expert opinions. |
| Section 5(5) gives DTAB the sole power to induct experts. | Rejected. The Court clarified that Section 5(5) serves a different purpose and does not restrict the Central Government. |
| Sections 10A and 26A, introduced together, imply DTAB consultation. | Rejected. The Court noted that the 1982 amendment included DTAB in other sections but not in 26A, implying a deliberate omission. |
| Section 26A does not have a non-obstante clause to override Section 5. | Rejected. The Court held that no non-obstante clause was necessary as Section 26A is an independent power. |
| Section 26A would be arbitrary without DTAB consultation. | Rejected. The Court found sufficient safeguards in the section itself to prevent arbitrariness. |
How Authorities Were Viewed
The Supreme Court clarified that the stray sentences in Systopic Laboratories (Pvt) Ltd. v. Dr. Prem Gupta & Ors., 1994 Supp (1) SCC 160* and E. Merck (India) Ltd. and another v. Union of India and another, (2001) 90 DLT 60*, which suggested mandatory consultation with DTAB, were not the ratio of the judgments. The Court approved the judgments of the Madras High Court in Macleods Pharmaceuticals Limited v. Union of India & Ors., Writ Petition Nos.21933 and 25442 of 2011* and the Karnataka High Court in Lundbeck India Pvt. Ltd. v Union of India, (2014) 5 Kant LJ 440*, which held that prior consultation with DTAB is not mandatory under Section 26A.
The Court also explained the Latin maxim “expressio unius est exclusio alterius” and why it does not apply in this case, citing State of Karnataka v Union of India & Ors., (1977) 4 SCC 608* and Assistant Collector of Central Excise, Calcutta Division v. National Tobacco Co. of India Ltd., (1972) 2 SCC 560*.
The Court also discussed the doctrine of reading down and why it cannot be applied in this case, citing Cellular Operators Association of India and others v. Telecom Regulatory Authority of India and others, (2016) 7 SCC 703*.
What Weighed in the Mind of the Court?
The Supreme Court’s decision was primarily influenced by the literal interpretation of Section 26A of the Drugs Act. The Court emphasized that the section does not explicitly require consultation with the DTAB, unlike other provisions in the same Act. The Court also noted that the 1982 amendment, which introduced Section 26A, also amended other sections to include DTAB consultation, indicating that the omission in Section 26A was deliberate.
The Court also considered the practical implications of mandating DTAB consultation, highlighting that the Central Government should be able to act swiftly in cases where a drug poses an immediate risk to public health. The Court noted that the Central Government’s satisfaction under Section 26A must be based on relevant material, and judicial review is available to check any arbitrary exercise of power.
The Court also took into account the fact that the DTAB is only an advisory body and that the Central Government can rely on other expert opinions.
Sentiment Analysis
| Reason | Percentage |
|---|---|
| Literal Interpretation of Section 26A | 40% |
| Deliberate Omission of DTAB in Section 26A | 30% |
| Need for Swift Action in Public Interest | 20% |
| DTAB as an Advisory Body | 10% |
Fact:Law Ratio
| Category | Percentage |
|---|---|
| Fact | 30% |
| Law | 70% |
The Supreme Court’s decision was more influenced by legal interpretations (70%) than factual considerations (30%).
Logical Reasoning
Issue: Is prior DTAB consultation mandatory under Section 26A?
Step 1: Literal interpretation of Section 26A
Section 26A does not explicitly mention DTAB consultation.
Step 2: Comparison with other provisions
Other sections explicitly require DTAB consultation.
Step 3: Analysis of 1982 amendment
DTAB included in other sections, but not 26A, indicating deliberate omission.
Step 4: Conclusion
Prior DTAB consultation is not mandatory under Section 26A.
The Court considered alternative interpretations, such as reading in a requirement for DTAB consultation. However, it rejected this interpretation because the language of Section 26A is clear and unambiguous. The Court also stated that reading down the provision to include such a requirement would be adding words to the statute, which is not permissible.
The Court also rejected the argument that Section 26A would be arbitrary without DTAB consultation, stating that the section itself provides sufficient safeguards against arbitrary exercise of power.
The Court also considered the argument that the DTAB is the sole technical expert under the Drugs Act, but rejected it stating that the Central Government can rely on other expert opinions.
The Court also rejected the argument that the DTAB alone can constitute sub-committees with external experts, stating that this power of the DTAB does not restrict the Central Government from consulting other experts.
The Court also rejected the argument that the absence of a non-obstante clause in Section 26A implies that Section 5 must be read along with it, stating that Section 26A is an independent power.
The Supreme Court’s decision was based on a careful analysis of the language of Section 26A and the legislative intent behind it, as well as the practical implications of the decision.
The judgment was unanimous, with both judges concurring on the interpretation of Section 26A.
“The Central Government may be “satisfied” on any relevant material that a drug is likely to involve any risk to human beings etc. as a result of which it is necessary in public interest to regulate, restrict or prohibit manufacture, sale or distribution thereof. So long as the Central Government’s satisfaction can be said to be based on relevant material, it is not possible to say that not having consulted the DTAB, the power exercised under the said Section would be non est.”