Prohibition of S(+) Etodolac + Paracetamol FDC Under Section 26A of the Drugs and Cosmetics Act
Introduction
The case of M/S Wings Pharmaceuticals Pvt Ltd and Anr v. Union of India and Anr was adjudicated by the Delhi High Court on January 22, 2020. The primary issue revolved around the Union of India's notification prohibiting the manufacture, sale, and distribution of a Fixed Dose Combination (FDC) drug comprising Etodolac and Paracetamol. M/S Wings Pharmaceuticals Pvt Ltd challenged this notification, arguing that their specific formulation, S(+) Etodolac + Paracetamol, should not fall under the prohibitive measures as delineated in the notification.
Summary of the Judgment
The Delhi High Court dismissed the petitions challenging the prohibition of 344 FDCs but took exception to the inclusion of the S(+) Etodolac + Paracetamol FDC in the prohibitive notification. The court held that while the general FDC of Etodolac + Paracetamol was rightfully scrutinized, the specific formulation using the S(+) isomer required separate consideration. Consequently, the court set aside the prohibition of the S(+) Etodolac + Paracetamol FDC and remanded the matter to the Drugs Technical Advisory Board (DTAB)/Sub-Committee for re-examination in line with Supreme Court directives.
Analysis
Precedents Cited
The judgment extensively referenced several landmark cases that shaped the current decision:
- Unison Pharmaceuticals Pvt. Ltd. v. Union of India: Affirmed that courts should not substitute their view for that of expert committees unless there is a clear error.
- Lupin Limited v. Union of India: Established that mere risk of overdose does not justify prohibition without considering regulation.
- Wockhardt Limited v. Union Of India: Emphasized that the Central Government's exercise of power under Section 26A must be based on cogent material and relevant considerations.
- Union of India & Anr. v. Pfizer Limited and Others: Directed that matters involving prohibition of multiple FDCs should be examined by DTAB to avoid further litigation and ensure informed decision-making.
Legal Reasoning
The court underscored the importance of adhering to procedural directives set by higher courts, notably the Supreme Court's direction in Pfizer v. Union of India. The Central Government's notification under Section 26A was deemed to have overstepped by not considering specific formulations like S(+) Etodolac + Paracetamol. The DTAB/Sub-Committee's recommendation to prohibit was based on a lack of therapeutic justification and potential risks, but the court found that their analysis did not extend to the isomer-specific formulation presented by the petitioners.
Furthermore, the court highlighted that the petitioners failed to provide additional evidence or clinical studies to support the therapeutic efficacy and safety of their specific FDC. The absence of approval from major developed countries and the reliance on a singular, critiqued clinical study weakened the petitioners' stance.
Impact
This judgment reinforces the necessity for comprehensive and formulation-specific evaluations when the Central Government exercises prohibitory powers under Section 26A. Pharmaceutical companies are now more vigilant in ensuring that any new FDCs demonstrate clear therapeutic benefits and safety profiles, supported by robust clinical data. Additionally, the decision emphasizes judicial deference to expert committees while ensuring that all relevant aspects of a specific formulation are adequately considered.
Complex Concepts Simplified
Section 26A of the Drugs and Cosmetics Act, 1940
This provision grants the Central Government the authority to prohibit the manufacture, sale, or distribution of any drug or cosmetic if it deems that its use poses risks to humans or animals, lacks therapeutic value, or contains unjustified ingredients. The power is exercised to protect public health and ensure the efficacy and safety of medicinal products.
Fixed Dose Combination (FDC)
FDCs are pharmaceutical products that combine two or more active ingredients in a single dosage form. They are intended to simplify treatment regimens, enhance patient compliance, and sometimes achieve synergistic therapeutic effects.
Drugs Technical Advisory Board (DTAB)
DTAB is a specialized committee constituted under the Drugs and Cosmetics Act to provide expert advice on matters related to drug safety, efficacy, and regulatory compliance. It plays a crucial role in evaluating and recommending actions regarding drug formulations and combinations.
Isomers in Pharmaceuticals
Isomers are molecules with the same molecular formula but different structural arrangements. In pharmaceuticals, different isomers can exhibit varied therapeutic effects and safety profiles, making their specific evaluation essential in drug formulation and approval processes.
Conclusion
The Delhi High Court's judgment in M/S Wings Pharmaceuticals Pvt Ltd and Anr v. Union of India and Anr underscores the imperative for meticulous and formulation-specific evaluation when prohibiting pharmaceutical products under Section 26A. By remanding the prohibition of the S(+) Etodolac + Paracetamol FDC back to the DTAB/Sub-Committee, the court ensures that pharmaceutical regulations are both precise and justifiable. This decision serves as a precedent for future cases, highlighting the balance between regulatory oversight and the rights of pharmaceutical manufacturers to advocate for their formulations. Ultimately, the judgment reinforces the judiciary's role in safeguarding public health while ensuring that regulatory actions are founded on robust scientific evidence and comprehensive analysis.
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