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The Delhi High Court held that the Fixed Dose Combination of Pioglitazone 30 mg + Metformin 500 mg’ could not be banned. The Union Government had passed a notification banning the manufacture, sale and distribution of drugs having Fixed Dose Combination of the drugs.
The petitioners—Lupin Ltd, Eris Lifesciences Ltd, and Systopic Laboratories Pvt. Ltd., are engaged in the sale of the FDC under the brand name Gluconorm P 30, Glitaris M 30 and PIO-M 30, respectively. The Central Government had banned the FDC because of Pioglitazone 30 mg formulation. Nevertheless, the sub-committee constituted under the Drug Technical Advisory Board (DTAB) emphasised the ban on FDCs because of the titration of Metformin, or in other words, the said drug results in the overdosage of Pioglitazone 30 mg which poses a serious risk. Besides, there was no scientific backing to the drug.
The Court was not satisfied to accept the contention raised on behalf of the sub-committee, because if the FDCs with Pioglitazone 30 had to be banned, all the FDCs formulated by the inclusion of the said drug should be banned. The committee did not have clarity on the reasoning behind banning this FDC in the instant case.
The petitioner challenged the central government notification claiming that they were not incorrect, and the sub-committee did not apply its mind while considering the safety concerns about the drug. The findings of the committee are contrary to the material on record. Nevertheless, the Court said that section 29 of the Drugs and Cosmetics Act, 1940 empowers the Central Government to ban a drug in the larger public interest. This power could be exercised only on the ground of risk to human or animal health, lack of therapeutic value backed by relevant material.
The Court emphasized that the risk of overdose is prevalent in the formulation of an FDC in the event of titration of any component drug. No dispute has arisen against the prescribed usage of FDC as second-line therapy in Type-II Diabetes; and therefore, the contention that the FDC had no therapeutic value could not be justified.
Having lifted the ban on the FDC, the sub-committee has been directed to act in accordance with the directions of the Supreme Court in Union of India Vs. Pfizer Limited and Ors. The Court said the sub-committee to submit a report containing an explanation for its recommendations backed by evidence to the central government. The Central government would decide based on the findings given in the report.
Senior Advocate Gopal Jain and a team of Khaitan& Co. consisting of partners—Ajay Bhargava and Aseem Chaturvedi with Associate Karan Gupta advocated for Lupin Ltd., Advocate Deepak Kumar Mahapatra appeared for Systopic Laboratories, and R Jawhar Lal, Siddharth Bawa and Shyamal Anand represented Eris Life sciences. Additional Solicitor General Maninder Acharya, CGSC Kirtiman Singh and Advocates Ripu Daman Bhardwaj, Waize Ali Noor, Shruti Dutt and ParthSemwal represented the Central Government.
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